Sample records for good tissue practice

  1. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Current good tissue practice requirements. 1271... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150 Current good tissue practice requirements. (a) General. This subpart D and subpart C of this part set...

  2. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...

  3. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...

  4. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...

  5. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...

  6. 76 FR 82308 - Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... Cells, Tissues, and Cellular and Tissue-Based Products; Availability AGENCY: Food and Drug... Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated... Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and...

  7. Development of good modelling practice for phsiologically based pharmacokinetic models for use in risk assessment: The first steps

    EPA Science Inventory

    The increasing use of tissue dosimetry estimated using pharmacokinetic models in chemical risk assessments in multiple countries necessitates the need to develop internationally recognized good modelling practices. These practices would facilitate sharing of models and model eva...

  8. Tissue banking in australia.

    PubMed

    Ireland, Lynette; McKelvie, Helen

    2003-01-01

    The legal structure for the regulation of tissue banking has existed for many years. In Australia, the donation of human tissue is regulated by legislation in each of the eight States and Territories. These substantially uniform Acts were passed in the late 1970's and early 1980's, based on model legislation and underpinned by the concept of consensual giving. However, it was not until the early 1990's that tissue banking came under the notice of regulatory authorities. Since then the Australian Government has moved quickly to oversee the tissue banking sector in Australia. Banked human tissue has been deemed to be a therapeutic good under the Therapeutic Goods Act 1989, and tissue banks are required to be licensed by the Therapeutic Goods Administration and are audited for compliance with the Code of Good Manufacturing Practice- Human Blood and Tissues. In addition, tissue banks must comply with a myriad of other standards, guidelines and recommendations.

  9. Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement. Final rule.

    PubMed

    2004-11-24

    The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; recordkeeping; and the establishment of a quality program. The agency is also issuing new regulations pertaining to labeling, reporting, inspections, and enforcement that will apply to manufacturers of those HCT/Ps regulated solely under the authority of the Public Health Service Act (PHS Act), and not as drugs, devices, and/or biological products. The agency's actions are intended to improve protection of the public health while keeping regulatory burden to a minimum, which in turn would encourage significant innovation.

  10. Procurement of Human Tissues for Research Banking in the Surgical Pathology Laboratory: Prioritization Practices at Washington University Medical Center

    PubMed Central

    Chernock, Rebecca D.; Leach, Tracey A.; Kahn, Ajaz A.; Yip, James H.; Rossi, Joan; Pfeifer, John D.

    2011-01-01

    Academic hospitals and medical schools with research tissue repositories often derive many of their internal human specimen acquisitions from their site's surgical pathology service. Typically, such acquisitions come from appropriately consented tissue discards sampled from surgical resections. Because the practice of surgical pathology has patient care as its primary mission, competing needs for tissue inevitably arise, with the requirement to preserve adequate tissue for clinical diagnosis being paramount. A set of best-practice gross pathology guidelines are summarized here, focused on the decision for tissue banking at the time specimens are macroscopically evaluated. These reflect our collective experience at Washington University School of Medicine, and are written from the point of view of our site biorepository. The involvement of trained pathology personnel in such procurements is very important. These guidelines reflect both good surgical pathology practice (including the pathologic features characteristic of various anatomic sites) and the typical objectives of research biorepositories. The guidelines should be helpful to tissue bank directors, and others charged with the procurement of tissues for general research purposes. We believe that appreciation of these principles will facilitate the partnership between surgical pathologists and biorepository directors, and promote both good patient care and strategic, value-added banking procurements. PMID:23386925

  11. Status quo of management of the human tissue banks in Taiwan.

    PubMed

    Chou, Ching-Pang; Chou, Szu-Cheng; Chen, Ying-Hua; Chen, Yu-Hsuan; Lee, Ming-Shin

    2017-03-01

    As the technologies associated with transplantation and biological tissue engineering continue to advance, human cells and tissues form an integral part to the practice of regenerative medicine. The patient's use of tissues entails the risk of introducing, transmitting and spreading communicable diseases. To prevent such risk and to ensure that the human organs, tissues and cells remain intact and functional after being handled and processed, the transplanted tissues must be subject to good management standards through all stages of collection, screening, processing, storage and distribution as the safety of the users is of the utmost importance. On February 2009, the government of Taiwan promulgated the Regulations for Administration on Human Organ Bank that requires all human tissues banks to adhere to the Good Tissue Practice for Human Organ, Tissue and Cell in terms of establishment and operation in order to cope with the international management trend and the development and management need of the domestic industry. Six years have passed since the law became effective. This article seeks to introduce the current management mechanism and status quo of management of human tissue banks in Taiwan. We also conducted statistical analysis of the data relating to the tissue banks to identify potential risks and the room for improvement. The study concludes that human tissue banks in Taiwan are on the right track with their management practice, leading to a state of steady development and progress.

  12. The implementation of tissue banking experiences for setting up a cGMP cell manufacturing facility.

    PubMed

    Arjmand, Babak; Emami-Razavi, Seyed Hassan; Larijani, Bagher; Norouzi-Javidan, Abbas; Aghayan, Hamid Reza

    2012-12-01

    Cell manufacturing for clinical applications is a unique form of biologics manufacturing that relies on maintenance of stringent work practices designed to ensure product consistency and prevent contamination by microorganisms or by another patient's cells. More extensive, prolonged laboratory processes involve greater risk of complications and possibly adverse events for the recipient, and so the need for control is correspondingly greater. To minimize the associate risks of cell manufacturing adhering to international quality standards is critical. Current good tissue practice (cGTP) and current good manufacturing practice (cGMP) are examples of general standards that draw a baseline for cell manufacturing facilities. In recent years, stem cell researches have found great public interest in Iran and different cell therapy projects have been started in country. In this review we described the role of our tissue banking experiences in establishing a new cGMP cell manufacturing facility. The authors concluded that, tissue banks and tissue banking experts can broaden their roles from preparing tissue grafts to manufacturing cell and tissue engineered products for translational researches and phase I clinical trials. Also they can collaborate with cell processing laboratories to develop SOPs, implement quality management system, and design cGMP facilities.

  13. Highlights of laser-tissue interaction mechanism

    NASA Astrophysics Data System (ADS)

    Gabay, Shimon

    2001-10-01

    The aim of this paper is to present the fundamentals of good practice when using the laser in medicine and surgery. As a 'good practice' recommendation, the laser beam wavelength and power should be determined to match the desired thermal effect. The energy losses to the surroundings of the initial absorbing volume, caused by the heat diffusion mechanism, are strongly dependent on the exposure time duration. The differences in the absorption and scattering coefficients of some tissue components are used for selectively destroying those components having the higher absorption coefficients. Selective destruction of some tissue components can be achieved even for components having the same absorption coefficient but different dimensions. The laser therapy strategy is discussed: the effective use of lasers in medicine can be achieved only if the physician has an extensive understanding of the laser-tissue interaction mechanisms; continuing education and training is a must for laser surgeons to improve their skill to get clinically optimal results.

  14. Current regulatory issues in cell and tissue therapy.

    PubMed

    Burger, S R

    2003-01-01

    Cell-based therapies have grown dramatically in power and scope in recent years. Once limited to blood and BM transplantation, these therapies now encompass tissue repair and regeneration, metabolic support, gene replacement, and immune effector functions, with established and investigational clinical applications in disorders affecting nearly every tissue and organ system. The complexity and novel applications of human cells, tissues, and cellular and tissue-based products (HCT/Ps), however, present potential risks for adverse events. The US Food and Drug Administration, responding to these concerns, has established a tiered, risk-based regulatory structure, in which more rigorous controls and safeguards are required for products thought to pose increased risk. The proposed good tissue practices (GTP) rule and existing good manufacturing practices (GMP) requirements form the principal elements of this regulatory framework. The proposed GTPs are intended to prevent HCT/P contamination with infectious disease agents, and to ensure that these cells and tissues maintain their integrity and function. GMPs focus on production of safe, pure, and potent products, and entail a higher level of process control and product characterization. All HCT/Ps will be required to comply with GTPs. HCT/Ps considered to present greater risks of adverse events, however, will be subject to both GTPs and GMPs, and must obtain premarket approval using the Investigational New Drug (IND) mechanism established for biologics. Although these requirements will present significant challenges for clinician- investigators and laboratories producing HCT/Ps, the regulations fundamentally support good clinical care by increasing safety and control, and enable good science by improving the quality and reliability of data.

  15. A review of the International Atomic Energy Agency (IAEA) international standards for tissue banks.

    PubMed

    Morales Pedraza, Jorge; Lobo Gajiwala, Astrid; Martinez Pardo, María Esther

    2012-03-01

    The IAEA International Standards for Tissue Banks published in 2003 were based on the Standards then currently in use in the USA and the European Union, among others, and reflect the best practices associated with the operation of a tissue bank. They cover legal, ethical and regulatory controls as well as requirements and procedures from donor selection and tissue retrieval to processing and distribution of finished tissue for clinical use. The application of these standards allows tissue banks to operate with the current good tissue practice, thereby providing grafts of high quality that satisfy the national and international demand for safe and biologically useful grafts. The objective of this article is to review the IAEA Standards and recommend new topics that could improve the current version.

  16. 21 CFR 1271.290 - Tracking.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.290 Tracking. (a) General. If you perform any... designed to facilitate effective tracking, using the distinct identification code, from the donor to the... for recording the distinct identification code and type of each HCT/P distributed to a consignee to...

  17. 21 CFR 1271.250 - Labeling controls.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Labeling controls. 1271.250 Section 1271.250 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.250 Labeling controls. (a) General. You must establish and maintain procedures to control the labeling of HCT/Ps. You must design...

  18. 21 CFR 1271.250 - Labeling controls.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Labeling controls. 1271.250 Section 1271.250 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.250 Labeling controls. (a) General. You must establish and maintain procedures to control the labeling of HCT/Ps. You must design...

  19. 21 CFR 1271.250 - Labeling controls.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Labeling controls. 1271.250 Section 1271.250 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.250 Labeling controls. (a) General. You must establish and maintain procedures to control the labeling of HCT/Ps. You must design...

  20. 21 CFR 1271.250 - Labeling controls.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Labeling controls. 1271.250 Section 1271.250 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.250 Labeling controls. (a) General. You must establish and maintain procedures to control the labeling of HCT/Ps. You must design...

  1. 21 CFR 1271.250 - Labeling controls.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Labeling controls. 1271.250 Section 1271.250 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.250 Labeling controls. (a) General. You must establish and maintain procedures to control the labeling of HCT/Ps. You must design...

  2. 21 CFR 1271.260 - Storage.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Storage. 1271.260 Section 1271.260 Food and Drugs... TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.260 Storage. (a) Control of storage areas. You must control your storage areas and stock rooms to prevent: (1) Mix-ups, contamination, and cross...

  3. 21 CFR 1271.260 - Storage.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Storage. 1271.260 Section 1271.260 Food and Drugs... TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.260 Storage. (a) Control of storage areas. You must control your storage areas and stock rooms to prevent: (1) Mix-ups, contamination, and cross...

  4. 21 CFR 1271.260 - Storage.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Storage. 1271.260 Section 1271.260 Food and Drugs... TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.260 Storage. (a) Control of storage areas. You must control your storage areas and stock rooms to prevent: (1) Mix-ups, contamination, and cross...

  5. 21 CFR 1271.260 - Storage.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Storage. 1271.260 Section 1271.260 Food and Drugs... TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.260 Storage. (a) Control of storage areas. You must control your storage areas and stock rooms to prevent: (1) Mix-ups, contamination, and cross...

  6. 21 CFR 1271.230 - Process validation.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Process validation. 1271.230 Section 1271.230 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.230 Process validation. (a... validation activities and results must be documented, including the date and signature of the individual(s...

  7. 21 CFR 1271.230 - Process validation.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Process validation. 1271.230 Section 1271.230 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.230 Process validation. (a... validation activities and results must be documented, including the date and signature of the individual(s...

  8. 21 CFR 1271.230 - Process validation.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Process validation. 1271.230 Section 1271.230 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.230 Process validation. (a... validation activities and results must be documented, including the date and signature of the individual(s...

  9. 21 CFR 1271.230 - Process validation.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Process validation. 1271.230 Section 1271.230 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.230 Process validation. (a... validation activities and results must be documented, including the date and signature of the individual(s...

  10. 21 CFR 1271.230 - Process validation.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Process validation. 1271.230 Section 1271.230 Food..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.230 Process validation. (a... validation activities and results must be documented, including the date and signature of the individual(s...

  11. 21 CFR 1271.270 - Records.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Records. 1271.270 Section 1271.270 Food and Drugs... TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.270 Records. (a) General. You must maintain records concurrently with the performance of each step required in this subpart and subpart C of this part...

  12. 21 CFR 1271.270 - Records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Records. 1271.270 Section 1271.270 Food and Drugs... TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.270 Records. (a) General. You must maintain records concurrently with the performance of each step required in this subpart and subpart C of this part...

  13. Dietary practices and associated factors during pregnancy in northwestern Ethiopia.

    PubMed

    Nana, Amanuel; Zema, Tona

    2018-05-25

    Pregnancy is the most crucial nutritionally demanding period of every woman's life. The high demand of nutrients to deposit energy in the form of new tissue, growth of existing maternal tissues such as breast and uterus and increased energy requirements for tissue synthesis makes pregnant women more vulnerable to malnutrition. Dietary practice is defined as an observable actions or behavior of dietary habit and can be classified as good dietary practices and poor dietary practices. The incidence of dietary inadequacies as a result of dietary habits and patterns in pregnancy is higher during pregnancy when compared to any other stage of the life cycle. Thus, this study aimed to assess dietary practices and associated factors during pregnancy in Bahir Dar town, Northwest Ethiopia. A community based cross sectional study was conducted from March 1 to April 1, 2016. A total of 616 pregnant women were participated in the study. All eligible pregnant women were identified through house-to-house visit with the help of health extension workers. Cluster sampling was used to select eligible pregnant women. The data were collected using interviewer administered questionnaire prepared in English and translated in to Amharic. Data were analyzed by using Statistical Package for Social Sciences (SPSS) version 20. Multivariate logistic regression analysis was employed to identify factors associated with dietary practices. This study has shown that 39.3% of the study participants had good dietary practices and the rest 60.7% of pregnant women reported poor dietary practices. Concerning dietary knowledge, 61.4% of the study participants had good dietary knowledge while 38.6% had poor dietary knowledge. Husband income, ownership of radio, history of disease and dietary knowledge were shown to have significant association (P < 0.05) with dietary practices. Dietary practices of pregnant women in the study area was suboptimal. Husband income, ownership of radio, history of disease and dietary knowledge were independent predictors of women dietary practices. Awareness should be created among pregnant women by concerned bodies such as governmental and non-governmental organization through local mass media.

  14. Regulatory requirements in the good manufacturing practice production of an epithelial cell graft for ocular surface reconstruction.

    PubMed

    Sheth-Shah, Radhika; Vernon, Amanda J; Seetharaman, Shankar; Neale, Michael H; Daniels, Julie T

    2016-04-01

    In the past decade, stem cell therapy has been increasingly employed for the treatment of various diseases. Subsequently, there has been a great interest in the manufacture of stem cells under good manufacturing practice, which is required by law for their use in humans. The cells for sight Stem Cell Therapy Research Unit, based at UCL Institute of Ophthalmology, delivers somatic cell-based and tissue-engineered therapies to patients suffering from blinding eye diseases at Moorfields Eye Hospital (London, UK). The following article is based on our experience in the conception, design, construction, validation and manufacturing within a good manufacturing practice manufacturing facility based in the UK. As such the regulations can be extrapolated to the 28 members stated within the EU. However, the principles may have a broad relevance outside the EU.

  15. Media fill for validation of a good manufacturing practice-compliant cell production process.

    PubMed

    Serra, Marta; Roseti, Livia; Bassi, Alessandra

    2015-01-01

    According to the European Regulation EC 1394/2007, the clinical use of Advanced Therapy Medicinal Products, such as Human Bone Marrow Mesenchymal Stem Cells expanded for the regeneration of bone tissue or Chondrocytes for Autologous Implantation, requires the development of a process in compliance with the Good Manufacturing Practices. The Media Fill test, consisting of a simulation of the expansion process by using a microbial growth medium instead of the cells, is considered one of the most effective ways to validate a cell production process. Such simulation, in fact, allows to identify any weakness in production that can lead to microbiological contamination of the final cell product as well as qualifying operators. Here, we report the critical aspects concerning the design of a Media Fill test to be used as a tool for the further validation of the sterility of a cell-based Good Manufacturing Practice-compliant production process.

  16. In vitro and in vivo biocompatibility study on laser 3D microstructurable polymers

    NASA Astrophysics Data System (ADS)

    Malinauskas, Mangirdas; Baltriukiene, Daiva; Kraniauskas, Antanas; Danilevicius, Paulius; Jarasiene, Rasa; Sirmenis, Raimondas; Zukauskas, Albertas; Balciunas, Evaldas; Purlys, Vytautas; Gadonas, Roaldas; Bukelskiene, Virginija; Sirvydis, Vytautas; Piskarskas, Algis

    2012-09-01

    Films and microstructured scaffolds have been fabricated using direct laser writing out of different polymers: hybrid organic-inorganic ORMOCORE b59, acrylate-based AKRE23, novel organic-inorganic Zr containing hybrid SZ2080, and biodegradable PEG-DA-258. Adult myogenic stem cells were grown on these surfaces in vitro. Their adhesion, growth, and viability test results suggest good potential applicability of the materials in biomedical practice. Pieces of these polymers were implanted in rat's paravertebral back tissue. Histological examination of the implants and surrounding tissue ex vivo after 3 weeks of implantation was conducted and results show the materials to be at least as biocompatible as surgical clips or sutures. The applied direct laser writing technique seems to offer good future prospects in a polymeric 3D scaffold design for artificial tissue engineering with autologous stem cells.

  17. 40 CFR 52.1870 - Identification of plan.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Chemical Corporation in Allen County, Crystal Tissue Company in Butler County, U.S. Steel Corporation.... (81) On March 3, 1986, the Ohio Environmental Protection Agency (OEPA) submitted Good Engineering... Engineering Practice Stack Height Regulations”. These rules were adopted by the State on February 12, 1986 and...

  18. Developing a policy for paediatric biobanks: principles for good practice

    PubMed Central

    Hens, Kristien; Van El, Carla E; Borry, Pascal; Cambon-Thomsen, Anne; Cornel, Martina C; Forzano, Francesca; Lucassen, Anneke; Patch, Christine; Tranebjaerg, Lisbeth; Vermeulen, Eric; Salvaterra, Elena; Tibben, Aad; Dierickx, Kris

    2013-01-01

    The participation of minors in biobank research can offer great benefits for science and health care. However, as minors are a vulnerable population they are also in need of adequate protective measures when they are enrolled in research. Research using biobanked biological samples from children poses additional ethical issues to those raised by research using adult biobanks. For example, small children have only limited capacity, if any, to understand the meaning and implications of the research and to give a documented agreement to it. Older minors are gradually acquiring this capacity. We describe principles for good practice related to the inclusion of minors in biobank research, focusing on issues related to benefits and subsidiarity, consent, proportionality and return of results. Some of these issues are currently heavily debated, and we conclude by providing principles for good practice for policy makers of biobanks, researchers and anyone involved in dealing with stored tissue samples from children. Actual implementation of the principles will vary according to different jurisdictions. PMID:22713814

  19. 78 FR 41934 - Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-12

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0731... Determination for Donors; and Current Good Tissue Practice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment...

  20. 75 FR 11545 - Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0101... Determination for Donors; and Current Good Tissue Practice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment...

  1. Tissue Engineering the Cornea: The Evolution of RAFT

    PubMed Central

    Levis, Hannah J.; Kureshi, Alvena K.; Massie, Isobel; Morgan, Louise; Vernon, Amanda J.; Daniels, Julie T.

    2015-01-01

    Corneal blindness affects over 10 million people worldwide and current treatment strategies often involve replacement of the defective layer with healthy tissue. Due to a worldwide donor cornea shortage and the absence of suitable biological scaffolds, recent research has focused on the development of tissue engineering techniques to create alternative therapies. This review will detail how we have refined the simple engineering technique of plastic compression of collagen to a process we now call Real Architecture for 3D Tissues (RAFT). The RAFT production process has been standardised, and steps have been taken to consider Good Manufacturing Practice compliance. The evolution of this process has allowed us to create biomimetic epithelial and endothelial tissue equivalents suitable for transplantation and ideal for studying cell-cell interactions in vitro. PMID:25809689

  2. Derivation of Xeno-Free and GMP-Grade Human Embryonic Stem Cells – Platforms for Future Clinical Applications

    PubMed Central

    Aizenman, Einat; Kirshberg, Sophie; Ilouz, Nili; Gil, Yaniv; Berman-Zaken, Yael; Perlman, Temima Schnitzer; Geva, Nitshia; Levy, Ora; Arbell, Daniel; Simon, Alex; Ben-Meir, Assaf; Shufaro, Yoel; Laufer, Neri; Reubinoff, Benjamin E.

    2012-01-01

    Clinically compliant human embryonic stem cells (hESCs) should be developed in adherence to ethical standards, without risk of contamination by adventitious agents. Here we developed for the first time animal-component free and good manufacturing practice (GMP)-compliant hESCs. After vendor and raw material qualification, we derived xeno-free, GMP-grade feeders from umbilical cord tissue, and utilized them within a novel, xeno-free hESC culture system. We derived and characterized three hESC lines in adherence to regulations for embryo procurement, and good tissue, manufacturing and laboratory practices. To minimize freezing and thawing, we continuously expanded the lines from initial outgrowths and samples were cryopreserved as early stocks and banks. Batch release criteria included DNA-fingerprinting and HLA-typing for identity, characterization of pluripotency-associated marker expression, proliferation, karyotyping and differentiation in-vitro and in-vivo. These hESCs may be valuable for regenerative therapy. The ethical, scientific and regulatory methodology presented here may serve for development of additional clinical-grade hESCs. PMID:22745653

  3. Biological aspects of tissue-engineered cartilage.

    PubMed

    Hoshi, Kazuto; Fujihara, Yuko; Yamawaki, Takanori; Harai, Motohiro; Asawa, Yukiyo; Hikita, Atsuhiko

    2018-04-01

    Cartilage regenerative medicine has been progressed well, and it reaches the stage of clinical application. Among various techniques, tissue engineering, which incorporates elements of materials science, is investigated earnestly, driven by high clinical needs. The cartilage tissue engineering using a poly lactide scaffold has been exploratorily used in the treatment of cleft lip-nose patients, disclosing good clinical results during 3-year observation. However, to increase the reliability of this treatment, not only accumulation of clinical evidence on safety and usefulness of the tissue-engineered products, but also establishment of scientific background on biological mechanisms, are regarded essential. In this paper, we reviewed recent trends of cartilage tissue engineering in clinical practice, summarized experimental findings on cellular and matrix changes during the cartilage regeneration, and discussed the importance of further studies on biological aspects of tissue-engineered cartilage, especially by the histological and the morphological methods.

  4. The biophysics of renal sympathetic denervation using radiofrequency energy.

    PubMed

    Patel, Hitesh C; Dhillon, Paramdeep S; Mahfoud, Felix; Lindsay, Alistair C; Hayward, Carl; Ernst, Sabine; Lyon, Alexander R; Rosen, Stuart D; di Mario, Carlo

    2014-05-01

    Renal sympathetic denervation is currently performed in the treatment of resistant hypertension by interventionists who otherwise do not typically use radiofrequency (RF) energy ablation in their clinical practice. Adequate RF lesion formation is dependent upon good electrode-tissue contact, power delivery, electrode-tissue interface temperature, target-tissue impedance and the size of the catheter's active electrode. There is significant interplay between these variables and hence an appreciation of the biophysical determinants of RF lesion formation is required to provide effective and safe clinical care to our patients. In this review article, we summarize the biophysics of RF ablation and explain why and how complications of renal sympathetic denervation may occur and discuss methods to minimise them.

  5. [Best practice guide for radiation therapy of non-small cell bronchial cancers].

    PubMed

    Martel-Lafay, I; Fourneret, P; Ayadi, M; Brun, O; Buatois, F; Carrie, C; Chilles, A; Claude, L; Cottin-Durrleman, G; Farsi, F; Fournel, P; Mongodin, B; Pouchard, I; Balestrière, V; Suchaud, J P

    2009-01-01

    The objective was the drafting of a practical document intended for radiotherapists and radiophysicists, describing the technique of irradiation of a non small cell bronchial cancer. The good practices concern the care of patients affected by bronchial cancer localized in the thorax and inoperable or patients who must undergo postoperative irradiation. The document has been developed according to a methodology aiming to join the current scientific data from an analysis of the literature on the subject and the assessment of radiotherapists, radiophysicists, lung specialists and methodologists from Rhône-Alpes area. From the stages necessary for the good progress of a radiotherapy, the writers of this document proposed common definitions concerning the centering and the location of the zone to be treated, the calculation of the dose distribution, the preparation of the patient for the treatment, the treatment and the surveillance during the treatment. The recommendations of this guide took into account the peculiarities bound to the nature of the treated region and more particularly the lung heterogeneity, respiratory movements and the radiosensibility of healthy lung tissue. Even if the technical aspect of the radiotherapy was particularly developed, the interest accorded to patient information takes on all its importance for a therapeutic coverage of quality. The authors of the document wished that this Guide of Good Practices, which will be regularly updated, helps the radiotherapists and allows them to harmonize their practices.

  6. Adenovirus-mediated transfer of hepatocyte growth factor gene to human dental pulp stem cells under good manufacturing practice improves their potential for periodontal regeneration in swine.

    PubMed

    Cao, Yu; Liu, Zhenhai; Xie, Yilin; Hu, Jingchao; Wang, Hua; Fan, Zhipeng; Zhang, Chunmei; Wang, Jingsong; Wu, Chu-Tse; Wang, Songlin

    2015-12-15

    Periodontitis is one of the most widespread infectious diseases in humans. We previously promoted significant periodontal tissue regeneration in swine models with the transplantation of autologous periodontal ligament stem cells (PDLSCs) and PDLSC sheet. We also promoted periodontal tissue regeneration in a rat model with a local injection of allogeneic bone marrow mesenchymal stem cells. The purpose of the present study is to investigate the roles of the hepatocyte growth factor (HGF) and human dental pulp stem cells (DPSCs) in periodontal tissue regeneration in swine. In the present study, we transferred an adenovirus that carried HGF gene into human DPSCs (HGF-hDPSCs) under good manufacturing practice (GMP) conditions. These cells were then transplanted into a swine model for periodontal regeneration. Twenty miniature pigs were used to generate periodontitis with bone defect of 5 mm in width, 7 mm in length, and 3 mm in depth. After 12 weeks, clinical, radiological, quantitative and histological assessment of regenerated periodontal tissues was performed to compare periodontal regeneration in swine treated with cell implantation. Our study showed that injecting HGF-hDPSCs into this large animal model could significantly improve periodontal bone regeneration and soft tissue healing. A hDPSC or HGF-hDPSC sheet showed superior periodontal tissue regeneration compared to the injection of dissociated cells. However, the sheets required surgical placement; thus, they were suitable for surgically-managed periodontitis treatments. The adenovirus-mediated transfer of the HGF gene markedly decreased hDPSC apoptosis in a hypoxic environment or in serum-free medium, and it increased blood vessel regeneration. This study indicated that HGF-hDPSCs produced under GMP conditions significantly improved periodontal bone regeneration in swine; thus, this method represents a potential clinical application for periodontal regeneration.

  7. Allograft update: the current status of tissue regulation, procurement, processing, and sterilization.

    PubMed

    McAllister, David R; Joyce, Michael J; Mann, Barton J; Vangsness, C Thomas

    2007-12-01

    Allografts are commonly used during sports medicine surgical procedures in the United States, and their frequency of use is increasing. Based on surgeon reports, it is estimated that more than 60 000 allografts were used in knee surgeries by members of the American Orthopaedic Society for Sports Medicine in 2005. In the United States, there are governmental agencies and other regulatory bodies involved in the oversight of tissue banks. In 2005, the Food and Drug Administration finalized its requirements for current good tissue practice and has mandated new rules regarding the "manufacture" of allogenic tissue. In response to well-publicized infections associated with the implantation of allograft tissue, some tissue banks have developed methods to sterilize allograft tissue. Although many surgeons have significant concerns about the safety of allografts, the majority believe that sterilized allografts are safe but that the sterilization process negatively affects tissue biology and biomechanics. However, most know very little about the principles of sterilization and the proprietary processes currently used in tissue banking. This article will review the current status of allograft tissue regulation, procurement, processing, and sterilization in the United States.

  8. Editorial Commentary: The Acellular Osteochondral Allograft, the Emperor Has New Clothes.

    PubMed

    Mandelbaum, Bert R; Chahla, Jorge

    2017-12-01

    For larger lesions (>2.5-cm 2 ), clinical evidence and practice have shown that fresh osteochondral allograft have good durability, with 88% return to sport and greater than 75% 10-year survival rates for treatment of large femoral condyle lesions. That said, the use of fresh osteochondral allografts in clinical practice is limited by the availability of acceptable donor tissues for eligible patients in a timely fashion. Significant diminution of chondrocyte viability and density occurs during the preservation and storage period. All osteochondral allografts are not equal in performance and outcome. Chondrocyte density and viability are critical for successful transplantation and outcome in the short and long term. This commentary highlights the high failure rates of tissue when it is acellular. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  9. Survey of current practice in clinical transvaginal ultrasound scanning in the UK

    PubMed Central

    Shaw, Adam; Lees, Christoph

    2015-01-01

    During transvaginal ultrasound scanning, the fetus and other sensitive tissues are placed close to the transducer. Heating of these tissues occurs by direct conduction from the transducer and by absorption of ultrasound in the tissue. The extent of any heating will depend on the equipment and settings used, the duration of the scan, imaging modes and other aspects of scanning practice. To ensure that scans are performed with minimum risk, staff should have an appropriate knowledge of safety and follow guidelines issued by professional bodies. An online survey aiming to document current practice in transvaginal ultrasound in the UK was created and distributed to individuals performing this type of scanning. The survey posed questions about the respondents, the departments where scans were performed, the equipment used, knowledge of ultrasound safety, scanning practice and the frequency, duration and mode of transvaginal ultrasound scans for gynaecology, obstetrics and fertility applications. In all, 294 responses were obtained, mostly from sonographers (94%). From the analysis of the responses, it was clear that there was a good understanding of the general meaning of thermal and mechanical index and high awareness of guidelines issued by professional bodies. However, 40% of respondents stated that they rarely or never monitor Thermal or Mechanical indices during scanning. Scanning practice was consistent in terms of the duration of scans, scan protocols followed and use of imaging modes. The results highlight the importance of continued ultrasound safety training and promotion of safety guidelines to users. PMID:27433250

  10. [Tissue bank of the National Centre for Tumour Disease. An innovative platform for translational tumour].

    PubMed

    Herpel, E; Koleganova, N; Schirmacher, P

    2008-11-01

    The tissue bank of the National Centre for Tumour Diseases (NCT) in Heidelberg, Germany, was founded in 2005 by the University Hospital of Heidelberg and the German Cancer Research Centre as a section of the NCT. It is a nonprofit organization with a completely evaluated legal and ethical framework and supports the Comprehensive Cancer Centre concept. Its main aim is the acquisition and characterization of fresh-frozen and paraffin-embedded human tissues according to the standards of good scientific practice and the promotion of interdisciplinary tumour research of the comprehensive cancer centre and its cooperating partners. It also offers expert project assistance: a project leader can submit a short proposal, and the tissue collecting/preparing process will be performed in cooperation with a specialised pathologist and, if applicable, an experienced clinical researcher. The tissue bank is also a central platform for further developing of innovative technologies for tissue handling, e.g. multi-tissue-array and virtual microscopy, with links to digital image analysis and bioinformatics. Thus, the NCT tissue bank represents a model for innovative biobanking and for institutions with active interdisciplinary cancer research.

  11. Simulation of temperature distribution in tumor Photothermal treatment

    NASA Astrophysics Data System (ADS)

    Zhang, Xiyang; Qiu, Shaoping; Wu, Shulian; Li, Zhifang; Li, Hui

    2018-02-01

    The light transmission in biological tissue and the optical properties of biological tissue are important research contents of biomedical photonics. It is of great theoretical and practical significance in medical diagnosis and light therapy of disease. In this paper, the temperature feedback-controller was presented for monitoring photothermal treatment in realtime. Two-dimensional Monte Carlo (MC) and diffuse approximation were compared and analyzed. The results demonstrated that diffuse approximation using extrapolated boundary conditions by finite element method is a good approximation to MC simulation. Then in order to minimize thermal damage, real-time temperature monitoring was appraised by proportional-integral-differential (PID) controller in the process of photothermal treatment.

  12. High pressure injection injury of the foot: a role of negative pressure wound therapy.

    PubMed

    Marinovic, Marin; Bakota, Bore; Spanjol, Josip; Sosa, Ivan; Grzalja, Nikola; Gulan, Gordan; Ivancic, Aldo; Cicvaric, Tedi

    2013-09-01

    High pressure injection injuries (HPII) of the foot are not common in every-day practice. We present a 50-year-old patient with a HPII of the left foot caused by water-gun in a self-inflicted accident working as a technical diver four meters under the sea surface. Surgical treatment included extensive debridement of necrotic tissue and fibrin deposits and removal of foreign material. A negative pressure wound therapy (NPWT) device was applied resulting in a good wound base for subsequent skin grafting leading to a good functional and cosmetic outcome. Copyright © 2013 Elsevier Ltd. All rights reserved.

  13. Brief report: investigation into recalled human tissue for transplantation--United States, 2005-2006.

    PubMed

    2006-05-26

    On September 29, 2005, a human tissue-processing company discovered inaccuracies in donor records forwarded from a tissue-recovery firm and notified the Food and Drug Administration (FDA). An FDA investigation determined that the recovery firm, Biomedical Tissue Services, Ltd. (BTS) (Fort Lee, New Jersey), recovered tissues from human donors who might not have met donor eligibility requirements and who were not screened properly for certain infectious diseases. In October 2005, BTS and the five processors that had received the tissues, working with FDA, issued a recall for all tissues recovered by BTS. The continuing FDA investigation determined that information for some donors (e.g., cause, place, or time of death) was not consistent with death certificate data obtained from the states where the deaths occurred. The investigation also determined that BTS had failed to recover tissues in a manner that would prevent contamination or cross-contamination and failed to control environmental conditions adequately during tissue recovery. These failures were violations of the Current Good Tissue Practice Rules (effective May 25, 2005), which require manufacturers to recover, process, store, label, package, and distribute human cells, tissue, and cellular and tissue-based products (HCT/Ps) to prevent introduction, transmission, or spread of communicable diseases. In January 2006, FDA ordered BTS to cease manufacturing and to retain all HCT/Ps.

  14. Platelet-lysate as an autologous alternative for fetal bovine serum in cardiovascular tissue engineering.

    PubMed

    Riem Vis, Paul W; Bouten, Carlijn V C; Sluijter, Joost P G; Pasterkamp, Gerard; van Herwerden, Lex A; Kluin, Jolanda

    2010-04-01

    There is an ongoing search for alternative tissue culture sera to engineer autologous tissues, since use of fetal bovine serum (FBS) is limited under Good Tissue Practice guidelines. We compared FBS with human platelet-lysate (PL) in media for in vitro cell culture. A threefold increase in duplication rate was found when human, saphenous vein-derived myofibroblasts were cultured in PL, whereas expression of marker proteins (alpha-smooth muscle actin, vimentin, desmin, and nonmuscle myosin heavy chain) was similar. Heat shock protein 47 mRNA expression was increased in PL cells, and type III collagen fibers were seen on PL-cell monolayers but not on cells cultured in FBS. These results imply a more efficient collagen fiber production. We also found higher levels of proteins involved in tissue repair and collagen remodeling, which could explain increased production of proteases and protease inhibitors by PL cells. Our findings indicate that PL is beneficial due to the increased duplication rate, in addition to the increased matrix production and remodeling. This could lead to production of strong tissue with properly organized collagen fibers, which is important for heart valve tissue engineering.

  15. Modeling the behavior of human body tissues on penetration

    NASA Astrophysics Data System (ADS)

    Conci, A.; Brazil, A. L.; Popovici, D.; Jiga, G.; Lebon, F.

    2018-02-01

    Several procedures in medicine (such as anesthesia, injections, biopsies and percutaneous treatments) involve a needle insertion. Such procedures operate without vision of the internal involved areas. Physicians and anesthetists rely on manual (force and tactile) feedback to guide their movements, so a number of medical practice is strongly based on manual skill. In order to be expert in the execution of such procedures the medical students must practice a number of times, but before practice in a real patient they must be trained in some place and a virtual environment, using Virtual Reality (VR) or Augmented Reality (AR) is the best possible solution for such training. In a virtual environment the success of user practices is improved by the addition of force output using haptic device to improve the manual sensations in the interactions between user and computer. Haptic devices enable simulate the physical restriction of the diverse tissues and force reactions to movements of operator hands. The trainees can effectively "feel" the reactions to theirs movements and receive immediate feedback from the actions executed by them in the implemented environment. However, in order to implement such systems, the tissue reaction to penetration and cutting must be modeled. A proper model must emulate the physical sensations of the needle action in the skin, fat, muscle, and so one, as if it really done in a patient that is as they are holding a real needle and feeling each tissue resistance when inserting it through the body. For example an average force value for human skin puncture is 6.0 N, it is 2.0 N for subcutaneous fat tissue and 4.4 N for muscles: this difference of sensations to penetration of each layers trespassed by the needle makes possible to suppose the correct position inside the body. This work presents a model for tissues before and after the cutting that with proper assumptions of proprieties can model any part of human body. It was based on experiments and used in embryonic system for epidural anesthesia having good evaluation as presented in the last section "Preliminary Results".

  16. Ebselen Preserves Tissue-Engineered Cell Sheets and their Stem Cells in Hypothermic Conditions

    PubMed Central

    Katori, Ryosuke; Hayashi, Ryuhei; Kobayashi, Yuki; Kobayashi, Eiji; Nishida, Kohji

    2016-01-01

    Clinical trials have been performed using autologous tissue-engineered epithelial cell sheets for corneal regenerative medicine. To improve stem cell-based therapy for convenient clinical practice, new techniques are required for preserving reconstructed tissues and their stem/progenitor cells until they are ready for use. In the present study, we screened potential preservative agents and developed a novel medium for preserving the cell sheets and their stem/progenitor cells; the effects were evaluated with a luciferase-based viability assay. Nrf2 activators, specifically ebselen, could maintain high ATP levels during preservation. Ebselen also showed a strong influence on maintenance of the viability, morphology, and stem cell function of the cell sheets preserved under hypothermia by protecting them from reactive oxygen species-induced damage. Furthermore, ebselen drastically improved the preservation performance of human cornea tissues and their stem cells. Therefore, ebselen shows good potential as a useful preservation agent in regenerative medicine as well as in cornea transplantation. PMID:27966584

  17. Ebselen Preserves Tissue-Engineered Cell Sheets and their Stem Cells in Hypothermic Conditions.

    PubMed

    Katori, Ryosuke; Hayashi, Ryuhei; Kobayashi, Yuki; Kobayashi, Eiji; Nishida, Kohji

    2016-12-14

    Clinical trials have been performed using autologous tissue-engineered epithelial cell sheets for corneal regenerative medicine. To improve stem cell-based therapy for convenient clinical practice, new techniques are required for preserving reconstructed tissues and their stem/progenitor cells until they are ready for use. In the present study, we screened potential preservative agents and developed a novel medium for preserving the cell sheets and their stem/progenitor cells; the effects were evaluated with a luciferase-based viability assay. Nrf2 activators, specifically ebselen, could maintain high ATP levels during preservation. Ebselen also showed a strong influence on maintenance of the viability, morphology, and stem cell function of the cell sheets preserved under hypothermia by protecting them from reactive oxygen species-induced damage. Furthermore, ebselen drastically improved the preservation performance of human cornea tissues and their stem cells. Therefore, ebselen shows good potential as a useful preservation agent in regenerative medicine as well as in cornea transplantation.

  18. A review of the emerging potential therapy for neurological disorders: human embryonic stem cell therapy

    PubMed Central

    Shroff, Geeta; Dhanda Titus, Jyoti; Shroff, Rhea

    2017-01-01

    The first human embryonic stem cell (hESC) line was developed in the late nineties. hESCs are capable of proliferating indefinitely and differentiate into all the three embryonic germ layers. Further, the differentiation of hESC lines into neural precursor cells and neurons, astrocytes and oligodendrocytes showed their potential in treating several incurable neurological disorders such as spinal cord injury (SCI), cerebral palsy (CP), Parkinson’s disease (PD). In this review, we will discuss the global scenario of research and therapeutic use of hESCs in the treatment of neurological disorders. Following this, we will discuss the development of a unique hESC line, how it differs from the other available hESC lines and its use in the treatment of neurological disorders. hESCs were isolated from mixture of neuronal and non-neuronal progenitor cells in their pre progenitor state in a Good Laboratory Practices, Good Tissue Practices and Good Manufacturing Practices compliant laboratory. Blastomere cells have served as a source to derive the hESCs and the xeno-free culture was demonstrated to be more safe and effective in clinical therapeutic application of hESCs. All the patients showed a remarkable improvement in their conditions and no serious adverse events were reported. This study concluded that hESC lines could be scalable and used in the treatment of various neurological disorders such as SCI, CP, and PD. PMID:28533935

  19. Self-assembled high-strength hydroxyapatite/graphene oxide/chitosan composite hydrogel for bone tissue engineering.

    PubMed

    Yu, Peng; Bao, Rui-Ying; Shi, Xiao-Jun; Yang, Wei; Yang, Ming-Bo

    2017-01-02

    Graphene hydrogel has shown greatly potentials in bone tissue engineering recently, but it is relatively weak in the practical use. Here we report a facile method to synthesize high strength composite graphene hydrogel. Graphene oxide (GO), hydroxyapatite (HA) nanoparticles (NPs) and chitosan (CS) self-assemble into a 3-dimensional hydrogel with the assistance of crosslinking agent genipin (GNP) for CS and reducing agent sodium ascorbate (NaVC) for GO simultaneously. The dense and oriented microstructure of the resulted composite gel endows it with high mechanical strength, high fixing capacity of HA and high porosity. These properties together with the good biocompatibility make the ternary composite gel a promising material for bone tissue engineering. Such a simultaneous crosslinking and reduction strategy can also be applied to produce a variety of 3D graphene-polymer based nanocomposites for biomaterials, energy storage materials and adsorbent materials. Copyright © 2016 Elsevier Ltd. All rights reserved.

  20. A549 Cells: Lung Carcinoma Cell Line for Adenovirus | NCI Technology Transfer Center | TTC

    Cancer.gov

    Scientists at the National Cancer Institute have developed a cell line designated A549 that was derived from explanted cultures of human lung cancer tissue. The A549 cell line has been tested under the guidance of the United States Food and Drug Administration (FDA) so, under current Good Manufacturing Practices (GMP), these cells may be suitable for use in manufacturing constructs for use in clinical trials. The National Cancer Institute seeks parties to non-exclusively license this research material.

  1. Importance of good manufacturing practices in microbiological monitoring in processing human tissues for transplant.

    PubMed

    Pianigiani, Elisa; Ierardi, Francesca; Fimiani, Michele

    2013-12-01

    Skin allografts represent an important therapeutic resource in the treatment of severe skin loss. The risk associated with application of processed tissues in humans is very low, however, human material always carries the risk of disease transmission. To minimise the risk of contamination of grafts, processing is carried out in clean rooms where air quality is monitored. Procedures and quality control tests are performed to standardise the production process and to guarantee the final product for human use. Since we only validate and distribute aseptic tissues, we conducted a study to determine what type of quality controls for skin processing are the most suitable for detecting processing errors and intercurrent contamination, and for faithfully mapping the process without unduly increasing production costs. Two different methods for quality control were statistically compared using the Fisher exact test. On the basis of the current study we selected our quality control procedure based on pre- and post-processing tissue controls, operator and environmental controls. Evaluation of the predictability of our control methods showed that tissue control was the most reliable method of revealing microbial contamination of grafts. We obtained 100 % sensitivity by doubling tissue controls, while maintaining high specificity (77 %).

  2. Development of new method and protocol for cryopreservation related to embryo and oocytes freezing in terms of fertilization rate: A comparative study including review of literature.

    PubMed

    Barik, Mayadhar; Bajpai, Minu; Patnaik, Santosh; Mishra, Pravash; Behera, Priyamadhaba; Dwivedi, Sada Nanda

    2016-01-01

    Cryopreservation is basically related to meritorious thin samples or small clumps of cells that are cooled quickly without loss. Our main objective is to establish and formulate an innovative method and protocol development for cryopreservation as a gold standard for clinical uses in laboratory practice and treatment. The knowledge regarding usefulness of cryopreservation in clinical practice is essential to carry forward the clinical practice and research. We are trying to compare different methods of cryopreservation (in two dozen of cells) at the same time we compare the embryo and oocyte freezing interms of fertilization rate according to the International standard protocol. The combination of cryoprotectants and regimes of rapid cooling and rinsing during warming often allows successful cryopreservation of biological materials, particularly cell suspensions or thin tissue samples. Examples include semen, blood, tissue samples like tumors, histological cross-sections, human eggs and human embryos. Although presently many studies have reported that the children born from frozen embryos or "frosties," show consistently positive results with no increase in birth defects or development abnormalities is quite good enough and similar to our study (50-85%). We ensure that cryopreservation technology provided useful cell survivability, tissue and organ preservation in a proper way. Although it varies according to different laboratory conditions, it is certainly beneficial for patient's treatment and research. Further studies are needed for standardization and development of new protocol.

  3. Recent developments in processing systems for cell and tissue cultures toward therapeutic application.

    PubMed

    Kino-oka, Masahiro; Taya, Masahito

    2009-10-01

    Innovative techniques of cell and tissue processing, based on tissue engineering, have been developed for therapeutic applications. Cell expansion and tissue reconstruction through ex vivo cultures are core processes used to produce engineered tissues with sufficient structural integrity and functionality. In manufacturing, strict management against contamination and human error is compelled due to direct use of un-sterilable products and the laboriousness of culture operations, respectively. Therefore, the development of processing systems for cell and tissue cultures is one of the critical issues for ensuring a stable process and quality of therapeutic products. However, the siting criterion of culture systems to date has not been made clear. This review article classifies some of the known processing systems into 'sealed-chamber' and 'sealed-vessel' culture systems based on the difference in their aseptic spaces, and describes the potential advantages of these systems and current states of culture systems, especially those established by Japanese companies. Moreover, on the basis of the guidelines for isolator systems used in aseptic processing for healthcare products, which are issued by the International Organization for Standardization, the siting criterion of the processing systems for cells and tissue cultures is discussed in perspective of manufacturing therapeutic products in consideration of the regulations according to the Good Manufacturing Practice.

  4. Embryogenic callus proliferation and regeneration conditions for genetic transformation of diverse sugarcane cultivars.

    PubMed

    Basnayake, Shiromani W V; Moyle, Richard; Birch, Robert G

    2011-03-01

    Amenability to tissue culture stages required for gene transfer, selection and plant regeneration are the main determinants of genetic transformation efficiency via particle bombardment into sugarcane. The technique is moving from the experimental phase, where it is sufficient to work in a few amenable genotypes, to practical application in a diverse and changing set of elite cultivars. Therefore, we investigated the response to callus initiation, proliferation, regeneration and selection steps required for microprojectile-mediated transformation, in a diverse set of Australian sugarcane cultivars. 12 of 16 tested cultivars were sufficiently amenable to existing routine tissue-culture conditions for practical genetic transformation. Three cultivars required adjustments to 2,4-D levels during callus proliferation, geneticin concentration during selection, and/or light intensity during regeneration. One cultivar gave an extreme necrotic response in leaf spindle explants and produced no callus tissue under the tested culture conditions. It was helpful to obtain spindle explants for tissue culture from plants with good water supply for growth, especially for genotypes that were harder to culture. It was generally possible to obtain several independent transgenic plants per bombardment, with time in callus culture limited to 11-15 weeks. A caution with this efficient transformation system is that separate shoots arose from different primary transformed cells in more than half of tested calli after selection for geneticin resistance. The results across this diverse cultivar set are likely to be a useful guide to key variables for rapid optimisation of tissue culture conditions for efficient genetic transformation of other sugarcane cultivars.

  5. Body Imaging

    NASA Technical Reports Server (NTRS)

    1990-01-01

    Magnetic Resonance Imaging (MRI) and Computer-aided Tomography (CT) images are often complementary. In most cases, MRI is good for viewing soft tissue but not bone, while CT images are good for bone but not always good for soft tissue discrimination. Physicians and engineers in the Department of Radiology at the University of Michigan Hospitals are developing a technique for combining the best features of MRI and CT scans to increase the accuracy of discriminating one type of body tissue from another. One of their research tools is a computer program called HICAP. The program can be used to distinguish between healthy and diseased tissue in body images.

  6. Establishing a stem cell culture laboratory for clinical trials

    PubMed Central

    Sekiya, Elíseo Joji; Forte, Andresa; Kühn, Telma Ingrid Borges de Bellis; Janz, Felipe; Bydlowski, Sérgio Paulo; Alves, Adelson

    2012-01-01

    Adult stem/progenitor cells are found in different human tissues. An in vitro cell culture is needed for their isolation or for their expansion when they are not available in a sufficient quantity to regenerate damaged organs and tissues. The level of complexity of these new technologies requires adequate facilities, qualified personnel with experience in cell culture techniques, assessment of quality and clear protocols for cell production. The rules for the implementation of cell therapy centers involve national and international standards of good manufacturing practices. However, such standards are not uniform, reflecting the diversity of technical and scientific development. Here standards from the United States, the European Union and Brazil are analyzed. Moreover, practical solutions encountered for the implementation of a cell therapy center appropriate for the preparation and supply of cultured cells for clinical studies are described. Development stages involved the planning and preparation of the project, the construction of the facility, standardization of laboratory procedures and development of systems to prevent cross contamination. Combining the theoretical knowledge of research centers involved in the study of cells with the practical experience of blood therapy services that manage structures for cell transplantation is presented as the best potential for synergy to meet the demands to implement cell therapy centers. PMID:23049427

  7. Rhabdomyolysis. The role of diagnostic and prognostic factors

    PubMed Central

    Keltz, Eran; Khan, Fahmi Yousef; Mann, Gideon

    2013-01-01

    Summary Rhabdomyolysis, literally meaning the breakdown of muscle tissue, is a common syndrome with many causes, acquired ones such as exertion, trauma, infections, temperature extremes, drugs, toxins, electrolyte and endocrine abnormalities, and congenital ones such as myopathies and connective tissue disorders. All results in a common pathophysiologic pathway which ends with the dispersing of muscle tissue content into the circulation. Rhabdomyolysis has characteristic clinical, laboratory and radiologic features, but does require a high index of suspicion so that the diagnosis would not be missed. The sensitivity and specificity of the various characteristics, as well as clinical guidelines, are discussed in this paper. The syndrome may present with several complications, e.g. arrhythmias, electrolyte abnormalities, acute renal injury, acidosis, volume depletion, compartment syndrome and disseminated intravascular coagulation. The prognosis is highly variable and depends on the underlying etiologies and complications, but is in general considered as good. The milestone of treatment is vigorous fluid resuscitation. Treatment options, in practice and in research, are discussed in the following pages. PMID:24596694

  8. Oral health knowledge and practices of dentists practicing in a teaching hospital in Nigeria.

    PubMed

    Jegede, Akinlolu Tolulope; Oyedele, Titus Ayodeji; Sodipo, Babasola Olufemi; Folayan, Morenike Oluwatoyin

    2016-01-01

    To assess the oral health practices and knowledge of practicing dentists at a tertiary health institution in Nigeria, and the possible association of age and sex with caries prevention practices. A cross-sectional study was conducted. All practicing dentists in the institution were eligible to participate in the study. A questionnaire that assessed oral health practices and knowledge was administered. Respondents were expected to select the most appropriate responses that reflected their knowledge of oral health practices and caries prevention practices. Questions included assessment of knowledge and practice of tooth brushing, flossing, refined carbohydrate intake, and dental service utilization. Participants' responses were scored and dichotomized to poor and good knowledge, and poor and good practices, using the median scores. Bivariate analysis was conducted to identify factors associated with good and poor oral health practices, and good and poor knowledge. Fifty-two eligible study participants were accessible at the time of questionnaire administration. Only 46 respondents returned the filled questionnaire giving a response rate of 88.5%. The age of respondents ranged between 25 and 48 years. The majority of respondents had good oral health practices (65.2%) and good oral health knowledge (85%). However, few respondents had good caries prevention practices: 39.2% brushed at least twice daily, 45.7% took refined carbohydrate less than once daily, 36.9% used dental floss at least once daily, and 60.9% undertook preventive dental care. The correlation between the dentists' oral health knowledge score and oral health practices score was insignificant (0.90; P = 0.55). A large number of dentists practicing in the tertiary hospital had good oral health practices and good oral health knowledge. However, the proportion of dentists with good caries prevention practices was low.

  9. Development of new method and protocol for cryopreservation related to embryo and oocytes freezing in terms of fertilization rate: A comparative study including review of literature

    PubMed Central

    Barik, Mayadhar; Bajpai, Minu; Patnaik, Santosh; Mishra, Pravash; Behera, Priyamadhaba; Dwivedi, Sada Nanda

    2016-01-01

    Background: Cryopreservation is basically related to meritorious thin samples or small clumps of cells that are cooled quickly without loss. Our main objective is to establish and formulate an innovative method and protocol development for cryopreservation as a gold standard for clinical uses in laboratory practice and treatment. The knowledge regarding usefulness of cryopreservation in clinical practice is essential to carry forward the clinical practice and research. Materials and Methods: We are trying to compare different methods of cryopreservation (in two dozen of cells) at the same time we compare the embryo and oocyte freezing interms of fertilization rate according to the International standard protocol. Results: The combination of cryoprotectants and regimes of rapid cooling and rinsing during warming often allows successful cryopreservation of biological materials, particularly cell suspensions or thin tissue samples. Examples include semen, blood, tissue samples like tumors, histological cross-sections, human eggs and human embryos. Although presently many studies have reported that the children born from frozen embryos or “frosties,” show consistently positive results with no increase in birth defects or development abnormalities is quite good enough and similar to our study (50–85%). Conclusions: We ensure that cryopreservation technology provided useful cell survivability, tissue and organ preservation in a proper way. Although it varies according to different laboratory conditions, it is certainly beneficial for patient's treatment and research. Further studies are needed for standardization and development of new protocol. PMID:27512686

  10. [Repair of a root perforation by using MTA: a case report].

    PubMed

    Riccitiello, Francesco; Di Caprio, Maria Patrizia; D'Amora, Marilina; Pizza, Nunzia Luisa; Vallone, Gianfranco; D'Ambrosio, Colomba; Amato, Massimo

    2013-01-01

    Root perforations are accidental events that may occur during the treatment, causing tissue inflammation and alveolar bone loss of integrity of the periodontium. In such cases, the radiological evidence is fundamental in the formulation of the diagnosis, in the choice of therapy (surgical or non-surgical) and finally for the assessment of prognosis of the dental element. In non-surgical treatment of endodontic lesions, the material used for the repair of the defect root should have biocompatibility, antibacterial activity, ability to induce healing of periodontal tissues and radiopacity. The Mineral Trioxide Aggregate (MTA) is a silicate-based cement introduced in dental clinical practice with good radiopacity, biocompatibility and bone induction. This article describes the use of MTA in endodontic repair of a perforation of the middle third root and the success of non-surgical treatment was dimonstrated radiographicaly.

  11. Combined photoacoustic and magneto-acoustic imaging.

    PubMed

    Qu, Min; Mallidi, Srivalleesha; Mehrmohammadi, Mohammad; Ma, Li Leo; Johnston, Keith P; Sokolov, Konstantin; Emelianov, Stanislav

    2009-01-01

    Ultrasound is a widely used modality with excellent spatial resolution, low cost, portability, reliability and safety. In clinical practice and in the biomedical field, molecular ultrasound-based imaging techniques are desired to visualize tissue pathologies, such as cancer. In this paper, we present an advanced imaging technique - combined photoacoustic and magneto-acoustic imaging - capable of visualizing the anatomical, functional and biomechanical properties of tissues or organs. The experiments to test the combined imaging technique were performed using dual, nanoparticle-based contrast agents that exhibit the desired optical and magnetic properties. The results of our study demonstrate the feasibility of the combined photoacoustic and magneto-acoustic imaging that takes the advantages of each imaging techniques and provides high sensitivity, reliable contrast and good penetrating depth. Therefore, the developed imaging technique can be used in wide range of biomedical and clinical application.

  12. Advanced Good Cell Culture Practice for human primary, stem cell-derived and organoid models as well as microphysiological systems.

    PubMed

    Pamies, David; Bal-Price, Anna; Chesné, Christophe; Coecke, Sandra; Dinnyes, Andras; Eskes, Chantra; Grillari, Regina; Gstraunthaler, Gerhard; Hartung, Thomas; Jennings, Paul; Leist, Marcel; Martin, Ulrich; Passier, Robert; Schwamborn, Jens C; Stacey, Glyn N; Ellinger-Ziegelbauer, Heidrun; Daneshian, Mardas

    2018-04-13

    A major reason for the current reproducibility crisis in the life sciences is the poor implementation of quality control measures and reporting standards. Improvement is needed, especially regarding increasingly complex in vitro methods. Good Cell Culture Practice (GCCP) was an effort from 1996 to 2005 to develop such minimum quality standards also applicable in academia. This paper summarizes recent key developments in in vitro cell culture and addresses the issues resulting for GCCP, e.g. the development of induced pluripotent stem cells (iPSCs) and gene-edited cells. It further deals with human stem-cell-derived models and bioengineering of organo-typic cell cultures, including organoids, organ-on-chip and human-on-chip approaches. Commercial vendors and cell banks have made human primary cells more widely available over the last decade, increasing their use, but also requiring specific guidance as to GCCP. The characterization of cell culture systems including high-content imaging and high-throughput measurement technologies increasingly combined with more complex cell and tissue cultures represent a further challenge for GCCP. The increasing use of gene editing techniques to generate and modify in vitro culture models also requires discussion of its impact on GCCP. International (often varying) legislations and market forces originating from the commercialization of cell and tissue products and technologies are further impacting on the need for the use of GCCP. This report summarizes the recommendations of the second of two workshops, held in Germany in December 2015, aiming map the challenge and organize the process or developing a revised GCCP 2.0.

  13. 21 CFR 110.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 110.5 Section...) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD General Provisions § 110.5 Current good manufacturing practice. (a) The criteria and...

  14. Reported infections after human tissue transplantation before and after new Food and Drug Administration (FDA) regulations, United States, 2001 through June, 2010.

    PubMed

    Mallick, Tarun K; Mosquera, Alexis; Zinderman, Craig E; St Martin, Laura; Wise, Robert P

    2012-06-01

    Processors distributed about 1.5 million human tissue allografts in the U.S. in 2007. The potential for transmitting infections through allografts concerns clinicians and patients. In 2005, FDA implemented Current Good Tissue Practice (CGTP) rules requiring tissue establishments to report to FDA certain serious infections after allograft transplantations. We describe infection reports following tissue transplants received by FDA from 2005 through June, 2010, and compare reporting before and after implementation of CGTP rules. We identified reports received by FDA from January 2001 through June, 2010, for infections in human tissue recipients, examining the reports by tissue type, organism, time to onset, severity, and reporter characteristics. Among 562 reports, 83 (20.8/year) were received from 2001-2004, before the CGTP rules, 43 in the 2005 transition year, and 436 (96.9/year) from 2006 through June, 2010, after the rules. Tissue processors accounted for 84.2% of reports submitted after the rules, compared to 26.5% previously. Bacterial infections were the most commonly reported organisms before (64.6%) and after (62.2%) the new rules. Afterward, 2.5% (11) of reports described deaths, and 33.7% (147) involved hospitalizations. Before the rules, 13% (11) described deaths, and another 72% involved hospitalizations. Reports received by the FDA quadrupled since 2005, suggesting that CGTP regulations have contributed to increased reporting and improved tissue safety surveillance. However, these data do not confirm that the reported infections were caused by suspect tissues; most reports may represent routine post-surgical infections not actually due to allografts.

  15. 76 FR 47593 - Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-05

    ...] Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission... entitled ``PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide.'' FDA has... consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency...

  16. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Current good manufacturing practice. 225.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS General Provisions § 225.1 Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act...

  17. 21 CFR 210.1 - Status of current good manufacturing practice regulations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Status of current good manufacturing practice... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.1 Status of current good manufacturing practice regulations...

  18. 21 CFR 226.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Current good manufacturing practice. 226.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES General Provisions § 226.1 Current good manufacturing practice. (a) The criteria in §§ 226.10 through 226.115, inclusive...

  19. Polysaccharides as cell carriers for tissue engineering: the use of cellulose in vascular wall reconstruction.

    PubMed

    Bačáková, L; Novotná, K; Pařízek, M

    2014-01-01

    Polysaccharides are long carbohydrate molecules of monosaccharide units joined together by glycosidic bonds. These biological polymers have emerged as promising materials for tissue engineering due to their biocompatibility, mostly good availability and tailorable properties. This complex group of biomolecules can be classified using several criteria, such as chemical composition (homo- and heteropolysaccharides), structure (linear and branched), function in the organism (structural, storage and secreted polysaccharides), or source (animals, plants, microorganisms). Polysaccharides most widely used in tissue engineering include starch, cellulose, chitosan, pectins, alginate, agar, dextran, pullulan, gellan, xanthan and glycosaminoglycans. Polysaccharides have been applied for engineering and regeneration of practically all tissues, though mostly at the experimental level. Polysaccharides have been tested for engineering of blood vessels, myocardium, heart valves, bone, articular and tracheal cartilage, intervertebral discs, menisci, skin, liver, skeletal muscle, neural tissue, urinary bladder, and also for encapsulation and delivery of pancreatic islets and ovarian follicles. For these purposes, polysaccharides have been applied in various forms, such as injectable hydrogels or porous and fibrous scaffolds, and often in combination with other natural or synthetic polymers or inorganic nanoparticles. The immune response evoked by polysaccharides is usually mild, and can be reduced by purifying the material or by choosing appropriate crosslinking agents.

  20. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false What is current good manufacturing practice for... HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS (Eff. 12-12-2011) General Provisions § 212.2 What is current good manufacturing practice for...

  1. Biobanking human endometrial tissue and blood specimens: standard operating procedure and importance to reproductive biology research and diagnostic development.

    PubMed

    Sheldon, Elizabeth; Vo, Kim Chi; McIntire, Ramsey A; Aghajanova, Lusine; Zelenko, Zara; Irwin, Juan C; Giudice, Linda C

    2011-05-01

    To develop a standard operating procedure (SOP) for collection, transport, storage of human endometrial tissue and blood samples, subject and specimen annotation, and establishing sample priorities. The SOP synthesizes sound scientific procedures, the literature on ischemia research, sample collection and gene expression profiling, good laboratory practices, and the authors' experience of workflow and sample quality. The National Institutes of Health, University of California, San Francisco, Human Endometrial Tissue and DNA Bank. Women undergoing endometrial biopsy or hysterectomy for nonmalignant indications. Collecting, processing, storing, distributing endometrial tissue and blood samples under approved institutional review board protocols and written informed consent from participating subjects. Standard operating procedure. The SOP addresses rigorous and consistent subject annotation, specimen processing and characterization, strict regulatory compliance, and a reference for researchers to track collection and storage times that may influence their research. The comprehensive and systematic approach to the procurement of human blood and endometrial tissue in this SOP ensures the high quality, reliability, and scientific usefulness of biospecimens made available to investigators by the National Institutes of Health, University of California, San Francisco, Human Endometrial Tissue and DNA Bank. The detail and perspective in this SOP also provides a blueprint for implementation of similar collection programs at other institutions. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  2. Emerging Good Practices for Transforming Value Assessment: Patients' Voices, Patients' Values.

    PubMed

    Perfetto, Eleanor M; Harris, Jason; Mullins, C Daniel; dosReis, Susan

    2018-04-01

    Patient engagement is a transformative strategy for improving value assessment. US value framework developers have increased engagement activities, but more needs to be learned about how to best achieve meaningful patient engagement in value assessment. The objective was to glean good practices in patient engagement emerging from patient community experiences, to be used in value assessment. The National Health Council Value Workgroup conducted a survey and held a focus group with its member advocacy organizations to gather experiences with value framework developers and views on emerging good practices. Ten of 13 organizations completed the survey; reporting 13 interactions with four framework developers. Most rated experiences as "good" to "very good." Emerging good practices included (1) engage early; (2) engage a range of patients; (3) leverage patient-provided information, data resources, and outreach mechanisms; (4) be transparent; and (5) appreciate and accommodate resource constraints. Twelve of 13 organizations participated in the focus group, and this produced 30 emerging good practices in four areas: (1) timing; (2) methodology and data; (3) partnering; and (4) characterizing engagement. Patient engagement was limited in early development of value frameworks but has increased in the past few years. Patient groups report positive experiences that can serve as emerging good practices. These groups also reported experienced challenges in their interactions and recommended good practices to mitigate those challenges. The growing pool of patient engagement experiences can be translated into good practices to advance a patient-centered, value-driven health care ecosystem. Lessons learned from these early experiences can help establish recommend emerging good practices that can eventually result in best practices and standards in the field. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  3. About ATMPs, SOPs and GMP: The Hurdles to Produce Novel Skin Grafts for Clinical Use

    PubMed Central

    Hartmann-Fritsch, Fabienne; Marino, Daniela; Reichmann, Ernst

    2016-01-01

    Background The treatment of severe full-thickness skin defects represents a significant and common clinical problem worldwide. A bio-engineered autologous skin substitute would significantly reduce the problems observed with today's gold standard. Methods Within 15 years of research, the Tissue Biology Research Unit of the University Children's Hospital Zurich has developed autologous tissue-engineered skin grafts based on collagen type I hydrogels. Those products are considered as advanced therapy medicinal products (ATMPs) and are routinely produced for clinical trials in a clean room facility following the guidelines for good manufacturing practice (GMP). This article focuses on hurdles observed for the translation of ATMPs from research into the GMP environment and clinical application. Results and Conclusion Personalized medicine in the field of rare diseases has great potential. However, ATMPs are mainly developed and promoted by academia, hospitals, and small companies, which face many obstacles such as high financial burdens. PMID:27781022

  4. National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities.

    PubMed

    Ricordi, Camillo; Goldstein, Julia S; Balamurugan, A N; Szot, Gregory L; Kin, Tatsuya; Liu, Chengyang; Czarniecki, Christine W; Barbaro, Barbara; Bridges, Nancy D; Cano, Jose; Clarke, William R; Eggerman, Thomas L; Hunsicker, Lawrence G; Kaufman, Dixon B; Khan, Aisha; Lafontant, David-Erick; Linetsky, Elina; Luo, Xunrong; Markmann, James F; Naji, Ali; Korsgren, Olle; Oberholzer, Jose; Turgeon, Nicole A; Brandhorst, Daniel; Chen, Xiaojuan; Friberg, Andrew S; Lei, Ji; Wang, Ling-Jia; Wilhelm, Joshua J; Willits, Jamie; Zhang, Xiaomin; Hering, Bernhard J; Posselt, Andrew M; Stock, Peter G; Shapiro, A M James; Chen, Xiaojuan

    2016-11-01

    Eight manufacturing facilities participating in the National Institutes of Health-sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 trial in subjects with type 1 diabetes. Manufacturing was controlled by a common master production batch record, standard operating procedures that included acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI product specifications, certificate of analysis, and test methods. The process was compliant with Current Good Manufacturing Practices and Current Good Tissue Practices. This report describes the manufacturing process for 75 PHPI clinical lots and summarizes the results, including lot release. The results demonstrate the feasibility of implementing a harmonized process at multiple facilities for the manufacture of a complex cellular product. The quality systems and regulatory and operational strategies developed by the CIT Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency, and identity and were successfully transplanted into 48 subjects. No adverse events attributable to the product and no cases of primary nonfunction were observed. © 2016 by the American Diabetes Association.

  5. National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities

    PubMed Central

    Balamurugan, A.N.; Szot, Gregory L.; Kin, Tatsuya; Liu, Chengyang; Czarniecki, Christine W.; Barbaro, Barbara; Bridges, Nancy D.; Cano, Jose; Clarke, William R.; Eggerman, Thomas L.; Hunsicker, Lawrence G.; Kaufman, Dixon B.; Khan, Aisha; Lafontant, David-Erick; Linetsky, Elina; Luo, Xunrong; Markmann, James F.; Naji, Ali; Korsgren, Olle; Oberholzer, Jose; Turgeon, Nicole A.; Brandhorst, Daniel; Chen, Xiaojuan; Friberg, Andrew S.; Lei, Ji; Wang, Ling-jia; Wilhelm, Joshua J.; Willits, Jamie; Zhang, Xiaomin; Hering, Bernhard J.; Posselt, Andrew M.; Stock, Peter G.; Shapiro, A.M. James

    2016-01-01

    Eight manufacturing facilities participating in the National Institutes of Health–sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 trial in subjects with type 1 diabetes. Manufacturing was controlled by a common master production batch record, standard operating procedures that included acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI product specifications, certificate of analysis, and test methods. The process was compliant with Current Good Manufacturing Practices and Current Good Tissue Practices. This report describes the manufacturing process for 75 PHPI clinical lots and summarizes the results, including lot release. The results demonstrate the feasibility of implementing a harmonized process at multiple facilities for the manufacture of a complex cellular product. The quality systems and regulatory and operational strategies developed by the CIT Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency, and identity and were successfully transplanted into 48 subjects. No adverse events attributable to the product and no cases of primary nonfunction were observed. PMID:27465220

  6. Good practices in Local Government - A first overview of Portuguese reality

    NASA Astrophysics Data System (ADS)

    Carvalhosa, P.; Portela, F.; Machado, J.; Santos, M. F.; Abelha, A.

    2017-03-01

    Good practices in eGov are being increasingly used by Local Governments being that it is considered by them as an advantage. The main goal is providing to the town hall a differentiation point and approximate their services to the citizens. For this, it is necessary to define and apply innovative strategies in order to increase the use of services by the citizens. This paper is framed in a research work and it presents a first overview of the existing good practices in eGov, taking in consideration the Portuguese’s reality. The good practices identified were distinguished with many awards and with a positive response from the target audience. The use of digital marketing strategies aims to increase their membership and coming closer the municipalities of its citizens through the dissemination of the good practices. At this moment the data collected are almost exclusively of good practice in Portugal, however some international practices were also identified. As a result of this study the community has a list of good practices that can be applied in their municipalities.

  7. Steps for successful implementation of proteomic research in the OR.

    PubMed

    Martin, Chidima Tsion; Henry, Linda; Martin, Lisa; Ad, Niv

    2010-02-01

    Proteomic studies (ie, the investigation and identification of proteins found in biological samples such as blood and tissue) are at the forefront of the identification of disease biomarkers and the understanding of proteins. These studies promise to enhance diagnostic and prognostic analysis across all disciplines of clinical practice. As the practice of nursing and medicine becomes more preventative in nature and predictive in terms of patient care, successfully integrating and implementing proteomic research will become increasingly important, especially in the OR. It is imperative that perioperative nurses and researchers establish a collaborative process for specimen collection. Steps in establishing and maintaining a successful specimen collection program include implementing and evaluating a protocol, developing good communication, and keeping all participants up to date on the progress of the study. Copyright 2010 AORN, Inc. Published by Elsevier Inc. All rights reserved.

  8. Production of human monoclonal antibody in eggs of chimeric chickens.

    PubMed

    Zhu, Lei; van de Lavoir, Marie-Cecile; Albanese, Jenny; Beenhouwer, David O; Cardarelli, Pina M; Cuison, Severino; Deng, David F; Deshpande, Shrikant; Diamond, Jennifer H; Green, Lynae; Halk, Edward L; Heyer, Babette S; Kay, Robert M; Kerchner, Allyn; Leighton, Philip A; Mather, Christine M; Morrison, Sherie L; Nikolov, Zivko L; Passmore, David B; Pradas-Monne, Alicia; Preston, Benjamin T; Rangan, Vangipuram S; Shi, Mingxia; Srinivasan, Mohan; White, Steven G; Winters-Digiacinto, Peggy; Wong, Susan; Zhou, Wen; Etches, Robert J

    2005-09-01

    The tubular gland of the chicken oviduct is an attractive system for protein expression as large quantities of proteins are deposited in the egg, the production of eggs is easily scalable and good manufacturing practices for therapeutics from eggs have been established. Here we examined the ability of upstream and downstream DNA sequences of ovalbumin, a protein produced exclusively in very high quantities in chicken egg white, to drive tissue-specific expression of human mAb in chicken eggs. To accommodate these large regulatory regions, we established and transfected lines of chicken embryonic stem (cES) cells and formed chimeras that express mAb from cES cell-derived tubular gland cells. Eggs from high-grade chimeras contained up to 3 mg of mAb that possesses enhanced antibody-dependent cellular cytotoxicity (ADCC), nonantigenic glycosylation, acceptable half-life, excellent antigen recognition and good rates of internalization.

  9. Particulated articular cartilage: CAIS and DeNovo NT.

    PubMed

    Farr, Jack; Cole, Brian J; Sherman, Seth; Karas, Vasili

    2012-03-01

    Cartilage Autograft Implantation System (CAIS; DePuy/Mitek, Raynham, MA) and DeNovo Natural Tissue (NT; ISTO, St. Louis, MO) are novel treatment options for focal articular cartilage defects in the knee. These methods involve the implantation of particulated articular cartilage from either autograft or juvenile allograft donor, respectively. In the laboratory and in animal models, both CAIS and DeNovo NT have demonstrated the ability of the transplanted cartilage cells to "escape" from the extracellular matrix, migrate, multiply, and form a new hyaline-like cartilage tissue matrix that integrates with the surrounding host tissue. In clinical practice, the technique for both CAIS and DeNovo NT is straightforward, requiring only a single surgery to affect cartilage repair. Clinical experience is limited, with short-term studies demonstrating both procedures to be safe, feasible, and effective, with improvements in subjective patient scores, and with magnetic resonance imaging evidence of good defect fill. While these treatment options appear promising, prospective randomized controlled studies are necessary to refine the indications and contraindications for both CAIS and DeNovo NT.

  10. Securing the Adoption of Good Practice in Scotland's Colleges. A Report by HM Inspectors of Education for the Scottish Funding Council

    ERIC Educational Resources Information Center

    Her Majesty's Inspectorate of Education, 2006

    2006-01-01

    The purpose of this report is to describe the main mechanisms currently in use in Scotland's colleges to ensure that the adoption of good practice actually happens. It investigates how colleges identify and promote good practice in their own institutions; how they develop strategies and processes to ensure good practice is shared, adopted and…

  11. The development of accurate and high quality radiotherapy treatment delivery

    NASA Astrophysics Data System (ADS)

    Griffiths, Susan E.

    Accurate radiotherapy delivery is required for curing cancer. Historical radiotherapy accuracy studies at Leeds (1983-1991) are discussed in context of when radiographers were not involved in practice design. The seminal research was unique in being led by a radiographer practitioner, and in prospectively studying the accuracy of different techniques within one department. The viability of alignment of treatment beams with marks painted on a patient's skin varied daily, and, using film I showed that the alignment of treatment on anatomy varied. I then led 6 sequential studies with collaborating oncologists. Unique outcomes were in identifying the origins of treatment inaccuracies, implementing and evidencing changes in multi-disciplinary practice, thus improving accuracy and reproducibility generally and achieving accuracy for the pelvis to within current norms. Innovations included: discontinuation of painted skin marks and developing whole-body patient positioning using lasers, tattoos, and standardised supports; unification of set-up conditions through planning and treatment; planning normal tissue margins round target tissue to allow for inaccuracies (1985); improved manual shielding methods, changed equipment usage, its quality assurance and design; influenced the development of portal imaging and image analysis. Consequences and current implications. The research, still cited internationally, contributed to clinical management of lymphoma, and critically underpins contemporary practice. It led to my becoming the first radiographer invited into multi-disciplinary collaborative work, to advise in the first multi-centre clinical trials to consider treatment delivery accuracy, contribute to books written from within other disciplines and inform guidelines for good practice so helping to improve practices, with recent publications. I thus led my profession into research activity. Later work included development of a national staffing formula for radiotherapy Centres, and contributing to the evidence-base for improved National radiotherapy resourcing. I recently researched and developed a textbook (second edition) on quality in treatment delivery.

  12. 21 CFR 184.1452 - Manganese gluconate.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... used in food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient... levels not to exceed current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this...

  13. The virtuous pathologist. An ethical basis for laboratory medicine.

    PubMed

    Stempsey, W E

    1989-06-01

    The profession of pathology is a practice in the technical sense used by many philosophers. Such practices have internal goods, which, it is hoped, lead to the attainment of a certain end. The ultimate end of the practice of pathology must be the good of the patient in terms of restoring health. Key internal goods in pathology are technical competence, the proper pathologist-patient relationship, and the proper pathologist-clinician relationship. Virtues are predispositions to act so as to attain the end of the practice and further the internal goods. Technical growth in the practice of pathology must be accompanied by continued attempts to articulate the goals and internal goods of the practice. Only if pathologists are predisposed to act in accordance with proper goals will an ethical practice be assured.

  14. [Good drug distribution practice and its implementation in drug distribution companies].

    PubMed

    Draksiene, Gailute

    2002-01-01

    Good Distribution Practice is based on the Directive of the Board of the European Community 92/25/EEC regarding the wholesale distribution of drugs for human consumption. It is stated in the Directive that the whole drug distribution channel is to be controlled from the point of drug production or import down to the supplies to the end user. In order to reach the goal, the drug distribution company must create the quality assurance system and facilitate its correct functioning. This aim requires development of the rules of the Good Distribution Practice. Those rules set the general requirements of the Good Distribution Practice for distribution companies that they must conduct. The article explains main requirements postulated in the rules of the Good Distribution Practice and implementation of the Good Distribution Practice requirements in drug distribution companies.

  15. Stem cell applications and tissue engineering approaches in surgical practice.

    PubMed

    Khan, Wasim S; Malik, Atif A; Hardingham, Timothy E

    2009-04-01

    There has been an increasing interest in stem cell applications and tissue engineering approaches in surgical practice to deal with damaged or lost tissue. Although there have been developments in almost all surgical disciplines, the greatest advances are being made in orthopaedics, especially in bone repair. Significant hurdles however remain to be overcome before tissue engineering becomes more routinely used in surgical practice.

  16. [Identification of Good-Practice Projects in Promoting Physical Activity - Methods, Pitfalls and Sampled Outcomes].

    PubMed

    Henn, Annette; Karger, Claudia; Wöhlken, Katrin; Meier, Diana; Ungerer-Röhrich, Ulrike; Graf, Christine; Woll, Alexander

    2017-03-01

    The aim of this paper is to identify and show examples of good practice of public health promotion. For this, uniform quality criteria were worked out under consideration of national and international scientific literature.For the identification of examples of good practice, a comparison of different quality criteria was carried out and combined with each other in a first step. In the following step, examples of good practice were identified after a comprehensive search. The choice of the "good-practice" projects is exemplary and lays no claim to completeness.6 main quality criteria (QC) of programs promoting physical activity could be identified in the national and international context. The analysis showed altogether 10 projects which can exemplarily be classified as examples of good practice of the target groups of children and teenagers, adults, older people and people with pre-existing illnesses. These projects, however, show major differences in their (methodological) quality.The analysis reports a lack of "Good-Practice" examples. Deficits lie mainly in documentation and sustainability. Because of incomplete documentation, an assessment as a "Good-Practice" example is only possible to a limited extent; a lot of information, particularly in the evaluation, is missing. © Georg Thieme Verlag KG Stuttgart · New York.

  17. 21 CFR 129.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 129.1 Section... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as the..., methods, practices, and controls used in the processing, bottling, holding, and shipping of bottled...

  18. Teleworking: Guidelines for Good Practice. IES Report 329.

    ERIC Educational Resources Information Center

    Huws, Ursula; And Others

    Because teleworking presents major new challenges to human resource managers, trade unions, and others involved in the development of good employment practices, this book provides practical guidelines for good practice in regard to teleworkers that recognize that teleworking is not a single category, but covers at least five distinct groups with…

  19. 21 CFR 184.1101 - Diacetyl tartaric acid esters of mono- and diglycerides.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... used in food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used in food as an... levels not to exceed current good manufacturing practice: baked goods and baking mixes as defined in...

  20. 21 CFR 184.1101 - Diacetyl tartaric acid esters of mono- and diglycerides.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... used in food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used in food as an... levels not to exceed current good manufacturing practice: baked goods and baking mixes as defined in...

  1. Protection of people and environment from radiation risk through good regulatory practice

    NASA Astrophysics Data System (ADS)

    Jais, Azlina Mohammad; Hassan, Najwa

    2017-01-01

    The term "good regulatory practice" has seen growing frequency of usage worldwide, especially since the 2011 Fukushima nuclear incident. However, the term appears quite ambiguous as it may mean differently to different people. This leads us to the first important question: what does "good regulatory practice" actually mean? When used in conjunction with the Fukushima incident, do we imply that there is an absence of "good regulatory practice" in the Japanese' Nuclear and Industry Safety Agency (NISA)? This is quite troubling. It is clear that the term should be defined formally so that our understanding of "good regulatory practice" can be standardized. There is still another important question beyond agreeing on what "good regulatory practice" is: is "good regulatory practice" specific to a region, or is it global? And is it applicable only to nuclear regulators, or to all types of regulators per se? This paper aims to deliberate on the above mentioned questions. Specifically, we hope to discuss the "good regulatory practice" for atomic energy activities in order to protect the people and the environment from radiation risk of such activities. By understanding what "good regulatory practice" truly means, a newcomer country such as Malaysia can quickly learn and adopt these practices so as to assure a competent national nuclear regulatory authority who will be responsible in ensuring the safety, security and safeguards of peaceful atomic energy activities in the country including nuclear liability. In understanding this concept, a holistic approach will be taken by looking into example of advanced and newcomer countries of various nuclear regulatory authorities all around the world. Then the paper will focus on the challenges that the current nuclear regulatory authority in Malaysia which is Atomic Energy Licensing Board has, its challenges to follow the concept of "good regulatory practice" and its ways to overcome it. This study explore the initiatives could be considered by nuclear regulatory authority and the necessary criteria of an "ideal" how nuclear regulatory authority should implement the "good regulatory practice" approach.

  2. 77 FR 31041 - Draft Standards and Best Practices for Interaction Between Medical Examiner/Coroner and Organ and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-24

    ... Best Practices for Interaction Between Medical Examiner/Coroner and Organ and Tissue Procurement... titled ``Organ and Tissue Procurement Committee Standards and Best Practices for Interaction Between Medical Examiner/Coroner Offices and Organ Tissue Procurement Organizations'' from May 12, 2012, to June...

  3. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 113.5 Section... CONTAINERS General Provisions § 113.5 Current good manufacturing practice. The criteria in §§ 113.10, 113.40..., methods, practices, and controls used by the commercial processor in the manufacture, processing, or...

  4. Feasibility of autologous bone marrow mesenchymal stem cell-derived extracellular matrix scaffold for cartilage tissue engineering.

    PubMed

    Tang, Cheng; Xu, Yan; Jin, Chengzhe; Min, Byoung-Hyun; Li, Zhiyong; Pei, Xuan; Wang, Liming

    2013-12-01

    Extracellular matrix (ECM) materials are widely used in cartilage tissue engineering. However, the current ECM materials are unsatisfactory for clinical practice as most of them are derived from allogenous or xenogenous tissue. This study was designed to develop a novel autologous ECM scaffold for cartilage tissue engineering. The autologous bone marrow mesenchymal stem cell-derived ECM (aBMSC-dECM) membrane was collected and fabricated into a three-dimensional porous scaffold via cross-linking and freeze-drying techniques. Articular chondrocytes were seeded into the aBMSC-dECM scaffold and atelocollagen scaffold, respectively. An in vitro culture and an in vivo implantation in nude mice model were performed to evaluate the influence on engineered cartilage. The current results showed that the aBMSC-dECM scaffold had a good microstructure and biocompatibility. After 4 weeks in vitro culture, the engineered cartilage in the aBMSC-dECM scaffold group formed thicker cartilage tissue with more homogeneous structure and higher expressions of cartilaginous gene and protein compared with the atelocollagen scaffold group. Furthermore, the engineered cartilage based on the aBMSC-dECM scaffold showed better cartilage formation in terms of volume and homogeneity, cartilage matrix content, and compressive modulus after 3 weeks in vivo implantation. These results indicated that the aBMSC-dECM scaffold could be a successful novel candidate scaffold for cartilage tissue engineering. © 2013 Wiley Periodicals, Inc. and International Center for Artificial Organs and Transplantation.

  5. Regulatory considerations in application of encapsulated cell therapies.

    PubMed

    van Zanten, J; de Vos, Paul

    2010-01-01

    The encapsulation of tissue in semi-permeable membranes is a technology with high potential and in due time several new therapies based on this technology will be tested in clinical trials. Recent, new legislation requires that these investigational medicinal products used in clinical trials Phase I must be produced according to Good Manufacturing Practice (GMP). Consequently, the activities of GMP are expanding to the field of research and researchers might need to change developed protocols in order to meet GMP legislation. This chapters gives an overview of the overall guidelines covering GMP and more specific guidelines dealing with cell based therapies and gene therapy.

  6. Treatment of pulmonary diseases with Holmium:YAG laser

    NASA Astrophysics Data System (ADS)

    Zhang, Mei-Jue; Zhu, Jing; Zhang, Hui-Guo; Wang, Fu-Juan; Ke, Lin; Ma, Wei; Luo, Qun-Hua; Zhang, Yue-E.

    1998-11-01

    We report 5 cases of pulmonary disease treated with Holmium:YAG laser through fibrous bronchoscope. 1 inflammatory granuloma was cured after three times of treatment. Compared with conventional methods such as electrocautery and microwave treatment, laser has the merit of good hemostasis effect and quick recovery of the operation area. The other 4 patients who were suffered late lung cancer received 3-7 times of palliative treatment. After the treatment, the tumor tissues become smaller variably, and tact were unobstructed, symptoms of tract- obstructed obviously alleviated. We think that laser treatment has some practical significance in alleviating tract blocking of pulmonary diseases of late stage, and therefore raise the life quality.

  7. Top 10 metrics for life science software good practices.

    PubMed

    Artaza, Haydee; Chue Hong, Neil; Corpas, Manuel; Corpuz, Angel; Hooft, Rob; Jimenez, Rafael C; Leskošek, Brane; Olivier, Brett G; Stourac, Jan; Svobodová Vařeková, Radka; Van Parys, Thomas; Vaughan, Daniel

    2016-01-01

    Metrics for assessing adoption of good development practices are a useful way to ensure that software is sustainable, reusable and functional. Sustainability means that the software used today will be available - and continue to be improved and supported - in the future. We report here an initial set of metrics that measure good practices in software development. This initiative differs from previously developed efforts in being a community-driven grassroots approach where experts from different organisations propose good software practices that have reasonable potential to be adopted by the communities they represent. We not only focus our efforts on understanding and prioritising good practices, we assess their feasibility for implementation and publish them here.

  8. Top 10 metrics for life science software good practices

    PubMed Central

    2016-01-01

    Metrics for assessing adoption of good development practices are a useful way to ensure that software is sustainable, reusable and functional. Sustainability means that the software used today will be available - and continue to be improved and supported - in the future. We report here an initial set of metrics that measure good practices in software development. This initiative differs from previously developed efforts in being a community-driven grassroots approach where experts from different organisations propose good software practices that have reasonable potential to be adopted by the communities they represent. We not only focus our efforts on understanding and prioritising good practices, we assess their feasibility for implementation and publish them here. PMID:27635232

  9. [Repairing of soft tissue defect in leg by free vascularized thoracoumbilical flap with reversed flow].

    PubMed

    Xu, Y Q; Li, Z Y; Li, J

    2000-11-01

    To investigate the clinical effect of free vascularized thoracoumbilical flap with reversal flow in repairing the soft tissue defect in leg with tibia exposure. Forty-four casting mould specimens of leg arteries were studied firstly. Then 25 cases with soft tissue defect and tibia exposure in the proximal-middle segment of leg were adopted in this study. Among them, 18 cases had long distance thrombosis of the anterior tibial vessels or posterior tibial vessels due to traumatic lesion. The maximal size of defect was 28 cm x 11 cm and the minimal size of defect was 11 cm x 9 cm. In operation, the thoracoumbilical flap which was based on the inferior epigastric vessels was anastomosed to the distal end of the anterior tibial vessels or posterior tibial vessels. Anterior tibial artery, posterior tibial artery and fibular artery had rich communication branches in foot and ankle. All the flaps survived, the color and cosmetic result of them were good. The free vascularized thoracoumbilical flap with reversed flow is practical in repairing the soft tissue defect of leg with tibia exposure. Either the anterior tibial vessels or the posterior tibial vessels is normal, and the distal end of injured blood vessels is available, this technique can be adopted.

  10. Evaluation of synovium-derived mesenchymal stem cells and 3D printed nanocomposite scaffolds for tissue engineering

    NASA Astrophysics Data System (ADS)

    Pan, Jian-Feng; Li, Shuo; Guo, Chang-An; Xu, Du-Liang; Zhang, Feng; Yan, Zuo-Qin; Mo, Xiu-Mei

    2015-08-01

    Stem cells and scaffolds play a very important role in tissue engineering. Here, we isolated synovium-derived mesenchymal stem cells (SMSCs) from synovial membrane tissue and characterized stem-cell properties. Gelatin nanoparticles (NP) were prepared using a two-step desolvation method and then pre-mixed into different host matrix (silk fibroin (SF), gelatin (Gel), or SF-Gel mixture) to generate various 3D printed nanocomposite scaffolds (NP/SF, NP/SF-Gel, NP/Gel-1, and NP/Gel-2). The microstructure was examined by scanning electron microscopy. Biocompatibility assessment was performed through CCK-8 assay by coculturing with SMSCs at 1, 3, 7 and 14 days. According to the results, SMSCs are similar to other MSCs in their surface epitope expression, which are negative for CD45 and positive for CD44, CD90, and CD105. After incubation in lineage-specific medium, SMSCs could differentiate into chondrocytes, osteocytes and adipocytes. 3D printed nanocomposite scaffolds exhibited a good biocompatibility in the process of coculturing with SMSCs and had no negative effect on cell behavior. The study provides a strategy to obtain SMSCs and fabricate 3D printed nanocomposite scaffolds, the combination of which could be used for practical applications in tissue engineering.

  11. Tissue Banking, Bioinformatics, and Electronic Medical Records: The Front-End Requirements for Personalized Medicine

    PubMed Central

    Suh, K. Stephen; Sarojini, Sreeja; Youssif, Maher; Nalley, Kip; Milinovikj, Natasha; Elloumi, Fathi; Russell, Steven; Pecora, Andrew; Schecter, Elyssa; Goy, Andre

    2013-01-01

    Personalized medicine promises patient-tailored treatments that enhance patient care and decrease overall treatment costs by focusing on genetics and “-omics” data obtained from patient biospecimens and records to guide therapy choices that generate good clinical outcomes. The approach relies on diagnostic and prognostic use of novel biomarkers discovered through combinations of tissue banking, bioinformatics, and electronic medical records (EMRs). The analytical power of bioinformatic platforms combined with patient clinical data from EMRs can reveal potential biomarkers and clinical phenotypes that allow researchers to develop experimental strategies using selected patient biospecimens stored in tissue banks. For cancer, high-quality biospecimens collected at diagnosis, first relapse, and various treatment stages provide crucial resources for study designs. To enlarge biospecimen collections, patient education regarding the value of specimen donation is vital. One approach for increasing consent is to offer publically available illustrations and game-like engagements demonstrating how wider sample availability facilitates development of novel therapies. The critical value of tissue bank samples, bioinformatics, and EMR in the early stages of the biomarker discovery process for personalized medicine is often overlooked. The data obtained also require cross-disciplinary collaborations to translate experimental results into clinical practice and diagnostic and prognostic use in personalized medicine. PMID:23818899

  12. Stromal vascular fraction isolated from lipo-aspirates using an automated processing system: bench and bed analysis.

    PubMed

    Doi, Kentaro; Tanaka, Shinsuke; Iida, Hideo; Eto, Hitomi; Kato, Harunosuke; Aoi, Noriyuki; Kuno, Shinichiro; Hirohi, Toshitsugu; Yoshimura, Kotaro

    2013-11-01

    The heterogeneous stromal vascular fraction (SVF), containing adipose-derived stem/progenitor cells (ASCs), can be easily isolated through enzymatic digestion of aspirated adipose tissue. In clinical settings, however, strict control of technical procedures according to standard operating procedures and validation of cell-processing conditions are required. Therefore, we evaluated the efficiency and reliability of an automated system for SVF isolation from adipose tissue. SVF cells, freshly isolated using the automated procedure, showed comparable number and viability to those from manual isolation. Flow cytometric analysis confirmed an SVF cell composition profile similar to that after manual isolation. In addition, the ASC yield after 1 week in culture was also not significantly different between the two groups. Our clinical study, in which SVF cells isolated with the automated system were transplanted with aspirated fat tissue for soft tissue augmentation/reconstruction in 42 patients, showed satisfactory outcomes with no serious side-effects. Taken together, our results suggested that the automated isolation system is as reliable a method as manual isolation and may also be useful in clinical settings. Automated isolation is expected to enable cell-based clinical trials in small facilities with an aseptic room, without the necessity of a good manufacturing practice-level cell processing area. Copyright © 2012 John Wiley & Sons, Ltd.

  13. Electrosurgery: principles and practice to reduce risk and maximize efficacy.

    PubMed

    Brill, Andrew I

    2011-12-01

    Science becomes art and art becomes function when fundamental principles are utilized to dictate surgical practice. Most important, the risk for inadvertent thermal injury during electrosurgery can be minimized by a sound comprehension of the predictable behaviors of electricity in living tissue.Guided by the Hippocratic charge of primum non nocere, the ultimate aim of energy-assisted surgery is the attainment of anatomic dissection and hemostasis with the least amount of collateral damage and subsequent scar tissue formation.Ideally, the surgeon’s final view of the operative field should accurately approximate the topography discoverable after postoperative healing. Despite the continued innovation of products borne to reduce thermal damage and then marketed as being comparatively safer, it is the hands and mind of the surgeon that serve to preserve tissue integrity by reducing the burden of delayed thermal necrosis and taking steps to prevent excessive devitalization of tissue. Regardless of the chosen modality, the inseparable and exponentially linked elements of time and the quantity of delivered energy must be integrated while purposefully moderating to attain the desired tissue effect. Ultimately, the reduction of unwanted thermal injury is inherently linked to good surgical judgment and technique, a sound comprehension of the applied energy modality, and the surgeon’s ability to recognize anatomic structures within the field of surgical dissection as well as those within the zone of significant thermal change.During the use of any energy-based device for hemostasis, out of sight must never mean out of mind. If the bowel, bladder, or ureter is in close proximity to a bleeder,they should be sufficiently mobilized before applying energy. Thermal energy should always be withheld until an orderly sequence of anatomic triage is carried out.Whenever a vital structure cannot be adequately mobilized, hemorrhage is preferentially controlled by using mechanical tamponade or suture ligature.

  14. Cryopreservation of human vascular umbilical cord cells under good manufacturing practice conditions for future cell banks.

    PubMed

    Polchow, Bianca; Kebbel, Kati; Schmiedeknecht, Gerno; Reichardt, Anne; Henrich, Wolfgang; Hetzer, Roland; Lueders, Cora

    2012-05-16

    In vitro fabricated tissue engineered vascular constructs could provide an alternative to conventional substitutes. A crucial factor for tissue engineering of vascular constructs is an appropriate cell source. Vascular cells from the human umbilical cord can be directly isolated and cryopreserved until needed. Currently no cell bank for human vascular cells is available. Therefore, the establishment of a future human vascular cell bank conforming to good manufacturing practice (GMP) conditions is desirable for therapeutic applications such as tissue engineered cardiovascular constructs. A fundamental step was the adaption of conventional research and development starting materials to GMP compliant starting materials. Human umbilical cord artery derived cells (HUCAC) and human umbilical vein endothelial cells (HUVEC) were isolated, cultivated, cryopreserved (short- and long-term) directly after primary culture and recultivated subsequently. Cell viability, expression of cellular markers and proliferation potential of fresh and cryopreserved cells were studied using trypan blue staining, flow cytometry analysis, immunofluorescence staining and proliferation assays. Statistical analyses were performed using Student's t-test. Sufficient numbers of isolated cells with acceptable viabilities and homogenous expression of cellular markers confirmed that the isolation procedure was successful using GMP compliant starting materials. The influence of cryopreservation was marginal, because cryopreserved cells mostly maintain phenotypic and functional characteristics similar to those of fresh cells. Phenotypic studies revealed that fresh cultivated and cryopreserved HUCAC were positive for alpha smooth muscle actin, CD90, CD105, CD73, CD29, CD44, CD166 and negative for smoothelin. HUVEC expressed CD31, CD146, CD105 and CD144 but not alpha smooth muscle actin. Functional analysis demonstrated acceptable viability and sufficient proliferation properties of cryopreserved HUCAC and HUVEC. Adaptation of cell isolation, cultivation and cryopreservation to GMP compliant starting materials was successful. Cryopreservation did not influence cell properties with lasting impact, confirming that the application of vascular cells from the human umbilical cord is feasible for cell banking. A specific cellular marker expression profile was established for HUCAC and HUVEC using flow cytometry analysis, applicable as a GMP compliant quality control. Use of these cells for the future fabrication of advanced therapy medicinal products GMP conditions are required by the regulatory authority.

  15. Human endothelial colony-forming cells expanded with an improved protocol are a useful endothelial cell source for scaffold-based tissue engineering.

    PubMed

    Denecke, Bernd; Horsch, Liska D; Radtke, Stefan; Fischer, Johannes C; Horn, Peter A; Giebel, Bernd

    2015-11-01

    One of the major challenges in tissue engineering is to supply larger three-dimensional (3D) bioengineered tissue transplants with sufficient amounts of nutrients and oxygen and to allow metabolite removal. Consequently, artificial vascularization strategies of such transplants are desired. One strategy focuses on endothelial cells capable of initiating new vessel formation, which are settled on scaffolds commonly used in tissue engineering. A bottleneck in this strategy is to obtain sufficient amounts of endothelial cells, as they can be harvested only in small quantities directly from human tissues. Thus, protocols are required to expand appropriate cells in sufficient amounts without interfering with their capability to settle on scaffold materials and to initiate vessel formation. Here, we analysed whether umbilical cord blood (CB)-derived endothelial colony-forming cells (ECFCs) fulfil these requirements. In a first set of experiments, we showed that marginally expanded ECFCs settle and survive on different scaffold biomaterials. Next, we improved ECFC culture conditions and developed a protocol for ECFC expansion compatible with 'Good Manufacturing Practice' (GMP) standards. We replaced animal sera with human platelet lysates and used a novel type of tissue-culture ware. ECFCs cultured under the new conditions revealed significantly lower apoptosis and increased proliferation rates. Simultaneously, their viability was increased. Since extensively expanded ECFCs could still settle on scaffold biomaterials and were able to form tubular structures in Matrigel assays, we conclude that these ex vivo-expanded ECFCs are a novel, very potent cell source for scaffold-based tissue engineering. Copyright © 2013 John Wiley & Sons, Ltd.

  16. Good practices in transportation evacuation preparedness and response : results of the FHWA workshop series.

    DOT National Transportation Integrated Search

    2009-08-01

    This document provides an overview of the good practices identified during a series of multi-state workshops on Transportation Evacuation Preparedness and Response in four regions across the United States. Good practices are not presented in priority...

  17. Good practices in transportation evacuation preparedness and response : results of the FHWA Workshop Series

    DOT National Transportation Integrated Search

    2009-08-01

    This document provides an overview of the good practices identified during a series of multi-state workshops on Transportation Evacuation Preparedness and Response in four regions across the United States. Good practices are not presented in priority...

  18. WHO Expert Committee on specifications for pharmaceutical preparations.

    PubMed

    2010-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: good practices for pharmaceutical quality control laboratories; supplementary guidelines for active pharmaceutical ingredients; good manufacturing practices for pharmaceutical products containing hazardous substances; good manufacturing practices for sterile pharmaceutical products; good distribution practices for pharmaceutical products; guidelines on the requalification of prequalified dossiers: and guidelines for the preparation of a contract research organization master file.

  19. Providing specialist clinical skills in soft tissue and intra-articular injection through a postgraduate masters module.

    PubMed

    Stevenson, Kay; Waterfield, Jackie

    2005-01-01

    Current philosophy and policy changes in the National Health Service are encouraging healthcare practitioners to extend their clinical skills to create a more patient-centred approach thus allowing patients to be seen in a timely and more appropriate manner. This often requires further development of the practitioners' skills and knowledge. One approach to achieve this is through collaboration between employers and educational providers to ensure that educational experience is not only evidence based but also responsive to the needs of the current and future workforce. A postgraduate module was developed to raise critical and evaluative skills, as well as the technical skills of practitioners using injections in the management of joint and soft tissue pathology, while developing a professional responsibility towards injection practice. The module emphasized learning though experience by contextualizing the theoretical aspects of the module and by its student centred assessments. Further strengths of this module are that it has utilized academic and clinical expertise and knowledge to enable clinicians to gain additional skills and the multidisciplinary approach engendered good working practice Overall the module was evaluated positively by both tutors and students and not only met its aims but also addressed the current professional and policy issues around continuing professional development. Copyright (c) 2005 John Wiley & Sons, Ltd.

  20. Narrative Practice and the Signs of Safety Approach: Engaging Adolescents in Building Rigorous Safety Plans

    ERIC Educational Resources Information Center

    Gibson, Matthew

    2014-01-01

    The Signs of Safety approach to child protection has been gaining prominence around the world and this approach has developed through learning from good practice. Generally, examples of good practice are derived from adults who pose a risk to children, while this paper outlines an example of good practice that engages an adolescent in building a…

  1. Hard, soft tissue and in vitro cell response to porous nickel-titanium: a biocompatibility evaluation.

    PubMed

    Rhalmi, S; Odin, M; Assad, M; Tabrizian, M; Rivard, C H; Yahia, L H

    1999-01-01

    Porous nickel-titanium (NiTi) alloys have demonstrated bone attachment as well as tissue ingrowth in the past. However, very few studies have compared porous NiTi soft and hard tissue reactions, and in vitro cell response. We therefore have evaluated the general muscle and bone reaction to porous nickel-titanium. The latter material was implanted in rabbit tibias and back muscle, and assessed after three, six and twelve weeks of implantation. Porous NiTi specimens did not cause any adverse effect regardless of both implantation site and post-surgery recovery time. Muscle tissue exhibited thin tightly adherent fibrous capsules with fibers penetrating into implant pores. We observed that attachment strength of the soft tissue to the porous implant seemed to increase with post-implantation time. Bone tissue demonstrated good healing of the osteotomy. There was bone remodeling characterized by osteoclastic and osteoblastic activity in the cortex. This general good in vivo biocompatibility with muscle and bone tissue corresponded very well with the in vitro cell culture results we obtained. Fibroblasts seeded on porous nickel-titanium sheets managed to grow into the pores and all around specimen edges showing an another interesting cytocompatibility behavior. These results indicate good biocompatibility acceptance of porous nickel-titanium and are very promising towards eventual NiTi medical device approbation.

  2. Perceptions of Science Teachers on Implementation of Seven Principles for Good Practice in Education by Chickering and Gamson in Courses

    ERIC Educational Resources Information Center

    Ugras, Mustafa; Asiltürk, Erol

    2018-01-01

    The present study aimed to determine the perceptions of science teachers on the implementation of the seven principles for good practice in education by Chickering and Gamson in their courses. Seven principles for good science education were used as a data collection tool in the survey. "The seven principles for good practice in science…

  3. Factors associated with good TB infection control practices among primary healthcare workers in the Free State Province, South Africa.

    PubMed

    Engelbrecht, Michelle; Janse van Rensburg, André; Kigozi, Gladys; van Rensburg, Hcj Dingie

    2016-11-04

    Despite the availability of TB infection control guidelines, and good levels of healthcare worker knowledge about infection control, often these measures are not well implemented. This study sought to determine the factors associated with healthcare workers' good TB infection control practices in primary health care facilities in the Free State Province, South Africa. A cross-sectional self-administered survey among nurses (n = 202) and facility-based community healthcare workers (n = 34) as well as facility observations were undertaken at all 41 primary health care facilities in a selected district of the Free State Province. The majority of respondents were female (n = 200; 87.7 %) and the average age was 44.19 years (standard deviation ±10.82). Good levels of knowledge were recorded, with 42.8 % (n = 101) having an average score (i.e. 65-79 %) and 31.8 % (n = 75) a good score (i.e. ≥ 80 %). Most respondents (n = 189; 80.4 %) had positive attitudes towards TB infection control practices (i.e. ≥ 80 %). While good TB infection control practices were reported by 72.9 % (n = 161) of the respondents (i.e. ≥75 %), observations revealed this to not necessarily be the case. For every unit increase in attitudes, good practices increased 1.090 times (CI:1.016-1.169). Respondents with high levels of knowledge (≥80 %) were 4.029 (CI: 1.550-10.469) times more likely to have good practices when compared to respondents with poor levels of knowledge (<65 %). The study did not find TB/HIV-related training to be a predictor of good practices. Positive attitudes and good levels of knowledge regarding TB infection control were the main factors associated with good infection control practices. Although many respondents reported good infection control practices - which was somewhat countered by the observations - there are areas that require attention, particularly those related to administrative controls and the use of personal protective equipment.

  4. 78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Device Good Manufacturing Practice Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Device Good Manufacturing Practice Advisory Committee. General Function of the Committee: To...

  5. 21 CFR 123.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 123.5 Section...) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS General Provisions § 123.5 Current good manufacturing practice. (a) Part 110 of this chapter applies in determining whether the facilities, methods...

  6. 21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Applicability of current good manufacturing practice regulations. 210.2 Section 210.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...

  7. Understanding Graduate School Aspirations: The Effect of Good Teaching Practices

    ERIC Educational Resources Information Center

    Hanson, Jana M.; Paulsen, Michael B.; Pascarella, Ernest T.

    2016-01-01

    This study examined the effects of good teaching practices on post-baccalaureate degree aspirations using logistic regression techniques on a multi-institutional, longitudinal sample of students at 4-year colleges and universities in the USA. We examined whether eight good teaching practices (non-classroom interactions with faculty, prompt…

  8. 77 FR 71804 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-04

    ... Representatives on the Device Good Manufacturing Practice Advisory Committee AGENCY: Food and Drug Administration... Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological... regarding good manufacturing practices governing the methods used in, and the facilities and controls used...

  9. Integrating Education: Parekhian Multiculturalism and Good Practice

    ERIC Educational Resources Information Center

    McGlynn, Claire

    2009-01-01

    This paper explores the concept of good practice in integrating education in divided societies. Using Northern Ireland as a case study, the paper draws on data from eight schools (both integrated Catholic and Protestant, and separate) that are identified as exemplifying good practice in response to cultural diversity. Analysis is provided through…

  10. 78 FR 16824 - Tobacco Product Manufacturing Practice; Establishment of a Public Docket

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-19

    ... recommendations for regulations on good manufacturing practice for tobacco products that were submitted to FDA by... performance of a tobacco product), packing, and storage of a tobacco product conform to current good... group of 13 tobacco companies submitted to FDA: (1) Recommendations for good manufacturing practice...

  11. Equilibrium ex vivo calibration of homogenized tissue for in vivo SPME quantitation of doxorubicin in lung tissue.

    PubMed

    Roszkowska, Anna; Tascon, Marcos; Bojko, Barbara; Goryński, Krzysztof; Dos Santos, Pedro Reck; Cypel, Marcelo; Pawliszyn, Janusz

    2018-06-01

    The fast and sensitive determination of concentrations of anticancer drugs in specific organs can improve the efficacy of chemotherapy and minimize its adverse effects. In this paper, ex vivo solid-phase microextraction (SPME) coupled to LC-MS/MS as a method for rapidly quantitating doxorubicin (DOX) in lung tissue was optimized. Furthermore, the theoretical and practical challenges related to the real-time monitoring of DOX levels in the lung tissue of a living organism (in vivo SPME) are presented. In addition, several parameters for ex vivo/in vivo SPME studies, such as extraction efficiency of autoclaved fibers, intact/homogenized tissue differences, critical tissue amount, and the absence of an internal standard are thoroughly examined. To both accurately quantify DOX in solid tissue and minimize the error related to the lack of an internal standard, a calibration method at equilibrium conditions was chosen. In optimized ex vivo SPME conditions, the targeted compound was extracted by directly introducing a 15 mm (45 µm thickness) mixed-mode fiber into 15 g of homogenized tissue for 20 min, followed by a desorption step in an optimal solvent mixture. The detection limit for DOX was 2.5 µg g -1 of tissue. The optimized ex vivo SPME method was successfully applied for the analysis of DOX in real pig lung biopsies, providing an averaged accuracy and precision of 103.2% and 12.3%, respectively. Additionally, a comparison between SPME and solid-liquid extraction revealed good agreement. The results presented herein demonstrate that the developed SPME method radically simplifies the sample preparation step and eliminates the need for tissue biopsies. These results suggest that SPME can accurately quantify DOX in different tissue compartments and can be potentially useful for monitoring and adjusting drug dosages during chemotherapy in order to achieve effective and safe concentrations of doxorubicin. Copyright © 2018 Elsevier B.V. All rights reserved.

  12. How to use PRICE treatment for soft tissue injuries.

    PubMed

    Norton, Cormac

    2016-08-24

    Rationale and key points This article assists nurses to use the acronym PRICE (protection, rest, ice, compression and elevation) to guide the treatment of patients with uncomplicated soft tissue injuries to their upper or lower limbs. » Treatment of soft tissue injuries to limbs is important to reduce complications following injury, alleviate pain and ensure normal limb function is restored promptly. » Nurses should have an understanding of the rationale and evidence base supporting PRICE treatment of soft tissue injuries. » Providing accurate information to patients and carers about the management of soft tissue injuries and anticipated recovery time is an important aspect of treatment. » Further research is required to develop best practice in the treatment of soft tissue injuries. Reflective activity 'How to' articles can help you update your practice and ensure it remains evidence based. Apply this article to your practice. Reflect on and write a short account of: 1. How this article might change your practice when managing patients with soft tissue injuries to upper or lower limbs. 2. Positive elements of your current practice and those that could be enhanced. Subscribers can upload their reflective accounts at: rcni.com/portfolio.

  13. Identifying and quantifying the stromal fibrosis in muscularis propria of colorectal carcinoma by multiphoton microscopy

    NASA Astrophysics Data System (ADS)

    Chen, Sijia; Yang, Yinghong; Jiang, Weizhong; Feng, Changyin; Chen, Zhifen; Zhuo, Shuangmu; Zhu, Xiaoqin; Guan, Guoxian; Chen, Jianxin

    2014-10-01

    The examination of stromal fibrosis within colorectal cancer is overlooked, not only because the routine pathological examinations seem to focus more on tumour staging and precise surgical margins, but also because of the lack of efficient diagnostic methods. Multiphoton microscopy (MPM) can be used to study the muscularis stroma of normal and colorectal carcinoma tissue at the molecular level. In this work, we attempt to show the feasibility of MPM for discerning the microstructure of the normal human rectal muscle layer and fibrosis colorectal carcinoma tissue practicably. Three types of muscularis propria stromal fibrosis beneath the colorectal cancer infiltration were first observed through the MPM imaging system by providing intercellular microstructural details in fresh, unstained tissue samples. Our approach also presents the capability of quantifying the extent of stromal fibrosis from both amount and orientation of collagen, which may further characterize the severity of fibrosis. By comparing with the pathology analysis, these results show that the MPM has potential advantages in becoming a histological tool for detecting the stromal fibrosis and collecting prognosis evidence, which may guide subsequent therapy procedures for patients into good prognosis.

  14. Perceptions of good medical practice in the NHS: a survey of senior health professionals.

    PubMed

    Hutchinson, A; Williams, M; Meadows, K; Barbour, R S; Jones, R

    1999-12-01

    To categorize senior health professionals' experience with poor medical practice in hospitals and in general practice, to describe perceptions which senior NHS staff have of good medical practice, and to describe how problems of poor medical practice are currently managed. A postal questionnaire survey. The questionnaire sought perceptions of good medical practice, asked participants to characterise deviations from good practice, and to describe experience with managing poor performance at the time of the introduction of the General Medical Council (GMC) performance procedures. A range of NHS settings in the UK: hospital trusts, health authorities/boards, local medical committees, community health councils. Senior health professionals involved in the management of medical professional performance. Perceptions of what constitutes good medical practice. Most respondents considered that persistent problems related to clinical practice (diagnosis, management, and outcome and prescribing) would require local management and, possibly, referral to the GMC performance procedures. Informal mechanisms, including informal discussion, education, training, and work shifting, were the most usual means of handling a doctor whose performance was poor. Many took a less serious view of deficiencies in performance on manner and attitude and communication, although consultation skills rather than technical skills comprised the greatest number of complaints about doctors. Senior NHS professionals seem reluctant to consider persistently poor consultation skills in the same critical light as they do persistently poor technical practice. These attitudes may need to change with the implementation of clinical governance and updated guidance from the GMC on what constitutes good medical practice.

  15. Mueller tensor approach for nonlinear optics in turbid media

    NASA Astrophysics Data System (ADS)

    Ulcickas, James R. W.; Deng, Fengyuan; Ding, Changqin; Simpson, Garth J.

    2018-02-01

    As plane-polarized light propagates through a turbid medium, scattering alters the phase and polarization differently in different locations. The corresponding depolarization of the beam complicates recovery of the rich information content contained within the polarization-dependence of second harmonic generation (SHG) microscopy. A theoretical framework connecting Jones and Stokes formalisms for describing optical polarization allows prediction of the polarization-dependent SHG produced from "ballistic", but depolarized incident light. Measurements with collagen-rich tissue sections support the predictions of the framework. Partially polarized SHG produced from a depolarized source enabled recovery of local orientation distribution for collagen and local tensor information. Bridging the gap between SHG instigated by fully depolarized light and partially polarized light more common to practical turbid systems, a method for predicting local nonlinear optical susceptibility tensor elements was developed and applied to collagen in thick sections. Recovered values for the tensor element ratio ρ are in good agreement with previous results for thin tissue and literature reports.

  16. Multidisciplinary approaches to stimulate wound healing.

    PubMed

    Businaro, Rita; Corsi, Mariangela; Di Raimo, Tania; Marasco, Sergio; Laskin, Debra L; Salvati, Bruno; Capoano, Raffaele; Ricci, Serafino; Siciliano, Camilla; Frati, Giacomo; De Falco, Elena

    2016-08-01

    New civil wars and waves of terrorism are causing crucial social changes, with consequences in all fields, including health care. In particular, skin injuries are evolving as an epidemic issue. From a physiological standpoint, although wound repair takes place more rapidly in the skin than in other tissues, it is still a complex organ to reconstruct. Genetic and clinical variables, such as diabetes, smoking, and inflammatory/immunological pathologies, are also important risk factors limiting the regenerative potential of many therapeutic applications. Therefore, optimization of current clinical strategies is critical. Here, we summarize the current state of the field by focusing on stem cell therapy applications in wound healing, with an emphasis on current clinical approaches being developed. These involve protocols for the ex vivo expansion of adipose tissue-derived mesenchymal stem cells by means of a patented Good Manufacturing Practice-compliant platelet lysate. Combinations of multiple strategies, including genetic modifications and stem cells, biomimetic scaffolds, and novel vehicles, such as nanoparticles, are also discussed as future approaches. © 2016 New York Academy of Sciences.

  17. Complications of ankle fracture in patients with diabetes.

    PubMed

    Chaudhary, Saad B; Liporace, Frank A; Gandhi, Ankur; Donley, Brian G; Pinzur, Michael S; Lin, Sheldon S

    2008-03-01

    Ankle fractures in patients with diabetes mellitus have long been recognized as a challenge to practicing clinicians. Complications of impaired wound healing, infection, malunion, delayed union, nonunion, and Charcot arthropathy are prevalent in this patient population. Controversy exists as to whether diabetic ankle fractures are best treated noninvasively or by open reduction and internal fixation. Patients with diabetes are at significant risk for soft-tissue complications. In addition, diabetic ankle fractures heal, but significant delays in bone healing exist. Also, Charcot ankle arthropathy occurs more commonly in patients who were initially undiagnosed and had a delay in immobilization and in patients treated nonsurgically for displaced ankle fractures. Several techniques have been described to minimize complications associated with diabetic ankle fractures (eg, rigid external fixation, use of Kirschner wires or Steinmann pins to increase rigidity). Regardless of the specifics of treatment, adherence to the basic principles of preoperative planning, meticulous soft-tissue management, and attention to stable, rigid fixation with prolonged, protected immobilization are paramount in minimizing problems and yielding good functional outcomes.

  18. Wheat (Triticum aestivum L.) transformation using mature embryos.

    PubMed

    Medvecká, Eva; Harwood, Wendy A

    2015-01-01

    In most protocols for the Agrobacterium-mediated transformation of wheat, the preferred target tissues are immature embryos. However, transformation methods relying on immature embryos require the growth of plants under controlled conditions to provide a continuous supply of good-quality target tissue. The use of mature embryos as a target tissue has the advantage of only requiring good-quality seed as the starting material. Here we describe a transformation method based on the Agrobacterium-mediated transformation of callus cultures derived from mature wheat embryos of the genotype Bobwhite S56.

  19. Investigating School-Wide Antecedents of Good Practice Dissemination from Individual Subject Projects

    ERIC Educational Resources Information Center

    Christophersen, Knut-Andreas; Elstad, Eyvind; Turmo, Are

    2012-01-01

    Good practice dissemination is an unsolved problem in education. This article describes how clear and "soft" leadership and perceptions of social and economic exchange operate in the bottom-up processes of school reforms and examines the relative impact of these factors on school-wide good practice dissemination and discusses how…

  20. The Conditional Nature of High Impact/Good Practices on Student Learning Outcomes

    ERIC Educational Resources Information Center

    Seifert, Tricia A.; Gillig, Benjamin; Hanson, Jana M.; Pascarella, Ernest T.; Blaich, Charles F.

    2014-01-01

    Using a multi-institutional sample of undergraduate students, this study found that the relationships between engaging in high impact/good practices and liberal arts outcomes differ based on students' precollege and background characteristics. Findings suggest that high impact/good practices are not a panacea and require a greater degree of…

  1. Good Practices for Transforming Education

    ERIC Educational Resources Information Center

    Benavente, Ana; Panchaud, Christine

    2008-01-01

    This text is a guide to the reading and interpretation of the "good practices" that are developing in the countries participating in this project and elsewhere. A systematic approach to the factors making up a "good practice" has enabled us to share our analyses in a more structured manner and to reflect on their potential for…

  2. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false What is current good manufacturing practice for PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION...

  3. 40 CFR 86.098-23 - Required data.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... accordance with good engineering practice to assure that the engines covered by a certificate issued under... and conducted in accordance with good engineering practice to assure that the vehicles covered by a... systems are designed, using good engineering practice, to meet the standards of § 86.096-10 or § 86.098-11...

  4. Good Laboratory Practice. Part 3. Implementing Good Laboratory Practice in the Analytical Lab

    ERIC Educational Resources Information Center

    Wedlich, Richard C.; Pires, Amanda; Fazzino, Lisa; Fransen, Joseph M.

    2013-01-01

    Laboratories submitting experimental results to the Food and Drug Administration (FDA) or the Environmental Protection Agency (EPA) in support of Good Laboratory Practice (GLP) nonclinical laboratory studies must conduct such work in compliance with the GLP regulations. To consistently meet these requirements, lab managers employ a "divide…

  5. Neural Stem Cells Derived from Human Parthenogenetic Stem Cells Engraft and Promote Recovery in a Nonhuman Primate Model of Parkinson's Disease.

    PubMed

    Gonzalez, Rodolfo; Garitaonandia, Ibon; Poustovoitov, Maxim; Abramihina, Tatiana; McEntire, Caleb; Culp, Ben; Attwood, Jordan; Noskov, Alexander; Christiansen-Weber, Trudy; Khater, Marwa; Mora-Castilla, Sergio; To, Cuong; Crain, Andrew; Sherman, Glenn; Semechkin, Andrey; Laurent, Louise C; Elsworth, John D; Sladek, John; Snyder, Evan Y; Redmond, D Eugene; Kern, Russell A

    2016-11-01

    Cell therapy has attracted considerable interest as a promising therapeutic alternative for patients with Parkinson's disease (PD). Clinical studies have shown that grafted fetal neural tissue can achieve considerable biochemical and clinical improvements in PD. However, the source of fetal tissue grafts is limited and ethically controversial. Human parthenogenetic stem cells offer a good alternative because they are derived from unfertilized oocytes without destroying potentially viable human embryos and can be used to generate an unlimited supply of neural cells for transplantation. We have previously reported that human parthenogenetic stem cell-derived neural stem cells (hpNSCs) successfully engraft, survive long term, and increase brain dopamine (DA) levels in rodent and nonhuman primate models of PD. Here we report the results of a 12-month transplantation study of hpNSCs in 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP)-lesioned African green monkeys with moderate to severe clinical parkinsonian symptoms. The hpNSCs manufactured under current good manufacturing practice (cGMP) conditions were injected bilaterally into the striatum and substantia nigra of immunosuppressed monkeys. Transplantation of hpNSCs was safe and well tolerated by the animals with no dyskinesia, tumors, ectopic tissue formation, or other test article-related serious adverse events. We observed that hpNSCs promoted behavioral recovery; increased striatal DA concentration, fiber innervation, and number of dopaminergic neurons; and induced the expression of genes and pathways downregulated in PD compared to vehicle control animals. These results provide further evidence for the clinical translation of hpNSCs and support the approval of the world's first pluripotent stem cell-based phase I/IIa study for the treatment of PD (Clinical Trial Identifier NCT02452723).

  6. Isoosmolar Enemas Demonstrate Preferential Gastrointestinal Distribution, Safety, and Acceptability Compared with Hyperosmolar and Hypoosmolar Enemas as a Potential Delivery Vehicle for Rectal Microbicides

    PubMed Central

    Leyva, Francisco J.; Bakshi, Rahul P.; Fuchs, Edward J.; Li, Liye; Caffo, Brian S.; Goldsmith, Arthur J.; Ventuneac, Ana; Carballo-Diéguez, Alex; Du, Yong; Leal, Jeffrey P.; Lee, Linda A.; Torbenson, Michael S.

    2013-01-01

    Abstract Rectally applied antiretroviral microbicides for preexposure prophylaxis (PrEP) of HIV infection are currently in development. Since enemas (rectal douches) are commonly used by men who have sex with men prior to receptive anal intercourse, a microbicide enema could enhance PrEP adherence by fitting seamlessly within the usual sexual practices. We assessed the distribution, safety, and acceptability of three enema types—hyperosmolar (Fleet), hypoosmolar (distilled water), and isoosmolar (Normosol-R)—in a crossover design. Nine men received each enema type in random order. Enemas were radiolabeled [99mTc-diethylene triamine pentaacetic acid (DTPA)] to assess enema distribution in the colon using single photon emission computed tomography/computed tomography (SPECT/CT) imaging. Plasma 99mTc-DTPA indicated mucosal permeability. Sigmoidoscopic colon tissue biopsies were taken to assess injury as well as tissue penetration of the 99mTc-DTPA. Acceptability was assessed after each product use and at the end of the study. SPECT/CT imaging showed that the isoosmolar enema had greater proximal colonic distribution (up to the splenic flexure) and greater luminal and colon tissue concentrations of 99mTc-DTPA when compared to the other enemas (p<0.01). Colon biopsies also showed that only the hyperosmolar enema caused sloughing of the colonic epithelium (p<0.05). In permeability testing, the hypoosmolar enema had higher plasma 99mTc-DTPA 24-h area under the concentration-time curve and peak concentration compared to the hyperosmolar and isoosmolar enemas, respectively. Acceptability was generally good with no clear preferences among the three enema types. The isoosmolar enema was superior or similar to the other enemas in all categories and is a good candidate for further development as a rectal microbicide vehicle. PMID:23885722

  7. 21 CFR 184.1449 - Manganese citrate.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

  8. 21 CFR 184.1449 - Manganese citrate.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

  9. 21 CFR 184.1449 - Manganese citrate.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

  10. 21 CFR 184.1449 - Manganese citrate.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

  11. Cytomegalovirus (CMV) and Pregnancy

    MedlinePlus

    ... way to prevent infection is to practice good hygiene, particularly proper hand washing. An interventional study in ... a CMV infection found that teaching about good hygiene (and practicing good hygiene) reduced the risk of ...

  12. Live attenuated tetravalent dengue vaccine.

    PubMed

    Bhamarapravati, N; Sutee, Y

    2000-05-26

    The development of a live attenuated tetravalent dengue vaccine is currently the best strategy to obtain a vaccine against dengue viruses. The Mahidol University group developed candidate live attenuated vaccines by attenuation through serial passages in certified primary cell cultures. Dengue serotype 1, 2 and 4 viruses were developed in primary dog kidney cells, whereas dengue serotype 3 was serially passaged in primary African green monkey kidney cells. Tissue culture passaged strain viruses were subjected to biological marker studies. Candidate vaccines have been tested as monovalent (single virus), bivalent (two viruses), trivalent (three viruses) and tetravalent (all four serotype viruses) vaccines in Thai volunteers. They were found to be safe and immunogenic in both adults and children. The Mahidol live attenuated dengue 2 virus was also tested in American volunteers and resulted in good immune response indistinguishable from those induced in Thai volunteers. The master seeds from the four live attenuated virus strains developed were provided to Pasteur Merieux Connaught of France for production on an industrial scale following good manufacturing practice guidelines.

  13. The diagnosis and treatment of infections of the pedal integument.

    PubMed

    Miller, S J

    1986-07-01

    Dr. Miller's discussion of the diagnosis and management of soft tissue infections is probably one of the most important topics in this issue. We are all faced with the potential for relatively minor infections becoming serious problems. Having a sound understanding of the infectious process and treatment regimens is extremely important in our general practices. Few things can make a patient as unhappy or destroy good surgical results as quickly and easily as an infection. I recommend reading the articles suggested by Dr. Miller and add that I believe that if the infection has not responded as quickly to therapy as is expected, an infectious disease consultation should be requested.

  14. Internal Tooth Structure and Burial Practices: Insights into the Neolithic Necropolis of Gurgy (France, 5100-4000 cal. BC).

    PubMed

    Le Luyer, Mona; Coquerelle, Michael; Rottier, Stéphane; Bayle, Priscilla

    2016-01-01

    Variations in the dental crown form are widely studied to interpret evolutionary changes in primates as well as to assess affinities among human archeological populations. Compared to external metrics of dental crown size and shape, variables including the internal structures such as enamel thickness, tissue proportions, and the three-dimensional shape of enamel-dentin junction (EDJ), have been described as powerful measurements to study taxonomy, phylogenetic relationships, dietary, and/or developmental patterns. In addition to providing good estimate of phenotypic distances within/across archeological samples, these internal tooth variables may help to understand phylogenetic, functional, and developmental underlying causes of variation. In this study, a high resolution microtomographic-based record of upper permanent second molars from 20 Neolithic individuals of the necropolis of Gurgy (France) was applied to evaluate the intrasite phenotypic variation in crown tissue proportions, thickness and distribution of enamel, and EDJ shape. The study aims to compare interindividual dental variations with burial practices and chronocultural parameters, and suggest underlying causes of these dental variations. From the non-invasive characterization of internal tooth structure, differences have been found between individuals buried in pits with alcove and those buried in pits with container and pits with wattling. Additionally, individuals from early and recent phases of the necropolis have been distinguished from those of the principal phase from their crown tissue proportions and EDJ shape. The results suggest that the internal tooth structure may be a reliable proxy to track groups sharing similar chronocultural and burial practices. In particular, from the EDJ shape analysis, individuals buried in an alcove shared a reduction of the distolingual dentin horn tip (corresponding to the hypocone). Environmental, developmental and/or functional underlying causes might be suggested for the origin of phenotypic differences shared by these individuals buried in alcoves.

  15. Quantitative Analysis of Microbicide Concentrations in Fluids, Gels and Tissues Using Confocal Raman Spectroscopy

    PubMed Central

    Chuchuen, Oranat; Henderson, Marcus H.; Sykes, Craig; Kim, Min Sung; Kashuba, Angela D. M.; Katz, David F.

    2013-01-01

    Topical vaginal anti-HIV microbicides are an important focus in female-based strategies to prevent the sexual transmission of HIV. Understanding microbicide pharmacokinetics is essential to development, characterization and implementation of efficacious microbicide drug delivery formulations. Current methods to measure drug concentrations in tissue (e.g., LC-MS/MS, liquid chromatography coupled with tandem mass spectrometry) are highly sensitive, but destructive and complex. This project explored the use of confocal Raman spectroscopy to detect microbicide drugs and to measure their local concentrations in fluids, drug delivery gels, and tissues. We evaluated three candidate microbicide drugs: tenofovir, Dapivirine and IQP-0528. Measurements were performed in freshly excised porcine buccal tissue specimens, gel vehicles and fluids using two Horiba Raman microscopes, one of which is confocal. Characteristic spectral peak calibrations for each drug were obtained using serial dilutions in the three matrices. These specific Raman bands demonstrated strong linear concentration dependences in the matrices and were characterized with respect to their unique vibrational signatures. At least one specific Raman feature was identified for each drug as a marker band for detection in tissue. Sensitivity of detection was evaluated in the three matrices. A specific peak was also identified for tenofovir diphosphate, the anti-HIV bioactive product of tenofovir after phosphorylation in host cells. Z-scans of drug concentrations vs. depth in excised tissue specimens, incubated under layers of tenofovir solution in a Transwell assay, showed decreasing concentration with depth from the surface into the tissue. Time-dependent concentration profiles were obtained from tissue samples incubated in the Transwell assay, for times ranging 30 minutes - 6 hours. Calibrations and measurements from tissue permeation studies for tenofovir showed good correlation with gold standard LC-MS/MS data. These results demonstrate that confocal Raman spectroscopy holds promise as a tool for practical, minimally invasive, label-free measurement of microbicide drug concentrations in fluids, gels and tissues. PMID:24386455

  16. A Model of Free Tissue Transfer: The Rat Epigastric Free Flap

    PubMed Central

    Casal, Diogo; Pais, Diogo; Iria, Inês; Mota-Silva, Eduarda; Almeida, Maria-Angélica; Alves, Sara; Pen, Cláudia; Farinho, Ana; Mascarenhas-Lemos, Luís; Ferreira-Silva, José; Ferraz-Oliveira, Mário; Vassilenko, Valentina; Videira, Paula A.; Gory O'Neill, João

    2017-01-01

    Free tissue transfer has been increasingly used in clinical practice since the 1970s, allowing reconstruction of complex and otherwise untreatable defects resulting from tumor extirpation, trauma, infections, malformations or burns. Free flaps are particularly useful for reconstructing highly complex anatomical regions, like those of the head and neck, the hand, the foot and the perineum. Moreover, basic and translational research in the area of free tissue transfer is of great clinical potential. Notwithstanding, surgical trainees and researchers are frequently deterred from using microsurgical models of tissue transfer, due to lack of information regarding the technical aspects involved in the operative procedures. The aim of this paper is to present the steps required to transfer a fasciocutaneous epigastric free flap to the neck in the rat. This flap is based on the superficial epigastric artery and vein, which originates from and drain into the femoral artery and vein, respectively. On average the caliber of the superficial epigastric vein is 0.6 to 0.8 mm, contrasting with the 0.3 to 0.5 mm of the superficial epigastric artery. Histologically, the flap is a composite block of tissues, containing skin (epidermis and dermis), a layer of fat tissue (panniculus adiposus), a layer of striated muscle (panniculus carnosus), and a layer of loose areolar tissue. Succinctly, the epigastric flap is raised on its pedicle vessels that are then anastomosed to the external jugular vein and to the carotid artery on the ventral surface of the rat's neck. According to our experience, this model guarantees the complete survival of approximately 70 to 80% of epigastric flaps transferred to the neck region. The flap can be evaluated whenever needed by visual inspection. Hence, the authors believe this is a good experimental model for microsurgical research and training. PMID:28117814

  17. 21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Applicability of current good manufacturing... AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.2 Applicability of current good manufacturing...

  18. 75 FR 16345 - Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    .... FDA-1999-N-3539] (formerly Docket No. 1999N-4783) Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule... Subjects in 21 CFR Part 10 Administrative practice and procedure, News media. 0 Therefore, under the...

  19. Monitoring clinical standards in a chronic peritoneal dialysis program.

    PubMed

    Leung, Dora K C

    2009-02-01

    Multiple factors may influence the effectiveness of a chronic peritoneal dialysis program. Continuous monitoring of various aspects of clinical standards with reviews enhances opportunities for bridging the gap between existing practice and good practice, and good practice to best practice.

  20. Translational Research in Pediatrics IV: Solid Tissue Collection and Processing.

    PubMed

    Gillio-Meina, Carolina; Zielke, H Ronald; Fraser, Douglas D

    2016-01-01

    Solid tissues are critical for child-health research. Specimens are commonly obtained at the time of biopsy/surgery or postmortem. Research tissues can also be obtained at the time of organ retrieval for donation or from tissue that would otherwise have been discarded. Navigating the ethics of solid tissue collection from children is challenging, and optimal handling practices are imperative to maximize tissue quality. Fresh biopsy/surgical specimens can be affected by a variety of factors, including age, gender, BMI, relative humidity, freeze/thaw steps, and tissue fixation solutions. Postmortem tissues are also vulnerable to agonal factors, body storage temperature, and postmortem intervals. Nonoptimal tissue handling practices result in nucleotide degradation, decreased protein stability, artificial posttranslational protein modifications, and altered lipid concentrations. Tissue pH and tryptophan levels are 2 methods to judge the quality of solid tissue collected for research purposes; however, the RNA integrity number, together with analyses of housekeeping genes, is the new standard. A comprehensive clinical data set accompanying all tissue samples is imperative. In this review, we examined: the ethical standards relating to solid tissue procurement from children; potential sources of solid tissues; optimal practices for solid tissue processing, handling, and storage; and reliable markers of solid tissue quality. Copyright © 2016 by the American Academy of Pediatrics.

  1. Should spikes on post-resection ECoG guide pediatric epilepsy surgery?

    PubMed

    Greiner, Hansel M; Horn, Paul S; Tenney, Jeffrey R; Arya, Ravindra; Jain, Sejal V; Holland, Katherine D; Leach, James L; Miles, Lili; Rose, Douglas F; Fujiwara, Hisako; Mangano, Francesco T

    2016-05-01

    There is wide variation in clinical practice regarding the role of electrocorticography immediately after resection (post-resection ECoG) for pediatric epilepsy surgery. Results can guide further resection of potentially epileptogenic tissue. We hypothesized that post-resection ECoG spiking represents a biomarker of the epileptogenic zone and predicts seizure outcome in children undergoing epilepsy surgery. We retrospectively identified 124 children with post-resection ECoG performed on the margins of resection. ECoG records were scored in a blinded fashion based on presence of frequent spiking. For patients identified as having additional resection based on clinical post-resection ECoG interpretation, these "second-look" ECoG results were re-reviewed for ongoing discharges or completeness of resection. Frequent spike populations were grouped using a standard scoring system into three ranges: 0.1-0.5Hz, 0.5-1Hz, >1Hz. Seizure outcomes were determined at minimum 12-month followup. Of 124 patients who met inclusion criteria, 60 (48%) had an identified spike population on post-resection ECoG. Thirty (50%) of these had further resection based on clinical interpretation. Overall, good outcome (ILAE 1) was seen in 56/124 (45%). Completeness of resection of spiking (absence of spiking on initial post-resection ECoG or resolution of spiking after further resection) showed a trend toward good outcome (OR 2.03, p=0.099). Patients with completeness of resection had good outcome in 41/80 (51%) of cases; patients with continued spikes had good outcome in 15/44 (35%) of cases. Post-resection ECoG identifies residual epileptogenic tissue in a significant number of children. Lower frequency or absence of discharges on initial recording showed a trend toward good outcome. Completeness of resection demonstrated on final ECoG recording did not show a significant difference in outcome. This suggests that post-resection discharges represent a prognostic marker rather than a remediable biomarker of the epileptogenic zone in all patients. Resecting residual spike-generating cortex may be beneficial in selected patients, including children with tumors. Copyright © 2016 Elsevier B.V. All rights reserved.

  2. 16 CFR 453.4 - Required purchase of funeral goods or funeral services.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Required purchase of funeral goods or funeral services. 453.4 Section 453.4 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES FUNERAL INDUSTRY PRACTICES § 453.4 Required purchase of funeral goods or funeral services. (a) Casket for cremation provisions—(1) Unfair or...

  3. 21 CFR 114.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 114.5 Section...) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS General Provisions § 114.5 Current good manufacturing practice. The criteria in §§ 114.10, 114.80, 114.83, 114.89, and 114.100, as well as the criteria in part...

  4. The Future of HPT Depends on Whether Practitioners Focus on Foundations or Fads

    ERIC Educational Resources Information Center

    Brethower, Dale M.

    2012-01-01

    The future of human performance technology (HPT) will be bright or dismal depending on how well HPT practitioners focus on careful and practical answers to three pivotal questions: What is good practice in human performance technology? What are the differences between good practice and bad? What are the connections between good research and…

  5. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET drugs? Current good manufacturing practice for PET drugs is the minimum requirements for the methods to be used...

  6. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET drugs? Current good manufacturing practice for PET drugs is the minimum requirements for the methods to be used...

  7. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET drugs? Current good manufacturing practice for PET drugs is the minimum requirements for the methods to be used...

  8. Implementing Good Practices Programs to Encourage Production of High-Quality, Safer Produce in Mississippi

    ERIC Educational Resources Information Center

    Mahmoud, Barakat S. M.; Stafne, Eric T.; Coker, Christine H.; Bachman, Gary R.; Bell, Nicole

    2016-01-01

    Fifty-four growers/producers attended four 1-day good agricultural practices (GAP) and good handling practices (GHP) workshops at four locations in Mississippi. Pre- and post workshop survey data indicated that the participants' food safety knowledge increased by 15%. Furthermore, the workshops helped producers develop their own food safety plans.…

  9. Quality control of human tissues--experience from the Indiana University Cancer Center-Lilly Research Labs human tissue bank.

    PubMed

    Sandusky, George E; Teheny, Katie Heinz; Esterman, Mike; Hanson, Jeff; Williams, Stephen D

    2007-01-01

    The success of molecular research and its applications in both the clinical and basic research arenas is strongly dependent on the collection, handling, storage, and quality control of fresh human tissue samples. This tissue bank was set up to bank fresh surgically obtained human tissue using a Clinical Annotated Tissue Database (CATD) in order to capture the associated patient clinical data and demographics using a one way patient encryption scheme to protect patient identification. In this study, we determined that high quality of tissue samples is imperative for both genomic and proteomic molecular research. This paper also contains a brief compilation of the literature involved in the patient ethics, patient informed consent, patient de-identification, tissue collection, processing, and storage as well as basic molecular research generated from the tissue bank using good clinical practices. The current applicable rules, regulations, and guidelines for handling human tissues are briefly discussed. More than 6,610 cancer patients have been consented (97% of those that were contacted by the consenter) and 16,800 tissue specimens have been banked from these patients in 9 years. All samples collected in the bank were QC'd by a pathologist. Approximately 1,550 tissue samples have been requested for use in basic, clinical, and/or biomarker cancer research studies. Each tissue aliquot removed from the bank for a research study were evaluated by a second H&E, if the samples passed the QC, they were submitted for genomic and proteomic molecular analysis/study. Approximately 75% of samples evaluated were of high histologic quality and used for research studies. Since 2003, we changed the patient informed consent to allow the tissue bank to gather more patient clinical follow-up information. Ninety two percent of the patients (1,865 patients) signed the new informed consent form and agreed to be re-contacted for follow-up information on their disease state. In addition, eighty five percent of patients (1,584) agreed to be re-contacted to provide a biological fluid sample to be used for biomarker research.

  10. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fiftieth report.

    PubMed

    2016-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Good pharmacopoeial practices; FIP-WHO technical guidelines: points to consider in the provision by health-care professionals of children-specific preparations that are not available as authorized products; Guidance on good manufacturing practices for biological products; Guidance on good manufacturing practices: inspection report, including Appendix 1: Model inspection report; Guidance on good data and record management practices; Good trade and distribution practices for starting materials; Guidelines on the conduct of surveys of the quality of medicines; Collaborative procedure between the World Health Organization (WHO) prequalification team and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines; Guidance for organizations performing in vivo bioequivalence studies; and World Health Organization (WHO) general guidance on variations to multisource pharmaceutical products.

  11. Adaptive self-organization in the embryo: its importance to adult anatomy and to tissue engineering.

    PubMed

    Davies, Jamie A

    2018-04-01

    The anatomy of healthy humans shows much minor variation, and twin-studies reveal at least some of this variation cannot be explained genetically. A plausible explanation is that fine-scale anatomy is not specified directly in a genetic programme, but emerges from self-organizing behaviours of cells that, for example, place a new capillary where it happens to be needed to prevent local hypoxia. Self-organizing behaviour can be identified by manipulating growing tissues (e.g. putting them under a spatial constraint) and observing an adaptive change that conserves the character of the normal tissue while altering its precise anatomy. Self-organization can be practically useful in tissue engineering but it is limited; generally, it is good for producing realistic small-scale anatomy but large-scale features will be missing. This is because self-organizing organoids miss critical symmetry-breaking influences present in the embryo: simulating these artificially, for example, with local signal sources, makes anatomy realistic even at large scales. A growing understanding of the mechanisms of self-organization is now allowing synthetic biologists to take their first tentative steps towards constructing artificial multicellular systems that spontaneously organize themselves into patterns, which may soon be extended into three-dimensional shapes. © 2017 The Authors Journal of Anatomy published by John Wiley & Sons Ltd on behalf of Anatomical Society.

  12. Good governance in national solid waste management policy (NSWMP) implementation: A case study of Malaysia

    NASA Astrophysics Data System (ADS)

    Wee, Seow Ta; Abas, Muhamad Azahar; Mohamed, Sulzakimin; Chen, Goh Kai; Zainal, Rozlin

    2017-10-01

    The National Solid Waste Management Policy (NSWMP) was introduced in 2007 under the Act 672. The execution of NSWMP involves stakeholders from various government agencies and a collaboration with the private sectors. Despite the initiatives taken by the stakeholders, the objectives of NSWMP failed to materialise. One of the major constraints is weak governance among stakeholders with regards to the NSWMP implementation. This paper will explore the good governance practices implemented by the stakeholders. Identifying the current good governance practices implemented by the stakeholders is crucial as it will serve as a guideline to improve good governance practice in the future. An exploratory research approach is applied in this study through in-depth interviews with several government agencies and concessionaires involved in the NSWMP implementation. A total of six respondents took part in this study. The findings of this study show that there are several good governance practices implemented in policy promotion, participation of stakeholders, and capacity enhancement programme for the staff. This study also proposed some points on good governance practices in the context of policy promotion and staff development. A paradigm shift by the stakeholders is imperative so as to enhance the good governance practice in NSWMP implementation towards an efficient solid waste management in Malaysia.

  13. Two differentially structured collagen scaffolds for potential urinary bladder augmentation: proof of concept study in a Göttingen minipig model.

    PubMed

    Leonhäuser, Dorothea; Stollenwerk, Katja; Seifarth, Volker; Zraik, Isabella M; Vogt, Michael; Srinivasan, Pramod K; Tolba, Rene H; Grosse, Joachim O

    2017-01-04

    The repair of urinary bladder tissue is a necessity for tissue loss due to cancer, trauma, or congenital abnormalities. Use of intestinal tissue is still the gold standard in the urological clinic, which leads to new problems and dysfunctions like mucus production, stone formation, and finally malignancies. Therefore, the use of artificial, biologically derived materials is a promising step towards the augmentation of this specialised tissue. The aim of this study was to investigate potential bladder wall repair by two collagen scaffold prototypes, OptiMaix 2D and 3D, naïve and seeded with autologous vesical cells, as potential bladder wall substitute material in a large animal model. Six Göttingen minipigs underwent cystoplastic surgery for tissue biopsy and cell isolation followed by implantation of unseeded scaffolds. Six weeks after the first operation, scaffolds seeded with the tissue cultured autologous urothelial and detrusor smooth muscle cells were implanted into the bladder together with additional unseeded scaffolds for comparison. Cystography and bladder ultrasound were performed to demonstrate structural integrity and as leakage test of the implantation sites. Eighteen, 22, and 32 weeks after the first operation, two minipigs respectively were sacrificed and the urinary tract was examined via different (immunohistochemical) staining procedures and the usage of two-photon laser scanning microscopy. Both collagen scaffold prototypes in vivo had good ingrowth capacity into the bladder wall including a quick lining with urothelial cells. The ingrowth of detrusor muscle tissue, along with the degradation of the scaffolds, could also be observed throughout the study period. We could show that the investigated collagen scaffolds OptiMaix 2D and 3D are a potential material for bladder wall substitution. The material has good biocompatible properties, shows a good cell growth of autologous cells in vitro, and a good integration into the present bladder tissue in vivo.

  14. Knowledge and Preventive Practices related to Avian Influenza among Poultry Workers of Kamalamai Municipality, Sindhuli, Nepal.

    PubMed

    Shrestha, R; Shrestha, K B; Ghimire, S; Shrestha, N

    2016-01-01

    Avian influenza (AI) is currently a threat to global health. Prevention and control of AI depends on the knowledge and preventive practices of the poultry workers as well as of general population. This study aims to assess knowledge and preventive practices related to AI among poultry workers. Cross-sectional study was carried out among poultry workers of Kamalamai Municipality, Sindhuli. Data was collected from randomly selected 122 respondents through face-to-face interview. The collected data was entered in Epi-data version 3.1 and analyzed in terms of descriptive statistics (proportion, 95% CI, mean and standard deviation) by using SPSS, version 20. A scoring system was used to assess knowledge and preventive practices. Out of total, 93.4% (95% CI, 87.6- 96.6%) of the respondents had heard about AI. More than half (54.9%) of the respondents had poor knowledge on AI. Only 5.3% of respondents had good preventive practice against AI. 30.3% respondents had good knowledge and good practice and 24.6% had poor knowledge as well as poor practice. 20.5% of the respondents had good practice but poor knowledge, whereas, 24.6% had good knowledge but poor practice towards prevention. The knowledge and practice of AI among poultry workers were low. The groups should be targeted for appropriate intervention based on whether they lack knowledge or practice or both.

  15. Good Practice and Recommendations for Research Team Leadership

    DTIC Science & Technology

    2017-05-01

    ARL-SR-0372 ● MAY 2017 US Army Research Laboratory Good Practice and Recommendations for Research Team Leadership by Mark L...Do not return it to the originator. ARL-SR-0372 ● MAY 2017 US Army Research Laboratory Good Practice and Recommendations for...information, including suggestions for reducing the burden, to Department of Defense, Washington Headquarters Services , Directorate for Information

  16. Impacts of Good Practices on Cognitive Development, Learning Orientations, and Graduate Degree Plans during the First Year of College

    ERIC Educational Resources Information Center

    Cruce, Ty M.; Wolniak, Gregory C.; Seifert, Tricia A.; Pascarella, Ernest T.

    2006-01-01

    This study estimated separately the unique effects of three dimensions of good practice and the global effects of a composite measure of good practices on the cognitive development, orientations to learning, and educational aspirations of students during their first year of college. Analyses of longitudinal data from a representative sample of…

  17. Knowledge for the good of the individual and society: linking philosophy, disciplinary goals, theory, and practice.

    PubMed

    McCurry, Mary K; Revell, Susan M Hunter; Roy, Sr Callista

    2010-01-01

    Nursing as a profession has a social mandate to contribute to the good of society through knowledge-based practice. Knowledge is built upon theories, and theories, together with their philosophical bases and disciplinary goals, are the guiding frameworks for practice. This article explores a philosophical perspective of nursing's social mandate, the disciplinary goals for the good of the individual and society, and one approach for translating knowledge into practice through the use of a middle-range theory. It is anticipated that the integration of the philosophical perspective and model into nursing practice will strengthen the philosophy, disciplinary goal, theory, and practice links and expand knowledge within the discipline. With the focus on humanization, we propose that nursing knowledge for social good will embrace a synthesis of the individual and the common good. This approach converges vital and agency needs described by Hamilton and the primacy of maintaining the heritage of the good within the human species as outlined by Maritain. Further, by embedding knowledge development in a changing social and health care context, nursing focuses on the goals of clinical reasoning and action. McCubbin and Patterson's Double ABCX Model of Family Adaptation was used as an example of a theory that can guide practice at the community and global level. Using the theory-practice link as a foundation, the Double ABCX model provides practising nurses with one approach to meet the needs of individuals and society. The integration of theory into nursing practice provides a guide to achieve nursing's disciplinary goals of promoting health and preventing illness across the globe. When nursing goals are directed at the synthesis of the good of the individual and society, nursing's social and moral mandate may be achieved.

  18. Equilibrium Passive Sampling of POP in Lipid-Rich and Lean Fish Tissue: Quality Control Using Performance Reference Compounds.

    PubMed

    Rusina, Tatsiana P; Carlsson, Pernilla; Vrana, Branislav; Smedes, Foppe

    2017-10-03

    Passive sampling is widely used to measure levels of contaminants in various environmental matrices, including fish tissue. Equilibrium passive sampling (EPS) of persistent organic pollutants (POP) in fish tissue has been hitherto limited to application in lipid-rich tissue. We tested several exposure methods to extend EPS applicability to lean tissue. Thin-film polydimethylsiloxane (PDMS) passive samplers were exposed statically to intact fillet and fish homogenate and dynamically by rolling with cut fillet cubes. The release of performance reference compounds (PRC) dosed to passive samplers prior to exposure was used to monitor the exchange process. The sampler-tissue exchange was isotropic, and PRC were shown to be good indicators of sampler-tissue equilibration status. The dynamic exposures demonstrated equilibrium attainment in less than 2 days for all three tested fish species, including lean fish containing 1% lipid. Lipid-based concentrations derived from EPS were in good agreement with lipid-normalized concentrations obtained using conventional solvent extraction. The developed in-tissue EPS method is robust and has potential for application in chemical monitoring of biota and bioaccumulation studies.

  19. Examples of Holistic Good Practices in Promoting and Protecting Mental Health in the Workplace: Current and Future Challenges.

    PubMed

    Sivris, Kelly C; Leka, Stavroula

    2015-12-01

    While attention has been paid to physical risks in the work environment and the promotion of individual employee health, mental health protection and promotion have received much less focus. Psychosocial risk management has not yet been fully incorporated in such efforts. This paper presents good practices in promoting mental health in the workplace in line with World Health Organization (WHO) guidance by identifying barriers, opportunities, and the way forward in this area. Semistructured interviews were conducted with 17 experts who were selected on the basis of their knowledge and expertise in relation to good practice identified tools. Interviewees were asked to evaluate the approaches on the basis of the WHO model for healthy workplaces. The examples of good practice for Workplace Mental Health Promotion (WMHP) are in line with the principles and the five keys of the WHO model. They support the third objective of the WHO comprehensive mental health action plan 2013-2020 for multisectoral implementation of WMHP strategies. Examples of good practice include the engagement of all stakeholders and representatives, science-driven practice, dissemination of good practice, continual improvement, and evaluation. Actions to inform policies/legislation, promote education on psychosocial risks, and provide better evidence were suggested for higher WMHP success. The study identified commonalities in good practice approaches in different countries and stressed the importance of a strong policy and enforcement framework as well as organizational responsibility for WMHP. For progress to be achieved in this area, a holistic and multidisciplinary approach was unanimously suggested as a way to successful implementation.

  20. Examples of Holistic Good Practices in Promoting and Protecting Mental Health in the Workplace: Current and Future Challenges

    PubMed Central

    Sivris, Kelly C.; Leka, Stavroula

    2015-01-01

    Background While attention has been paid to physical risks in the work environment and the promotion of individual employee health, mental health protection and promotion have received much less focus. Psychosocial risk management has not yet been fully incorporated in such efforts. This paper presents good practices in promoting mental health in the workplace in line with World Health Organization (WHO) guidance by identifying barriers, opportunities, and the way forward in this area. Methods Semistructured interviews were conducted with 17 experts who were selected on the basis of their knowledge and expertise in relation to good practice identified tools. Interviewees were asked to evaluate the approaches on the basis of the WHO model for healthy workplaces. Results The examples of good practice for Workplace Mental Health Promotion (WMHP) are in line with the principles and the five keys of the WHO model. They support the third objective of the WHO comprehensive mental health action plan 2013–2020 for multisectoral implementation of WMHP strategies. Examples of good practice include the engagement of all stakeholders and representatives, science-driven practice, dissemination of good practice, continual improvement, and evaluation. Actions to inform policies/legislation, promote education on psychosocial risks, and provide better evidence were suggested for higher WMHP success. Conclusion The study identified commonalities in good practice approaches in different countries and stressed the importance of a strong policy and enforcement framework as well as organizational responsibility for WMHP. For progress to be achieved in this area, a holistic and multidisciplinary approach was unanimously suggested as a way to successful implementation. PMID:26929841

  1. 12 CFR 308.7 - Good faith certification.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 5 2014-01-01 2014-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  2. 12 CFR 1780.7 - Good faith certification.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 7 2011-01-01 2011-01-01 false Good faith certification. 1780.7 Section 1780.7... DEVELOPMENT RULES OF PRACTICE AND PROCEDURE RULES OF PRACTICE AND PROCEDURE General Rules § 1780.7 Good faith... record is well-grounded in fact and is warranted by existing law or a good faith, nonfrivolous argument...

  3. 12 CFR 263.7 - Good faith certification.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 4 2014-01-01 2014-01-01 false Good faith certification. 263.7 Section 263.7... (CONTINUED) RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  4. 12 CFR 263.7 - Good faith certification.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 3 2011-01-01 2011-01-01 false Good faith certification. 263.7 Section 263.7... RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith certification... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  5. 12 CFR 263.7 - Good faith certification.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 4 2013-01-01 2013-01-01 false Good faith certification. 263.7 Section 263.7... (CONTINUED) RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  6. 12 CFR 308.7 - Good faith certification.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 12 Banks and Banking 5 2012-01-01 2012-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  7. 12 CFR 263.7 - Good faith certification.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 12 Banks and Banking 4 2012-01-01 2012-01-01 false Good faith certification. 263.7 Section 263.7... (CONTINUED) RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  8. 12 CFR 308.7 - Good faith certification.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 5 2013-01-01 2013-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  9. 12 CFR 308.7 - Good faith certification.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 4 2011-01-01 2011-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  10. 12 CFR 308.7 - Good faith certification.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  11. 12 CFR 1780.7 - Good faith certification.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Good faith certification. 1780.7 Section 1780.7... DEVELOPMENT RULES OF PRACTICE AND PROCEDURE RULES OF PRACTICE AND PROCEDURE General Rules § 1780.7 Good faith... record is well-grounded in fact and is warranted by existing law or a good faith, nonfrivolous argument...

  12. 12 CFR 263.7 - Good faith certification.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 3 2010-01-01 2010-01-01 false Good faith certification. 263.7 Section 263.7... RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith certification... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  13. Optimized human platelet lysate as novel basis for a serum-, xeno-, and additive-free corneal endothelial cell and tissue culture.

    PubMed

    Thieme, Daniel; Reuland, Lynn; Lindl, Toni; Kruse, Friedrich; Fuchsluger, Thomas

    2018-02-01

    The expansion of donor-derived corneal endothelial cells (ECs) is a promising approach for regenerative therapies in corneal diseases. To achieve the best Good Manufacturing Practice standard the entire cultivation process should be devoid of nonhuman components. However, so far, there is no suitable xeno-free protocol for clinical applications. We therefore introduce a processed variant of a platelet lysate for the use in corneal cell and tissue culture based on a Good Manufacturing Practice-grade thrombocyte concentrate. This processed human platelet lysate (phPL), free of any animal components and of anticoagulants such as heparin with a physiological ionic composition, was used to cultivate corneal ECs in vitro and ex vivo in comparison to standard cultivation with fetal calf serum (FCS). Human donor corneas were cut in quarters while 2 quarters of each cornea were incubated with the respective medium supplement. Three fields of view per quarter were taken into account for the analysis. Evaluation of phPL as a medium supplement in cell culture of immortalized EC showed a superior viability compared with FCS control with reduced cell proliferation. Furthermore, the viability during the expansion of primary cells is significantly (3-fold ±0.5) increased with phPL compared with FCS standard medium. Quartering donor corneas was traumatic for the endothelium and therefore resulted in increased EC loss. Interestingly, however, cultivation of the quartered pieces for 2 weeks in 0.1-mg/ml pHPL in Biochrome I showed a 21 (±10) % EC loss compared with 67 (±12) % EC loss when cultivated in 2% FCS in Biochrome I. The cell culture protocol with pHPL as FCS replacement seems to be superior to the standard FCS protocols with respect to EC survival. It offers a xeno-free and physiological environment for corneal endothelial cells. This alternative cultivation protocol could facilitate the use of EC for human corneal cell therapy. Copyright © 2017 John Wiley & Sons, Ltd.

  14. Simulation of changes on the psychosocial risk in the nursing personnel after implementing the policy of good practices on the risk treatment.

    PubMed

    Bolívar Murcia, María Paula; Cruz González, Joan Paola; Rodríguez Bello, Luz Angélica

    2018-02-01

    Evaluate the change over time of psychosocial risk management for the nursing personnel of an intermediate complexity clinic of Bogota (Colombia). Descriptive and correlational research performed under the approach of risk management (identification, analysis, assessment and treatment). The psychosocial risk of the nursing personnel was studied through 10-year system dynamics models (with and without the implementation of the policy of good practices on the risk treatment) in two scenarios: when the nursing personnel works shifts of 6 hours (morning or afternoon) and when they work over 12 hours (double shift or night shift). When implementing a policy of good practices on the risk treatment, the double shift scenario shows an improvement among 25% to 88% in the variables of: health, labor motivation, burnout, service level and productivity; as well as in the variables of the organization associated to number of patients, nursing personnel and profit. Likewise, the single shift scenario with good practices improves in all the above-mentioned variables and generates stability on the variables of absenteeism and resignations. The best scenario is the single shift scenario with the application of good practices of risk treatment in comparison with the double shift scenario with good practices, which allows concluding that the good practices have a positive effect on the variables of nursing personnel and on those associated to the organization. Copyright© by the Universidad de Antioquia.

  15. European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of multifocal motor neuropathy.

    PubMed

    van Schaik, I N; Bouche, P; Illa, I; Léger, J-M; Van den Bergh, P; Cornblath, D R; Evers, E M A; Hadden, R D M; Hughes, R A C; Koski, C L; Nobile-Orazio, E; Pollard, J; Sommer, C; van Doorn, P A

    2006-08-01

    Several diagnostic criteria for multifocal motor neuropathy have been proposed in recent years and a beneficial effect of intravenous immunoglobulin (IVIg) and various other immunomodulatory drugs has been suggested in several trials and uncontrolled studies. The objectives were to prepare consensus guidelines on the definition, investigation and treatment of multifocal motor neuropathy. Disease experts and a patient representative considered references retrieved from MEDLINE and the Cochrane Library in July 2004 and prepared statements which were agreed in an iterative fashion. The Task Force agreed good practice points to define clinical and electrophysiological diagnostic criteria for multifocal motor neuropathy and investigations to be considered. The principal recommendations and good practice points were: (i) IVIg (2 g/kg given over 2-5 days) should be considered as the first line treatment (level A recommendation) when disability is sufficiently severe to warrant treatment. (ii) Corticosteroids are not recommended (good practice point). (iii) If initial treatment with IVIg is effective, repeated IVIg treatment should be considered (level C recommendation). The frequency of IVIg maintenance therapy should be guided by the individual response (good practice point). Typical treatment regimens are 1 g/kg every 2-4 weeks or 2 g/kg every 4-8 weeks (good practice point). (iv) If IVIg is not or not sufficiently effective then immunosuppressive treatment may be considered. Cyclophosphamide, ciclosporin, azathioprine, interferon beta1a, or rituximab are possible agents (good practice point). (v) Toxicity makes cyclophosphamide a less desirable option (good practice point).

  16. 7 CFR 1437.3 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... (including ornamental fish), and floriculture, an environment in which everything that can practicably be..., as determined by CCC. Good farming practices means the cultural practices generally used for the crop... good farming practices. T-Yield means the yield which is based on the county expected yield of the crop...

  17. Laboratory considerations of United States Pharmacopeia Chapter <71> sterility tests and its application to pharmaceutical compounding.

    PubMed

    Hyde, Tiffany D

    2014-01-01

    The purpose of this article is to describe United States Pharmacopeia Chapter <71> Sterility Tests from the perspective of Current Good Manufacturing Practices in order to aid compounding pharmacists in understanding the details and complexities that are required. Compounding pharmacists face a unique challenge in the industry today, with their compounding practice and the U.S. Food and Drug Administration trying to impose Current Good Manufacturing Practices guidelines. Naturally, this becomes a challenge to contract testing laboratories as well, as they are caught between the testing for non-Current Good Manufacturing Practices compounding standards and Current Good Manufacturing Practices manufacturing. It is important that the compounding pharmacist and their partner testing laboratory work closely together to ensure appropriate requirements are being met.

  18. [What everybody should know about good clinical practices].

    PubMed

    Osorio, Lyda

    2015-01-01

    An increasing number of countries are adopting good clinical practices guidelines as part of the regulation of clinical studies to register pharmaceutical products and other health-related products. Consequently, all parties involved in the research and development of these products should know them, implement them and ensure their compliance. However, good clinical practices guidelines are just one of the initiatives seeking to achieve the highest ethical and scientific standards in health research and in other areas where humans are research subjects. This review defines such practices and their objectives presenting in a practical manner their legal framework in Colombia, and clarifying their application in studies where interventions use no medications or those that are not clinical trials. Finally, the work discusses the challenges to ensure that good clinical practices contribute to the protection of research participants, the education of trustworthy health professionals, and a culture of respect for human beings.

  19. Guidelines for Good Epidemiology Practices for Occupational and Environmental Epidemiologic Research. The Chemical Manufacturers Association's Epidemiology Task Group.

    PubMed

    1991-12-01

    The Guidelines for Good Epidemiology Practices (GEPs) for Occupational and Environmental Epidemiologic Research address the conduct of studies generally undertaken to answer questions about human health in relationship to the work place or the environment. The GEPs propose minimum practices and procedures that should be considered to help ensure the quality and integrity of data used in epidemiologic research and to provide adequate documentation of the research methods. The GEPs address the process of conducting individual epidemiologic studies and do not prescribe specific research methods. The Guidelines for Good Epidemiology Practices propose minimum practices and procedures in the following areas: I. Organization and Personnel II. Facilities, Resource Commitment, and Contractors III. Protocol IV. Review and Approval V. Study Conduct VI. Communication VII. Archiving VIII. Quality Assurance Although the Guidelines for Good Epidemiology Practices will not guarantee good epidemiology, they do provide a useful framework for ensuring that all research issues are adequately addressed. This framework is proposed as a first step in improving epidemiologic research practices through adherence to sound scientific research principles. Appendices provide an overview of standard operating procedures, a glossary of terms used in the Guidelines, and suggested references on occupational epidemiology methods.

  20. 16 CFR 301.48a - Guaranties not received in good faith.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 1 2012-01-01 2012-01-01 false Guaranties not received in good faith. 301.48a Section 301.48a Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF... received in good faith. A guaranty shall not be deemed to have been received in good faith within the...

  1. 16 CFR 301.48a - Guaranties not received in good faith.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Guaranties not received in good faith. 301.48a Section 301.48a Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF... received in good faith. A guaranty shall not be deemed to have been received in good faith within the...

  2. 16 CFR 301.48a - Guaranties not received in good faith.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 1 2013-01-01 2013-01-01 false Guaranties not received in good faith. 301.48a Section 301.48a Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF... received in good faith. A guaranty shall not be deemed to have been received in good faith within the...

  3. 16 CFR 301.48a - Guaranties not received in good faith.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 1 2014-01-01 2014-01-01 false Guaranties not received in good faith. 301.48a Section 301.48a Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF... received in good faith. A guaranty shall not be deemed to have been received in good faith within the...

  4. [Experimental and clinical studies of flomoxef in the field of obstetrics and gynecology. Representative Committee Members of the Research Team for Infections in the Field of Obstetrics and Gynecology].

    PubMed

    Matsuda, S; Okada, H; Ninomiya, K; Shimizu, T; Noda, K; Deguchi, K

    1988-12-01

    Flomoxef (FMOX) has a broad antibacterial spectrum against Gram-positive and Gram-negative bacteria; especially its potent antibacterial activity against Staphylococcus aureus is a significant advantage that may not be found with other cephem compounds. In our determination of its antibacterial potency against various clinical isolates obtained from clinical materials (amniotic fluid, intrauterine secretions, exudates of the pelvic dead space) of patients with various infections, we obtained results representing specific features of this drug. From the results, the drug may be expected to produce an excellent effect in the treatment of various infections. Our study on drug concentrations in body fluids and genital tissues demonstrated a good transfer of this drug into various tissues; in every tissue examined, the drug administered by the usual method in the usual dose yielded a concentration exceeding MIC for principal pathogens, thus promising a good clinical response. Indeed a high clinical efficacy rate of 90.1% (good to very good responses) was obtained in a clinical trial involving 222 cases. Administration of the drug in 2 g quantity daily produced a high response rate of 92.8%. It was especially noteworthy that a good response was obtained in 30 of 32 cases (93.8%) in which other cephem compounds had failed. In evaluation of the bacteriological effect, furthermore, the drug showed an excellent rate of bacterial elimination. In conclusion, this drug is expected to be greatly useful in the light of its good transfer into genital tissues and its strong antibacterial activities against Gram-positive cocci, Gram-negative bacteria and anaerobes as well as against multiple bacterial infections predominating among women with genital infections.

  5. Good manufacturing practice production of [68Ga]Ga-ABY-025 for HER2 specific breast cancer imaging

    PubMed Central

    Velikyan, Irina; Wennborg, Anders; Feldwisch, Joachim; Lindman, Henrik; Carlsson, Jörgen; Sörensen, Jens

    2016-01-01

    Therapies targeting human epidermal growth factor receptor type 2 (HER2) have revolutionized breast cancer treatment, but require invasive biopsies and rigorous histopathology for optimal patient stratification. A non-invasive and quantitative diagnostic method such as positron emission tomography (PET) for the pre-therapeutic determination of the presence and density of the HER2 would significantly improve patient management efficacy and treatment cost. The essential part of the PET methodology is the production of the radiopharmaceutical in compliance with good manufacturing practice (GMP). The use of generator produced positron emitting 68Ga radionuclide would provide worldwide accessibility of the agent. GMP compliant, reliable and highly reproducible production of [68Ga]Ga-ABY-025 with control over the product peptide concentration and amount of radioactivity was accomplished within one hour. Two radiopharmaceuticals were developed differing in the total peptide content and were validated independently. The specific radioactivity could be kept similar throughout the study, and it was 6-fold higher for the low peptide content radiopharmaceutical. Intrapatient comparison of the two peptide doses allowed imaging optimization. The high peptide content decreased the uptake in healthy tissue, in particular liver, improving image contrast. The later imaging time points enhanced the contrast. The combination of high peptide content radiopharmaceutical and whole-body imaging at 2 hours post injection appeared to be optimal for routine clinical use. PMID:27186441

  6. Importance and globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients

    PubMed Central

    Abdellah, Abubaker; Noordin, Mohamed Ibrahim; Wan Ismail, Wan Azman

    2013-01-01

    Pharmaceutical excipients are no longer inert materials but it is effective and able to improve the characteristics of the products’ quality, stability, functionality, safety, solubility and acceptance of patients. It can interact with the active ingredients and alter the medicament characteristics. The globalization of medicines’ supply enhances the importance of globalized good manufacturing practice (GMP) requirements for pharmaceutical excipients. This review was intended to assess the globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients. The review outcomes demonstrate that there is a lack of accurately defined methods to evaluate and measure excipients’ safety. Furthermore good manufacturing practice requirements for excipients are not effectively globalized. PMID:25685037

  7. [The first experience with the concurrent effect of YAG-neodymium and YAG-erbium laser on experimental animal tissues and the possibility of its use in surgery].

    PubMed

    Roshal', L M; Gorbatova, N E; Livshits, Iu L; Parkhomenko, Iu G; Osiko, V V; Danileĭko, Iu K; Sidorin, A V; Tylaĭkova, T B; Ivanov, A D

    1991-08-01

    To guarantee the necessary rate of cutting live tissues with adequate hemostasis along the line of the incision, the authors studied isolated and joint effect of radiations of AIG-neodymium and AIG-erbium lasers on the tissues of laboratory animals. The possibility of accomplishing intraoperative hemostasis on the parenchymal organs was studied in experiments with AIG-neodymium laser. A good dissection effect in cutting various tissues was produced in the second series of experiments with AIG-erbium laser. The simultaneous action of AIG-neodymium and AIG-erbium beams converged at one point on the surface of the biological object was studied in the third series of experiments. It was found that the effect ensures a good dissection of tissues with sufficient hemostasis. The results of dynamic morphological studies are shown. The possibility of using the device in surgery is discussed.

  8. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2011-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format.

  9. Cryopreservation of human vascular umbilical cord cells under good manufacturing practice conditions for future cell banks

    PubMed Central

    2012-01-01

    Background In vitro fabricated tissue engineered vascular constructs could provide an alternative to conventional substitutes. A crucial factor for tissue engineering of vascular constructs is an appropriate cell source. Vascular cells from the human umbilical cord can be directly isolated and cryopreserved until needed. Currently no cell bank for human vascular cells is available. Therefore, the establishment of a future human vascular cell bank conforming to good manufacturing practice (GMP) conditions is desirable for therapeutic applications such as tissue engineered cardiovascular constructs. Materials and methods A fundamental step was the adaption of conventional research and development starting materials to GMP compliant starting materials. Human umbilical cord artery derived cells (HUCAC) and human umbilical vein endothelial cells (HUVEC) were isolated, cultivated, cryopreserved (short- and long-term) directly after primary culture and recultivated subsequently. Cell viability, expression of cellular markers and proliferation potential of fresh and cryopreserved cells were studied using trypan blue staining, flow cytometry analysis, immunofluorescence staining and proliferation assays. Statistical analyses were performed using Student’s t-test. Results Sufficient numbers of isolated cells with acceptable viabilities and homogenous expression of cellular markers confirmed that the isolation procedure was successful using GMP compliant starting materials. The influence of cryopreservation was marginal, because cryopreserved cells mostly maintain phenotypic and functional characteristics similar to those of fresh cells. Phenotypic studies revealed that fresh cultivated and cryopreserved HUCAC were positive for alpha smooth muscle actin, CD90, CD105, CD73, CD29, CD44, CD166 and negative for smoothelin. HUVEC expressed CD31, CD146, CD105 and CD144 but not alpha smooth muscle actin. Functional analysis demonstrated acceptable viability and sufficient proliferation properties of cryopreserved HUCAC and HUVEC. Conclusion Adaptation of cell isolation, cultivation and cryopreservation to GMP compliant starting materials was successful. Cryopreservation did not influence cell properties with lasting impact, confirming that the application of vascular cells from the human umbilical cord is feasible for cell banking. A specific cellular marker expression profile was established for HUCAC and HUVEC using flow cytometry analysis, applicable as a GMP compliant quality control. Use of these cells for the future fabrication of advanced therapy medicinal products GMP conditions are required by the regulatory authority. PMID:22591741

  10. Studies on the quantitative autoradiography. III. Quantitative comparison of a novel tissue-mold measurement technique "paste-mold method," to the semiquantitative whole body autoradiography (WBA), using the same animals.

    PubMed

    Motoji, N; Hamai, Y; Niikura, Y; Shigematsu, A

    1995-01-01

    A novel preparation technique, so called "Paste Mold," was devised for organ and tissue distribution studies. This is the most powerful by joining with autoradioluminography (ARLG), which was established and validated recently in the working group of Forum '93 of Japanese Society for study of xenobiotics. A small piece (10-50 mg) of each organ or tissue was available for measuring its radioactive concentration and it was sampled from the remains of frozen carcass used for macroautoradiography (MARG). The solubilization of the frozen pieces was performed with mixing a suitable volume of gelatine and strong alkaline solution prior to mild heating kept at 40 degrees C for a few hours. After that, the tissue paste was molded in template pattern to form the small plates. The molded plates were contacted with Imaging plate (IP) for recording their radioactive concentration. The recorded IP was processed by BAS2000. The molded plate was formed in thickness of 200 microns, so called infinit thickness against soft beta rays, and therefore the resulting relative intensities, represented by (PSL-BG)/S values, indicated practically responsible ratio of the radioactive concentration in organs and tissues, without any calibulation for beta-self absorption coefficiency. On the other hand, the left half body of the frozen carcass was used for making whole body autoradiography (WBA) before the Paste-Mold preparation. Comparison was performed for difference in (PSL-BG)/S values of organs and tissues between frozen and dried sections. A good concordance in relative intensities, (PSL-BG)/S by the Paste-Mold preparation was given with those by the frozen sections rather than dried sections.(ABSTRACT TRUNCATED AT 250 WORDS)

  11. Variable implementation of good practice recommendations for the assessment and management of UK children with neurodisability.

    PubMed

    Gray, L; Gibbs, J; Jolleff, N; Williams, J; McConachie, H; Parr, J R

    2015-11-01

    The aims of this study were to determine whether UK child development teams (CDTs) have implemented good practice recommendations for the co-ordinated assessment and support of children with neurodisability and to explore some of the factors associated with variations in good practice implementation. Surveys were sent to every UK CDT in 2009/2010. Responses about CDT provision and ways of working were compared with good practice recommendations from national policy documents and professional organizations. The extent to which CDTs in England and Wales met 11 selected good practice recommendations was scored; teams in Scotland and Northern Ireland were given a score out of 9 to reflect the optional use of the common assessment framework and early support materials in these countries. Responses were received from 225/240 (94%) UK CDTs. Thirty-seven per cent of CDTs in England and Wales had implemented nine or more of the 11 recommendations. Fifty-nine per cent of teams in Scotland and 78% of teams in Northern Ireland met between six and nine recommendations of good working practice. Higher levels of implementation of recommendations were found when the CDT had a Child Development Centre base and for teams who had received increased funding in the 5 years preceding the survey. There was considerable variability in the degree to which CDTs implemented good practice recommendations for the diagnosis and management of children with neurodisability. Evidence about child and parent satisfaction, and the effectiveness of CDT practices and provision, is required, so policymakers, healthcare commissioners and clinicians can provide the most appropriate services to children with neurodisability and their families. © 2015 John Wiley & Sons Ltd.

  12. 9 CFR 149.1 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... generates a written record documenting a pork production site's adherence to the required good production... production site for compliance with good production practices and other program requirements of the Trichinae... or higher, based on adherence to good production practices and other program requirements as provided...

  13. 9 CFR 149.1 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... generates a written record documenting a pork production site's adherence to the required good production... production site for compliance with good production practices and other program requirements of the Trichinae... or higher, based on adherence to good production practices and other program requirements as provided...

  14. Diabetes and Diabetic Retinopathy: Knowledge, Attitude, Practice (KAP) among Diabetic Patients in A Tertiary Eye Care Centre

    PubMed Central

    Srinivasan, Nithin Keshav; John, Deepa; Rebekah, Grace; Kujur, Evon Selina; Paul, Padma

    2017-01-01

    Introduction Diabetic retinopathy is becoming an increasingly important cause of visual impairment in India. Many diabetic patients who come to our centre have undetected, advanced diabetic retinopathy. If diabetic retinopathy had been detected earlier in these patients, irreversible visual impairment could have been prevented. Aim To document Knowledge, Attitude and Practice (KAP) patterns of diabetic patients regarding diabetes and diabetic retinopathy, to determine association between them, and to identify barriers to compliance with follow up and treatment regimes. Materials and Methods This was a hospital-based, cross-sectional study, conducted at the Department of Ophthalmology at Christian Medical College, Vellore, Tamil Nadu, India, over a six-month period from June 2013 to November 2013. Two hundred and eighty eight diabetic patients, who fulfilled the eligibility criteria, were included in the study. KAP of patients was assessed using a 45-point, verbally administered questionnaire. Patients were placed in different categories, such as, ‘good/ poor’ knowledge, ‘positive/negative’ attitude and ‘good/poor’ practice. Data were analysed using Chi-square test and binary logistic regression, as appropriate. The proportion of patients with ‘good/poor’ knowledge, ‘positive/negative’ attitude and ‘good/poor’ practice, and the association between KAP were studied. Barriers to compliance with follow up/treatment regimes were identified. Results Out of the 288 patients in the study, 42% had good knowledge about diabetes, but only 4.5% had good knowledge about retinopathy. Good knowledge about diabetes was significantly associated with positive attitude towards diabetes and good practice patterns regarding retinopathy; awareness of retinopathy was also significantly associated with good practice. A total of 61.1% of patients did not have periodic eye examination; most common barrier identified was lack of awareness about the necessity for this (38.5%). Conclusion Good knowledge about the disease was significantly associated with positive attitude and good practice patterns. Knowledge about diabetic retinopathy was poor among the patients in our study. Lack of awareness concerning the need for screening for retinopathy was a major barrier to regular screening. There is an urgent need to educate diabetic patients about this potentially blinding complication of diabetes. PMID:28892947

  15. The Utilization of the Seven Principles for Good Practices of Full-Time and Adjunct Faculty in Teaching Health & Science in Community Colleges

    ERIC Educational Resources Information Center

    Musaitif, Linda M.

    2013-01-01

    Purpose: The purpose of this study was to determine the degree to which undergraduate full-time and adjunct faculty members in the health and science programs at community colleges in Southern California utilize the seven principles of good practice as measured by the Faculty Inventory of the Seven Principles for Good Practice in Undergraduate…

  16. Guide to good practices for operations and administration updates through required reading

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    1992-12-01

    The purpose of this Guide to Good Practices is to provide Department of Energy (DOE) contractors with information that can be used to validate and/or modify existing programs relative to Conduct of Operations. This Guide to Good Practices is part of a series of guides designed to enhance the guidelines set forth in DOE Order 5480. 19, Conduct of Operations Requirements for DOE Facilities.'' (JDB)

  17. Guide to good practices for operations and administration updates through required reading

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    1992-12-01

    The purpose of this Guide to Good Practices is to provide Department of Energy (DOE) contractors with information that can be used to validate and/or modify existing programs relative to Conduct of Operations. This Guide to Good Practices is part of a series of guides designed to enhance the guidelines set forth in DOE Order 5480. 19, ``Conduct of Operations Requirements for DOE Facilities.`` (JDB)

  18. CHRODIS criteria applied to the MASK (MACVIA-ARIA Sentinel NetworK) Good Practice in allergic rhinitis: a SUNFRAIL report.

    PubMed

    Bousquet, J; Onorato, G L; Bachert, C; Barbolini, M; Bedbrook, A; Bjermer, L; de Sousa, J Correia; Chavannes, N H; Cruz, A A; De Manuel Keenoy, E; Devillier, P; Fonseca, J; Hun, S; Kostka, T; Hellings, P W; Illario, M; Ivancevich, J C; Larenas-Linnemann, D; Millot-Keurinck, J; Ryan, D; Samolinski, B; Sheikh, A; Yorgancioglu, A; Agache, I; Arnavielhe, S; Bewick, M; Annesi-Maesano, I; Anto, J M; Bergmann, K C; Bindslev-Jensen, C; Bosnic-Anticevich, S; Bouchard, J; Caimmi, D P; Camargos, P; Canonica, G W; Cardona, V; Carriazo, A M; Cingi, C; Colgan, E; Custovic, A; Dahl, R; Demoly, P; De Vries, G; Fokkens, W J; Fontaine, J F; Gemicioğlu, B; Guldemond, N; Gutter, Z; Haahtela, T; Hellqvist-Dahl, B; Jares, E; Joos, G; Just, J; Khaltaev, N; Keil, T; Klimek, L; Kowalski, M L; Kull, I; Kuna, P; Kvedariene, V; Laune, D; Louis, R; Magnan, A; Malva, J; Mathieu-Dupas, E; Melén, E; Menditto, E; Morais-Almeida, M; Mösges, R; Mullol, J; Murray, R; Neffen, H; O'Hehir, R; Palkonen, S; Papadopoulos, N G; Passalacqua, G; Pépin, J L; Portejoie, F; Price, D; Pugin, B; Raciborski, F; Simons, F E R; Sova, M; Spranger, O; Stellato, C; Todo Bom, A; Tomazic, P V; Triggiani, M; Valero, A; Valovirta, E; VandenPlas, O; Valiulis, A; van Eerd, M; Ventura, M T; Wickman, M; Young, I; Zuberbier, T; Zurkuhlen, A; Senn, A

    2017-01-01

    A Good Practice is a practice that works well, produces good results, and is recommended as a model. MACVIA-ARIA Sentinel Network (MASK), the new Allergic Rhinitis and its Impact on Asthma (ARIA) initiative, is an example of a Good Practice focusing on the implementation of multi-sectoral care pathways using emerging technologies with real life data in rhinitis and asthma multi-morbidity. The European Union Joint Action on Chronic Diseases and Promoting Healthy Ageing across the Life Cycle (JA-CHRODIS) has developed a checklist of 28 items for the evaluation of Good Practices. SUNFRAIL (Reference Sites Network for Prevention and Care of Frailty and Chronic Conditions in community dwelling persons of EU Countries), a European Union project, assessed whether MASK is in line with the 28 items of JA-CHRODIS. A short summary was proposed for each item and 18 experts, all members of ARIA and SUNFRAIL from 12 countries, assessed the 28 items using a Survey Monkey-based questionnaire. A visual analogue scale (VAS) from 0 (strongly disagree) to 100 (strongly agree) was used. Agreement equal or over 75% was observed for 14 items (50%). MASK is following the JA-CHRODIS recommendations for the evaluation of Good Practices.

  19. Tools to share good chairside teaching practice: a clinical scenario and appreciative questionnaire.

    PubMed

    Sweet, J; Wilson, J; Pugsley, L; Schofield, M

    2008-12-13

    This article provides a scenario for analysis of good chairside teaching practice to serve as a starting point for continued discussion in this complex field. Documented issues of good chairside teaching practice are cross-referenced to a clinical scenario with explanations in the form of a commentary. This provided the context for generating a set of questions that are provided as tools to support good chairside practice. These tools are designed to be used with 'Appreciative Inquiry', which claims that there is much to be gained by discovering where excellence is possible and elaborating upon this. Although this process can be carried out in single units or departments, it is proposed that collaboration between institutions would allow sharing of valuable innovations and greater understanding of educational training, production of good practice guidance and professional development of staff. This article is the third in a series of three and provides a scaffold for a scenario and questions to encourage collaboration in evolving and sharing good chairside teaching practice. The first article investigated the perceptions of stakeholders in chairside teaching at a single dental school and the second evaluated chairside teaching on a UK wide scale. A further accompanying article reviews some of the educational methodology and innovations in teaching and learning that may be applied to dentistry.

  20. 76 FR 24291 - Proposed National Marketing Agreement Regulating Leafy Green Vegetables; Recommended Decision and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-29

    ... Practices (GAPs) and Good Manufacturing Practices (GMPs), and United States Department of Agriculture (USDA) Good Handling Practices (GHPs). The program would be voluntary, and cover both United States and... referred to as the ``Act'', and the applicable rules of practice and procedure governing the formulation of...

  1. University hospital doctors: what are their beliefs about organ donation?

    PubMed

    Bassit, N H; Habiblah, M; Fadili, W; Laouad, I

    2013-01-01

    Organ and human tissue donation is not well developed in Morocco. This is due in part to the refusal of families, but also to a lack of awareness. We conducted a survey of a representative sample of doctors more exposed to the donation process to assess their knowledge and attitudes toward organ donation and their training needs. This is a cross-sectional study of physicians in Marrakech University Hospital. An anonymous questionnaire adapted to Moroccan context, assessing the knowledge, opinions, attitudes, and needs regarding organ donation was given to doctors. Among 130 distributed questionnaires, we collected 115 completely answered surveys. Respondees were as follows: 60.8% were females, 87 were residents and 28 interns, 80% were aged from 25 to 34 years, and 60% had practiced their profession for 1 to 5 years. Results showed that 28% don't know that tissue and organ donation from a cadaver is authorized in Morocco, 6% are aware of the organs and tissues that can be taken, 76% know the definition of brain death, 35% don't believe in this concept, 88% were favorable for the removal of organs and tissue of deceased persons, 10% ignore that Islam allows organ donation, 62% will give their organs and tissues after death, 25% refuse organ donation of a parent, and 30% refuse it of their children after death. Our findings show that there is discordance between knowledge and attitudes of doctors in our hospital toward organ donation. The promotion of organ donation requires good training of our teams to sensitize the population. Copyright © 2013 Elsevier Inc. All rights reserved.

  2. Harnessing the therapeutic potential of mesenchymal stem cells in multiple sclerosis

    PubMed Central

    Darlington, Peter J; Boivin, Marie-Noëlle; Bar-Or, Amit

    2011-01-01

    Phase I clinical trials exploring the use of autologous mesenchymal stem cell (MSC) therapy for the treatment of multiple sclerosis (MS) have begun in a number of centers across the world. MS is a complex and chronic immune-mediated and neurodegenerative disease influenced by genetic susceptibility and environmental risk factors. The ideal treatment for MS would involve both attenuation of detrimental inflammatory responses, and induction of a degree of tissue protection/regeneration within the CNS. Preclinical studies have demonstrated that both human-derived and murine-derived MSCs are able to improve outcomes in the animal model of MS, experimental autoimmune encephalomyelitis. How MSCs ameliorate experimental autoimmune encephalomyelitis is being intensely investigated. One of the major mechanisms of action of MSC therapy is to inhibit various components of the immune system that contribute to tissue destruction. Emerging evidence now supports the idea that MSCs can access the CNS where they can provide protection against tissue damage, and may facilitate tissue regeneration through the production of growth factors. The prospect of cell-based therapy using MSCs has several advantages, including the relative ease with which they can be extracted from autologous bone marrow or adipose tissue and expanded in vitro to reach the purity and numbers required for transplantation, and the fact that MSC therapy has already been used in other human disease settings, such as graft-versus-host and cardiac disease, with initial reports indicating a good safety profile. This article will focus on the theoretical and practical issues relevant to considerations of MSC therapy in the context of MS. PMID:21864075

  3. Becaplermin Topical

    MedlinePlus

    ... along with good ulcer care including: removal of dead tissue by a medical professional; the use of ... It works by helping to repair and replace dead skin and other tissues, attracting cells that repair ...

  4. Low-level lasers: their role in the mechanisms of the stimulation of the reparative processes

    NASA Astrophysics Data System (ADS)

    Yeliseenko, Vladimir I.

    1994-08-01

    The transformation of light energy into thermal energy with extremely high temperatures, the evaporation of interstitial and intracellular fluids, and the cytoplasmic proteins coagulation are the most important factors in the mechanism of high-power lasers effect on biological tissues. A set of dystrophic disorders develops in tissues as a result, up to the coagulative necrosis, which lays in the basis of the laser thermal crust at incised edges. With CO2 laser the damage is evident from the first cell layers. Its size is in the linear correlation with exposure time. The Nd:YAG and argon lasers' light penetrates the superficial cell layers without damage practically and realizes in deeper well vascularized tissue layers, the submucous layer of the gastrointestinal hollow organs, in particular. It depends on the closeness of the irradiation spectrum of absorption of hemoglobin and result in blood coagulation in the vascular lumine with formation of the `coagulative laser thrombi.' That explains a wide use of laser irradiation in urgent endoscopy for arresting acute gastrointestinal hemorrhages. For these reasons Nd:YAG laser `contact scalpel' technique with sapphire tips is used for incisions on parenchymatous organs with simultaneous blood coagulation in vessels lumina with good hemostasis and holestasis (hepatobiliar surgery), and for pancreas and thyroid surgery, in gynecology and other surgical areas.

  5. Clinical and forensic signs related to opioids abuse.

    PubMed

    Dinis-Oliveira, Ricardo Jorge; Carvalho, Felix; Moreira, Roxana; Duarte, Jose Alberto; Proenca, Jorge Brandao; Santos, Agostinho; Magalhaes, Teresa

    2012-12-01

    For a good performance in Clinical and Forensic Toxicology it is important to be aware of the biological and non-biological signs and symptoms related to xenobiotic exposure. This manuscript highlights and analyzes clinical and forensic imaging related to opioids abuse critically. Particularly, respiratory depression, track marks and hemorrhages, skin "popping", practices of phlebotomy, tissue necrosis and ulceration, dermatitis, tongue hyperpigmentation, "coma blisters", intra-arterial administration, candidiasis, wounds associated with anthrax or clostridium contaminated heroin, desomorphine related lesions and characteristic non-biological evidences are some commonly reported findings in opioids abuse, which will be discussed. For this purpose, clinical and forensic cases from our database (National Institute of Legal Medicine and Forensic Sciences, North Branch, Portugal), in addition to literature data, are reviewed.

  6. Juvenile Hormone Analogues, Methoprene and Fenoxycarb Dose-Dependently Enhance Certain Enzyme Activities in the Silkworm Bombyx Mori (L)

    PubMed Central

    Mamatha, Devi M.; Kanji, Vijaya K.; Cohly, Hari H.P.; Rao, M. Rajeswara

    2008-01-01

    Use of Juvenile Hormone Analogues (JHA) in sericulture practices has been shown to boost good cocoon yield; their effect has been determined to be dose-dependent. We studied the impact of low doses of JHA compounds such as methoprene and fenoxycarb on selected key enzymatic activities of the silkworm Bombyx mori. Methoprene and fenoxycarb at doses of 1.0 μg and 3.0fg/larvae/48 hours showed enhancement of the 5th instar B. mori larval muscle and silkgland protease, aspartate aminotransaminase (AAT) and alanine aminotransaminase (ALAT), adenosine triphosphate synthase (ATPase) and cytochrome-c-oxidase (CCO) activity levels, indicating an upsurge in the overall oxidative metabolism of the B.mori larval tissues. PMID:18678927

  7. Examination of the regulatory frameworks applicable to biologic drugs (including stem cells and their progeny) in Europe, the U.S., and Australia: part II--a method of software documentary analysis.

    PubMed

    Ilic, Nina; Savic, Snezana; Siegel, Evan; Atkinson, Kerry; Tasic, Ljiljana

    2012-12-01

    A wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Eighteen high-tier documents from the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and Therapeutic Goods Administration (TGA) regulatory frameworks were subject to automated text analysis. Selected documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Concepts, themes, and their co-occurrence were identified and compared. The most frequent concepts in TGA, FDA, and EMA frameworks were "biological," "product," and "medicinal," respectively. This was consistent with the previous manual terminology search. Good Manufacturing Practice documents, across frameworks, identified "quality" and "appropriate" as main concepts, whereas in Good Clinical Practice (GCP) documents it was "clinical," followed by "trial," "subjects," "sponsor," and "data." GCP documents displayed considerably higher concordance between different regulatory frameworks, as demonstrated by a smaller number of concepts, similar size, and similar distance between them. Although high-tier documents often use different terminology, they share concepts and themes. This paper may be a modest contribution to the recognition of similarities and differences between analyzed regulatory documents. It may also fill the literature gap and provide some foundation for future comparative research of biologic drug regulations on a global level.

  8. Tissue adaptation to physical stress: a proposed "Physical Stress Theory" to guide physical therapist practice, education, and research.

    PubMed

    Mueller, Michael J; Maluf, Katrina S

    2002-04-01

    The purpose of this perspective is to present a general theory--the Physical Stress Theory (PST). The basic premise of the PST is that changes in the relative level of physical stress cause a predictable adaptive response in all biological tissue. Specific thresholds define the upper and lower stress levels for each characteristic tissue response. Qualitatively, the 5 tissue responses to physical stress are decreased stress tolerance (eg, atrophy), maintenance, increased stress tolerance (eg, hypertrophy), injury, and death. Fundamental principles of tissue adaptation to physical stress are described that, in the authors' opinion, can be used to help guide physical therapy practice, education, and research. The description of fundamental principles is followed by a review of selected literature describing adaptation to physical stress for each of the 4 main organ systems described in the Guide to Physical Therapist Practice (ie, cardiovascular/pulmonary, integumentary, musculoskeletal, neuromuscular). Limitations and implications of the PST for practice, research, and education are presented.

  9. A flexible microneedle array as low-voltage electroporation electrodes for in vivo DNA and siRNA delivery.

    PubMed

    Wei, Zewen; Zheng, Shuquan; Wang, Renxin; Bu, Xiangli; Ma, Huailei; Wu, Yidi; Zhu, Ling; Hu, Zhiyuan; Liang, Zicai; Li, Zhihong

    2014-10-21

    In vivo electroporation is an appealing method to deliver nucleic acid into living tissues, but the clinical application of such a method was limited due to severe tissue damage and poor coverage of the tissue surface. Here we present the validation of a novel flexible microneedle array electrode (MNAE) chip, in which the microneedle array and the flexible substrate are integrated together to simultaneously facilitate low-voltage electroporation and accomplish good coverage of the tissue surface. The efficient delivery of both DNA and siRNA was demonstrated on mice. Upon penetrating the high-resistance stratum corneum, the electroporation voltage was reduced to about 35 V, which was generally recognized safe for humans. Also, a pathological analysis of the microneedle-electroporated tissues was carried out to thoroughly assess the skin damage, which is an important consideration in pre-clinical studies of electroporation devices. This MNAE constitutes a novel way of in vivo delivery of siRNA and DNA to certain tissues or organs with satisfactory efficiency and good adaptation to the tissue surface profile as well as minimum tissue damage, thus avoiding the disadvantages of existing electroporation methods.

  10. 21 CFR 184.1452 - Manganese gluconate.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ....1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

  11. 21 CFR 184.1452 - Manganese gluconate.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ....1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

  12. 21 CFR 184.1452 - Manganese gluconate.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ....1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

  13. 21 CFR 184.1452 - Manganese gluconate.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ....1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

  14. Documentation: Records and Reports.

    PubMed

    Akers, Michael J

    2017-01-01

    This article deals with documentation to include the beginning of documentation, the requirements of Good Manufacturing Practice reports and records, and the steps that can be taken to minimize Good Manufacturing Practice documentation problems. It is important to remember that documentation for 503a compounding involves the Formulation Record, Compounding Record, Standard Operating Procedures, Safety Data Sheets, etc. For 503b outsourcing facilities, compliance with Current Good Manufacturing Practices is required, so this article is applicable to them. For 503a pharmacies, one can see the development and modification of Good Manufacturing Practice and even observe changes as they are occurring in 503a documentation requirements and anticipate that changes will probably continue to occur. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

  15. Knowledge and practice of tuberculosis infection control among health professionals in Northwest Ethiopia; 2011.

    PubMed

    Temesgen, Chanie; Demissie, Meaza

    2014-11-19

    Tuberculosis (TB) is highly prevalent in sub-Saharan Africa, making the risk of infection transmission high in these countries. Despite high prevalence of TB and expected high probability of nosocomial transmission in Ethiopia, a rapid assessment done in 2008 revealed that most health facilities in Ethiopia do not use tuberculosis infection control (TBIC) practices. Patients and providers are therefore at risk of exposure to TB, especially at high case load facilities. The purpose of this study was to assess TBIC knowledge and practices among health professionals working in hospitals in the Amhara region of Northwest Ethiopia. An institution-based hybrid study was implemented form August 2010 to January 2011. The subjects were health professionals who were proportionally selected from each hospital. Subjects self-administered a questionnaire that contained sections on socio-demographics and on TBIC knowledge and practice. Those answering ≥60% of knowledge questions correctly and ≥50% of practice questions correctly were considered to have good knowledge and practice, respectively. A total of 313 healthcare professionals were enrolled from four healthcare facilities. The response rate was 96%. Only 18.8% received in-service training. Among those who were trained, 74.4%, 95% CI (69.6, 79.3%) were found to have good knowledge and 63.2%, 95% CI (57.9, 68.6%) good practice on TBIC. Training was found to be a predictor of TBIC knowledge, AOR* 3.386 and 95% CI (1.377, 8.330) while knowledge of TBIC was a strong predictor of good TBIC practice, AOR* 10.667 and 95% CI (5.769, 19.721). Though the majority of the respondents had good TBIC knowledge and practice, a considerable proportion of healthcare professionals were not trained on TBIC. Respondents trained on TBIC were found to be more knowledgeable than those not trained. Similarly, respondents with good TBIC knowledge were 10 times more likely to have good TBIC practice compared to those with poor TBIC knowledge. Training was not found to have an effect on TBIC practice. *Adjusted Odds Ratio.

  16. Soil, nickel and low nickel food

    NASA Astrophysics Data System (ADS)

    Chami, Ziad Al; Cavoski, Ivana; Mondelli, Donato; Mimiola, Giancarlo; Miano, Teodoro

    2013-04-01

    Nickel is an ubiquitous trace element and occurs in soil, water, air and in the biosphere. Ni is an essential element for several plants, microorganisms and vertebrates. Human requirement for Ni has not been conclusively demonstrated. Nickel is normally present in human tissues at low concentration and, under conditions of high exposure, these levels may increase significantly. Food is the major source of Ni exposure. Nickel is present in many food products, especially vegetables. The amount of Ni present in vegetables is increasing because of environmental contamination and cultural practices. It has been demonstrated that the consumption of a Ni-rich diet can cause an increase of immunological disorders including Systemic Ni Allergy Syndrome (SNAS). The SNAS patients are currently treated with a diet that is closely Ni-free. Therefore, there is a need to produce certified and guaranteed vegetables with a low Ni concentration in the market. The proposed research aims to develop new methods for vegetable production and innovative cultural practices through a suitable choice of agricultural soil, cultivar, amendments and fertilizers as well as good agricultural practices in order to reduce Ni plant uptake and its translocation to the edible plant parts and therefore to produce Ni-free food products for SNAS patients.

  17. What Is "Good" Mentoring? Understanding Mentoring Practices of Teacher Induction through Case Studies of Finland and Australia

    ERIC Educational Resources Information Center

    Pennanen, Matti; Bristol, Laurette; Wilkinson, Jane; Heikkinen, Hannu L. T.

    2016-01-01

    Mentoring is a practice widely utilised to support new teachers. However, in locally formed systems, the practice of mentoring is conditioned by traditions and arrangements specific to the site. To understand "good" mentoring, these local arrangements cannot be ignored. In this article, the theory of practice architectures is employed to…

  18. 40 CFR 792.1 - Scope.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) GOOD LABORATORY PRACTICE STANDARDS General Provisions § 792.1 Scope. (a) This part prescribes good laboratory practices for conducting studies relating to health effects, environmental effects, and chemical...

  19. 40 CFR 792.1 - Scope.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) GOOD LABORATORY PRACTICE STANDARDS General Provisions § 792.1 Scope. (a) This part prescribes good laboratory practices for conducting studies relating to health effects, environmental effects, and chemical...

  20. Good Policy, Good Practice II. Improving Outcomes and Productivity in Higher Education: A Guide for Policymakers

    ERIC Educational Resources Information Center

    Brenneman, Meghan Wilson; Callan, Patrick M.; Ewell, Peter T.; Finney, Joni E.; Jones, Dennis P.; Zis, Stacey

    2010-01-01

    This new edition of "Good Policy, Good Practice II" revises and updates the authors' 2007 publication. Like the earlier edition, it responds to one of the questions that is raised most frequently in the authors' work with public policy and education leaders as they begin to address the national and state imperatives to increase the proportion of…

  1. Global perspectives on ensuring the safety of pharmaceutical products in the distribution process
.

    PubMed

    Jeong, Sohyun; Ji, Eunhee

    2018-01-01

    The distribution of counterfeit or falsified drugs is increasing worldwide. This can contribute to the high burden of disease and cost to society and is of global concern with the worldwide circulation of pharmaceuticals. The preparation and implementation of good distribution practice should be one of the most important aspects of ensuring safe drug circulation and administration. This research aimed to compare and analyze good distribution practice guidelines from advanced countries and international organizations, and to evaluate the status of the current good distribution practice guidelines in the world. Advanced pharmaceutical countries and international organizations, such as the World Health Organization, European Union, Pharmaceutical Inspection Co-operation Scheme, United States of America, Canada, and Australia, which have stable good distribution practice guidelines and public confidence, were included in the analysis. The World Health Organization and European Union guidelines are models for standardized good distribution practice for nations worldwide. The United States of America has a combination of four different series of distribution practices which have a unique structure and detailed content compared to those of other countries. The Canadian guidelines focus on temperature control during storage and transportation. The Australian guidelines apply to both classes of medicinal products and medical devices and need separate standardization. Transparent information about the Internet chain, international cooperation regarding counterfeiting, a high-standard qualification of sellers and customers, and technology to track and trace the whole life cycle of drugs should be the main focus of future good distribution practice guidelines worldwide.
.

  2. Hydroxyapatite-doped polycaprolactone nanofiber membrane improves tendon-bone interface healing for anterior cruciate ligament reconstruction.

    PubMed

    Han, Fei; Zhang, Peng; Sun, Yaying; Lin, Chao; Zhao, Peng; Chen, Jiwu

    2015-01-01

    Hamstring tendon autograft is a routine graft for anterior cruciate ligament (ACL) reconstruction. However, ways of improving the healing between the tendon and bone is often overlooked in clinical practice. This issue can be addressed by using a biomimetic scaffold. Herein, a biomimetic nanofiber membrane of polycaprolactone/nanohydroxyapatite/collagen (PCL/nHAp/Col) is fabricated that mimics the composition of native bone tissue for promoting tendon-bone healing. This membrane has good cytocompatibility, allowing for osteoblast cell adhesion and growth and bone formation. As a result, MC3T3 cells reveal a higher mineralization level in PCL/nHAp/Col membrane compared with PCL membrane alone. Further in vivo studies in ACL reconstruction in a rabbit model shows that PCL/nHAp/Col-wrapped tendon may afford superior tissue integration to nonwrapped tendon in the interface between the tendon and host bone as well as improved mechanical strength. This study shows that PCL/nHAp/Col nanofiber membrane wrapping of autologous tendon is effective for improving tendon healing with host bone in ACL reconstruction.

  3. The ethical dimensions of wildlife disease management in an evolutionary context.

    PubMed

    Crozier, Gkd; Schulte-Hostedde, Albrecht I

    2014-08-01

    Best practices in wildlife disease management require robust evolutionary ecological research (EER). This means not only basing management decisions on evolutionarily sound reasoning, but also conducting management in a way that actively contributes to the on-going development of that research. Because good management requires good science, and good science is 'good' science (i.e., effective science is often science conducted ethically), good management therefore also requires practices that accord with sound ethical reasoning. To that end, we propose a two-part framework to assist decision makers to identify ethical pitfalls of wildlife disease management. The first part consists of six values - freedom, fairness, well-being, replacement, reduction, and refinement; these values, developed for the ethical evaluation of EER practices, are also well suited for evaluating the ethics of wildlife disease management. The second part consists of a decision tree to help identify the ethically salient dimensions of wildlife disease management and to guide managers toward ethically responsible practices in complex situations. While ethical reasoning cannot be used to deduce from first principles what practices should be undertaken in every given set of circumstances, it can establish parameters that bound what sorts of practices will be acceptable or unacceptable in certain types of scenarios.

  4. Measuring water contents in animal organ tissues using terahertz spectroscopic imaging.

    PubMed

    Lee, Kyumin; Jeoung, Kiyong; Kim, Sang Hoon; Ji, Young-Bin; Son, Hyeyoung; Choi, Yuna; Huh, Young-Min; Suh, Jin-Suck; Oh, Seung Jae

    2018-04-01

    We investigated the water contents in several organ tissues such as the liver, spleen, kidney, and brain tissue of rats using the terahertz spectroscopic imaging technique. The water contents of the tissues were determined by using a simple equation containing the absorption coefficients of fresh and lyophilized tissues and water. We compared the measured water contents with the difference in mass of tissues before and after lyophilization. All results showed a good match except for the kidney, which has several Bowman's capsules.

  5. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 4 2010-10-01 2010-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than 10...

  6. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 4 2014-10-01 2014-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than 10...

  7. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 4 2012-10-01 2012-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than 10...

  8. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 4 2013-10-01 2013-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than 10...

  9. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 4 2011-10-01 2011-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than 10...

  10. 76 FR 49509 - Records Schedules; Availability and Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-10

    ... Agency (N1-258-09-3, 1 item, 1 temporary item). Good Farming Practice Documentation, including producer... reconsideration of adverse good farming practice determinations. 3. Department of Agriculture, Risk Management... materials, legislation files, negotiation files, review files, unfair trade practices files, and...

  11. 76 FR 55067 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-06

    ... Pharmaceutical Current Good Manufacturing Practice AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Good Manufacturing Practice--(OMB Control Number 0910-0563)--Extension The guidance is intended to... products, on how to resolve disputes of scientific and technical issues relating to current good...

  12. 21 CFR 184.1449 - Manganese citrate.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

  13. I Am Mentor, I Am Coach

    ERIC Educational Resources Information Center

    Augustine-Shaw, Donna; Reilly, Marceta

    2017-01-01

    Preparing good leaders depends not only on providing good initial professional learning, but also on creating a strong support structure during the early years of practice. However, what good mentoring looks and sounds like varies widely in practice. Many mentoring programs for education leaders consist of buddy-like relationships that provide…

  14. The new laparoscopic proctocolectomy training (in soft cadaver).

    PubMed

    Pattana-arun, Jirawat; Udomsawaengsup, Suthep; Sahakitrungruang, Chucheep; Tansatit, Tanvaa; Tantiphlachiva, Kasaya; Rojanasakul, Arun

    2005-09-01

    The purpose of the present study was to evaluate the quality of preservation (tissue plane, named vessels identification, consistency of colon and rectum), quality of performing procedures, difficulties and problems and finally the satisfaction of surgeons in laparoscopic proctocolectomy in soft cadaver. Colorectal Division, Department of Surgery and Surgical Training Center Department of Anatomy, Faculty of Medicine, Chulalongkorn University. Prospective descriptive study 10 soft cadavers were scheduled for laparoscopic proctocolectomy. The procedures (colon-rectum mobilization and named vessels identification) were performed by 14 experienced surgeons (8 colorectal surgeons) and assisted by surgical residents. The quality of preservation, successfulness and the satisfaction in performing the procedures were recorded using questionnaires for evaluation. The preservation was very good in every aspect especially tissue plane between colon, mesocolon and retroperitoneum which was clearly dissected, same asfasciapropria of rectum. The named vessels and the tissue consistency were very well preserved and tolerated to laparoscopic equipment handling. The surgeons were satisfied with the tissue handling and dissections. There were two difficulties, the first was air leakage but simply corrected with purse string suture and the second was unflavored smell which was not concerned. Laparoscopic proctocolectomy could be completely performed in soft cadaver. Laparoscopic proctocolectomy could be performed in soft cadavers with great satisfaction. Repeated practice is possible, so the surgeons can gain their experiences outside the operating theatre. This success may shorten the learning curve and may be the new era in cadaver-based training.

  15. Animal imaging using immersion

    NASA Astrophysics Data System (ADS)

    Kalogerakis, Konstantinos S.; Kotz, Kenneth T.; Rand, Kendra; Faris, Gregory W.

    2003-07-01

    We are using rodent animal models to study and compare contrast mechanisms for detection of breast cancer. These measurements are performed with the animals immersed in a matching scattering medium. The matching scattering medium or liquid tissue phantom comprises a mixture of Ropaque (hollow acrylic/styrene microspheres) and ink. We have previously applied matched imaging to imaging in humans. Surrounding the imaged region with a matched tissue phantom compensates for variations in tissue thickness and geometry, provides more uniform illumination, and allows better use of the dynamic range of the imaging system. If the match is good, the boundaries of the imaged region should almost vanish, enhancing the contrast from internal structure as compared to contrast from the boundaries and surface topography. For our measurements in animals, the immersion plays two additional roles. First, we can readily study tumors through tissue thickness similar to that of a human breast. Although the heterogeneity of the breast is lost, this is a practical method to study the detection of small tumors and monitor changes as they grow. Second, the immersion enhances our ability to quantify the contrast mechanisms for peripheral tumors on the animal because the boundary effects on photon migration are eliminated. We are currently developing two systems for these measurements. One is a continuous-wave (CW) system based on near-infrared LED illumination and a CCD (charge-coupled device) camera. The second system, a frequency domain system, can help quantify the changes observed with the CW system.

  16. Comparative study of different techniques for the sterilization of poly-L-lactide electrospun microfibers: effectiveness vs. material degradation.

    PubMed

    Rainer, Alberto; Centola, Matteo; Spadaccio, Cristiano; Gherardi, Giovanni; Genovese, Jorge A; Licoccia, Silvia; Trombetta, Marcella

    2010-02-01

    Electrospinning of biopolymeric scaffolds is a new and effective approach for creating replacement tissues to repair defects and/or damaged tissues with direct clinical application. However, many hurdles and technical concerns regarding biological issues, such as cell retention and the ability to grow, still need to be overcome to gain full access to the clinical arena. Interaction with the host human tissues, immunogenicity, pathogen transmission as well as production costs, technical expertise, and good manufacturing and laboratory practice requirements call for careful consideration when aiming at the production of a material that is available off-the-shelf, to be used immediately in operative settings. The issue of sterilization is one of the most important steps for the clinical application of these scaffolds. Nevertheless, relatively few studies have been performed to systematically investigate how sterilization treatments may affect the properties of electrospun polymers for tissue engineering. This paper presents the results of a comparative study of different sterilization techniques applied to an electrospun poly-L-lactide scaffold: soaking in absolute ethanol, dry oven and autoclave treatments, UV irradiation, and hydrogen peroxide gas plasma treatment. Morphological and chemical characterization was coupled with microbiological sterility assay to validate the examined sterilization techniques in terms of effectiveness and modifications to the scaffold. The results of this study reveal that UV irradiation and hydrogen peroxide gas plasma are the most effective sterilization techniques, as they ensure sterility of the electrospun scaffolds without affecting their chemical and morphological features.

  17. Reconstructing in-vivo reflectance spectrum of pigmented skin lesion by Monte Carlo simulation

    NASA Astrophysics Data System (ADS)

    Wang, Shuang; He, Qingli; Zhao, Jianhua; Lui, Harvey; Zeng, Haishan

    2012-03-01

    In dermatology applications, diffuse reflectance spectroscopy has been extensively investigated as a promising tool for the noninvasive method to distinguish melanoma from benign pigmented skin lesion (nevus), which is concentrated with the skin chromophores like melanin and hemoglobin. We carried out a theoretical study to examine melanin distribution in human skin tissue and establish a practical optical model for further pigmented skin investigation. The theoretical simulation was using junctional nevus as an example. A multiple layer skin optical model was developed on established anatomy structures of skin, the published optical parameters of different skin layers, blood and melanin. Monte Carlo simulation was used to model the interaction between excitation light and skin tissue and rebuild the diffuse reflectance process from skin tissue. A testified methodology was adopted to determine melanin contents in human skin based on in vivo diffuse reflectance spectra. The rebuild diffuse reflectance spectra were investigated by adding melanin into different layers of the theoretical model. One of in vivo reflectance spectra from Junctional nevi and their surrounding normal skin was studied by compare the ratio between nevus and normal skin tissue in both the experimental and simulated diffuse reflectance spectra. The simulation result showed a good agreement with our clinical measurements, which indicated that our research method, including the spectral ratio method, skin optical model and modifying the melanin content in the model, could be applied in further theoretical simulation of pigmented skin lesions.

  18. Images of otoscopy: rate and extent of non-compliance with good practice standards.

    PubMed

    Crundwell, G; Harmer, J; Maltby, M; Mills, T; Neumann, C; Walsh, L; Baguley, D

    2015-01-01

    The British Society of Audiology has produced clear guidelines as to how otoscopy should be undertaken; however, no nationally recognised guidelines exist for the wider clinical community. Images of otoscopy appear in many books, journals, magazines and websites. This study aimed to determine the rate of non-compliance with good practice in images of otoscopy, the seriousness of the breach, and whether this is more common in sites for professionals or the general public. Google Images was searched using the terms 'otoscopy' and 'ear examination'. A total of 200 images were identified and collated. The images were reviewed for compliance with good practice standards. Only 12.75 per cent of the images were graded as having no breach of good practice standards. Professional websites have a responsibility to show best practice. When choosing an image, the source of the image needs to be carefully considered.

  19. Good documentation practice in clinical research

    PubMed Central

    Bargaje, Chitra

    2011-01-01

    One of the most common inspection findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data. This article focuses on the key principles of good documentation practice and offers suggestions for improvement. PMID:21731856

  20. Good documentation practice in clinical research.

    PubMed

    Bargaje, Chitra

    2011-04-01

    One of the most common inspection findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data. This article focuses on the key principles of good documentation practice and offers suggestions for improvement.

  1. The confusion in complying with good manufacturing practice requirements in Malaysia

    NASA Astrophysics Data System (ADS)

    Jali, Mohd Bakri; Ghani, Maaruf Abdul; Nor, Norazmir Md

    2016-11-01

    Food manufacturing operations need to fulfil regulatory requirements related to hygiene and good manufacturing practices (GMP) to successfully market their products as safe and quality products. GMP based on its ten elements used as guidelines to ensure control over biological, chemical and physical hazards. This study aims to investigate the confusion for design and facilities elements among food industries. Both qualitative and quantitative techniques are used as systematic tools. Design and facilities elements lay a firm foundation for good manufacturing practice to ensure food hygiene and should be used in conjunction with each specific code of hygiene practice and guidelines.

  2. Evaluation Instruments and Good Practices in Online Education

    ERIC Educational Resources Information Center

    Baldwin, Sally J.; Trespalacios, Jesús

    2017-01-01

    Chickering and Gamson's (1987) "Seven Principles for Good Practice in Undergraduate Education" offers extensively researched and validated tenets for best practices in higher education. After a review of the literature, twenty-eight evaluation instruments currently used to design and review online courses in higher education institutions…

  3. Leading Change in Tissue Viability Best Practice: An Action Learning Programme for Link Nurse Practitioners

    ERIC Educational Resources Information Center

    Kellie, Jean; Henderson, Eileen; Milsom, Brian; Crawley, Hayley

    2010-01-01

    This account of practice reports on an action learning initiative designed and implemented in partnership between a regional NHS Acute Trust and a UK Business School. The central initiative was the implementation of an action learning programme entitled "Leading change in tissue viability best practice: a development programme for Link Nurse…

  4. Knowledge, attitude, and practice regarding dengue virus infection among inhabitants of Aceh, Indonesia: a cross-sectional study.

    PubMed

    Harapan, Harapan; Rajamoorthy, Yogambigai; Anwar, Samsul; Bustamam, Aslam; Radiansyah, Arsil; Angraini, Pradiba; Fasli, Riny; Salwiyadi, Salwiyadi; Bastian, Reza Akbar; Oktiviyari, Ade; Akmal, Imaduddin; Iqbalamin, Muhammad; Adil, Jamalul; Henrizal, Fenni; Darmayanti, Darmayanti; Pratama, Rovy; Setiawan, Abdul Malik; Mudatsir, Mudatsir; Hadisoemarto, Panji Fortuna; Dhimal, Mandira Lamichhane; Kuch, Ulrich; Groneberg, David Alexander; Imrie, Allison; Dhimal, Meghnath; Müller, Ruth

    2018-02-27

    The Indonesian region of Aceh was the area most severely affected by the earthquake and tsunami of 26 December 2004. Department of Health data reveal an upward trend of dengue cases in Aceh since the events of the tsunami. Despite the increasing incidence of dengue in the region, there is limited understanding of dengue among the general population of Aceh. The aim of this study was to assess the knowledge, attitude, and practice (KAP) regarding dengue among the people of Aceh, Indonesia in order to design intervention strategies for an effective dengue prevention program. A community-based cross-sectional study was conducted in Aceh between November 2014 and March 2015 with a total of 609 participants living in seven regencies and two municipalities. Information on the socio-demographic characteristics of participants and their KAP regarding dengue was collected using a pre-tested structured questionnaire. The KAP status (good vs. poor) of participants with different socio-demographic characteristics was compared using Chi Square-test, ANOVA or Fisher's exact test as appropriate. Logistic regression analysis was used to determine the predictors of each KAP domain. We found that 45% of participants had good knowledge regarding dengue and only 32% had good attitudes and good dengue preventive practices. There was a significant positive correlation between knowledge and attitudes, knowledge and practice, and attitudes and practice. In addition, people who had good knowledge were 2.7 times more likely to have good attitudes, and people who had good attitudes were 2.2 times more likely to have good practices regarding dengue. The level of education, occupation, marital status, monthly income, socioeconomic status (SES) and living in the city were associated with the knowledge level. Occupation, SES, and having experienced dengue fever were associated with attitudes. Education, occupation, SES and type of residence were associated with preventive practices. Our study suggests that dengue prevention programs are required to increase KAP levels regarding dengue in the communities of Aceh.

  5. A knowledge infrastructure for occupational safety and health.

    PubMed

    van Dijk, Frank J H; Verbeek, Jos H; Hoving, Jan L; Hulshof, Carel T J

    2010-12-01

    Occupational Safety and Health (OSH) professionals should use scientific evidence to support their decisions in policy and practice. Although examples from practice show that progress has been made in evidence-based decision making, there is a challenge to improve and extend the facilities that support knowledge translation in practice. A knowledge infrastructure that supports OSH practice should include scientific research, systematic reviews, practice guidelines, and other tools for professionals such as well accessible virtual libraries and databases providing knowledge, quality tools, and good learning materials. A good infrastructure connects facilities with each other and with practice. Training and education is needed for OSH professionals in the use of evidence to improve effectiveness and efficiency. New initiatives show that occupational health can profit from intensified international collaboration to establish a good functioning knowledge infrastructure.

  6. Human dental pulp stem cells: from biology to clinical applications.

    PubMed

    d'Aquino, Riccardo; De Rosa, Alfredo; Laino, Gregorio; Caruso, Filippo; Guida, Luigi; Rullo, Rosario; Checchi, Vittorio; Laino, Luigi; Tirino, Virginia; Papaccio, Gianpaolo

    2009-07-15

    Dental pulp stem cells (DPSCs) can be found within the "cell rich zone" of dental pulp. Their embryonic origin, from neural crests, explains their multipotency. Up to now, two groups have studied these cells extensively, albeit with different results. One group claims that these cells produce a "dentin-like tissue", whereas the other research group has demonstrated that these cells are capable of producing bone, both in vitro and in vivo. In addition, it has been reported that these cells can be easily cryopreserved and stored for long periods of time and still retain their multipotency and bone-producing capacity. Moreover, recent attention has been focused on tissue engineering and on the properties of these cells: several scaffolds have been used to promote 3-D tissue formation and studies have demonstrated that DPSCs show good adherence and bone tissue formation on microconcavity surface textures. In addition, adult bone tissue with good vascularization has been obtained in grafts. These results enforce the notion that DPSCs can be used successfully for tissue engineering. (c) 2008 Wiley-Liss, Inc.

  7. 29 CFR 790.18 - “Administrative practice or enforcement policy.”

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Faith Reliance on Administrative Regulations, Etc. § 790.18 “Administrative practice or enforcement... employee, because of reliance in good faith on an administrative practice or enforcement policy only (1... acts or omissions led the employer to believe in good faith that such acts or omissions were not...

  8. 29 CFR 790.18 - “Administrative practice or enforcement policy.”

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Faith Reliance on Administrative Regulations, Etc. § 790.18 “Administrative practice or enforcement... employee, because of reliance in good faith on an administrative practice or enforcement policy only (1... acts or omissions led the employer to believe in good faith that such acts or omissions were not...

  9. 29 CFR 790.18 - “Administrative practice or enforcement policy.”

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Faith Reliance on Administrative Regulations, Etc. § 790.18 “Administrative practice or enforcement... employee, because of reliance in good faith on an administrative practice or enforcement policy only (1... acts or omissions led the employer to believe in good faith that such acts or omissions were not...

  10. 9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... rodent population and other pests under control; (6) Tailor vaccination programs to needs of farm and... and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma... management practices for the control of Salmonella and Mycoplasma infections. (a) The following procedures...

  11. 9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... rodent population and other pests under control; (6) Tailor vaccination programs to needs of farm and... and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma... management practices for the control of Salmonella and Mycoplasma infections. (a) The following procedures...

  12. 9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... rodent population and other pests under control; (6) Tailor vaccination programs to needs of farm and... and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma... management practices for the control of Salmonella and Mycoplasma infections. (a) The following procedures...

  13. 16 CFR 453.3 - Misrepresentations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Misrepresentations. (a) Embalming provisions—(1) Deceptive acts or practices. In selling or offering to sell funeral... practices. In selling or offering to sell funeral goods or funeral services to the public, it is a deceptive... practices. In selling or offering to sell funeral goods and funeral services to the public, it is a...

  14. 9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma... management practices for the control of Salmonella and Mycoplasma infections. (a) The following procedures...) Allow no visitors except under controlled conditions to minimize the introduction of Salmonella and...

  15. The constraints of good governance practice in national solid waste management policy (NSWMP) implementation: A case study of Malaysia

    NASA Astrophysics Data System (ADS)

    Wee, Seow Ta; Abas, Muhamad Azahar; Chen, Goh Kai; Mohamed, Sulzakimin

    2017-10-01

    Nowadays, international donors have emphasised on the adoption of good governance practices in solid waste management which include policy implementation. In Malaysia, the National Solid Waste Management Policy (NSWMP) was introduced as the main guideline for its solid waste management and the Malaysian government has adopted good governance practice in the NSMWP implementation. However, the good governance practices implemented by the Malaysian government encountered several challenges. This study was conducted to explore the good governance constraints experienced by stakeholders in the NSWMP implementation. An exploratory research approach is applied in this study through in-depth interviews with several government agencies and concessionaires that involved in the NSWMP implementation in Malaysia. A total of six respondents took part in this study. The findings revealed three main good governance constraints in the NSWMP implementation, namely inadequate fund, poor staff's competency, and ambiguity of policy implementation system. Moreover, this study also disclosed that the main constraint influenced the other constraints. Hence, it is crucial to identify the main constraint in order to minimise its impact on the other constraints.

  16. Development of dopant-free conductive bioelastomers

    PubMed Central

    Xu, Cancan; Huang, Yihui; Yepez, Gerardo; Wei, Zi; Liu, Fuqiang; Bugarin, Alejandro; Tang, Liping; Hong, Yi

    2016-01-01

    Conductive biodegradable materials are of great interest for various biomedical applications, such as tissue repair and bioelectronics. They generally consist of multiple components, including biodegradable polymer/non-degradable conductive polymer/dopant, biodegradable conductive polymer/dopant or biodegradable polymer/non-degradable inorganic additives. The dopants or additives induce material instability that can be complex and possibly toxic. Material softness and elasticity are also highly expected for soft tissue repair and soft electronics. To address these concerns, we designed a unicomponent dopant-free conductive polyurethane elastomer (DCPU) by chemically linking biodegradable segments, conductive segments, and dopant molecules into one polymer chain. The DCPU films which had robust mechanical properties with high elasticity and conductivity can be degraded enzymatically and by hydrolysis. It exhibited great electrical stability in physiological environment with charge. Mouse 3T3 fibroblasts survived and proliferated on these films exhibiting good cytocompatibility. Polymer degradation products were non-toxic. DCPU could also be processed into a porous scaffold and in an in vivo subcutaneous implantation model, exhibited good tissue compatibility with extensive cell infiltration over 2 weeks. Such biodegradable DCPU with good flexibility and elasticity, processability, and electrical stability may find broad applications for tissue repair and soft/stretchable/wearable bioelectronics. PMID:27686216

  17. Trade in human tissue products.

    PubMed

    Tonti-Filippini, Nicholas; Zeps, Nikolajs

    2011-03-07

    Trade in human tissue in Australia is prohibited by state law, and in ethical guidelines by the National Health and Medical Research Council: National statement on ethical conduct in human research; Organ and tissue donation by living donors: guidelines for ethical practice for health professionals. However, trade in human tissue products is a common practice especially for: reconstructive orthopaedic or plastic surgery; novel human tissue products such as a replacement trachea created by using human mesenchymal stem cells; biomedical research using cell lines, DNA and protein provided through biobanks. Cost pressures on these have forced consideration of commercial models to sustain their operations. Both the existing and novel activities require a robust framework to enable commercial uses of human tissue products while maintaining community acceptability of such practices, but to date no such framework exists. In this article, we propose a model ethical framework for ethical governance which identifies specific ethical issues such as: privacy; unique value of a person's tissue; commodification of the body; equity and benefit to the community; perverse incentives; and "attenuation" as a potentially useful concept to help deal with the broad range of subjective views relevant to whether it is acceptable to commercialise certain human tissue products.

  18. Good cell culture practices &in vitro toxicology.

    PubMed

    Eskes, Chantra; Boström, Ann-Charlotte; Bowe, Gerhard; Coecke, Sandra; Hartung, Thomas; Hendriks, Giel; Pamies, David; Piton, Alain; Rovida, Costanza

    2017-12-01

    Good Cell Culture Practices (GCCP) is of high relevance to in vitro toxicology. The European Society of Toxicology In Vitro (ESTIV), the Center for Alternatives for Animal Testing (CAAT) and the In Vitro Toxicology Industrial Platform (IVTIP) joined forces to address by means of an ESTIV 2016 pre-congress session the different aspects and applications of GCCP. The covered aspects comprised the current status of the OECD guidance document on Good In Vitro Method Practices, the importance of quality assurance for new technological advances in in vitro toxicology including stem cells, and the optimized implementation of Good Manufacturing Practices and Good Laboratory Practices for regulatory testing purposes. General discussions raised the duality related to the difficulties in implementing GCCP in an academic innovative research framework on one hand, and on the other hand, the need for such GCCP principles in order to ensure reproducibility and robustness of in vitro test methods for toxicity testing. Indeed, if good cell culture principles are critical to take into consideration for all uses of in vitro test methods for toxicity testing, the level of application of such principles may depend on the stage of development of the test method as well as on the applications of the test methods, i.e., academic innovative research vs. regulatory standardized test method. Copyright © 2017 Elsevier Ltd. All rights reserved.

  19. [Qualitative evaluation of employer requirements associated with occupational health and safety as good practice in small-scale enterprises].

    PubMed

    Kuroki, Naomi; Miyashita, Nana; Hino, Yoshiyuki; Kayashima, Kotaro; Fujino, Yoshihisa; Takada, Mikio; Nagata, Tomohisa; Yamataki, Hajime; Sakuragi, Sonoko; Kan, Hirohiko; Morita, Tetsuya; Ito, Akiyoshi; Mori, Koji

    2009-09-01

    The purpose of this study was to identify what motivates employers to promote good occupational health and safety practices in small-scale enterprises. Previous studies have shown that small-scale enterprises generally pay insufficient attention to issues of occupational health and safety. These findings were mainly derived from questionnaire based surveys. Nevertheless, some small-scale enterprises in which employers exercise good leadership do take a progressive approach to occupational health and safety. Although good practices can be identified in small-scale enterprises, it remains unclear what motivates employers in small-scale enterprises to actively implement occupational health and safety practices. We speculated that identifying employer motivations in promoting occupational health would help to spread good practices among small-scale enterprises. Using a qualitative approach based on the KJ methods, we interviewed ten employers who actively promote occupational health and safety in the workplace. The employers were asked to discuss their views of occupational health and safety in their own words. A semi-structured interview format was used, and transcripts were made of the interviews. Each transcript was independently coded by two or more researchers. These transcripts and codes were integrated and then the research group members discussed the heading titles and structural relationships between them according to the KJ method. Qualitative analysis revealed that all the employers expressed a strong interest in a "good company" and "good management". They emphasized four elements of "good management", namely "securing human resources", "trust of business partners", "social responsibility" and "employer's health condition itself", and considered that addressing occupational health and safety was essential to the achievement of these four elements. Consistent with previous findings, the results showed that implementation of occupational health and safety activities depended on "cost", "human resources", "time to perform", and "advisory organization". These results suggest that employer awareness of the relationship between good management and occupational health is essential to the implementation of occupational health and safety practices in small-scale enterprises.

  20. "Inclusive Working Life" in Norway--experience from "Models of Good Practice" enterprises.

    PubMed

    Lie, Arve

    2008-08-01

    To determine whether enterprises belonging to the Bank of Models of Good Practice were more successful than average Norwegian enterprises in the reduction of sickness absence, promotion of early return to work, and prevention of early retirement. In 2004 we selected 86 enterprises with a total of approximately 90000 employees from the Inclusive Working Life (IWL) Bank of Models of Good Practice. One representative of workers and one of management from each enterprise received a questionnaire on the aims, organization, and the results of the IWL program by mail. Data on sickness absence, use of early retirement, and disability retirement in the 2000-2004 period were collected from the National Insurance Registry. Data on comparable enterprises were obtained from the National Bureau of Statistics. The response rate was 65%. Although the IWL campaign was directed at reducing sickness absence, preventing early retirement, and promoting employment of the functionally impaired, most attention was paid to reducing sickness absence. Sickness absence rate in Models of Good Practice enterprises (8.2%) was higher than in comparable enterprises that were not part of the Models of Good Practice (6.9%). Implementation of many IWL activities, empowerment and involvement of employees, and good cooperation with the occupational health service were associated with a lower rate of sickness absence. On average, 0.7% new employees per year received disability pension, which is a significantly lower percentage than expected on the basis of the rate of 1.3% per year in comparable enterprises. Frequent use of disability pensioning was associated with high rate of sickness absence and having many employees older than 50 years. On average, 0.4% employees per year received early retirement compensation, which was expected on the basis of national estimates. Frequent use of early retirement was associated with having many employees older than 50 years. Models of Good Practice enterprises had a higher than expected sickness absence rate. This indicates that it is difficult to identify Models of Good Practice enterprises and that they cannot be treated as role model enterprises. Good cooperation with the occupational health service and the empowerment and involvement of the employees is associated with a low sickness absence rate.

  1. Pay for performance of Estonian family doctors and impact of different practice- and patient-related characteristics on a good outcome: A quantitative assessment.

    PubMed

    Merilind, Eero; Salupere, Rauno; Västra, Katrin; Kalda, Ruth

    2016-01-01

    Several practice- and patient-related characteristics are reported to have an influence on a good quality outcome. Estonia started the pay-for-performance (P4P) system for family doctors (FDs) in 2006. Every year the number of FDs participating in P4P has increased, but only half of the FDs achieved good outcome. The aim of this study was to find out which practice- and patient-related characteristics could have an impact on a good outcome. The study was conducted using the database from the Estonian Health Insurance Fund. All working FDs were divided into two groups (with "good" and "poor" outcomes) according their achievements in P4P. We chose characteristics which described structure (practice list size, number of doctors, composition of FDs list: age, number of chronically ill patients) during the observation period 2006-2012. During the observation period 2006-2012, the number of FDs with a good outcome in P4P increased from 6% (2006) to 53% (2012). The high number of FDs in primary care teams, longer experience of participation in P4P and the smaller number of patients on FDs' lists all have an impact on a good outcome. The number of chronically ill patients in FDs lists has no significant effect on an outcome, but P4P increases the number of disease-diagnosed patients. Different practice and patient-related characteristics have an impact on a good outcome. As workload increases, smaller lists of FDs patients or increased staff levels are needed in order to maintain a good outcome. Copyright © 2016 The Lithuanian University of Health Sciences. Production and hosting by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

  2. Workplace etiquette for the medical practice employee.

    PubMed

    Hills, Laura

    2010-01-01

    Medical practice workplace etiquette is slowly being modified and fine-tuned. New workplace etiquette rules have become necessary because of advances in communications technology, shifting norms, and expectations of what constitutes good manners. Today's medical practice employees must concern themselves with traditional workplace manners but also the manners that come into play when they make or receive cell phone calls, text messages, and e-mails, and when they use social networking media outside of work. This article offers 25 rules for good manners in the medical practice that relate to the ways employees interact with people today, whether face-to-face or when using electronic communications technologies. It offers practical guidelines for making introductions both inside and outside the medical practice. This article also provides a self-quiz to help medical practice employees assess their workplace etiquette intelligence and 12 tips for good workplace table manners.

  3. The "general recognition and acceptance" standard of objectivity for good faith in prescribing: legal and medical implications.

    PubMed

    Brushwood, David B

    2007-01-01

    The United States Court of Appeals for the 4th Circuit has ruled that a jury considering charges of drug trafficking against a pain management physician should be instructed that the defendant's good faith is a defense to the charges. The court rejected a subjective standard of good faith, and instead ruled that the good faith of the defendant must be evaluated from an objective perspective. This objective standard requires that the jury determine whether the defendant was practicing in accordance with the standard generally recognized and accepted in the United States. General recognition and acceptance are determined on a case-by-case basis, within the context of a defendant's practice. Simply because a physician's practice is out of the norm for many physicians does not mean it can't be generally recognized and accepted within the standard of medical practice. Expert witness testimony of pain management physicians will assist juries in the application of this standard for good faith in prescribing.

  4. Non-invasive assessment of leaf water status using a dual-mode microwave resonator.

    PubMed

    Dadshani, Said; Kurakin, Andriy; Amanov, Shukhrat; Hein, Benedikt; Rongen, Heinz; Cranstone, Steve; Blievernicht, Ulrich; Menzel, Elmar; Léon, Jens; Klein, Norbert; Ballvora, Agim

    2015-01-01

    The water status in plant leaves is a good indicator for the water status in the whole plant revealing stress if the water supply is reduced. The analysis of dynamic aspects of water availability in plant tissues provides useful information for the understanding of the mechanistic basis of drought stress tolerance, which may lead to improved plant breeding and management practices. The determination of the water content in plant tissues during plant development has been a challenge and is currently feasible based on destructive analysis only. We present here the application of a non-invasive quantitative method to determine the volumetric water content of leaves and the ionic conductivity of the leaf juice from non-invasive microwave measurements at two different frequencies by one sensor device. A semi-open microwave cavity loaded with a ceramic dielectric resonator and a metallic lumped-element capacitor- and inductor structure was employed for non-invasive microwave measurements at 150 MHz and 2.4 Gigahertz on potato, maize, canola and wheat leaves. Three leaves detached from each plant were chosen, representing three developmental stages being representative for tissue of various age. Clear correlations between the leaf- induced resonance frequency shifts and changes of the inverse resonator quality factor at 2.4 GHz to the gravimetrically determined drying status of the leaves were found. Moreover, the ionic conductivity of Maize leaves, as determined from the ratio of the inverse quality factor and frequency shift at 150 MHz by use of cavity perturbation theory, was found to be in good agreement with direct measurements on plant juice. In conjunction with a compact battery- powered circuit board- microwave electronic module and a user-friendly software interface, this method enables rapid in-vivo water amount assessment of plants by a handheld device for potential use in the field.

  5. 76 FR 2123 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-12

    ...; Current Good Manufacturing Practice Quality System Regulation AGENCY: Food and Drug Administration, HHS... information entitled ``Current Good Manufacturing Practice Quality System Regulation'' has been approved by...

  6. 40 CFR 68.56 - Maintenance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CHEMICAL... testing procedures shall follow recognized and generally accepted good engineering practices. The...' recommendations, industry standards or codes, good engineering practices, and prior operating experience. ...

  7. 40 CFR 68.56 - Maintenance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CHEMICAL... testing procedures shall follow recognized and generally accepted good engineering practices. The...' recommendations, industry standards or codes, good engineering practices, and prior operating experience. ...

  8. 40 CFR 68.56 - Maintenance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CHEMICAL... testing procedures shall follow recognized and generally accepted good engineering practices. The...' recommendations, industry standards or codes, good engineering practices, and prior operating experience. ...

  9. 40 CFR 68.56 - Maintenance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CHEMICAL... testing procedures shall follow recognized and generally accepted good engineering practices. The...' recommendations, industry standards or codes, good engineering practices, and prior operating experience. ...

  10. 40 CFR 68.56 - Maintenance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CHEMICAL... testing procedures shall follow recognized and generally accepted good engineering practices. The...' recommendations, industry standards or codes, good engineering practices, and prior operating experience. ...

  11. 21 CFR 184.1143 - Ammonium sulfate.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... chapter, and processing aid as defined in § 170.3(o)(24) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.15 percent for baked goods as defined in...

  12. Virtue Ethics, Care Ethics, and "The Good Life of Teaching"

    ERIC Educational Resources Information Center

    Silverman, Marissa

    2012-01-01

    In "The Good Life of Teaching: An Ethics of Professional Practice," Chris Higgins (2011) reminds people that "self-interest and altruism, personal freedom and social roles, and practical wisdom and personhood" have been ancient philosophical topics that remain vitally important in the practice of contemporary teaching and learning. One of the most…

  13. Assuring Best Practice in Technology-Enhanced Learning Environments

    ERIC Educational Resources Information Center

    Keppell, Mike; Suddaby, Gordon; Hard, Natasha

    2015-01-01

    This paper documents the development and findings of the Good Practice Report on Technology-Enhanced Learning and Teaching funded by the Australian Learning and Teaching Council (ALTC). Developing the Good Practice Report required a meta-analysis of 33 ALTC learning and teaching projects relating to technology funded between 2006 and 2010. This…

  14. Discrimination and Good Practice Activities in Education: Trends and Developments in the 27 EU Member States

    ERIC Educational Resources Information Center

    Pollak, Alexander

    2008-01-01

    The European Union Agency for Fundamental Rights collects, through its network of observation points, information on discrimination and good practice in the areas of legislation, employment, housing, racist violence, and education. Data on education includes information on: access to education for vulnerable groups, discriminatory practices,…

  15. Good Laboratory Practice. Part 1. An Introduction

    ERIC Educational Resources Information Center

    Wedlich, Richard C.; Libera, Agata E.; Pires, Amanda; Therrien, Matthew T.

    2013-01-01

    The Good Laboratory Practice (GLP) regulations were put into place in 1978. They establish a standard of practice to ensure that results from the nonclinical laboratory study reported to the U.S. Food and Drug Administration (FDA) are valid and that the study report accurately reflects the conduct of the study. While the GLP regulations promulgate…

  16. Mycobacteriosis in zebrafish colonies.

    PubMed

    Whipps, Christopher M; Lieggi, Christine; Wagner, Robert

    2012-01-01

    Mycobacteriosis, a chronic bacterial infection, has been associated with severe losses in some zebrafish facilities and low-level mortalities and unknown impacts in others. The occurrence of at least six different described species (Mycobacterium abscessus, M. chelonae, M. fortuitum, M. haemophilum, M. marinum, M. peregrinum) from zebrafish complicates diagnosis and control because each species is unique. As a generalization, mycobacteria are often considered opportunists, but M. haemophilum and M. marinum appear to be more virulent. Background genetics of zebrafish and environmental conditions influence the susceptibility of fish and progression of disease, emphasizing the importance of regular monitoring and good husbandry practices. A combined approach to diagnostics is ultimately the most informative, with histology as a first-level screen, polymerase chain reaction for rapid detection and species identification, and culture for strain differentiation. Occurrence of identical strains of Mycobacterium in both fish and biofilms in zebrafish systems suggests transmission can occur when fish feed on infected tissues or tank detritus containing mycobacteria. Within a facility, good husbandry practices and sentinel programs are essential for minimizing the impacts of mycobacteria. In addition, quarantine and screening of animals coming into a facility is important for eliminating the introduction of the more severe pathogens. Elimination of mycobacteria from an aquatic system is likely not feasible because these species readily establish biofilms on surfaces even in extremely low nutrient conditions. Risks associated with each commonly encountered species need to be identified and informed management plans developed. Basic research on the growth characteristics, disinfection, and pathogenesis of zebrafish mycobacteria is critical moving forward.

  17. Development and validation of a multiplex quantitative polymerase chain reaction assay for the detection of Mollicutes impurities in human cells, cultured under good manufacturing practice conditions, and following European Pharmacopoeia requirements and the International Conference on Harmonization guidelines.

    PubMed

    Vanni, Irene; Ugolotti, Elisabetta; Raso, Alessandro; Di Marco, Eddi; Melioli, Giovanni; Biassoni, Roberto

    2012-07-01

    The clinical applications of in vitro manipulated cultured cells and their precursors are often made use of in therapeutic trials. However, tissue cultures can be easily contaminated by the ubiquitous Mollicutes micro-organisms, which can cause various and severe alterations in cellular function. Thus methods able to detect and trace Mollicutes impurities contaminating cell cultures are required before starting any attempt to grow cells under good manufacturing practice (GMP) conditions. We developed a multiplex quantitative polymerase chain reaction (qPCR) assay specific for the 16S-23S rRNA intergenic spacer regions, for the Tuf and P1 cytoadhesin genes, able to detect contaminant Mollicutes species in a single tube reaction. The system was validated by analyzing different cell lines and the positive samples were confirmed by 16S and P1 cytoadhesin gene dideoxy sequencing. Our multiplex qPCR detection system was able to reach a sensitivity, specificity and robustness comparable with the culture and the indicator cell culture method, as required by the European Pharmacopoeia guidelines. We have developed a multiplex qPCR method, validated following International Conference on Harmonization (ICH) guidelines, as a qualitative limit test for impurities, assessing the validation characteristics of limit of detection and specificity. It also follows the European Pharmacopoeia guidelines and Food and Drug Administration (FDA) requirements.

  18. The biochemical, nanomechanical and chemometric signatures of brain cancer

    NASA Astrophysics Data System (ADS)

    Abramczyk, Halina; Imiela, Anna

    2018-01-01

    Raman spectroscopy and imaging combined with AFM topography and mechanical indentation by AFM have been shown to be an effective tool for analysis and discrimination of human brain tumors from normal structures. Raman methods have potential to be applied in clinical practice as they allow for identification of tumor margins during surgery. In this study, we investigate medulloblastoma (grade IV WHO) (n = 5) and the tissue from the negative margins used as normal controls. We compare a high grade medulloblastoma (IV grade), and non-tumor samples from human central nervous system (CNS) tissue. Based on the properties of the Raman vibrational spectra and Raman images we provide a real-time feedback that is label-free method to monitor tumor metabolism that reveals reprogramming of biosynthesis of lipids, and proteins. We have found that the high-grade tumors of central nervous system (medulloblastoma) exhibit enhanced level of β-sheet conformation and down-regulated level of α-helix conformation when comparing against normal tissue. We have shown that the ratio of Raman intensities I2930/I2845 at 2930 and 2845 cm- 1 is a good source of information on the ratio of lipid and protein contents. We have found that the ratio reflects the lipid and protein contents of tumorous brain tissue compared to the non-tumor tissue. Almost all brain tumors have the Raman intensity ratios significantly higher (1.99 ± 0.026) than that found in non-tumor brain tissue, which is 1.456 ± 0.02, and indicates that the relative amount of lipids compared to proteins is significantly higher in the normal brain tissue. Mechanical indentation using AFM on sliced human brain tissues (medulloblastoma, grade IV) revealed that the mechanical properties of this tissue are strongly heterogeneous, between 1.8 and 75.7 kPa, and the mean of 27.16 kPa. The sensitivity and specificity obtained directly from PLSDA and cross validation gives a sensitivity and specificity of 98.5% and 96% and 96.3% and 92% for cross-validation, respectively. The high sensitivity and specificity demonstrates usefulness for a proper decision for a Raman diagnostic test on biochemical alterations monitored by Raman spectroscopy related to brain cancer development.

  19. Proteomic analysis of formalin-fixed paraffin-embedded renal tissue samples by label-free MS: assessment of overall technical variability and the impact of block age.

    PubMed

    Craven, Rachel A; Cairns, David A; Zougman, Alexandre; Harnden, Patricia; Selby, Peter J; Banks, Rosamonde E

    2013-04-01

    Protein profiling of formalin-fixed paraffin-embedded (FFPE) tissues has enormous potential for the discovery and validation of disease biomarkers. The aim of this study was to systematically characterize the effect of length of time of storage of such tissue blocks in pathology archives on the quality of data produced using label-free MS. Normal kidney and clear cell renal cell carcinoma tissues routinely collected up to 10 years prior to analysis were profiled using LC-MS/MS and the data analyzed using MaxQuant. Protein identities and quantification data were analyzed to examine differences between tissue blocks of different ages and assess the impact of technical and biological variability. An average of over 2000 proteins was seen in each sample with good reproducibility in terms of proteins identified and quantification for normal kidney tissue, with no significant effect of block age. Greater biological variability was apparent in the renal cell carcinoma tissue, possibly reflecting disease heterogeneity, but again there was good correlation between technical replicates and no significant effect of block age. These results indicate that archival storage time does not have a detrimental effect on protein profiling of FFPE tissues, supporting the use of such tissues in biomarker discovery studies. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  20. ASSESSMENT OF GOOD PRACTICES IN HOSPITAL FOOD SERVICE BY COMPARING EVALUATION TOOLS.

    PubMed

    Macedo Gonçalves, Juliana; Lameiro Rodrigues, Kelly; Santiago Almeida, Ângela Teresinha; Pereira, Giselda Maria; Duarte Buchweitz, Márcia Rúbia

    2015-10-01

    since food service in hospitals complements medical treatment, it should be produced in proper hygienic and sanitary conditions. It is a well-known fact that food-transmitted illnesses affect with greater severity hospitalized and immunosuppressed patients. good practices in hospital food service are evaluated by comparing assessment instruments. good practices were evaluated by a verification list following Resolution of Collegiate Directory n. 216 of the Brazilian Agency for Sanitary Vigilance. Interpretation of listed items followed parameters of RCD 216 and the Brazilian Association of Collective Meals Enterprises (BACME). Fisher's exact test was applied to detect whether there were statistically significant differences. Analysis of data grouping was undertaken with Unweighted Pair-group using Arithmetic Averages, coupled to a correlation study between dissimilarity matrixes to verify disagreement between the two methods. Good Practice was classified with mean total rates above 75% by the two methods. There were statistically significant differences between services and food evaluated by BACME instrument. Hospital Food Services have proved to show conditions of acceptable good practices. the comparison of interpretation tools based on RCD n. 216 and BACME provided similar results for the two classifications. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  1. The innovative safe fixative for histology, histopathology, and immunohistochemistry techniques: "pilot study using shellac alcoholic solution fixative".

    PubMed

    Ali Jamal, Awatif; Abd El-Aziz, Gamal Said; Hamdy, Raid Mahmoud; Al-Hayani, Abdulmonem; Al-Maghrabi, Jaudah

    2014-05-01

    The concerns over health and workplace hazards of formalin fixative, joined to its cross-linking of molecular groups that results in suboptimal immunohistochemistry, led us to search for an innovative safe fixative. Shellac is a natural material which is used as a preservative in foods and pharmaceutical industries. This study was undertaken to evaluate the fixation adequacy and staining quality of histopathological specimens fixed in the "shellac alcoholic solution" (SAS), and also to determine the validity of immunohistochemical staining of SAS-fixed material in comparison to those fixed in formalin. Fresh samples from 26 cases from various human tissues were collected at the frozen section room of King Abdulaziz University Hospital, and fixed in SAS fixative or in neutral buffered formaldehyde (NBF) for 12, 18, 24, and 48 h, and processed for paraffin sectioning. Deparaffinized sections were stained with hematoxylin and eosin (H&E) and immunostained for different antigens. The tissues fixed in SAS for >18 h showed best staining quality of H&E comparable to NBF-fixed tissues. Comparison of the immunohistochemical staining of different tissues yielded nearly equivalent readings with good positive nuclear staining quality in both fixatives. These findings support the fixation and preservation adequacy of SAS. Furthermore, it was concluded that the good staining quality obtained with SAS-fixed tissues, which was more or less comparable with the quality obtained with the formalin fixed tissues, supports the validity of this new solution as a good innovative fixative. Copyright © 2014 Wiley Periodicals, Inc.

  2. An investigation of the application of laser-assisted indocyanine green fluorescent dye angiography in pedicle transverse rectus abdominus myocutaneous breast reconstruction.

    PubMed

    Newman, Martin I; Samson, Michel C; Tamburrino, Joseph F; Swartz, Kimberly A; Brunworth, Louis

    2011-01-01

    Pedicle transverse rectus abdominus myocutaneous (pTRAM) flaps remain the most common method of autologous tissue breast reconstruction. Using pTRAM flaps, complications often arise postoperatively, secondary to inadequate circulation. Tissues from distant angiosomes are associated with poorer perfusion, but this differs among patients. Many modalities have been used to reduce the risk of complications, but none have achieved widespread application. The authors believe that laser-assisted indocyanine green fluorescent dye angiography (LA-ICGA) can potentially reduce the risk of complications. In two routine, single-pedicle, ipsilateral pTRAM flaps, LA-ICGA imaging was performed following the division of the distal rectus muscle and deep inferior epigastric pedicle. The resulting images were used to guide design of the flap and debridement. In case 1, good perfusion was observed in zone 1 and part of zone 2. In case 2, good perfusion was observed in zone 1 and 50% of zone 3, with little perfusion in zone 2. In both cases, tissues with poor perfusion were debrided before transfer and inset. In both patients, there were no issues with wound healing, tissue necrosis or fat necrosis. The variability of perfusion of the pTRAM flap among individuals is well appreciated. LA-ICGA helped to determine the limits of good perfusion and, therefore, the limits of tissue to be preserved for transfer and inset. This helped to avoid harvesting poorly perfused tissue that would have almost certainly experienced necrosis and, ultimately, would have reduced the risk of postoperative complications.

  3. An investigation of the application of laser-assisted indocyanine green fluorescent dye angiography in pedicle transverse rectus abdominus myocutaneous breast reconstruction

    PubMed Central

    Newman, Martin I; Samson, Michel C; Tamburrino, Joseph F; Swartz, Kimberly A; Brunworth, Louis

    2011-01-01

    BACKGROUND: Pedicle transverse rectus abdominus myocutaneous (pTRAM) flaps remain the most common method of autologous tissue breast reconstruction. Using pTRAM flaps, complications often arise postoperatively, secondary to inadequate circulation. Tissues from distant angiosomes are associated with poorer perfusion, but this differs among patients. Many modalities have been used to reduce the risk of complications, but none have achieved widespread application. The authors believe that laser-assisted indocyanine green fluorescent dye angiography (LA-ICGA) can potentially reduce the risk of complications. METHODS: In two routine, single-pedicle, ipsilateral pTRAM flaps, LA-ICGA imaging was performed following the division of the distal rectus muscle and deep inferior epigastric pedicle. The resulting images were used to guide design of the flap and debridement. RESULTS: In case 1, good perfusion was observed in zone 1 and part of zone 2. In case 2, good perfusion was observed in zone 1 and 50% of zone 3, with little perfusion in zone 2. In both cases, tissues with poor perfusion were debrided before transfer and inset. In both patients, there were no issues with wound healing, tissue necrosis or fat necrosis. CONCLUSIONS: The variability of perfusion of the pTRAM flap among individuals is well appreciated. LA-ICGA helped to determine the limits of good perfusion and, therefore, the limits of tissue to be preserved for transfer and inset. This helped to avoid harvesting poorly perfused tissue that would have almost certainly experienced necrosis and, ultimately, would have reduced the risk of postoperative complications. PMID:22379372

  4. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...

  5. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...

  6. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...

  7. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...

  8. 21 CFR 26.15 - Monitoring continued equivalence.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM... COMMUNITY Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.15 Monitoring... number of joint inspections; and the conduct of common training sessions. ...

  9. 21 CFR 26.15 - Monitoring continued equivalence.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM... COMMUNITY Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.15 Monitoring... number of joint inspections; and the conduct of common training sessions. ...

  10. The Responses of Tissues from the Brain, Heart, Kidney, and Liver to Resuscitation following Prolonged Cardiac Arrest by Examining Mitochondrial Respiration in Rats

    PubMed Central

    Kim, Junhwan; Perales Villarroel, José Paul; Zhang, Wei; Yin, Tai; Shinozaki, Koichiro; Hong, Angela; Lampe, Joshua W.; Becker, Lance B.

    2016-01-01

    Cardiac arrest induces whole-body ischemia, which causes damage to multiple organs. Understanding how each organ responds to ischemia/reperfusion is important to develop better resuscitation strategies. Because direct measurement of organ function is not practicable in most animal models, we attempt to use mitochondrial respiration to test efficacy of resuscitation on the brain, heart, kidney, and liver following prolonged cardiac arrest. Male Sprague-Dawley rats are subjected to asphyxia-induced cardiac arrest for 30 min or 45 min, or 30 min cardiac arrest followed by 60 min cardiopulmonary bypass resuscitation. Mitochondria are isolated from brain, heart, kidney, and liver tissues and examined for respiration activity. Following cardiac arrest, a time-dependent decrease in state-3 respiration is observed in mitochondria from all four tissues. Following 60 min resuscitation, the respiration activity of brain mitochondria varies greatly in different animals. The activity after resuscitation remains the same in heart mitochondria and significantly increases in kidney and liver mitochondria. The result shows that inhibition of state-3 respiration is a good marker to evaluate the efficacy of resuscitation for each organ. The resulting state-3 respiration of brain and heart mitochondria following resuscitation reenforces the need for developing better strategies to resuscitate these critical organs following prolonged cardiac arrest. PMID:26770657

  11. Laser therapy of muscle injuries.

    PubMed

    Dawood, Munqith S; Al-Salihi, Anam Rasheed; Qasim, Amenah Wala'a

    2013-05-01

    Low-level lasers are used in general therapy and healing process due to their good photo-bio-stimulation effects. In this paper, the effects of diode laser and Nd:YAG laser on the healing process of practically managed skeletal muscle trauma has been successfully studied. Standard impact trauma was induced by using a specially designed mechanical device. The impacted muscle was left for 3 days for complete development of blunt trauma. After that it was irradiated by five laser sessions for 5 days. Two types of lasers were used; 785-nm diode laser and 1.064-nm Nd:YAG laser, both in continuous and pulsed modes. A special electronic circuit was designed and implemented to modulate the diode laser for this purpose. Tissue samples of crushed skeletal muscle have been dissected from the injured irradiated muscle then bio-chemically analyzed for the regeneration of contractile and collagenous proteins using Lowry assay for protein determination and Reddy and Enwemeka assay for hydroxyproline determination. The results showed that both lasers stimulate the regeneration capability of traumatized skeletal muscle. The diode laser in CW and pulsed modes showed better results than the Nd:YAG in accelerating the preservation of the normal tissue content of collagenous and contractile proteins beside controlling the regeneration of non-functional fibrous tissue. This study proved that the healing achieved by the laser treatment was faster than the control group by 15-20 days.

  12. The Twenty-Year Story of a Plant-Based Vaccine Against Hepatitis B: Stagnation or Promising Prospects?

    PubMed Central

    Pniewski, Tomasz

    2013-01-01

    Hepatitis B persists as a common human disease despite effective vaccines having been employed for almost 30 years. Plants were considered as alternative sources of vaccines, to be mainly orally administered. Despite 20-year attempts, no real anti-HBV plant-based vaccine has been developed. Immunization trials, based on ingestion of raw plant tissue and conjugated with injection or exclusively oral administration of lyophilized tissue, were either impractical or insufficient due to oral tolerance acquisition. Plant-produced purified HBV antigens were highly immunogenic when injected, but their yields were initially insufficient for practical purposes. However, knowledge and technology have progressed, hence new plant-derived anti-HBV vaccines can be proposed today. All HBV antigens can be efficiently produced in stable or transient expression systems. Processing of injection vaccines has been developed and needs only to be successfully completed. Purified antigens can be used for injection in an equivalent manner to the present commercial vaccines. Although oral vaccines require improvement, plant tissue, lyophilized or extracted and converted into tablets, etc., may serve as a boosting vaccine. Preliminary data indicate also that both vaccines can be combined in an effective parenteral-oral immunization procedure. A partial substitution of injection vaccines with oral formulations still offers good prospects for economically viable and efficacious anti-HBV plant-based vaccines. PMID:23337199

  13. The Responses of Tissues from the Brain, Heart, Kidney, and Liver to Resuscitation following Prolonged Cardiac Arrest by Examining Mitochondrial Respiration in Rats.

    PubMed

    Kim, Junhwan; Villarroel, José Paul Perales; Zhang, Wei; Yin, Tai; Shinozaki, Koichiro; Hong, Angela; Lampe, Joshua W; Becker, Lance B

    2016-01-01

    Cardiac arrest induces whole-body ischemia, which causes damage to multiple organs. Understanding how each organ responds to ischemia/reperfusion is important to develop better resuscitation strategies. Because direct measurement of organ function is not practicable in most animal models, we attempt to use mitochondrial respiration to test efficacy of resuscitation on the brain, heart, kidney, and liver following prolonged cardiac arrest. Male Sprague-Dawley rats are subjected to asphyxia-induced cardiac arrest for 30 min or 45 min, or 30 min cardiac arrest followed by 60 min cardiopulmonary bypass resuscitation. Mitochondria are isolated from brain, heart, kidney, and liver tissues and examined for respiration activity. Following cardiac arrest, a time-dependent decrease in state-3 respiration is observed in mitochondria from all four tissues. Following 60 min resuscitation, the respiration activity of brain mitochondria varies greatly in different animals. The activity after resuscitation remains the same in heart mitochondria and significantly increases in kidney and liver mitochondria. The result shows that inhibition of state-3 respiration is a good marker to evaluate the efficacy of resuscitation for each organ. The resulting state-3 respiration of brain and heart mitochondria following resuscitation reenforces the need for developing better strategies to resuscitate these critical organs following prolonged cardiac arrest.

  14. [Good practices and techniques for prevention of accidents at work and occupational diseases. New database of Inail].

    PubMed

    Bindi, L; Ossicini, A

    2007-01-01

    The project "The publication of good practices and good techniques for prevention" is one the priorities of nail. This computerized system for the collection of good practices and standards of Good Technology is aimed to health and safety of workers. The basic objective of the database is to provide a valuable tool, usable, dynamic and implemented, in order to facilitate and direct the access to BP and BT it by people responsible for SSL. At the same time constitutes a tool strategically important for enterprises (especially SMEs) in terms of technological innovation and competitiveness, related to the prevention, safety and health of workers. The realization of this project has involved many of the professionals (chemists, engineers, doctors, biologists, geologists, etc.), and everyone gives his intake of qualified professional competence.

  15. Do quality indicators for general practice teaching practices predict good outcomes for students?

    PubMed

    Bartlett, Maggie; Potts, Jessica; McKinley, Bob

    2016-07-01

    Keele medical students spend 113 days in general practices over our five-year programme. We collect practice data thought to indicate good quality teaching. We explored the relationships between these data and two outcomes for students; Objective Structured Clinical Examination (OSCE) scores and feedback regarding the placements. Though both are surrogate markers of good teaching, they are widely used. We collated practice and outcome data for one academic year. Two separate statistical analyses were carried out: (1) to determine how much of the variation seen in the OSCE scores was due to the effect of the practice and how much to the individual student. (2) to identify practice characteristics with a relationship to student feedback scores. (1) OSCE performance: 268 students in 90 practices: six quality indicators independently influenced the OSCE score, though without linear relationships and not to statistical significance. (2) Student satisfaction: 144 students in 69 practices: student feedback scores are not influenced by practice characteristics. The relationships between the quality indicators we collect for practices and outcomes for students are not clear. It may be that neither the quality indicators nor the outcome measures are reliable enough to inform decisions about practices' suitability for teaching.

  16. Helping Displaced Older Workers Get Back into Employment: Good Practice Guide

    ERIC Educational Resources Information Center

    Callahan, Victor J.; Bowman, Kaye

    2015-01-01

    This good practice guide is based on the report "Industry Restructuring and Job Loss: Helping Older Workers Get Back into Employment" by Victor J. Callan and Kaye Bowman. The aim of the research was to identify evidence-based practices that led to successful skills transfer, re-skilling, training and the attainment of new jobs for older…

  17. A Lesson Plan for the Enhancement of Training and Research in Academia by the Adaptation and Adoption of Good Laboratory Practice Guidelines

    ERIC Educational Resources Information Center

    Sitaraman, Ramakrishnan

    2010-01-01

    The implementation of good laboratory practices (GLPs) is recognized by the biotechnology and pharmaceutical industries as being critical for ensuring the international acceptability of products. However, as universities and colleges (and research organizations) do not necessarily work under similar constraints, actual laboratory practices vary…

  18. Addressing the Challenge of Diversity in the Graduate Ranks: Good Practices Yield Good Outcomes

    ERIC Educational Resources Information Center

    Thompson, Nancy L.; Campbell, Andrew G.

    2013-01-01

    In this paper, we examine the impact of implementing three systemic practices on the diversity and institutional culture in biomedical and public health PhD training at Brown University. We hypothesized that these practices, designed as part of the National Institutes of Health-funded Initiative to Maximize Student Development (IMSD) program in…

  19. Knowledge, Attitudes and Practices Regarding Risk to Human Infection due to Mycobacterium bovis among Cattle Farming Communities in Western Uganda.

    PubMed

    Kazoora, H B; Majalija, S; Kiwanuka, N; Kaneene, J B

    2016-12-01

    A cross-sectional study involving multistage cluster sampling was undertaken in Kashari county, Mbarara district, western Uganda, in which quantitative and qualitative approaches were utilized to determine the knowledge, attitudes and practices regarding risk of human infection with zoonotic tuberculosis due to Mycobacterium bovis among cattle farmers. Of 496 respondents, 50% were farm owners and 50% herdsmen. Males were 70.9% of all the study participants. Among these, 37.5% had good knowledge, 41.4% had positive attitudes and 75.2% good practices regarding zoonotic tuberculosis. In the multivariable model, good knowledge was associated with having ever received health education, spending more than 5 years keeping cattle, having heard of cattle condemned at the abattoir due to tuberculosis and marital status. Positive attitudes were associated with having ever received health education, having heard of cattle condemned at the abattoir due to tuberculosis and being a farm owner versus being a herdsman. Good practices were associated with health education and good knowledge of the disease. Overall, knowledge and attitudes towards zoonotic tuberculosis due to M. bovis in humans was found to be low. While the majority of the respondents reported good practices, there were some still consuming raw milk and its products, which may predispose them to infection and indicates the need for greater outreach for zoonotic tuberculosis education. © 2016 Blackwell Verlag GmbH.

  20. [Assessment Method of Remnant α-1, 3-galactosyle Epitopes in Animal Tissue-derived Biomaterials].

    PubMed

    Shan, Yongqiang; Xu, Liming; Ke, Linnan; Lu, Yan; Shao, Anliang; Zhang, Na; Zeng, Bixin

    2015-06-01

    The aim of this study was to establish an assessment method for determining α-Gal (α-1, 3-galactosyle) epitopes contained in animal tissue or animal tissue-derived biological materials with ELISA inhibition assay. Firstly, a 96 well plate was coated with Gal α-1, 3-Gal/bovine serum albumin (BSA) as a solid phase antigen and meanwhile, the anti-α-Gal M86 was used to react with α-Gal antigens which contained in the test materials. Then, the residual antibodies (M86) in the supernatant of M86-Gal reaction mixture were measured using ELISA inhibition assay by the α-Gal coating plate. The inhibition curve of the ELISA inhibition assay, the R2 = 0.999, was well established. Checking using both α-Gal positive materials (rat liver tissues) and α-Gal negative materials (human placenta tissues) showed a good sensitivity and specificity. Based on the presently established method, the α-Gal expression profile of rat tissues, decellular animal tissue-derived biological materials and porcine dermal before and after decellular treatment were determined. The M86 ELISA inhibition assay method, which can quantitatively determine the α-Gal antigens contained in animal tissues or animal tissue-derived biomaterials, was refined. This M86 specific antibody based-ELISA inhibition assay established in the present study has good sensitivity and specificity, and could be a useful method for determining remnant α-1, 3Gal antigens in animal tissue-derived biomaterials.

  1. Good practices : incorporating safety into resurfacing and restoration projects

    DOT National Transportation Integrated Search

    2006-12-01

    Integrating safety improvements into resurfacing and restoration projects is a subject of long-standing interest by Federal, State, and local transportation agencies. A Scan Tour was conducted to identify and subsequently observe good practices in th...

  2. Estimating Tissue Iron Burden: Current Status and Future Prospects

    PubMed Central

    Wood, John C.

    2015-01-01

    SUMMARY Iron overload is becoming an increasing problem as haemoglobinopathy patients gain greater access to good medical care and as therapies for myelodysplastic syndromes improve. Therapeutic options for iron chelation therapy have increased and many patients now receive combination therapies. However, optimal utilization of iron chelation therapy requires knowledge not only of the total body iron burden but the relative iron distribution among the different organs. The physiological basis for extrahepatic iron deposition is presented in order to help identify patients at highest risk for cardiac and endocrine complications. This manuscript reviews the current state of the art for monitoring global iron overload status as well as its compartmentalization. Plasma markers, computerized tomography, liver biopsy, magnetic susceptibility devices and magnetic resonance imaging (MRI) techniques are all discussed but MRI has come to dominate clinical practice. The potential impact of recent pancreatic and pituitary MRI studies on clinical practice are discussed as well as other works-in-progress. Clinical protocols are derived from experience in haemoglobinopathies but may provide useful guiding principles for other iron overload disorders, such as myelodysplastic syndromes. PMID:25765344

  3. Good Practices in Forensic Toxicology.

    PubMed

    Drummer, Olaf H

    2017-01-01

    This manuscript provides an overview for analysts, medical and scientific investigators, and laboratory administrators, the range of factors that should be considered to implement best practice forensic toxicology. These include laboratory influence over the collection of specimens, their proper transport and chain-of-custody before arrival in the laboratory. In addition, the laboratory needs to ensure properly trained staff use suitably validated and documented analytical procedures that meet the intended purpose and type of case in an accredited or suitably quality oriented management system. To assist the investigating officers laboratory results require an interpretation over their possible significance when sufficient details are available over the circumstances of the case. This requires a thorough understanding of the various factors that influence concentrations of substances and ultimately their likely physiological effect. These include consideration of the route of ingestion, influence over chronicity of usage on tissue concentrations and tolerance, possible combined drug effects or likely adverse reactions and consideration of relevant genetic factors that may have influenced pharmacokinetic or pharmacodynamic response. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  4. The principles and best practice of question writing for postgraduate examinations.

    PubMed

    Hayes, Kevin; McCrorie, Peter

    2010-12-01

    Postgraduate medical education has changed enormously in the last 10 years presenting huge logistical challenges for local, regional and national organisations. Assessment is under change in line with major revisions of postgraduate curricula. Old methods of assessment are changing to newer evidence-based methods supported by ongoing research into good practice. This review examines the purpose and practical considerations of written assessment, the pros and cons of different assessment methods and how good practice can be evaluated and quality assured. Good quality assessment comes at a cost in terms of time and money, and organisations need to invest in their assessment strategies to ensure the highest possible standards. Copyright © 2010 Elsevier Ltd. All rights reserved.

  5. Robust data enables managers to promote good practice.

    PubMed

    Bassett, Sally; Westmore, Kathryn

    2012-11-01

    This is the third in a series of articles examining the components of good corporate governance. The effective and efficient use of information and sources of information is crucial for good governance. This article explores the ways in which boards and management can obtain and use information to monitor performance and promote good practice, and how boards can be assured about the quality of information on which they rely. The final article in this series will look at the role of accountability in corporate governance.

  6. Cartilage tissue engineering approaches applicable in orthopaedic surgery: the past, the present, and the future.

    PubMed

    Khan, Wasim S; Hardingham, Timothy E

    2012-01-01

    Tissue is frequently damaged or lost in injury and disease. There has been an increasing interest in stem cell applications and tissue engineering approaches in surgical practice to deal with damaged or lost tissue. Although there have been developments in almost all surgical disciplines, the greatest advances are being made in orthopaedics, especially in cartilage repair. This is due to many factors including the familiarity with bone marrow derived mesenchymal stem cells and cartilage being a relatively simpler tissue to engineer. Unfortunately significant hurdles remain to be overcome in many areas before tissue engineering becomes more routinely used in clinical practice. In this paper we discuss the structure, function and embryology of cartilage and osteoarthritis. This is followed by a review of current treatment strategies for the repair of cartilage and the use of tissue engineering.

  7. Donor cornea tissue in cases of drowning or water submersion: eye banks practice patterns and tissue outcomes.

    PubMed

    Vijayakumar, Nithya P; Parikh, Purak; Mian, Shahzad I; Tennant, Brad; Grossman, Gregory H; Albrecht, Bob; Niziol, Leslie M; Woodward, Maria A

    2018-03-01

    Surgical use of donor corneal tissue from victims of water submersion (drowning or submersion secondary to death) remains controversial due to limited evidence about the quality of these tissues. To assess the safety of donor corneal tissue from victims of water submersion, an investigation of eye banks' practice patterns and tissue outcomes was conducted. All 79 Eye Bank Association of America accredited eye banks were contacted for a phone interview of practices regarding tissue from victims of water submersion. A retrospective review of corneal tissues from 2014 to 2016 from a large eye bank network was performed to identify all donors submerged in water. Corneal epithelial integrity, endothelial cell density (ECD), rim cultures, and adverse events were analyzed for associations with water submersion characteristics. 49 eye banks (62% response) participated in the survey. 55% of these eye banks had specific, written protocol for tissue eligibility from donors submerged in water. With or without specific protocol, eye banks reported considering water type (84%) and length of time submerged (92%) to determine eligibility. 22% of eye banks reported medical director involvement when eligibility determination was unclear. 79 tissues from 40 donors who were submerged were identified in 2014-2016 eye bank data. No donor tissues had pre-processing corneal infiltrates, positive rim cultures, or adverse events post-keratoplasty. Corneal epithelial integrity and ECD were not associated with water type or length of time submerged. In conclusion, data from a large eye bank network showed no adverse events or outcomes, indicating these tissues may be safe.

  8. Cell/tissue processing information system for regenerative medicine.

    PubMed

    Iwayama, Daisuke; Yamato, Masayuki; Tsubokura, Tetsuya; Takahashi, Minoru; Okano, Teruo

    2016-11-01

    When conducting clinical studies of regenerative medicine, compliance to good manufacturing practice (GMP) is mandatory, and thus much time is needed for manufacturing and quality management. It is therefore desired to introduce the manufacturing execution system (MES), which is being adopted by factories manufacturing pharmaceutical products. Meanwhile, in manufacturing human cell/tissue processing autologous products, it is necessary to protect patients' personal information, prevent patients from being identified and obtain information for cell/tissue identification. We therefore considered it difficult to adopt conventional MES to regenerative medicine-related clinical trials, and so developed novel software for production/quality management to be used in cell-processing centres (CPCs), conforming to GMP. Since this system satisfies the requirements of regulations in Japan and the USA for electronic records and electronic signatures (ER/ES), the use of ER/ES has been allowed, and the risk of contamination resulting from the use of recording paper has been eliminated, thanks to paperless operations within the CPC. Moreover, to reduce the risk of mix-up and cross-contamination due to contact during production, we developed a touchless input device with built-in radio frequency identification (RFID) reader-writer devices and optical sensors. The use of this system reduced the time to prepare and issue manufacturing instructions by 50% or more, compared to the conventional handwritten system. The system contributes to producing more large-scale production and to reducing production costs for cell and tissue products in regenerative medicine. Copyright © 2014 John Wiley & Sons, Ltd. Copyright © 2014 John Wiley & Sons, Ltd.

  9. Comparison of different cooling rates for fibroblast and keratinocyte cryopreservation.

    PubMed

    Naaldijk, Yahaira; Friedrich-Stöckigt, Annett; Sethe, Sebastian; Stolzing, Alexandra

    2016-10-01

    Easy, cost-effective and reliable cryopreservation protocols are crucial for the successful and effective application of tissue engineering. Several different protocols are in use, but no comprehensive comparisons across different machine-based and manual methods have been made. Here, we compare the effects of different cooling rates on the post-thaw survival and proliferative capacity of two basic cell lines for skin tissue engineering fibroblasts and keratinocytes, cultured and frozen in suspension or as a monolayer. We demonstrate that effectiveness of cryopreservation cannot be reliably determined immediately after thawing: the results at this stage were not indicative of cell growth in culture 3 days post-thaw. Cryopreservation of fibroblasts in an adherent state greatly diminishes their subsequent growth potential. This was not observed when freezing in suspension. In keratinocytes, however, adherent freezing is as effective as freezing in suspension, which could lead to significant cost and labour savings in a tissue-engineering environment. The 'optimal' cryopreservation protocol depends on cell type and intended use. Where time, ease and cost are dominant factors, the direct freezing into a nitrogen tank (straight freeze) approach remains a viable method. The most effective solution across the board, as measured by viability 3 days post-thaw, was the commonly used, freezing container method. Where machine-controlled cryopreservation is deemed important for tissue-engineering Good Manufacturing Practice, we present results using a portfolio of different cooling rates, identifying the 'optimal' protocol depending on cell type and culture method. Copyright © 2013 John Wiley & Sons, Ltd. Copyright © 2013 John Wiley & Sons, Ltd.

  10. Aging changes in organs - tissue - cells

    MedlinePlus

    ... usually occurs to compensate for a loss of cells. It allows some organs and tissues to regenerate, including the skin, lining of the intestines, liver, and bone marrow. The liver is especially good at regeneration. It can replace up to 70% of its ...

  11. An indentation depth-force sensing wheeled probe for abnormality identification during minimally invasive surgery.

    PubMed

    Liu, H; Puangmali, P; Zbyszewski, D; Elhage, O; Dasgupta, P; Dai, J S; Seneviratne, L; Althoefer, K

    2010-01-01

    This paper presents a novel wheeled probe for the purpose of aiding a surgeon in soft tissue abnormality identification during minimally invasive surgery (MIS), compensating the loss of haptic feedback commonly associated with MIS. Initially, a prototype for validating the concept was developed. The wheeled probe consists of an indentation depth sensor employing an optic fibre sensing scheme and a force/torque sensor. The two sensors work in unison, allowing the wheeled probe to measure the tool-tissue interaction force and the rolling indentation depth concurrently. The indentation depth sensor was developed and initially tested on a homogenous silicone phantom representing a good model for a soft tissue organ; the results show that the sensor can accurately measure the indentation depths occurring while performing rolling indentation, and has good repeatability. To validate the ability of the wheeled probe to identify abnormalities located in the tissue, the device was tested on a silicone phantom containing embedded hard nodules. The experimental data demonstrate that recording the tissue reaction force as well as rolling indentation depth signals during rolling indentation, the wheeled probe can rapidly identify the distribution of tissue stiffness and cause the embedded hard nodules to be accurately located.

  12. [Biomaterials or Donor Tissue - What is the Future of Tissue Engenieering for Cornea Reconstruction?

    PubMed

    Bachmann, Björn O; Schrader, Stefan

    2017-06-01

    For the replacement of corneal tissue, corneal grafts or amniotic membrane are still used as a standard material. Since this is biological tissue, there is only a limited standardization regarding preparation, tissue properties and behaviour after transplantation. In addition, there is a risk of disease transmission, and the availability of both human corneas and amniotic membrane is insufficient in many regions of the world, which is why alternative biomaterials have been explored for many years now. Among the natural biomaterials, materials based on collagen or keratin provide characteristics that make them good candidates for corneal tissue replacement. However, there are still many unsolved problems, particularly regarding the degradation after implantation and the seam strength of the materials. Initial clinical studies with different biomaterials based on collagen prove their good biocompatibility to integrate and their low immunogenicity. Currently, there is no biomaterial that meets the requirements in every situation. It can be assumed that different biomaterials will be available in the future, which, depending on the underlying corneal disease, will fulfill different functions and thus make a patient- and disease-specific care possible. Georg Thieme Verlag KG Stuttgart · New York.

  13. GUIDING PRINCIPLES FOR GOOD PRACTICES IN HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT UNITS.

    PubMed

    Sampietro-Colom, Laura; Lach, Krzysztof; Pasternack, Iris; Wasserfallen, Jean-Blaise; Cicchetti, Americo; Marchetti, Marco; Kidholm, Kristian; Arentz-Hansen, Helene; Rosenmöller, Magdalene; Wild, Claudia; Kahveci, Rabia; Ulst, Margus

    2015-01-01

    Health technology assessment (HTA) carried out for policy decision making has well-established principles unlike hospital-based HTA (HB-HTA), which differs from the former in the context characteristics and ways of operation. This study proposes principles for good practices in HB-HTA units. A framework for good practice criteria was built inspired by the EFQM excellence business model and information from six literature reviews, 107 face-to-face interviews, forty case studies, large-scale survey, focus group, Delphi survey, as well as local and international validation. In total, 385 people from twenty countries have participated in defining the principles for good practices in HB-HTA units. Fifteen guiding principles for good practices in HB-HTA units are grouped in four dimensions. Dimension 1 deals with principles of the assessment process aimed at providing contextualized information for hospital decision makers. Dimension 2 describes leadership, strategy and partnerships of HB-HTA units which govern and facilitate the assessment process. Dimension 3 focuses on adequate resources that ensure the operation of HB-HTA units. Dimension 4 deals with measuring the short- and long-term impact of the overall performance of HB-HTA units. Finally, nine core guiding principles were selected as essential requirements for HB-HTA units based on the expertise of the HB-HTA units participating in the project. Guiding principles for good practices set up a benchmark for HB-HTA because they represent the ideal performance of HB-HTA units; nevertheless, when performing HTA at hospital level, context also matters; therefore, they should be adapted to ensure their applicability in the local context.

  14. Biocompatible magnetic core-shell nanocomposites for engineered magnetic tissues

    NASA Astrophysics Data System (ADS)

    Rodriguez-Arco, Laura; Rodriguez, Ismael A.; Carriel, Victor; Bonhome-Espinosa, Ana B.; Campos, Fernando; Kuzhir, Pavel; Duran, Juan D. G.; Lopez-Lopez, Modesto T.

    2016-04-01

    The inclusion of magnetic nanoparticles into biopolymer matrixes enables the preparation of magnetic field-responsive engineered tissues. Here we describe a synthetic route to prepare biocompatible core-shell nanostructures consisting of a polymeric core and a magnetic shell, which are used for this purpose. We show that using a core-shell architecture is doubly advantageous. First, gravitational settling for core-shell nanocomposites is slower because of the reduction of the composite average density connected to the light polymer core. Second, the magnetic response of core-shell nanocomposites can be tuned by changing the thickness of the magnetic layer. The incorporation of the composites into biopolymer hydrogels containing cells results in magnetic field-responsive engineered tissues whose mechanical properties can be controlled by external magnetic forces. Indeed, we obtain a significant increase of the viscoelastic moduli of the engineered tissues when exposed to an external magnetic field. Because the composites are functionalized with polyethylene glycol, the prepared bio-artificial tissue-like constructs also display excellent ex vivo cell viability and proliferation. When implanted in vivo, the engineered tissues show good biocompatibility and outstanding interaction with the host tissue. Actually, they only cause a localized transitory inflammatory reaction at the implantation site, without any effect on other organs. Altogether, our results suggest that the inclusion of magnetic core-shell nanocomposites into biomaterials would enable tissue engineering of artificial substitutes whose mechanical properties could be tuned to match those of the potential target tissue. In a wider perspective, the good biocompatibility and magnetic behavior of the composites could be beneficial for many other applications.The inclusion of magnetic nanoparticles into biopolymer matrixes enables the preparation of magnetic field-responsive engineered tissues. Here we describe a synthetic route to prepare biocompatible core-shell nanostructures consisting of a polymeric core and a magnetic shell, which are used for this purpose. We show that using a core-shell architecture is doubly advantageous. First, gravitational settling for core-shell nanocomposites is slower because of the reduction of the composite average density connected to the light polymer core. Second, the magnetic response of core-shell nanocomposites can be tuned by changing the thickness of the magnetic layer. The incorporation of the composites into biopolymer hydrogels containing cells results in magnetic field-responsive engineered tissues whose mechanical properties can be controlled by external magnetic forces. Indeed, we obtain a significant increase of the viscoelastic moduli of the engineered tissues when exposed to an external magnetic field. Because the composites are functionalized with polyethylene glycol, the prepared bio-artificial tissue-like constructs also display excellent ex vivo cell viability and proliferation. When implanted in vivo, the engineered tissues show good biocompatibility and outstanding interaction with the host tissue. Actually, they only cause a localized transitory inflammatory reaction at the implantation site, without any effect on other organs. Altogether, our results suggest that the inclusion of magnetic core-shell nanocomposites into biomaterials would enable tissue engineering of artificial substitutes whose mechanical properties could be tuned to match those of the potential target tissue. In a wider perspective, the good biocompatibility and magnetic behavior of the composites could be beneficial for many other applications. Electronic supplementary information (ESI) available. See DOI: 10.1039/c6nr00224b

  15. Isolation, characterization and preclinical development of human glial-restricted progenitor cells for treatment of neurological disorders.

    PubMed

    Sandrock, Robert W; Wheatley, Will; Levinthal, Cynthia; Lawson, Jennifer; Hashimoto, Brooke; Rao, Mahendra; Campanelli, James T

    2010-05-01

    Glial-restricted progenitor cells (GRPs), a neural cell population that gives rise to astrocytes and oligodendrocytes both in vitro and in vivo, hold great promise as a cellular therapeutic for the treatment of demyelinating and neurodegenerative diseases of the CNS. The manufacturing and characterization protocols of human-derived GRPs (hGRPs; trade name Q-Cells) for use in a clinical setting that adhere to rigorous standards for their isolation, propagation, characterization and storage are presented. hGRPs, defined by their immunoreactivity with A2B5 antibodies, were isolated from fetal cadaver forebrain tissue of mice 17-24 weeks gestational age using Miltenyi paramagnetic bead cell separation technology. GRPs were grown in a defined xenobiotic-free medium for 6 days. At harvest, hGRPs were characterized using immunocytochemical techniques. Long-term cryopreservation and storage conditions, and viability upon freeze-thaw were determined. The phenotypic differentiation potential of hGRPs was determined by implantation experiments into the CNS of shiverer mice. hGRPs were isolated from over 50 neural tissues of either sex during gestational ages of 17-24 weeks. Cells expanded out to 6 days in vitro in a xenobiotic-free medium demonstrated very consistent immunocytochemical profiles. No residual antibody used in the purification process was detected after 6 days of growth in vitro. GRPs could be frozen at up to 24 million cells/ml and were over 70% viable upon freeze-thaw. Thawed hGRPs transplanted into the brain of the dysmyelinated shiverer mouse model were observed to differentiate into both glial fibrillary acidic protein-positive astrocytes and myelin basic protein-positive oligodendrocytes; no human-derived NeuN-positive neuronal cells were observed and no abnormal cell proliferation was observed. We demonstrate that hGRPs can be consistently obtained, propagated, cryopreserved and characterized using protocols that can be transferred to a good laboratory practice/good manufacturing practice setting for the manufacture of clinical-grade hGRP cellular therapeutics. Functional data demonstrate that cells manufactured under these conditions are able to differentiate into appropriate cellular phenotypes in an animal model of dysmyelination.

  16. 21 CFR 26.1 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN... regulatory systems means that the systems are sufficiently comparable to assure that the process of... require that the respective regulatory systems have identical procedures. (c) Good Manufacturing Practices...

  17. 40 CFR 68.73 - Mechanical integrity.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 3 Prevention Program § 68.73 Mechanical integrity. (a... accepted good engineering practices. (3) The frequency of inspections and tests of process equipment shall be consistent with applicable manufacturers' recommendations and good engineering practices, and more...

  18. 40 CFR 68.73 - Mechanical integrity.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 3 Prevention Program § 68.73 Mechanical integrity. (a... accepted good engineering practices. (3) The frequency of inspections and tests of process equipment shall be consistent with applicable manufacturers' recommendations and good engineering practices, and more...

  19. 40 CFR 68.73 - Mechanical integrity.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 3 Prevention Program § 68.73 Mechanical integrity. (a... accepted good engineering practices. (3) The frequency of inspections and tests of process equipment shall be consistent with applicable manufacturers' recommendations and good engineering practices, and more...

  20. 40 CFR 68.73 - Mechanical integrity.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 3 Prevention Program § 68.73 Mechanical integrity. (a... accepted good engineering practices. (3) The frequency of inspections and tests of process equipment shall be consistent with applicable manufacturers' recommendations and good engineering practices, and more...

  1. In vivo evaluation of hybrid patches composed of PLA based copolymers and collagen/chondroitin sulfate for ligament tissue regeneration.

    PubMed

    Pinese, Coline; Gagnieu, Christian; Nottelet, Benjamin; Rondot-Couzin, Capucine; Hunger, Sylvie; Coudane, Jean; Garric, Xavier

    2017-10-01

    Biomaterials for soft tissues regeneration should exhibit sufficient mechanical strength, demonstrating a mechanical behavior similar to natural tissues and should also promote tissues ingrowth. This study was aimed at developing new hybrid patches for ligament tissue regeneration by synergistic incorporation of a knitted structure of degradable polymer fibers to provide mechanical strength and of a biomimetic matrix to help injured tissues regeneration. PLA- Pluronic ® (PLA-P) and PLA-Tetronic ® (PLA-T) new copolymers were shaped as knitted patches and were associated with collagen I (Coll) and collagen I/chondroitine-sulfate (Coll CS) 3-dimensional matrices. In vitro study using ligamentocytes showed the beneficial effects of CS on ligamentocytes proliferation. Hybrid patches were then subcutaneously implanted in rats for 4 and 12 weeks. Despite degradation, patches retained strength to answer the mechanical physiological needs. Tissue integration capacity was assessed with histological studies. We showed that copolymers, associated with collagen and chondroitin sulfate sponge, exhibited very good tissue integration and allowed neotissue synthesis after 12 weeks in vivo. To conclude, PLA-P/CollCS and PLA-T/CollCS hybrid patches in terms of structure and composition give good hopes for tendon and ligament regeneration. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 1778-1788, 2017. © 2016 Wiley Periodicals, Inc.

  2. Tissue Integration of a Volume-Stable Collagen Matrix in an Experimental Soft Tissue Augmentation Model.

    PubMed

    Ferrantino, Luca; Bosshardt, Dieter; Nevins, Myron; Santoro, Giacomo; Simion, Massimo; Kim, David

    Reducing the need for a connective tissue graft by using an efficacious biomaterial is an important task for dental professionals and patients. This experimental study aimed to test the soft tissue response to a volume-stable new collagen matrix. The device demonstrated good stability during six different time points ranging from 0 to 90 days of healing with no alteration of the wound-healing processes. The 90-day histologic specimen demonstrates eventual replacement of most of the matrix with new connective tissue fibers.

  3. Good Practice Guide: Bringing a Social Capital Approach into the Teaching of Adult Literacy and Numeracy

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2010

    2010-01-01

    This good practice guide is based on research that looked at how to teach adult literacy and numeracy using a social capital approach. The guide suggests ways vocational education and training (VET) practitioners can adopt a social capital approach to their teaching practice. A social capital approach refers to the process in which networks are…

  4. Who Sleeps by Whom Revisited: A Method for Extracting the Moral Goods Implicit in Practice.

    ERIC Educational Resources Information Center

    Schweder, Richard A; And Others

    1995-01-01

    Explores the specific family practice of determining which family members share a bed or sleeping space. Discusses ways of extracting the moral principles implicit in the practice of arranging where family members sleep at night. Examines similarities and differences in the preferred moral goods of two culture regions--rural Hindu India and urban…

  5. Good Practices in Undergraduate Education from the Students' and Faculty's View: Consensus or Disagreement. AIR 1996 Annual Forum Paper.

    ERIC Educational Resources Information Center

    Negron-Morales, Patricia; And Others

    This study examined teaching practices in undergraduate education by surveying 180 undergraduate students and 29 faculty, most in the school of education, at the Rio Piedras Campus of the University of Puerto Rico. Factors investigated include: (1) degree of agreement between faculty and students on good teaching practices; (2) relationship…

  6. The procurement of cells for the derivation of human embryonic stem cell lines for therapeutic use: recommendations for good practice.

    PubMed

    Murdoch, Alison; Braude, Peter; Courtney, Aidan; Brison, Daniel; Hunt, Charles; Lawford-Davies, James; Moore, Harry; Stacey, Glyn; Sethe, Sebastian

    2012-03-01

    The donation of human embryos for the derivation of embryonic stem cell lines that may be used in the development of therapeutic products raises more complex ethical, practical and regulatory problems than the donation of embryos for non-clinical research. This review considers these issues and offers recommendations for good practice.

  7. 21 CFR 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... practice operating system in accordance with paragraph (b) of this section, the following requirements..., and the current good manufacturing practice operating system has been shown to comply with the drug... operating system has been shown to comply with the QS regulation, the following provisions of the drug CGMPs...

  8. 21 CFR 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... practice operating system in accordance with paragraph (b) of this section, the following requirements..., and the current good manufacturing practice operating system has been shown to comply with the drug... operating system has been shown to comply with the QS regulation, the following provisions of the drug CGMPs...

  9. Good surgeon: A search for meaning.

    PubMed

    Akopov, Andrey L; Artioukh, Dmitri Y

    2017-01-01

    The art and philosophy of surgery are not as often discussed as scientific discoveries and technological advances in the modern era of surgery. Although these are difficult to teach and pass on to the next generations of surgeons they are no less important for training good surgeons and maintaining their high standards. The authors of this review and opinion article tried to define what being a good surgeon really means and to look into the subject by analysing the essential conditions for being a good surgeon and the qualities that such a specialist should possess. In addition to a strong theoretic knowledge and practical skills and among the several described professional and personal characteristics, a good surgeon is expected to have common sense. It enables a surgeon to make a sound practical judgment independent of specialized medical knowledge and training. The possible ways of developing and/or enhancing common sense during surgical training and subsequent practice require separate analysis.

  10. 21 CFR 172.870 - Hydroxypropyl cellulose.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... per anhydroglucose unit. The common name for this form of the additive is low substituted... colloid, stabilizer, suspending agent, or thickener, in accordance with good manufacturing practice. (2... additive is used in accordance with good manufacturing practice. [46 FR 50065, Oct. 9, 1981] ...

  11. 21 CFR 58.200 - Purpose.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Disqualification of Testing Facilities § 58.200 Purpose. (a) The purposes of... testing facility which has failed to comply with the requirements of the good laboratory practice...

  12. 21 CFR 58.200 - Purpose.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Disqualification of Testing Facilities § 58.200 Purpose. (a) The purposes of... testing facility which has failed to comply with the requirements of the good laboratory practice...

  13. The Health Behavior Checklist: Factor structure in community samples and validity of a revised good health practices scale.

    PubMed

    Hampson, Sarah E; Edmonds, Grant W; Goldberg, Lewis R

    2017-01-01

    This study examined the factor structure and predictive validity of the commonly used multidimensional Health Behavior Checklist. A three-factor structure was found in two community samples that included men and women. The new 16-item Good Health Practices scale and the original Wellness Maintenance scale were the only Health Behavior Checklist scales to be related to cardiovascular and metabolic risk factors. While the other Health Behavior Checklist scales require further validation, the Good Health Practices scale could be used where more objective or longer measures are not feasible.

  14. The histopathologic reliability of tissue taken from cadavers within the gross anatomy laboratory.

    PubMed

    Rae, Guenevere; Newman, William P; McGoey, Robin; Donthamsetty, Supriya; Karpinski, Aryn C; Green, Jeffrey

    2018-03-01

    The purpose of this study was to examine the histopathologic reliability of embalmed cadaveric tissue taken from the gross anatomy laboratory. Tissue samples from hearts, livers, lungs, and kidneys were collected after the medical students' dissection course was completed. All of the cadavers were embalmed in a formalin-based fixative solution. The tissue was processed, embedded in paraffin, sectioned at six micrometers, and stained with H&E. The microscope slides were evaluated by a board certified pathologist to determine whether the cellular components of the tissues were preserved at a high enough quality to allow for histopathologic diagnosis. There was a statistically significant relationship between ratings and organ groups. Across all organs, there was a smaller proportion of "poor" ratings. The lung group had the highest percentage of "poor" ratings (23.1%). The heart group had the least "poor" ratings (0.0%). The largest percentage of "satisfactory" ratings were in the lung group (52.8%), and the heart group contained the highest percentage of "good" ratings (58.5%) The lung group had the lowest percentage of "good" ratings (24.2%). These results indicate that heart tissue is more reliable than lung, kidney, or liver tissue when utilizing tissue from the gross anatomy laboratory for research and/or educational purposes. This information advises educators and researchers about the quality and histopathologic reliability of tissue samples obtained from the gross anatomy laboratory. Anat Sci Educ 11: 207-214. © 2017 American Association of Anatomists. © 2017 American Association of Anatomists.

  15. What makes a good GP? An empirical perspective on virtue in general practice

    PubMed Central

    Braunack-Mayer, A

    2005-01-01

    This paper takes a virtuist approach to medical ethics to explore, from an empirical angle, ideas about settled ways of living a good life. Qualitative research methods were used to analyse the ways in which a group of 15 general practitioners (GPs) articulated notions of good doctoring and the virtues in their work. I argue that the GPs, whose talk is analysed here, defined good general practice in terms of the ideals of accessibility, comprehensiveness, and continuity. They regarded these ideals significant both for the way they dealt with morally problematic situations and for how they conducted their professional lives more generally. In addition, I argue that the GPs who articulated these ideals most clearly were able to, in part, because they shared the experience of working in rural areas. This experience helped them to develop an understanding of the nature of general practice that their urban colleagues were less able to draw on. In that sense, the structural and organisational framework of general practice in rural areas provided the context for their understanding of ideals in general practice. PMID:15681671

  16. The importance of ethic in the field of human tissue banking.

    PubMed

    Morales Pedraza, Jorge; Herson, Marisa Roma

    2012-03-01

    A tissue bank is accountable before the community in fulfilling the expectations of tissue donors, their families and recipients. The expected output from the altruistic donation is that safe and high quality human tissue grafts will be provided for the medical treatment of patients. Thus, undertakings of tissue banks have to be not only authorised and audited by national competent health care authorities, but also comply with a strong ethical code, a code of practices and ethical principles. Ethical practice in the field of tissue banking requires the setting of principles, the identification of possible deviations and the establishment of mechanisms that will detect and hinder abuses that may occur during the procurement, processing and distribution of human tissues for transplantation. The opinions and suggestions manifested by the authors in this paper may not be necessarily a reflection of those within the institutions or community they are linked to.

  17. Magnetic resonance imaging-three-dimensional printing technology fabricates customized scaffolds for brain tissue engineering

    PubMed Central

    Fu, Feng; Qin, Zhe; Xu, Chao; Chen, Xu-yi; Li, Rui-xin; Wang, Li-na; Peng, Ding-wei; Sun, Hong-tao; Tu, Yue; Chen, Chong; Zhang, Sai; Zhao, Ming-liang; Li, Xiao-hong

    2017-01-01

    Conventional fabrication methods lack the ability to control both macro- and micro-structures of generated scaffolds. Three-dimensional printing is a solid free-form fabrication method that provides novel ways to create customized scaffolds with high precision and accuracy. In this study, an electrically controlled cortical impactor was used to induce randomized brain tissue defects. The overall shape of scaffolds was designed using rat-specific anatomical data obtained from magnetic resonance imaging, and the internal structure was created by computer-aided design. As the result of limitations arising from insufficient resolution of the manufacturing process, we magnified the size of the cavity model prototype five-fold to successfully fabricate customized collagen-chitosan scaffolds using three-dimensional printing. Results demonstrated that scaffolds have three-dimensional porous structures, high porosity, highly specific surface areas, pore connectivity and good internal characteristics. Neural stem cells co-cultured with scaffolds showed good viability, indicating good biocompatibility and biodegradability. This technique may be a promising new strategy for regenerating complex damaged brain tissues, and helps pave the way toward personalized medicine. PMID:28553343

  18. Telesurgery: Windows of Opportunity

    PubMed Central

    Arora, Sulbha; Allahbadia, Gautam N

    2007-01-01

    Minimally Invasive Surgery is the most important revolution in surgical technique since the early 1900s. Its development was facilitated by the introduction of miniaturized video cameras with good image reproduction. The marvels of electronic and information technology have strengthened the biochemical and molecular power of diagnosis and the surgical and medical management of gynecology, transforming the very practice of medical science into a reality that could barely be envisaged two decades ago. We now enter the age of Robotics, Telesurgery, and Therapeutic Cloning. This dynamic process of reform continues to deliver practitioners with information, ideas and tools that spell answers to some of the most pressing dilemmas in clinical management. New technology will provide us with better opportunities of vision of the operative field, such as 3-D Endoscopy. Other promising technologies such as incorporation of ultrasonography, magnetic resonance imaging, laser-based technology or assisted optical coherence tomography will not only enhance better visualization of the surgical field, but also discriminate the pathologic tissue from the normal one, enabling the surgeon to excise the pathologic tissue accurately. Pain mapping and photodiagnosis offer a new direction in the diagnosis of microscopic endometriosis. Better detection of the disease results in higher chances of success following treatment. PMID:21475455

  19. Telesurgery: windows of opportunity.

    PubMed

    Arora, Sulbha; Allahbadia, Gautam N

    2007-01-01

    Minimally Invasive Surgery is the most important revolution in surgical technique since the early 1900s. Its development was facilitated by the introduction of miniaturized video cameras with good image reproduction. The marvels of electronic and information technology have strengthened the biochemical and molecular power of diagnosis and the surgical and medical management of gynecology, transforming the very practice of medical science into a reality that could barely be envisaged two decades ago. We now enter the age of Robotics, Telesurgery, and Therapeutic Cloning. This dynamic process of reform continues to deliver practitioners with information, ideas and tools that spell answers to some of the most pressing dilemmas in clinical management. New technology will provide us with better opportunities of vision of the operative field, such as 3-D Endoscopy. Other promising technologies such as incorporation of ultrasonography, magnetic resonance imaging, laser-based technology or assisted optical coherence tomography will not only enhance better visualization of the surgical field, but also discriminate the pathologic tissue from the normal one, enabling the surgeon to excise the pathologic tissue accurately. Pain mapping and photodiagnosis offer a new direction in the diagnosis of microscopic endometriosis. Better detection of the disease results in higher chances of success following treatment.

  20. Rabbit tissue model (RTM) harvesting technique.

    PubMed

    Medina, Marelyn

    2002-01-01

    A method for creating a tissue model using a female rabbit for laparoscopic simulation exercises is described. The specimen is called a Rabbit Tissue Model (RTM). Dissection techniques are described for transforming the rabbit carcass into a small, compact unit that can be used for multiple training sessions. Preservation is accomplished by using saline and refrigeration. Only the animal trunk is used, with the rest of the animal carcass being discarded. Practice exercises are provided for using the preserved organs. Basic surgical skills, such as dissection, suturing, and knot tying, can be practiced on this model. In addition, the RTM can be used with any pelvic trainer that permits placement of larger practice specimens within its confines.

  1. The barriers and motivators to learning infection control in clinical placements: interviews with midwifery students.

    PubMed

    Ward, Deborah J

    2013-05-01

    To investigate the barriers to and motivators for learning infection prevention and control as identified by midwifery students. Semi-structured interviews were undertaken with 15 undergraduate midwifery students within one large university. Data were analysed using Framework Analysis. Barriers to good clinical practice were identified by students which were concordant with previous literature related to reasons for non-compliance with infection control precautions. Issues such as competing demands specific to midwifery were also identified. Factors which act as barriers to learning good practice in placements included conflicting information and practices from different staff and placement areas and staff attitudes towards students who tried to comply with precautions. Motivators to good practice included the perceived vulnerability of infants to infection, the role modelling of good practice to new mothers and the monitoring of practice. This study demonstrated that midwifery students perceive barriers and motivators to learning infection prevention and control in their clinical placements. Many of the barriers identified are related to the attitudes and practices of qualified staff. Some of the motivators are related specifically to midwifery practice. Midwives need to be aware of the effects of what is observed in practice on midwifery students and how their practices and attitudes can influence learning both positively and negatively. As healthcare-associated infection and poor compliance with precautions are a global problem, this research should be of benefit to midwives and midwifery educators worldwide in terms of addressing barriers and ensuring better clinical education. Copyright © 2012 Elsevier Ltd. All rights reserved.

  2. Synthesis of highly interconnected 3D scaffold from Arothron stellatus skin collagen for tissue engineering application.

    PubMed

    Ramanathan, Giriprasath; Singaravelu, Sivakumar; Raja, M D; Sivagnanam, Uma Tiruchirapalli

    2015-11-01

    The substrate which is avidly used for tissue engineering applications should have good mechanical and biocompatible properties, and all these parameters are often considered as essential for dermal reformation. Highly interconnected three dimensional (3D) wound dressing material with enhanced structural integrity was synthesized from Arothron stellatus fish skin (AsFS) collagen for tissue engineering applications. The synthesized 3D collagen sponge (COL-SPG) was further characterized by different physicochemical methods. The scanning electron microscopy analysis of the material demonstrated that well interconnected pores with homogeneous microstructure on the surface aids higher swelling index and that the material also possessed good mechanical properties with a Young's modulus of 0.89±0.2 MPa. Biocompatibility of the 3D COL-SPG showed 92% growth for both NIH 3T3 fibroblasts and keratinocytes. Overall, the study revealed that synthesized 3D COL-SPG from fish skin will act as a promising wound dressing in skin tissue engineering. Copyright © 2015 Elsevier Ltd. All rights reserved.

  3. Clinical-Grade Manufacturing of Therapeutic Human Mesenchymal Stem/Stromal Cells in Microcarrier-Based Culture Systems.

    PubMed

    Fernandes-Platzgummer, Ana; Carmelo, Joana G; da Silva, Cláudia Lobato; Cabral, Joaquim M S

    2016-01-01

    The therapeutic potential of mesenchymal stem/stromal cells (MSC) has triggered the need for high cell doses in a vast number of clinical applications. This demand requires the development of good manufacturing practices (GMP)-compliant ex vivo expansion protocols that should be effective to deliver a robust and reproducible supply of clinical-grade cells in a safe and cost-effective manner. Controlled stirred-tank bioreactor systems under xenogeneic (xeno)-free culture conditions offer ideal settings to develop and optimize cell manufacturing to meet the standards and needs of human MSC for cellular therapies. Herein we describe two microcarrier-based stirred culture systems using spinner flasks and controlled stirred-tank bioreactors under xeno-free conditions for the efficient ex vivo expansion of human bone marrow and adipose tissue-derived MSC.

  4. Current Strategies to Improve the Bioactivity of PEEK

    PubMed Central

    Ma, Rui; Tang, Tingting

    2014-01-01

    The synthetic thermoplastic polymer polyetheretherketone (PEEK) is becoming a popular component of clinical orthopedic and spinal applications, but its practical use suffers from several limitations. Although PEEK is biocompatible, chemically stable, radiolucent and has an elastic modulus similar to that of normal human bone, it is biologically inert, preventing good integration with adjacent bone tissues upon implantation. Recent efforts have focused on increasing the bioactivity of PEEK to improve the bone-implant interface. Two main strategies have been used to overcome the inert character of PEEK. One approach is surface modification to activate PEEK through surface treatment alone or in combination with a surface coating. Another strategy is to prepare bioactive PEEK composites by impregnating bioactive materials into PEEK substrate. Researchers believe that modified bioactive PEEK will have a wide range of orthopedic applications. PMID:24686515

  5. Conjoint analysis applications in health--a checklist: a report of the ISPOR Good Research Practices for Conjoint Analysis Task Force.

    PubMed

    Bridges, John F P; Hauber, A Brett; Marshall, Deborah; Lloyd, Andrew; Prosser, Lisa A; Regier, Dean A; Johnson, F Reed; Mauskopf, Josephine

    2011-06-01

    The application of conjoint analysis (including discrete-choice experiments and other multiattribute stated-preference methods) in health has increased rapidly over the past decade. A wider acceptance of these methods is limited by an absence of consensus-based methodological standards. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Research Practices for Conjoint Analysis Task Force was established to identify good research practices for conjoint-analysis applications in health. The task force met regularly to identify the important steps in a conjoint analysis, to discuss good research practices for conjoint analysis, and to develop and refine the key criteria for identifying good research practices. ISPOR members contributed to this process through an extensive consultation process. A final consensus meeting was held to revise the article using these comments, and those of a number of international reviewers. Task force findings are presented as a 10-item checklist covering: 1) research question; 2) attributes and levels; 3) construction of tasks; 4) experimental design; 5) preference elicitation; 6) instrument design; 7) data-collection plan; 8) statistical analyses; 9) results and conclusions; and 10) study presentation. A primary question relating to each of the 10 items is posed, and three sub-questions examine finer issues within items. Although the checklist should not be interpreted as endorsing any specific methodological approach to conjoint analysis, it can facilitate future training activities and discussions of good research practices for the application of conjoint-analysis methods in health care studies. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  6. Practical Instruction in Tissue Culture and Cytogenetics for Sandwich Students.

    ERIC Educational Resources Information Center

    Williams, D. C.; Bishun, N. P.

    1973-01-01

    Describes the training and practical techniques taught to students involved in a sandwich course at the Tissue Culture and Cytogenetics Unit of the Marie Curie Memorial Foundation, Surrey, England. Students spend a minimum of six months involved in the sandwich course before returning to university for a final academic year. (JR)

  7. Organ and tissue donation in clinical settings: a systematic review of the impact of interventions aimed at health professionals

    PubMed Central

    2014-01-01

    In countries where presumed consent for organ donation does not apply, health professionals (HP) are key players for identifying donors and obtaining their consent. This systematic review was designed to verify the efficacy of interventions aimed at HPs to promote organ and tissue donation in clinical settings. CINAHL (1982 to 2012), COCHRANE LIBRARY, EMBASE (1974 to 2012), MEDLINE (1966 to 2012), PsycINFO (1960 to 2012), and ProQuest Dissertations and Theses were searched for papers published in French or English until September 2012. Studies were considered if they met the following criteria: aimed at improving HPs’ practices regarding the donation process or at increasing donation rates; HPs working in clinical settings; and interventions with a control group or pre-post assessments. Intervention behavioral change techniques were analyzed using a validated taxonomy. A risk ratio was computed for each study having a control group. A total of 15 studies were identified, of which only 5 had a control group. Interventions were either educational, organizational or a combination of both, and had a weak theoretical basis. The most common behavior change technique was providing instruction. Two sets of interventions showed a significant risk ratio. However, most studies did not report the information needed to compute their efficacy. Therefore, interventions aimed at improving the donation process or at increasing donation rates should be based on sound theoretical frameworks. They would benefit from more rigorous evaluation methods to ensure good knowledge translation and appropriate organizational decisions to improve professional practices. PMID:24628967

  8. Commodification of human tissue: implications for feminist and development ethics.

    PubMed

    Dickenson, Donna

    2002-05-01

    One effect of late capitalism--the commodification of practically everything--is to knock down the Chinese walls between the natural and productive realms, to use a Marxist framework. Women's labour in egg extraction and 'surrogate' motherhood might then be seen as what it is, labour which produces something of value. But this does not necessarily mean that women will benefit from the commodification of practically everything, in either North or South. In the newly developing biotechnologies involving stem cells, the reverse is more likely, particular given the the shortage in the North of the egg donors who will be increasingly necessary to therapeutic cloning. Although most of the ethical debate has focused on the status of the embryo, this is to define ethics with no reference to global or gender justice. There has been little or no debate about possible exploitation of women, particularly of ovum donors from the South. Countries of the South without national ethics committees or guidelines may be particularly vulnerable: although there is increasing awareness of the susceptibility of poorer countries to abuses in research ethics, very little has been written about how they might be affected by the enormously profitable new technologies exploiting human tissue. Even in the UK, although the new Medical Research Council guidelines make a good deal of the 'gift relationship', what they are actually about is commodification. If donors believe they are demonstrating altruism, but biotechnology firms and researchers use the discourse of commodity and profit, we have not 'incomplete commodification' but complete commodification with a plausibly human face.

  9. Examples of sex/gender sensitivity in epidemiological research: results of an evaluation of original articles published in JECH 2006-2014.

    PubMed

    Jahn, Ingeborg; Börnhorst, Claudia; Günther, Frauke; Brand, Tilman

    2017-02-15

    During the last decades, sex and gender biases have been identified in various areas of biomedical and public health research, leading to compromised validity of research findings. As a response, methodological requirements were developed but these are rarely translated into research practice. The aim of this study is to provide good practice examples of sex/gender sensitive health research. We conducted a systematic search of research articles published in JECH between 2006 and 2014. An instrument was constructed to evaluate sex/gender sensitivity in four stages of the research process (background, study design, statistical analysis, discussion). In total, 37 articles covering diverse topics were included. Thereof, 22 were evaluated as good practice example in at least one stage; two articles achieved highest ratings across all stages. Good examples of the background referred to available knowledge on sex/gender differences and sex/gender informed theoretical frameworks. Related to the study design, good examples calculated sample sizes to be able to detect sex/gender differences, selected sex/gender sensitive outcome/exposure indicators, or chose different cut-off values for male and female participants. Good examples of statistical analyses used interaction terms with sex/gender or different shapes of the estimated relationship for men and women. Examples of good discussions interpreted their findings related to social and biological explanatory models or questioned the statistical methods used to detect sex/gender differences. The identified good practice examples may inspire researchers to critically reflect on the relevance of sex/gender issues of their studies and help them to translate methodological recommendations of sex/gender sensitivity into research practice.

  10. Alternative Pathways to Apprenticeships. Good Practice Guide

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2015

    2015-01-01

    Apprenticeships are changing. The increasing proportions of people entering apprenticeships at various levels of ability and backgrounds are stimulating demand for alternative pathways to completions. This good practice guide assembles the key findings for education practitioners and workplace supervisors from three related research reports on…

  11. Good Laboratory Practices of Materials Testing at NASA White Sands Test Facility

    NASA Technical Reports Server (NTRS)

    Hirsch, David; Williams, James H.

    2005-01-01

    An approach to good laboratory practices of materials testing at NASA White Sands Test Facility is presented. The contents include: 1) Current approach; 2) Data analysis; and 3) Improvements sought by WSTF to enhance the diagnostic capability of existing methods.

  12. 78 FR 32541 - Technical Amendments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

    ... objectives in the most economical and practical manner; and maintaining good public relations with public... economical and practical manner; and maintaining good public relations with public, private and governmental... Enforcement for Mortgage Licensing Act of 2008,\\3\\ which were transferred to the CFPB. \\1\\ Public Law 111-203...

  13. 78 FR 76836 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-19

    ... Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements... of FDA's regulations regarding current good manufacturing practice (CGMP) for dietary supplements..., or Holding Operations for Dietary Supplements--21 CFR Part 111 (OMB Control Number 0910-0606...

  14. 75 FR 40840 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-14

    ... Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements... regulations regarding current good manufacturing practice (CGMP) for dietary supplements. DATES: Submit either... in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements--21 CFR Part 111...

  15. 40 CFR 51.164 - Stack height procedures.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 51.164 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... source's stack height that exceeds good engineering practice or by any other dispersion technique, except... source based on a good engineering practice stack height that exceeds the height allowed by § 51.100(ii...

  16. Sharing Good Practices: Teenage Girls, Sport, and Physical Activities.

    ERIC Educational Resources Information Center

    Vescio, Johanna A.; Crosswhite, Janice J.

    2002-01-01

    Investigated initiatives to increase teenage girls' participation in sport and physical activities, examining good practice case studies from Australia. Surveys of national, state, and regional sporting organizations and various community and school organizations (including culturally diverse girls and girls with disabilities) highlighted three…

  17. 21 CFR 131.110 - Milk.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... nonfat dry milk. Milk may be homogenized. (b) Vitamin addition (Optional). (1) If added, vitamin A shall... Units thereof within limits of good manufacturing practice. (2) If added, vitamin D shall be present in... good manufacturing practice. (c) Optional ingredients. The following safe and suitable ingredients may...

  18. 76 FR 718 - General Administrative Regulations; Good-Performance Refunds

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-06

    ... demonstrate good farming practices, providing, in effect, a premium discount to individual producers... Refund program will specifically encourage sound management practices as well as encouraging insured... regardless of the size of their farming operation. The amount of work required of the insurance companies...

  19. Emerging good practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) measures.

    PubMed

    Acquadro, Catherine; Patrick, Donald L; Eremenco, Sonya; Martin, Mona L; Kuliś, Dagmara; Correia, Helena; Conway, Katrin

    2017-01-01

    This paper presents emerging Good Practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) Measures. The ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) undertook the review of several TA approaches, with the collaboration of organizations who are involved in conducting TA, and members of the TCA-SIG. The effort led to agreement by the writing group on Good Practices for 1) the terminology to be used in referring to translatability process, 2) the best definition of TA, 3) the methodology that is recommended at each step of the process, 4) the persons involved in TA, 5) the timing of assessment, 6) the review criteria for TA, and 7) the recommendations to be made at the end of the TA process. With input from the TCA-SIG membership and in consultation with experts in the field, these emerging good practices can guide the future use of TA in the development of PROs.

  20. WHO expert committee on specifications for pharmaceutical preparations. Fortieth report.

    PubMed

    2006-01-01

    This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. The report is complemented by a number of annexes. These include: a list of available International Chemical Reference Substances and International Infrared Spectra; supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; updated supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines; supplementary guidelines on good manufacturing practices for validation; good distribution practices for pharmaceutical products; a model quality assurance system for procurement agencies (recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products); multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability; a proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; and additional guidance for organizations performing in vivo bioequivalence studies.

  1. Pharmacokinetics and tissue distribution of furanodiene W/O/W multiple emulsions in rats by a fast and sensitive HPLC-APCI-MS/MS method.

    PubMed

    Zhang, Li-Feng; Lu, Tao-Tao; Zhang, Shu-Qiu; Lin, Wen-Han; Li, Qing-Shan

    2013-12-01

    A sensitive and specific HPLC-APCI-MS/MS method was developed and validated for the quantification of furanodiene, a natural antitumor compound in rat plasma and tissues. W/O/W multiple emulsions of furanodiene, identified through microscope-observation and eosin staining method, were prepared with a two-step-procedure. Pharmacokinetics and tissue distribution were studied in rats after oral, intraperitoneal and intravenous injection with the dose of 5, 10 and 50 mg/kg, respectively. The assay achieved a good sensitivity and specificity for the determination of furanodiene in biological samples. The results showed that the concentration-time curves of furanodiene in rats after intravenous injection were fitted to a two-compartment model and the linear pharmacokinetic characteristic. The highest concentration in rat tissue was observed in the spleen, followed by heart, liver, lung, kidney, small intestine and brain. Comparing with the low concentration in plasma, furanodiene could be detected in various tissue samples after oral or intraperitoneal injection which indicated furanodiene had good and rapid tissue uptake. The results suggested that the wide tissue distribution of furanodiene could conduce to the therapeutic effects, but the short biological half-life limited its further application as an antitumor agent. The results are helpful for the structure modification of furanodiene as an antitumor candidate.

  2. Advances in participatory occupational health aimed at good practices in small enterprises and the informal sector.

    PubMed

    Kogi, Kazutaka

    2006-01-01

    Participatory programmes for occupational risk reduction are gaining importance particularly in small workplaces in both industrially developing and developed countries. To discuss the types of effective support, participatory steps commonly seen in our "work improvement-Asia" network are reviewed. The review covered training programmes for small enterprises, farmers, home workers and trade union members. Participatory steps commonly focusing on low-cost good practices locally achieved have led to concrete improvements in multiple technical areas including materials handling, workstation ergonomics, physical environment and work organization. These steps take advantage of positive features of small workplaces in two distinct ways. First, local key persons are ready to accept local good practices conveyed through personal, informal approaches. Second, workers and farmers are capable of understanding technical problems affecting routine work and taking flexible actions leading to solving them. This process is facilitated by the use of locally adjusted training tools such as local good examples, action checklists and group work methods. It is suggested that participatory occupational health programmes can work in small workplaces when they utilize low-cost good practices in a flexible manner. Networking of these positive experiences is essential.

  3. The health belief model and determinants of oral hygiene practices and beliefs in preteen children: a pilot study.

    PubMed

    Walker, Kimberly; Jackson, Richard

    2015-01-01

    There is limited understanding of children's behavioral decisions for practicing good oral hygiene. The purpose of this study was to identify factors that may motivate children to practice good oral hygiene. Guided by the Health Belief Model (HBM), eight focus groups of 42 American children (second through fifth graders) were interviewed concerning their histories with caries, perceived confidence in brushing, self-perceived susceptibility and vulnerability for caries and/or poor oral health, and perceived benefits and barriers to practicing oral hygiene. Most children equated good oral health as being central to their overall health; however, some viewed poor oral health as occurring only in the elderly while others believed poor oral health could begin at any age. Children cited esthetic appearance of teeth and the desire to please others by brushing without reminders as motivators of good oral hygiene. The greatest barriers to performing oral hygiene were a perceived lack of time and limited access to toothbrushes and dentifrice when away. To motivate children in this age range, emphasis should be placed on the positive aspects of maintaining good oral hygiene for its contribution to appearance and its implication for an overall healthy body and self-image.

  4. Practical ways to facilitate ergonomics improvements in occupational health practice.

    PubMed

    Kogi, Kazutaka

    2012-12-01

    Recent advances in participatory programs for improving workplace conditions are discussed to examine practical ways to facilitate ergonomics improvements. Participatory training programs are gaining importance, particularly in promoting occupational health and safety in small-scale workplaces. These programs have led to many improvements that can reduce work-related risks in varied situations. Recent experiences in participatory action-oriented training programs in small workplaces and agriculture are reviewed.The emphasis of the review is on training steps, types of improvements achieved, and the use of action tools by trainers and training participants. Immediate improvements in multiple technical areas are targeted, including materials handling,workstation design, physical environment, welfare facilities, and work organization. In facilitating ergonomics improvements in each local situation, it is important to focus on (a) building on local good practices; (b) applying practical, simple improvements that apply the basic principles of ergonomics; and (c) developing action-oriented toolkits for direct use by workers and managers. This facilitation process is effective when locally designed action toolkits are used by trainers, including local good examples, action checklists, and illustrated how-to guides. Intervention studies demonstrate the effectiveness of participatory steps that use these toolkits in promoting good practices and reducing work-related risks. In facilitating ergonomics improvements in small-scale workplaces, it is important to focus on practical, low-cost improvements that build on local good practices. The use of action-oriented toolkits reflecting basic ergonomics principles is helpful.The promotion of the intercountry networking of positive experiences in participatory training is suggested.

  5. [Tissue engineering applied to the trachea as a graft].

    PubMed

    Barrera-Ramírez, Elisa; Rico-Escobar, Edna; Garrido-Cardona, Rubén E

    2016-01-01

    Tissue engineering offers, through new technologies, an ex vivo generation of organs and functional tissues as grafts for transplants, for the improvement and substitution of biological functions, with an absence of immunological response. The treatment of extended tracheal lesions is a substitution of the affected segment; nevertheless, the allogeneic transplant has failed and the use of synthetic materials has not had good results. New tissue engineering technology is being developed to offer a tracheal graft for a posterior implantation. The purpose of this article is to review all the methods and components used by the engineering of tissue for tracheal grafts.

  6. The ethical dimensions of wildlife disease management in an evolutionary context

    PubMed Central

    Crozier, GKD; Schulte-Hostedde, Albrecht I

    2014-01-01

    Best practices in wildlife disease management require robust evolutionary ecological research (EER). This means not only basing management decisions on evolutionarily sound reasoning, but also conducting management in a way that actively contributes to the on-going development of that research. Because good management requires good science, and good science is ‘good’ science (i.e., effective science is often science conducted ethically), good management therefore also requires practices that accord with sound ethical reasoning. To that end, we propose a two-part framework to assist decision makers to identify ethical pitfalls of wildlife disease management. The first part consists of six values – freedom, fairness, well-being, replacement, reduction, and refinement; these values, developed for the ethical evaluation of EER practices, are also well suited for evaluating the ethics of wildlife disease management. The second part consists of a decision tree to help identify the ethically salient dimensions of wildlife disease management and to guide managers toward ethically responsible practices in complex situations. While ethical reasoning cannot be used to deduce from first principles what practices should be undertaken in every given set of circumstances, it can establish parameters that bound what sorts of practices will be acceptable or unacceptable in certain types of scenarios. PMID:25469160

  7. Determination of sulfonamides in animal tissues by modified QuEChERS and liquid chromatography tandem mass spectrometry.

    PubMed

    Wen, Ching-Hsuan; Lin, Shu-Ling; Fuh, Ming-Ren

    2017-03-01

    In this study, the salting-out solvent extraction and dispersive solid-phase extraction (dSPE) clean-up steps in QuEChERS (quick, easy, cheap, effective, rugged, and safe) method were optimized to reduce matrix effect and efficiently extract target sulfonamides from a variety of edible animal tissues. The extracted sulfonamides were then analyzed using liquid chromatography tandem mass spectrometry (LC-MS/MS). Good extraction recoveries (74.0-100.3% in five different sources of animal tissues; n=3) with acceptable matrix effect (<10%, except for liver samples) were obtained using the proposed method. For the first time, a commercial ND-lipids cartridge was used to remove hydrophobic matrix components from fat-rich animal tissues in the clean-up step of QuEChERS. In addition, good linearity (0.125-12.5ngg -1 ) was observed using matrix-matched calibration (in beef). Limits of detection (LODs) were estimated at 0.01-0.03ngg -1 in beef, pork, and chicken samples. For beef tripe and pig liver samples, the LODs were in the range of 0.02-0.04ngg -1 . Good intra-day/inter-day precision (1.0-10.5%/0.4-8.0%) and accuracy (95.2-107.2%/97.8-102.1%) were also achieved using the modified QuEChERS for sample pretreatment. The applicability of the modified QuEChERS-LC-MS/MS method was demonstrated by determining the occurrence of target sulfonamides in various edible animal tissues for potential food safety analysis. Copyright © 2016 Elsevier B.V. All rights reserved.

  8. Assessment of knowledge and practice of menstrual hygiene among high school girls in Western Ethiopia.

    PubMed

    Upashe, Shivaleela P; Tekelab, Tesfalidet; Mekonnen, Jalane

    2015-10-14

    The issue of menstrual hygiene is inadequately acknowledged and has not received proper attention. Use of sanitary pads and washing the genital area are essential practices to keep the menstrual hygiene. Unhygienic menstrual practices can affect the health of the girls and there is an increased vulnerability to reproductive tract infections and pelvic inflammatory diseases and other complications. Therefore, the objective of this study was to assess the knowledge and practice of menstrual hygiene among high school girls at Nekemte town, Oromia region, Western Ethiopia. A school based cross-sectional study design was employed in Nekemte Town, Western Ethiopia. A multi stage sampling technique was used to select 828 female high school students. Data collection was carried out from May 04 to May 30, 2014 using a pre- tested structured questionnaire. The data were entered into a computer using Epi-info version 3.5.1 and then exported to SPSS for Windows version 20.0 for analysis. Bivariate and multivariate logistic regression analysis was done at 95 % confidence interval. In this study, 504 (60.9 %) and 330 (39.9 %) respondents had good knowledge and practice of menstrual hygiene respectively. The findings of the study showed a significant positive association between good knowledge of menstruation and educational status of mothers (AOR = 1.51, 95 % CI = 1.02 - 2.22), having radio/TV (AOR = 2.42, 95 % CI: 1.64 - 3.56). Educational status of the mother (AOR = 2.03, 95 % CI = 1.38 - 2.97) and earning permanent pocket money from parents (AOR = 2.73, 95 % CI = 1.76 - 4.26) revealed significant positive association with good practice of menstrual hygiene. The findings showed that the knowledge and practice of menstrual hygiene is low. Awareness regarding the need for information about good menstrual practices is very important. So, health education program should be setup to create awareness and practice of good menstrual hygiene.

  9. Clinical role of protein binding of quinolones.

    PubMed

    Bergogne-Bérézin, Eugénie

    2002-01-01

    Protein binding of antibacterials in plasma and tissues has long been considered a component of their pharmacokinetic parameters, playing a potential role in distribution, excretion and therapeutic effectiveness. Since the beginning of the 'antibacterial era', this factor has been extensively analysed for all antibacterial classes, showing that wide variations of the degree of protein binding occur even in the same antibacterial class, as with beta-lactams. As the understanding of protein binding grew, the complexity of the binding system was increasingly perceived and its dynamic character described. Studies of protein binding of the fluoroquinolones have shown that the great majority of these drugs exhibit low protein binding, ranging from approximately 20 to 40% in plasma, and that they are bound predominantly to albumin. The potential role in pharmacokinetics-pharmacodynamics of binding of fluoroquinolones to plasma, tissue and intracellular proteins has been analysed, but it has not been established that protein binding has any significant direct or indirect impact on therapeutic effectiveness. Regarding the factors influencing the tissue distribution of antibacterials, physicochemical characteristics and the small molecular size of fluoroquinolones permit a rapid penetration into extravascular sites and intracellularly, with a rapid equilibrium being established between intravascular and extravascular compartments. The high concentrations of these drugs achieved in tissues, body fluids and intracellularly, in addition to their wide antibacterial spectrum, mean that fluoroquinolones have therapeutic effectiveness in a large variety of infections. The tolerability of quinolones has generally been reported as good, based upon long experience in using pefloxacin, ciprofloxacin and ofloxacin in clinical practice. Among more recently developed molecules, good tolerability has been reported for levofloxacin, moxifloxacin and gatifloxacin, but certain other new compounds have been removed from the market because of renal, hepatic and cardiac toxicity. To what extent the protein binding of fluoroquinolones can play a role in their tolerability is unclear. In terms of drug-drug interactions, the role of protein binding is questionable: several drug combinations can be responsible for toxicity, such as with beta-lactams, metronidazole, theophylline, nonsteroidal anti-inflammatory agents or a series of drugs used for cardiac diseases, but protein binding does not seem to be involved in these interactions. In conclusion, protein binding of fluoroquinolones appears to be a complex phenomenon, but has no clear role in therapeutic effectiveness or toxicity.

  10. 77 FR 23732 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-20

    ...; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and ``Lookback'' AGENCY: Food and Drug Administration, HHS... information entitled ``Current Good Manufacturing Practices and Related Regulations for Blood and Blood...

  11. 40 CFR 52.2465 - Original identification of plan section.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... engineering practice (GEP) stack height,” “hazardous air pollutant,” “nearby,” “stationary source” and... good engineering practice (GEP) stack height requirements submitted on May 12, 1986 by the Virginia... Executive Director, Virginia State Air Pollution Control Board, transmitting the revised good engineering...

  12. Practical Strategies for Integrating Final Ecosystem Goods and Services into Community Decision-Making.

    EPA Science Inventory

    The concept of Final Ecosystem Goods and Services (FEGS) explicitly connects ecosystem services to the people that benefit from them. This report presents a number of practical strategies for incorporating FEGS, and more broadly ecosystem services, into the decision-making proces...

  13. 21 CFR 26.7 - Participation in the equivalence assessment and determination.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... determination. 26.7 Section 26.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE... EUROPEAN COMMUNITY Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.7...

  14. Personal Transferable Skills in Higher Education: The Problems of Implementing Good Practice.

    ERIC Educational Resources Information Center

    Drummond, Ian; Nixon, Iain; Wiltshire, John

    1998-01-01

    Promotion of effective development of personal transferable skills has had limited success in British higher education. Difficulties inherent in implementing established good practice include institutional inertia, issues of academic freedom, resources, high levels of commitment to a particular discipline, and modularization. (SK)

  15. Learning Community Assessment 101--Best Practices

    ERIC Educational Resources Information Center

    Huerta, Juan Carlos; Hansen, Michele J.

    2013-01-01

    Good assessment is part of all good learning communities, and this article provides a useful set of best practices for learning community assessment planning: (1) articulating agreed-upon learning community program goals; (2) identifying the purpose of assessment (e.g., summative or formative); (3) employing qualitative and quantitative assessment…

  16. Dual nanoenzyme modified microelectrode based on carbon fiber coated with AuPd alloy nanoparticles decorated graphene quantum dots assembly for electrochemical detection in clinic cancer samples.

    PubMed

    Xu, Qi; Yuan, Hao; Dong, Xulin; Zhang, Yan; Asif, Muhammad; Dong, Zehua; He, Wenshan; Ren, Jinghua; Sun, Yimin; Xiao, Fei

    2018-06-01

    The development of high-efficient technologies for cancer biomarkers detection has attracted tremendous research effort for its great clinic significance. In this work, we designed a new type of flexible and robust nanohybrid microelectrode by modifying carbon fiber with dual nanoenzyme, i.e., AuPd alloy nanoparticles (AuPd-ANPs) decorated graphene quantum dots (GQDs) assembly, and explored its practical application in electrochemical sensing system for sensitive detection of cancer biomarker hydrogen peroxide (H 2 O 2 ) in human breast cancer cells and tissue. For the preparation of dual nanoenzyme modified microelectrode, ionic liquid was used as the electrolyte for the effective electrodeposition of GQDs on carbon fiber substrate to form a close-packed assembly under a very negative potential, then the highly dense AuPd-ANPs were uniformly decorated on GQDs assembly by electrodeposition. In virtue of the structural merits and synergistic contribution of dual nanoenzyme in enhancing the electrocatalytic activity to H 2 O 2 , the resultant nanohybrid microelectrode exhibited good sensing performances for electrochemical detection of H 2 O 2 , including a high sensitivity of 371 μA cm -2 mM -1 , a wide linear range from 1.0 μM to 18.44 mM, a low detection limit of 500 nM (a signal-to-noise ratio of 3:1), as well as good selectivity and biocompatibility, which could be used for real-time tracking H 2 O 2 released from different types of human breast cells and in situ sensitive detection of H 2 O 2 in clinical breast cancer tissue. Copyright © 2018 Elsevier B.V. All rights reserved.

  17. College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference on good laboratory practices in gynecologic cytology: background, rationale, and organization.

    PubMed

    Tworek, Joseph A; Henry, Michael R; Blond, Barbara; Jones, Bruce Allen

    2013-02-01

    Gynecologic cytopathology is a heavily regulated field, with Clinical Laboratory Improvement Amendments of 1988 mandating the collection of many quality metrics. There is a lack of consensus regarding methods to collect, monitor, and benchmark these data and how these data should be used in a quality assurance program. Furthermore, the introduction of human papilloma virus testing and proficiency testing has provided more data to monitor. To determine good laboratory practices in quality assurance of gynecologic cytopathology. Data were collected through a written survey consisting of 98 questions submitted to 1245 Clinical Laboratory Improvement Amendments-licensed or Department of Defense laboratories. There were 541 usable responses. Additional input was sought through a Web posting of results and questions on the College of American Pathologists Web site. Four senior authors who authored the survey and 28 cytopathologists and cytotechnologists were assigned to 5 working groups to analyze data and present statements on good laboratory practices in gynecologic cytopathology at the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference. Ninety-eight attendees at the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference discussed and voted on good laboratory practice statements to obtain consensus. This paper describes the rationale, background, process, and strengths and limitations of a series of papers that summarize good laboratory practice statements in quality assurance in gynecologic cytopathology.

  18. Taking personal responsibility: Nurses' and assistant nurses' experiences of good nursing practice in psychiatric inpatient care.

    PubMed

    Gabrielsson, Sebastian; Sävenstedt, Stefan; Olsson, Malin

    2016-10-01

    Therapeutic nurse-patient relationships are considered essential for good nursing practice in psychiatric inpatient care. Previous research suggests that inpatient care fails to fulfil patients' expectations in this regard, and that nurses might experience the reality of inpatient care as an obstruction. The aim of the present study was to explore nurses' and assistant nurses' experiences of good nursing practice in the specific context of psychiatric inpatient care. Qualitative interviews were conducted with 12 skilled, relationship-oriented nurses and assistant nurses in order to explore their experiences with nursing practice related to psychiatric inpatient care. Interviews were transcribed and analysed using an interpretive descriptive approach. Findings describe good nursing practice as a matter of nurses and assistant nurses taking personal responsibility for their actions and for the individual patient as a person. Difficulties in providing dignified nursing care and taking personal responsibility cause them to experience feelings of distress and frustration. Shared values and nursing leadership supports being moral and treating patients with respect, having enough time supports being present and connecting with patients, and working as a part of a competent team with critical daily discussions and diversity supports being confident and building trust. The findings suggest that taking personal responsibility is integral to good nursing practice. If unable to improve poor circumstances, nurses might be forced to promote their own survival by refuting or redefining their responsibility. Nurses need to prioritize being with patients and gain support in shaping their own nursing practice. Nursing leadership should provide moral direction and defend humanistic values. © 2016 Australian College of Mental Health Nurses Inc.

  19. Analytical performance, agreement and user-friendliness of six point-of-care testing urine analysers for urinary tract infection in general practice

    PubMed Central

    Schot, Marjolein J C; van Delft, Sanne; Kooijman-Buiting, Antoinette M J; de Wit, Niek J; Hopstaken, Rogier M

    2015-01-01

    Objective Various point-of-care testing (POCT) urine analysers are commercially available for routine urine analysis in general practice. The present study compares analytical performance, agreement and user-friendliness of six different POCT urine analysers for diagnosing urinary tract infection in general practice. Setting All testing procedures were performed at a diagnostic centre for primary care in the Netherlands. Urine samples were collected at four general practices. Primary and secondary outcome measures Analytical performance and agreement of the POCT analysers regarding nitrite, leucocytes and erythrocytes, with the laboratory reference standard, was the primary outcome measure, and analysed by calculating sensitivity, specificity, positive and negative predictive value, and Cohen's κ coefficient for agreement. Secondary outcome measures were the user-friendliness of the POCT analysers, in addition to other characteristics of the analysers. Results The following six POCT analysers were evaluated: Uryxxon Relax (Macherey Nagel), Urisys 1100 (Roche), Clinitek Status (Siemens), Aution 11 (Menarini), Aution Micro (Menarini) and Urilyzer (Analyticon). Analytical performance was good for all analysers. Compared with laboratory reference standards, overall agreement was good, but differed per parameter and per analyser. Concerning the nitrite test, the most important test for clinical practice, all but one showed perfect agreement with the laboratory standard. For leucocytes and erythrocytes specificity was high, but sensitivity was considerably lower. Agreement for leucocytes varied between good to very good, and for the erythrocyte test between fair and good. First-time users indicated that the analysers were easy to use. They expected higher productivity and accuracy when using these analysers in daily practice. Conclusions The overall performance and user-friendliness of all six commercially available POCT urine analysers was sufficient to justify routine use in suspected urinary tract infections in general practice. PMID:25986635

  20. Practices and Procedures to Prevent the Transmission of Skin and Soft Tissue Infections in High School Athletes

    ERIC Educational Resources Information Center

    Fritz, Stephanie A.; Long, Marcus; Gaebelein, Claude J.; Martin, Madeline S.; Hogan, Patrick G.; Yetter, John

    2012-01-01

    Skin and soft tissue infections (SSTIs) are frequent in student athletes and are often caused by community-associated methicillin-resistant "Staphylococcus aureus" (CA-MRSA). We evaluated the awareness of CA-MRSA among high school coaches and athletic directors in Missouri (n = 4,408) and evaluated hygiene practices affecting SSTI…

  1. Managers' duty to maintain good workplace communications skills.

    PubMed

    Timmins, Fiona

    2011-06-01

    Communication is a fundamental element of care at every level of nursing practice. It is important, therefore, for nurse managers to create environments that promote and encourage good communication, and help nurses to develop their communication skills formally and informally. This article discusses the effects of communication on the quality of care. It examines nurses' professional duty to maintain good communication skills and how managers can help them do this. It also discusses nurse managers' communication skills in the context of leadership style, conflict resolution and self-awareness. Finally, it considers the notion of shared governance as good practice.

  2. A finite element model to study the effect of tissue anisotropy on ex vivo arterial shear wave elastography measurements

    NASA Astrophysics Data System (ADS)

    Shcherbakova, D. A.; Debusschere, N.; Caenen, A.; Iannaccone, F.; Pernot, M.; Swillens, A.; Segers, P.

    2017-07-01

    Shear wave elastography (SWE) is an ultrasound (US) diagnostic method for measuring the stiffness of soft tissues based on generated shear waves (SWs). SWE has been applied to bulk tissues, but in arteries it is still under investigation. Previously performed studies in arteries or arterial phantoms demonstrated the potential of SWE to measure arterial wall stiffness—a relevant marker in prediction of cardiovascular diseases. This study is focused on numerical modelling of SWs in ex vivo equine aortic tissue, yet based on experimental SWE measurements with the tissue dynamically loaded while rotating the US probe to investigate the sensitivity of SWE to the anisotropic structure. A good match with experimental shear wave group speed results was obtained. SWs were sensitive to the orthotropy and nonlinearity of the material. The model also allowed to study the nature of the SWs by performing 2D FFT-based and analytical phase analyses. A good match between numerical group velocities derived using the time-of-flight algorithm and derived from the dispersion curves was found in the cross-sectional and axial arterial views. The complexity of solving analytical equations for nonlinear orthotropic stressed plates was discussed.

  3. An international eDelphi study identifying the research and education priorities in wound management and tissue repair.

    PubMed

    Cowman, Seamus; Gethin, Georgina; Clarke, Eric; Moore, Zena; Craig, Gerardine; Jordan-O'Brien, Julie; McLain, Niamh; Strapp, Helen

    2012-02-01

    To incorporate an international and multidisciplinary consensus in the determination of the research and education priorities for wound healing and tissue repair. A compelling reason for the study is the lack of an agreed list of priorities for wound care research and education. Furthermore, there is a growth in the prevalence of chronic wounds, a growth in wound care products and marketing, and an increase in clinician attendance at conferences and education programmes. The study used a survey method. A four-round eDelphi technique was used to collect responses from an international population of health professionals across 24 countries. Responses were obtained from 360 professionals representing many health care settings. The top education priorities related to the standardisation of all foundation education programmes in wound care, the inclusion of wound care in all professional undergraduate and postgraduate education programmes, selecting dressings and the prevention of pressure ulcers. The top research priorities related to the dressing selection, pressure ulcer prevention and wound infection. conclusion: Professionals from different backgrounds and countries who are engaged in wound management share a common set of priorities for research and education. Most notably, the priorities identified relate to long-established clinical challenges in wound care and underpin the principles of good patient care practices. The priorities are closely allied to an ageing population and identify many challenges ahead for practitioners engaged in wound management services. The provision of wound care is a major investment of health service resources and remains a clinical challenge today. Research is essential to building evidence-based practice and fundamental to development of quality in standards of practice; education is central to achieving competence to deliver effective care. The determination of research and education priorities is therefore an absolute requirement in developing services. © 2011 Blackwell Publishing Ltd.

  4. Understanding Graduate School Aspirations: The Effect of Good Teaching Practices

    ERIC Educational Resources Information Center

    Hanson, Jana Marie

    2013-01-01

    This study examined the effects of good teaching practices on post-baccalaureate degree aspirations using logistic regression techniques on a multi-institutional, longitudinal sample of students at four-year colleges and universities. Using College Choice and College Outcomes models as a theoretical foundation, I examined whether eight good…

  5. 40 CFR 89.324 - Calibration of other equipment.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... represent good engineering practice. For each range calibrated, if the deviation from a least-squares best... shall be calibrated as often as required by the instrument manufacturer or necessary according to good practice. (b) If a methane analyzer is used, the methane analyzer shall be calibrated prior to introduction...

  6. Liberal Arts Colleges and Good Practices in Undergraduate Education: Additional Evidence

    ERIC Educational Resources Information Center

    Seifert, Tricia A.; Pascarella, Ernest T.; Goodman, Kathleen M.; Salisbury, Mark H.; Blaich, Charles F.

    2010-01-01

    Liberal arts colleges have prided themselves on providing students with a quality undergraduate education among a scholarly community who are interested in their holistic development. Past research has found students who attended liberal arts colleges more frequently experienced Chickering and Gamson's (1987, 1991) good practices in undergraduate…

  7. 21 CFR 26.20 - Alert system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Alert system. 26.20 Section 26.20 Food and Drugs... PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN... Provisions for Pharmaceutical Good Manufacturing Practices § 26.20 Alert system. (a) The details of an alert...

  8. 21 CFR 26.20 - Alert system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Alert system. 26.20 Section 26.20 Food and Drugs... PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN... Provisions for Pharmaceutical Good Manufacturing Practices § 26.20 Alert system. (a) The details of an alert...

  9. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

  10. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

  11. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

  12. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

  13. 21 CFR 184.1139 - Ammonium hydroxide.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... this chapter; a surface-finishing agent as defined in § 170.3(o)(30) of this chapter; and as a boiler... additive at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this... used in food with no limitation other than current good manufacturing practice. The affirmation of this...

  14. 21 CFR 184.1139 - Ammonium hydroxide.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... this chapter; a surface-finishing agent as defined in § 170.3(o)(30) of this chapter; and as a boiler... additive at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this... used in food with no limitation other than current good manufacturing practice. The affirmation of this...

  15. 21 CFR 184.1139 - Ammonium hydroxide.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... this chapter; a surface-finishing agent as defined in § 170.3(o)(30) of this chapter; and as a boiler... additive at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this... used in food with no limitation other than current good manufacturing practice. The affirmation of this...

  16. 21 CFR 184.1139 - Ammonium hydroxide.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... this chapter; a surface-finishing agent as defined in § 170.3(o)(30) of this chapter; and as a boiler... additive at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this... used in food with no limitation other than current good manufacturing practice. The affirmation of this...

  17. 21 CFR 184.1676 - Pyridoxine hydrochloride.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... hydrochloride that is prepared by chemical synthesis. (b) The ingredient meets the specifications of the Food... manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in... exceed current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter...

  18. 77 FR 49449 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food...

  19. 77 FR 49448 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food...

  20. 21 CFR 26.20 - Alert system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Alert system. 26.20 Section 26.20 Food and Drugs... Provisions for Pharmaceutical Good Manufacturing Practices § 26.20 Alert system. (a) The details of an alert...

  1. 21 CFR 129.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... drinking water are in conformance with or are operated or administered in conformity with good manufacturing practice to assure that bottled drinking water is safe and that it has been processed, bottled...) FOOD FOR HUMAN CONSUMPTION PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER General Provisions § 129.1...

  2. Values Education as Good Practice Pedagogy: Evidence from Australian Empirical Research

    ERIC Educational Resources Information Center

    Lovat, Terence

    2017-01-01

    This article focuses on the Australian Government's Values Education Program and, within its context, the "Values Education Good Practice Schools Project" (VEGPSP) Reports and the "Project to Test and Measure the Impact of Values Education on Student Effects and School Ambience," funded federally from 2003 to 2010. Findings…

  3. Engagement Theory in Action: An Investigation of Athletic Training Program Directors

    ERIC Educational Resources Information Center

    Peer, Kimberly S.

    2007-01-01

    Objective: To examine the use of good practice indicators by athletic training program directors and to provide a theoretical framework using engagement theory, a learner-centered process focusing on program improvement through continuous planning and evaluation, as a foundation for implementing good practices in athletic training education…

  4. Multiple Images, Common Threads. Case Studies of Good Practice in Adult Community Education.

    ERIC Educational Resources Information Center

    Bradshaw, Delia

    This document presents 10 case studies of adult community education programs (ACE) in the state of Victoria, Australia, in the mid 1990s, that were identified as exemplifying the following principles of good practice in ACE: expansiveness, integration, responsiveness, innovation, belonging, explicitness, autonomy, accessibility, synthesis, and…

  5. 21 CFR 146.151 - Orange juice for manufacturing.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... apply to the hybrid species described in § 146.135). Seeds (except embryonic seeds and small fragments of seeds that cannot be separated by good manufacturing practice) are removed, and pulp and orange oil may be adjusted in accordance with good manufacturing practice. If pulp is added it shall be other...

  6. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...

  7. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...

  8. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...

  9. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...

  10. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...

  11. On the Need for Practical Formal Methods

    DTIC Science & Technology

    1998-01-01

    additional research and engineering that is needed to make the current set of formal methods more practical. To illustrate the ideas, I present several exam ...either a good violin or a highly talented violinist. Light-weight techniques o er software developers good violins . A user need not be a talented

  12. Students' Preferences for Discipline Practices in Schools.

    ERIC Educational Resources Information Center

    Lovegrove, Malcolm; And Others

    Using data collected in Australia, the United States, and Norway, this paper discusses teachers' utilization of disciplinary techniques. Students in each country were asked to identify, from a list of 34 teacher characteristics and practices, those which were "good" and "bad." In general, the study found that the good teacher…

  13. 21 CFR 161.170 - Canned Pacific salmon.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., the common or usual name or names of each species of fish enumerated in paragraph (a)(2)(i) of this... accordance with good manufacturing practice; and then washing. Canned Pacific salmon is prepared in one of... good manufacturing practices. (iii) “Minced salmon” consists of salmon which has been minced or ground...

  14. VET Providers Planning to Deliver Degrees: Good Practice Guide

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2015

    2015-01-01

    This good practice guide is intended to assist public and private registered training organisations (RTOs) planning to commence higher education (HE) delivery. The guide is based on research undertaken by Victor Callan and Kaye Bowman, who completed case studies with six providers currently delivering higher education qualifications in addition to…

  15. Creating Opportunities: Good Practice in Small Business Training for Australian Rural Women.

    ERIC Educational Resources Information Center

    Simpson, Lyn; Daws, Leonie; Wood, Leanne

    2002-01-01

    To overcome barriers to participation in small business training faced by rural Australian women, training needs and delivery issues were identified and a good practice matrix was developed with the following components: marketing, content, delivery, support, impact, and innovation. Underlying principles included unique needs, diversity, use of…

  16. 21 CFR 58.219 - Reinstatement of a disqualified testing facility.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES GENERAL GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Disqualification of Testing... disqualified may be reinstated as an acceptable source of nonclinical laboratory studies to be submitted to the... laboratory studies in compliance with the good laboratory practice regulations set forth in this part and, if...

  17. 21 CFR 58.219 - Reinstatement of a disqualified testing facility.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... SERVICES GENERAL GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Disqualification of Testing... disqualified may be reinstated as an acceptable source of nonclinical laboratory studies to be submitted to the... laboratory studies in compliance with the good laboratory practice regulations set forth in this part and, if...

  18. Identification of Good Practices in the Implementation of Innovative Learning Methodologies

    ERIC Educational Resources Information Center

    Lincaru, Cristina; Ciuca, Vasilica; Grecu, Liliana; Atanasiu, Draga; Dragoiu, Codruta

    2011-01-01

    We intend to present the partial issues resulted from the development of the European Project DeInTRA "cooperation for innovative training methodologies deployment in the European Labour Market"--Stage 4: Identification of good practices in the implementation of innovative learning methodologies. This project is included into the…

  19. 78 FR 27178 - Notice of Funds Availability (NOFA) Inviting Applications for the Specialty Crop Block Grant...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    ... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Doc. No. AMS-FV-13-0002] Notice of Funds Availability (NOFA) Inviting Applications for the Specialty Crop Block Grant Program-Farm Bill (SCBGP-FB... crop distribution chain in developing ``Good Agricultural Practices'', ``Good Handling Practices...

  20. Towards an empirical ethics in care: relations with technologies in health care.

    PubMed

    Pols, Jeannette

    2015-02-01

    This paper describes the approach of empirical ethics, a form of ethics that integrates non-positivist ethnographic empirical research and philosophy. Empirical ethics as it is discussed here builds on the 'empirical turn' in epistemology. It radicalizes the relational approach that care ethics introduced to think about care between people by drawing in relations between people and technologies as things people relate to. Empirical ethics studies care practices by analysing their intra-normativity, or the ways of living together the actors within these practices strive for or bring about as good practices. Different from care ethics, what care is and if it is good is not defined beforehand. A care practice may be contested by comparing it to alternative practices with different notions of good care. By contrasting practices as different ways of living together that are normatively oriented, suggestions for the best possible care may be argued for. Whether these suggestions will actually be put to practice is, however, again a relational question; new actors need to re-localize suggestions, to make them work in new practices and fit them in with local intra-normativities with their particular routines, material infrastructures, know-how and strivings.

  1. The science of conventional and water-cooled monopolar lumbar radiofrequency rhizotomy: an electrical engineering point of view.

    PubMed

    Ball, Richard D

    2014-01-01

    Radiofrequency ablation (RFA) is a safe and effective pain therapy used to create sensory dysfunction in appropriate nerves via thermal damage. While commonly viewed as a simple process, RF heating is actually quite complex from an electrical engineering standpoint, and it is difficult for the non-electrical engineer to achieve a thorough understanding of the events that occur. RFA is highly influenced by the configuration and properties of the peri-electrode tissues. To rationally discuss the science of RFA requires that examples be procedure-specific, and lumbar RFA is the procedure selected for this review. Adequate heating of the lumbar medial branch has many potential failure points, and the underlying science is discussed with recommendations to reduce the frequency of failure in heating target tissues. Important technical details of the procedure that are not generally appreciated are discussed, and the status quo is challenged on several aspects of accepted technique. The rationale underlying electrode placement and the limitations of RF heating are, for the most part, commonly misunderstood, and there may even need to be significant changes in how lumbar radiofrequency rhizotomy (RFR) is performed. A new paradigm for heating target tissue may be of value. Foremost in developing best practices for this procedure is avoiding pitfalls. Good RF heating and medial branch lesioning are the rewards for understanding how the process functions, attention to detail, and meticulous attention to electrode positioning.

  2. Piezosurgery in Modified Pterional Orbital Decompression Surgery in Graves Disease.

    PubMed

    Grauvogel, Juergen; Scheiwe, Christian; Masalha, Waseem; Jarc, Nadja; Grauvogel, Tanja; Beringer, Andreas

    2017-10-01

    Piezosurgery uses microvibrations to selectively cut bone, preserving the adjacent soft tissue. The present study evaluated the use of piezosurgery for bone removal in orbital decompression surgery in Graves disease via a modified pterional approach. A piezosurgical device (Piezosurgery medical) was used in 14 patients (20 orbits) with Graves disease who underwent orbital decompression surgery in additional to drills and rongeurs for bone removal of the lateral orbital wall and orbital roof. The practicability, benefits, and drawbacks of this technique in orbital decompression surgery were recorded. Piezosurgery was evaluated with respect to safety, preciseness of bone cutting, and preservation of the adjacent dura and periorbita. Preoperative and postoperative clinical outcome data were assessed. The orbital decompression surgery was successful in all 20 orbits, with good clinical outcomes and no postoperative complications. Piezosurgery proved to be a safe tool, allowing selective bone cutting with no damage to the surrounding soft tissue structures. However, there were disadvantages concerning the intraoperative handling in the narrow space and the efficiency of bone removal was limited in the orbital decompression surgery compared with drills. Piezosurgery proved to be a useful tool in bone removal for orbital decompression in Graves disease. It is safe and easy to perform, without any danger of damage to adjacent tissue because of its selective bone-cutting properties. Nonetheless, further development of the device is necessary to overcome the disadvantages in intraoperative handling and the reduced bone removal rate. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. 19 CFR 102.12 - Fungible goods.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... RULES OF ORIGIN Rules of Origin § 102.12 Fungible goods. When fungible goods of different countries of origin are commingled the country of origin of the goods: (a) Is the countries of origin of those... the origin of the commingled good is not practical, the country or countries of origin may be...

  4. Methods for quantifying adipose tissue insulin resistance in overweight/obese humans.

    PubMed

    Ter Horst, K W; van Galen, K A; Gilijamse, P W; Hartstra, A V; de Groot, P F; van der Valk, F M; Ackermans, M T; Nieuwdorp, M; Romijn, J A; Serlie, M J

    2017-08-01

    Insulin resistance of adipose tissue is an important feature of obesity-related metabolic disease. However, assessment of lipolysis in humans requires labor-intensive and expensive methods, and there is limited validation of simplified measurement methods. We aimed to validate simplified methods for the quantification of adipose tissue insulin resistance against the assessment of insulin sensitivity of lipolysis suppression during hyperinsulinemic-euglycemic clamp studies. We assessed the insulin-mediated suppression of lipolysis by tracer-dilution of [1,1,2,3,3- 2 H 5 ]glycerol during hyperinsulinemic-euglycemic clamp studies in 125 overweight or obese adults (85 men, 40 women; age 50±11 years; body mass index 38±7 kg m -2 ). Seven indices of adipose tissue insulin resistance were validated against the reference measurement method. Low-dose insulin infusion resulted in suppression of the glycerol rate of appearance ranging from 4% (most resistant) to 85% (most sensitive), indicating a good range of adipose tissue insulin sensitivity in the study population. The reference method correlated with (1) insulin-mediated suppression of plasma glycerol concentrations (r=0.960, P<0.001), (2) suppression of plasma non-esterified fatty acid (NEFA) concentrations (r=0.899, P<0.001), (3) the Adipose tissue Insulin Resistance (Adipo-IR) index (fasting plasma insulin-NEFA product; r=-0.526, P<0.001), (4) the fasting plasma insulin-glycerol product (r=-0.467, P<0.001), (5) the Adipose Tissue Insulin Resistance Index (fasting plasma insulin-basal lipolysis product; r=0.460, P<0.001), (6) the Quantitative Insulin Sensitivity Check Index (QUICKI)-NEFA index (r=0.621, P<0.001), and (7) the QUICKI-glycerol index (r=0.671, P<0.001). Bland-Altman plots showed no systematic errors for the suppression indices but proportional errors for all fasting indices. Receiver-operator characteristic curves confirmed that all indices were able to detect adipose tissue insulin resistance (area under the curve ⩾0.801, P<0.001). Adipose tissue insulin sensitivity (that is, the antilipolytic action of insulin) can be reliably quantified in overweight and obese humans by simplified index methods. The sensitivity and specificity of the Adipo-IR index and the fasting plasma insulin-glycerol product, combined with their simplicity and acceptable agreement, suggest that these may be most useful in clinical practice.

  5. The biochemical, nanomechanical and chemometric signatures of brain cancer.

    PubMed

    Abramczyk, Halina; Imiela, Anna

    2018-01-05

    Raman spectroscopy and imaging combined with AFM topography and mechanical indentation by AFM have been shown to be an effective tool for analysis and discrimination of human brain tumors from normal structures. Raman methods have potential to be applied in clinical practice as they allow for identification of tumor margins during surgery. In this study, we investigate medulloblastoma (grade IV WHO) (n=5) and the tissue from the negative margins used as normal controls. We compare a high grade medulloblastoma (IV grade), and non-tumor samples from human central nervous system (CNS) tissue. Based on the properties of the Raman vibrational spectra and Raman images we provide a real-time feedback that is label-free method to monitor tumor metabolism that reveals reprogramming of biosynthesis of lipids, and proteins. We have found that the high-grade tumors of central nervous system (medulloblastoma) exhibit enhanced level of β-sheet conformation and down-regulated level of α-helix conformation when comparing against normal tissue. We have shown that the ratio of Raman intensities I2930/I2845 at 2930 and 2845cm -1 is a good source of information on the ratio of lipid and protein contents. We have found that the ratio reflects the lipid and protein contents of tumorous brain tissue compared to the non-tumor tissue. Almost all brain tumors have the Raman intensity ratios significantly higher (1.99±0.026) than that found in non-tumor brain tissue, which is 1.456±0.02, and indicates that the relative amount of lipids compared to proteins is significantly higher in the normal brain tissue. Mechanical indentation using AFM on sliced human brain tissues (medulloblastoma, grade IV) revealed that the mechanical properties of this tissue are strongly heterogeneous, between 1.8 and 75.7kPa, and the mean of 27.16kPa. The sensitivity and specificity obtained directly from PLSDA and cross validation gives a sensitivity and specificity of 98.5% and 96% and 96.3% and 92% for cross-validation, respectively. The high sensitivity and specificity demonstrates usefulness for a proper decision for a Raman diagnostic test on biochemical alterations monitored by Raman spectroscopy related to brain cancer development. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  6. The challenges for quantitative photoacoustic imaging

    NASA Astrophysics Data System (ADS)

    Cox, B. T.; Laufer, J. G.; Beard, P. C.

    2009-02-01

    In recent years, some of the promised potential of biomedical photoacoustic imaging has begun to be realised. It has been used to produce good, three-dimensional, images of blood vasculature in mice and other small animals, and in human skin in vivo, to depths of several mm, while maintaining a spatial resolution of <100 μm. Furthermore, photoacoustic imaging depends for contrast on the optical absorption distribution of the tissue under study, so, in the same way that the measurement of optical spectra has traditionally provided a means of determining the molecular constituents of an object, there is hope that multiwavelength photoacoustic imaging will provide a way to distinguish and quantify the component molecules of optically-scattering biological tissue (which may include exogeneous, targeted, chromophores). In simple situations with only a few significant absorbers and some prior knowledge of the geometry of the arrangement, this has been shown to be possible, but significant hurdles remain before the general problem can be solved. The general problem may be stated as follows: is it possible, in general, to take a set of photoacoustic images obtained at multiple optical wavelengths, and process them in a way that results in a set of quantitatively accurate images of the concentration distributions of the constituent chromophores of the imaged tissue? If such an 'inversion' procedure - not specific to any particular situation and free of restrictive suppositions - were designed, then photoacoustic imaging would offer the possibility of high resolution 'molecular' imaging of optically scattering tissue: a very powerful technique that would find uses in many areas of the life sciences and in clinical practice. This paper describes the principal challenges that must be overcome for such a general procedure to be successful.

  7. Vulval fibroadenoma - a report of two cases with review of literature.

    PubMed

    Kalyani, R; Srinivas, Murthy V; Veda, P

    2014-06-01

    Vulval fibroadenoma is rare benign tumours arising from ectopic breast tissue or mammary like anogenital glands tissue. Only a few cases are reported in medical literature. It is usually seen between 20 - 80 years of age. Excision usually has good prognosis and rarely recurs. We present two cases of vulval fibroadenoma, one in a 26 years woman as a well defined soft tissue mass in right labia major and other in a 45 years woman as a pedunculated soft tissue mass in left labia major.

  8. Vulval Fibroadenoma — A Report of Two Cases with Review of Literature

    PubMed Central

    Kalyani, R.; Srinivas, Murthy V.; Veda, P.

    2014-01-01

    Vulval fibroadenoma is rare benign tumours arising from ectopic breast tissue or mammary like anogenital glands tissue. Only a few cases are reported in medical literature. It is usually seen between 20 – 80 years of age. Excision usually has good prognosis and rarely recurs. We present two cases of vulval fibroadenoma, one in a 26 years woman as a well defined soft tissue mass in right labia major and other in a 45 years woman as a pedunculated soft tissue mass in left labia major. PMID:25018684

  9. You and your manager: reducing workplace stress by creating and maintaining a good relationship.

    PubMed

    Hills, Laura Sachs

    2007-01-01

    The relationship a medical practice employee has with his or her practice manager is probably the most important relationship the employee will have at work. No matter what position an employee has in the medical practice, it's to his or her advantage to get along well with the practice manager. This article offers concrete suggestions to medical practice employees to help them establish and cultivate a positive working relationship with their practice managers. It examines different working styles of practice managers and suggests strategies for medical practice employees who want or need different amounts and styles of supervision. It describes five personal characteristics a practice manager expects in employees and two basic rules of thumb for using the practice manager's time efficiently. This article also emphasizes the importance of good communication with the practice manager and offers 12 practical and specific tips for building the employee-practice manager relationship. Finally, this article offers advice to medical practice employees about what to do when they disagree with their practice managers.

  10. An improved biofunction of titanium for keratoprosthesis by hydroxyapatite-coating.

    PubMed

    Dong, Ying; Yang, Jingxin; Wang, Liqiang; Ma, Xiao; Huang, Yifei; Qiu, Zhiye; Cui, Fuzhai

    2014-03-01

    Titanium framework keratoprosthesis has been commonly used in the severe corneal blindness, but the tissue melting occurred frequently around titanium. Since hydroxyapatite has been approved to possess a good tissue integration characteristic, nanostructured hydroxyapatite was coated on the surface of titanium through the aerosol deposition method. In this study, nanostructured hydroxyapatite coating was characterized by X-ray diffraction, scanning electron microscopy, atomic force microscopy, and auger electronic spectrometer. Biological evaluations were performed with rabbit cornea fibroblast in vitro and an animal model in vivo. The outcomes showed the coating had a grain-like surface topography and a good atomic mixed area with substrate. The rabbit cornea fibroblasts appeared a good adhesion on the surface of nanostructured hydroxyapatite in vitro. In the animal model, nanostructured hydroxyapatite-titanium implants were stably retained in the rabbit cornea, and by contrast, the corneal stroma became thinner anterior to the implants in the control. Therefore, our findings proved that nanostructured hydroxyapatite-titanium could not only provide an improved bond for substrate but also enhance the tissue integration with implants in host. As a promising material, nanostructured hydroxyapatite-titanium-based keratoprosthesis prepared by the aerosol deposition method could be utilized for the corneal blindness treatment.

  11. Gelatine/PLLA sponge-like scaffolds: morphological and biological characterization.

    PubMed

    Lazzeri, Luigi; Cascone, Maria Grazia; Danti, Serena; Serino, Lorenzo Pio; Moscato, Stefania; Bernardini, Nunzia

    2006-12-01

    Biodegradable synthetic polymers such as poly(lactic acid) are widely used to prepare scaffolds for cell transplantation and tissue growth, using different techniques set up for the purpose. However the poor hydrophilicity of these polymers represents the main limitation to their use as scaffolds because it causes a low affinity for the cells. An effective way to solve this problem could be represented by the addition of biopolymers that are in general highly hydrophilic. The present work concerns porous biodegradable sponge-like systems based on poly(L-lactic acid) and gelatine. Morphology and porosity characteristics of the sponges were studied by scanning electron microscopy and mercury intrusion porosimetry respectively. Blood compatibility was investigated by bovine plasma fibrinogen adsorption test and platelet adhesion test. The cell culture method was used in order to evaluate the ability of the matrices to work as scaffolds for tissue regeneration. The obtained results indicate that the sponges have interesting porous characteristics, good blood compatibility and above all good ability to support cell adhesion and growth. In fact viable and metabolically active animal cells were found inside the sponges after 8 weeks in culture. On this basis the systems produced seem to be good candidates as scaffolds for tissue regeneration.

  12. Dialogical nursing ethics: the quality of freedom restrictions.

    PubMed

    Abma, Tineke A; Widdershoven, Guy A M; Frederiks, Brenda J M; van Hooren, Rob H; van Wijmen, Frans; Curfs, Paul L M G

    2008-11-01

    This article deals with the question of how ethicists respond to practical moral problems emerging in health care practices. Do they remain distanced, taking on the role of an expert, or do they become engaged with nurses and other participants in practice and jointly develop contextualized insights about good care? A basic assumption of dialogical ethics entails that the definition of good care and what it means to be a good nurse is a collaborative product of ongoing dialogues among various stakeholders engaged in the practice. This article discusses the value of a dialogical approach to ethics by drawing on the work of various nursing scholars. We present a case example concerning the quality of freedom restrictions for intellectually disabled people. Issues for discussion include the role and required competences of the ethicist and dealing with asymmetrical relationships between stakeholders.

  13. Controlled destruction and temperature distributions in biological tissues subjected to monoactive electrocoagulation.

    PubMed

    Erez, A; Shitzer, A

    1980-02-01

    An analysis of the temperature fields developed in a biological tissue undergoing a monoactive electrical coagulating process is presented, including thermal recovery following prolonged heating. The analysis is performed for the passage of alternating current and assumes a homogeneous and isotropic tissue model which is uniformly perfused by blood at arterial temperature. Solution for the one-dimensional spherical geometry is obtained by a Laplace transform and numerical integrations. Results obtained indicate the major role which blood perfusion plays in determining the effects of the coagulating process; tissue temperatures and depth of destruction are drastically reduced as blood perfusion increases. Metabolic heat generation rate is found to have negligible effects on tissue temperatures whereas electrode thermal inertia affects temperature levels appreciably. However, electrodes employed in practice would have a low thermal inertia which might be regarded as zero for all practical purposes. It is also found that the depth of tissue destruction is almost directly proportional to the electrical power and duration of application. To avoid excessively high temperatures and charring, it would be advantageous to reduce power and increase the time of application. Results of this study should be regarded as a first approximation to the rather complex phenomena associated with electrocoagulation. They may, nevertheless, serve as preliminary guidelines to practicing surgeons applying this technique.

  14. Good Education, the Good Teacher, and a Practical Art of Living a Good Life: A Catholic Perspective

    ERIC Educational Resources Information Center

    Hermans, Chris

    2017-01-01

    What is good education? We value education for reasons connected to the good provided by education in society. This good is connected to be the pedagogical aim of education. This article distinguishes five criteria for good education based on the concept of "Bildung". Next, these five criteria are used to develop the idea of the good…

  15. Maintaining women's oral health.

    PubMed

    McCann, A L; Bonci, L

    2001-07-01

    Women must adopt health-promoting strategies for both general health and the oral cavity, because the health of a woman's body and oral cavity are bidirectional. For general health-maintenance strategies, dental practitioners should actively advise women to minimize alcohol use, abstain from or cease smoking, stay physically active, and choose the right foods to nourish both the body and mind. For oral health-maintenance strategies, dental practitioners should advise women on how to prevent or control oral infections, particularly dental caries and periodontal diseases. Specifically, women need to know how to remove plaque from the teeth mechanically, use appropriate chemotherapeutic agents and dentifrices, use oral irrigation, and control halitosis. Dental practitioners also need to stress the importance of regular maintenance visits for disease prevention. Adolescent women are more prone to gingivitis and aphthous ulcers when they begin their menstrual cycles and need advice about cessation of tobacco use, mouth protection during athletic activities, cleaning orthodontic appliances, developing good dietary habits, and avoiding eating disorders. Women in early to middle adulthood may be pregnant or using oral contraceptives with concomitant changes in oral tissues. Dental practitioners need to advise them how to take care of the oral cavity during these changes and how to promote the health of their infants, including good nutrition. Older women experience the onset of menopause and increased vulnerability to osteoporosis. They may also experience xerostomia and burning mouth syndrome. Dental practitioners need to help women alleviate these symptoms and encourage them to continue good infection control and diet practices.

  16. Constitutive Modeling of Porcine Liver in Indentation Using 3D Ultrasound Imaging

    PubMed Central

    Jordan, P.; Socrate, S.; Zickler, T.E.; Howe, R.D.

    2009-01-01

    In this work we present an inverse finite-element modeling framework for constitutive modeling and parameter estimation of soft tissues using full-field volumetric deformation data obtained from 3D ultrasound. The finite-element model is coupled to full-field visual measurements by regularization springs attached at nodal locations. The free ends of the springs are displaced according to the locally estimated tissue motion and the normalized potential energy stored in all springs serves as a measure of model-experiment agreement for material parameter optimization. We demonstrate good accuracy of estimated parameters and consistent convergence properties on synthetically generated data. We present constitutive model selection and parameter estimation for perfused porcine liver in indentation and demonstrate that a quasilinear viscoelastic model with shear modulus relaxation offers good model-experiment agreement in terms of indenter displacement (0.19 mm RMS error) and tissue displacement field (0.97 mm RMS error). PMID:19627823

  17. Re-introducing honey in the management of wounds and ulcers - theory and practice.

    PubMed

    Molan, Peter C

    2002-11-01

    Dressing wounds with honey, a standard practice in past times, went out of fashion when antibiotics came into use. Because antibiotic-resistant bacteria have become a widespread clinical problem, a renaissance in honey use has occurred. Laboratory studies and clinical trials have shown that honey is an effective broad-spectrum antibacterial agent that has no adverse effects on wound tissues. As well as having an antibacterial action, honey also provides rapid autolytic debridement, deodorizes wounds, and stimulates the growth of wound tissues to hasten healing and start the healing process in dormant wounds. Its anti-inflammatory activity rapidly reduces pain, edema, and exudate and minimizes hypertrophic scarring. It also provides a moist healing environment for wound tissues with no risk of maceration of surrounding skin and completely prevents adherence of dressings to the wound bed so no pain or tissue damage is associated with dressing changes. Using appropriate dressing practice overcomes potential messiness and handling problems.

  18. Tourism. Leonardo da Vinci Series: Good Practices.

    ERIC Educational Resources Information Center

    Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

    This brochure, part of a series about good practices in vocational training in the European Union, describes 10 projects that have promoted investment in human resources through training in the tourism sector to promote sustainable, or responsible, tourism. The projects and their countries of origin are as follows: (1) BEEFT, training of mobility…

  19. 21 CFR 814.118 - Denial of approval or withdrawal of approval of an HDE.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... contains an untrue statement of material fact, or omits material information; (5) The device's labeling... in compliance with the good laboratory practice regulations in part 58 of this chapter and no reason... conducting the study and the good laboratory practice regulations do not support the validity of the study...

  20. A Critical Analysis of the INQAAHE Guidelines of Good Practice for Higher Education Quality Assurance Agencies

    ERIC Educational Resources Information Center

    Blackmur, Douglas

    2008-01-01

    The International Network of Quality Assurance Agencies in Higher Education's Guidelines of Good Practice by higher education quality assurance agencies need substantial revision before they can be considered adequate by stakeholders in any national higher education system. Various revisions are proposed in this article. But the International…

  1. Standards of Good Practice for Education Abroad. Fourth Edition

    ERIC Educational Resources Information Center

    Forum on Education Abroad, 2011

    2011-01-01

    This fourth edition of the Forum on Education Abroad's "Standards of Good Practice for Education Abroad" augments previous editions of the "Standards." Since the last edition was published in 2008, Forum member institutions and organizations have implemented the Standards in program development and assessment, using the Standards in the Forum's…

  2. Good Laboratory Practice. Part 2. Recording and Retaining Raw Data

    ERIC Educational Resources Information Center

    Wedlich, Richard C.; Libera, Agata E.; Pires, Amanda; Tellarini, Cassandra

    2013-01-01

    A clear understanding of how "raw data" is defined, recorded, and retained in the laboratory record is essential to the chemist employed in the laboratory compliant with the Good Laboratory Practices regulations. This article is intended to provide an understanding by drawing upon examples taken from the modern pharmaceutical analysis…

  3. Investigating Good Practice in Supporting Deaf Pupils in Mainstream Schools.

    ERIC Educational Resources Information Center

    Powers, Steve

    2001-01-01

    A survey of parents, teachers, therapists, psychologists, and deaf adults (n=628) and 15 case study sites were used to identify the following good practices supporting deaf students in mainstream schools: direct support for teachers of the deaf, joint planning by support and mainstream teachers, student involvement in decision making, and…

  4. Do Liberal Arts Colleges Really Foster Good Practices in Undergraduate Education?

    ERIC Educational Resources Information Center

    Pascarella, Ernest T.; Cruce, Ty M.; Wolniak, Gregory C.; Blaich, Charles F.

    2004-01-01

    Researchers estimated the net effects of liberal arts colleges on 19 measures of good practices in undergraduate education grouped into seven categories. Analyses of 3-year longitudinal data from five liberal arts colleges, four research universities, and seven regional universities were conducted. Net of a battery of student precollege…

  5. Good Practice in GNVQ Induction Programmes. Project Report.

    ERIC Educational Resources Information Center

    Benett, Yves

    A 2-year research and development project was conducted to identify existing good practices for introducing students in the United Kingdom (UK) to General National Vocational Qualifications (GNVQs) and available teaching and learning materials for use in the induction of GNVQs in UK schools and colleges. The main activities of the project's three…

  6. Knowledge Gained from Good Agricultural Practices Courses for Iowa Growers

    ERIC Educational Resources Information Center

    Shaw, Angela; Strohbehn, Catherine; Naeve, Linda; Domoto, Paul; Wilson, Lester

    2015-01-01

    Good Agricultural Practices (GAP) educational courses provide produce growers with the fundamental information for producing and processing safe produce. To determine the effectiveness of the current 7-hour GAP course provided in Iowa, growers were surveyed before and 7-14 days after the course to determine changes in knowledge and opinions.…

  7. How Good Is Good Enough?

    ERIC Educational Resources Information Center

    Wiggins, Grant

    2014-01-01

    Education has a long-standing practice of turning worthwhile learning goals into lists of bits. One might even say that this practice is the original sin in curriculum design: take a complex whole, divide it into small pieces, string those together in a rigid sequence of instruction and testing, and call completion of this sequence…

  8. 23 CFR 971.212 - Federal lands safety management system (SMS).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    .... (b) The SMS may be based on the guidance in “Safety Management Systems: Good Practices for Development and Implementation.”3 3 “Safety Management Systems: Good Practices for Development and... various levels of complexity depending on the nature of the facility and/or network involved. (e) The SMS...

  9. 23 CFR 971.212 - Federal lands safety management system (SMS).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    .... (b) The SMS may be based on the guidance in “Safety Management Systems: Good Practices for Development and Implementation.”3 3 “Safety Management Systems: Good Practices for Development and... various levels of complexity depending on the nature of the facility and/or network involved. (e) The SMS...

  10. 23 CFR 971.212 - Federal lands safety management system (SMS).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    .... (b) The SMS may be based on the guidance in “Safety Management Systems: Good Practices for Development and Implementation.”3 3 “Safety Management Systems: Good Practices for Development and... various levels of complexity depending on the nature of the facility and/or network involved. (e) The SMS...

  11. 23 CFR 971.212 - Federal lands safety management system (SMS).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    .... (b) The SMS may be based on the guidance in “Safety Management Systems: Good Practices for Development and Implementation.”3 3 “Safety Management Systems: Good Practices for Development and... various levels of complexity depending on the nature of the facility and/or network involved. (e) The SMS...

  12. 23 CFR 971.212 - Federal lands safety management system (SMS).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    .... (b) The SMS may be based on the guidance in “Safety Management Systems: Good Practices for Development and Implementation.”3 3 “Safety Management Systems: Good Practices for Development and... various levels of complexity depending on the nature of the facility and/or network involved. (e) The SMS...

  13. 21 CFR 184.1697 - Riboflavin-5′-phosphate (sodium).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in milk products, as...

  14. 21 CFR 184.1697 - Riboflavin-5′-phosphate (sodium).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in milk products, as...

  15. 21 CFR 184.1697 - Riboflavin-5′-phosphate (sodium).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in milk products, as...

  16. 21 CFR 184.1697 - Riboflavin-5′-phosphate (sodium).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in milk products, as...

  17. Student Accommodation Projects: A Guide to PFI Contracts. Good Practice.

    ERIC Educational Resources Information Center

    Curtis, Pinsent

    This guide is intended for higher education institutions in England that are about to embark on student residential accommodation projects. It focuses on procurements under the Private Financial Initiative (PFI), a form of Public Private Partnership in the United Kingdom, but other approaches are considered. The guide draws on good practices from…

  18. The Virtuous, Wise, and Knowledgeable Teacher: Living the Good Life as a Professional Practitioner

    ERIC Educational Resources Information Center

    Campbell, Elizabeth

    2013-01-01

    In this essay, Elizabeth Campbell reviews three recent books that address the ethical nature of professional practice: "Knowledge and Virtue in Teaching and Learning: The Primacy of Dispositions," by Hugh Sockett; "The Good Life of Teaching: An Ethics of Professional Practice," by Chris Higgins; and "Towards Professional…

  19. 21 CFR 184.1069 - Malic acid.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., CAS Reg. No. of DL-form 617-48-1) is the common name for 1-hydroxy-1, 2-ethanedicarboxylic acid. L... ingredients are used in food, except baby food, at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of...

  20. 21 CFR 184.1069 - Malic acid.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., CAS Reg. No. of DL-form 617-48-1) is the common name for 1-hydroxy-1, 2-ethanedicarboxylic acid. L... ingredients are used in food, except baby food, at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of...

  1. Accommodating Learning Styles: Relevance and Good Practice in Vocational Education and Training--Supporting Documents

    ERIC Educational Resources Information Center

    Smith, Peter; Dalton, Jennifer; Henry, John

    2005-01-01

    This document was produced by the author(s) based on their research for the Australian report, "Accommodating Learning Styles: Relevance and Good Practice in Vocational Education and Training," and contains three parts. Part 1, Research Methodology and Findings (Peter Smith and Jennifer Dalton), contains: (1) Research Questions; (2)…

  2. 77 FR 36277 - Academic Development of a Training Program for Good Laboratory Practices in High Containment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-18

    ... requirements in high and maximum biocontainment, scientists working in this environment and FDA staff who will...] Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments... Containment Environments (U24).'' In this FOA, FDA announces its intention to accept and consider a single...

  3. 77 FR 27658 - Common Crop Insurance Regulations; Processing Sweet Corn Crop Insurance Provisions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-11

    ... CFR part 400, subpart J for the informal administrative review process of good farming practices as... 7 CFR part 400, subpart J for determinations of good farming practices, as applicable, must be... farming operation. For instance, all producers are required to submit an application and acreage report to...

  4. 76 FR 71276 - Common Crop Insurance Regulations; Pecan Revenue Crop Insurance Provisions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-17

    ... CFR part 400, subpart J for the informal administrative review process of good farming practices as... farming operation. For instance, all producers are required to submit an application and acreage report to... and discourages good management practices. Language in sections 3(d)(3) and 6(b) provides consequences...

  5. Encouraging Good Writing Practice in First-Year Psychology Students: An Intervention Using Turnitin

    ERIC Educational Resources Information Center

    Betts, Lucy R.; Bostock, Stephen J.; Elder, Tracey J.; Trueman, Mark

    2012-01-01

    There is growing concern among many regarding plagiarism within student writing. This has promoted investigation into both the factors that predict plagiarism and potential methods of reducing plagiarism. Consequently, we developed and evaluated an intervention to enhance good practice within academic writing through the use of the plagiarism…

  6. Building Skills and Qualifications among SME Employees. Leonardo da Vinci Good Practices Series.

    ERIC Educational Resources Information Center

    Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

    This document profiles 10 European programs that exemplify good practice in building skills and qualifications among employees of small and medium enterprises (SMEs). The programs profiled are as follows: (1) TRICTSME (a program providing World Wide Web-based information and communication technologies training for SMEs in manufacturing); (2)…

  7. Social and Occupational Integration of Disadvantaged People. Leonardo da Vinci Good Practices Series.

    ERIC Educational Resources Information Center

    Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

    This document profiles nine European programs that exemplify good practice in social and occupational integration of disadvantaged people. The programs profiled are as follows: (1) Restaurant Venezia (a CD-ROM program to improve the reading and writing skills of young people in Luxembourg who have learning difficulties); (2) an integrated…

  8. A New Survey of "Good Practices" Could Be an Alternative to Rankings.

    ERIC Educational Resources Information Center

    Gose, Ben

    1999-01-01

    A new national survey, developed by professionals in higher education assessment, seeks to measure the extent to which colleges use "good practices" that encourage learning. Creators of the National Survey of Student Engagement will study undergraduates at 750 colleges over three years to establish benchmarks for different institution…

  9. Family Planning Practice Among Rural Reproductive-Age Married Women in Myanmar.

    PubMed

    Jirapongsuwan, Ann; Latt, Kyaw Thu; Siri, Sukhontha; Munsawaengsub, Chokchai

    2016-05-01

    A cross-sectional study was undertaken to investigate family planning (FP) practices and associated factors among reproductive-age married women. Data were collected by interviewing the 300 married women living in a rural area of Myanmar. The questionnaire had reliability coefficients ranging from .8 to .9. Results indicated that 73.3% of women performed FP, and contraceptive injection was the most common method. Significant associations were found with age 21 to 35 years (adjusted odds ratio [adj OR] = 3.748, 95% CI = 2.179-6.445), adequacy of income (adj OR = 2.520, 95% CI = 1.477-4.290), good attitude toward FP (adj OR = 0.386, 95% CI = 0.228-0.656), good support from health care providers (adj OR = 0.129, 95% CI = 0.054-0.313), good support from family (adj OR = 0.304, 95% CI = 0.163-0.565), good support from friends (adj OR = 0.344, 95% CI = 0.193-0.613), and FP practice. It is recommended that designing FP programs with peers and family involvement could increase the practice of FP among rural Myanmar women. © 2016 APJPH.

  10. Reducing the Environmental Impact of Clinical Laboratories.

    PubMed

    Lopez, Joseph B; Jackson, David; Gammie, Alistair; Badrick, Tony

    2017-02-01

    Healthcare is a significant contributor to environmental impact but this has received little attention. The typical laboratory uses far more energy and water per unit area than the typical office building. There is a need to sensitise laboratories to the importance of adopting good environmental practices. Since this comes at an initial cost, it is vital to obtain senior management support. Convincing management of the various tangible and intangible benefits that can accrue in the long run should help achieve this support. Many good environmental practices do not have a cost but will require a change in the culture and mind-set of the organisation. Continuing education and training are important keys to successful implementation of good practices. There is a need to undertake a rigorous cost-benefit analysis of every change that is introduced in going green. The adoption of good practices can eventually lead to ISO certification if this is desired. This paper provides suggestions that will allow a laboratory to start going green. It will allow the industry to enhance its corporate citizenship whilst improving its competitive advantage for long-term.

  11. Self-assessed competency at working with a medical interpreter is not associated with knowledge of good practice.

    PubMed

    Hudelson, Patricia; Perneger, Thomas; Kolly, Véronique; Perron, Noëlle Junod

    2012-01-01

    Specific knowledge and skills are needed to work effectively with an interpreter, but most doctors have received limited training. Self-assessed competency may not accurately identify training needs. The purpose of this study is to explore the association between self-assessed competency at working with an interpreter and the ability to identify elements of good practice, using a written vignette. A mailed questionnaire was sent to 619 doctors and medical students in Geneva, Switzerland. 58.6% of respondents considered themselves to be highly competent at working with a professional interpreter, but 22% failed to mention even one element of good practice in response to the vignette, and only 39% could name more than one. There was no association between self-rated competency and number of elements mentioned. Training efforts should challenge the assumption that working with an interpreter is intuitive. Evaluation of clinicians' ability to work with an interpreter should not be limited to self-ratings. In the context of large-scale surveys, written vignettes may provide a simple method for identifying knowledge of good practice and topics requiring further training.

  12. [Implementation of good quality and safety practices. Descriptive study in a occupational mutual health centre].

    PubMed

    Manzanera, R; Plana, M; Moya, D; Ortner, J; Mira, J J

    2016-01-01

    To describe the level of implementation of quality and safety good practice elements in a Mutual Society health centre. A Cross-sectional study was conducted to assess the level of implementation of good practices using a questionnaire. Some quality dimensions were also assessed (scale 0 to 10) by a set of 87 quality coordinators of health centres and a random sample of 54 healthcare professionals working in small centres. Seventy quality coordinators and 27 professionals replied (response rates 80% and 50%, respectively. There were no differences in the assessment of quality attributes between both groups. They identified as areas for improvement: use of practice guidelines (7.6/10), scientific and technical skills (7.5/10), and patient satisfaction (7.7/10). Availability and accessibility to clinical reports, informed consent, availability of hydro-alcoholic solution, and to record allergies, were considered of high importance to be implemented, with training and research, improvements in equipment and technology plans, adherence to clinical practice guidelines and the preparation of risk maps, being of less importance. The good practices related to equipment and resources have a higher likelihood to be implemented, meanwhile those related to quality and safety attitudes have more barriers before being implemented. The mutual has a similar behaviour than other healthcare institutions. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

  13. Factors affecting vaccine handling and storage practices among immunization service providers in Ibadan, Oyo State, Nigeria.

    PubMed

    Dairo, David M; Osizimete, Oyarebu E

    2016-06-01

    Improper handling has been identified as one of the major reasons for the decline in vaccine potency at the time of administration. Loss of potency becomes evident when immunised individuals contract the diseases the vaccines were meant to prevent. Assessing the factors associated with vaccine handling and storage practices. This was a cross-sectional study. Three-stage sampling was used to recruit 380 vaccine handlers from 273 health facilities from 11 Local Government areas in Ibadan. Data was analysed using SPSS version 16. Seventy-three percent were aware of vaccine handling and storage guidelines with 68.4% having ever read such guidelines. Only 15.3% read a guideline less than 1 month prior to the study. About 65.0% had received training on vaccine management. Incorrect handling practices reported included storing injections with vaccines (13.7%) and maintaining vaccine temperature using ice blocks (7.6%). About 43.0% had good knowledge of vaccine management, while 66.1% had good vaccine management practices. Respondents who had good knowledge of vaccine handling and storage [OR=10.0, 95%CI (5.28 - 18.94), p < 0.001] and had received formal training on vaccine management [OR=5.3, 95%CI (2.50 - 11.14), p< 0.001] were more likely to have good vaccine handling and storage practices. Regular training is recommended to enhance vaccine handling and storage practices.

  14. Good pharmacovigilance practices: technology enabled.

    PubMed

    Nelson, Robert C; Palsulich, Bruce; Gogolak, Victor

    2002-01-01

    The assessment of spontaneous reports is most effective it is conducted within a defined and rigorous process. The framework for good pharmacovigilance process (GPVP) is proposed as a subset of good postmarketing surveillance process (GPMSP), a functional structure for both a public health and corporate risk management strategy. GPVP has good practices that implement each step within a defined process. These practices are designed to efficiently and effectively detect and alert the drug safety professional to new and potentially important information on drug-associated adverse reactions. These practices are enabled by applied technology designed specifically for the review and assessment of spontaneous reports. Specific practices include rules-based triage, active query prompts for severe organ insults, contextual single case evaluation, statistical proportionality and correlational checks, case-series analyses, and templates for signal work-up and interpretation. These practices and the overall GPVP are supported by state-of-the-art web-based systems with powerful analytical engines, workflow and audit trials to allow validated systems support for valid drug safety signalling efforts. It is also important to understand that a process has a defined set of steps and any one cannot stand independently. Specifically, advanced use of technical alerting methods in isolation can mislead and allow one to misunderstand priorities and relative value. In the end, pharmacovigilance is a clinical art and a component process to the science of pharmacoepidemiology and risk management.

  15. GP wellbeing and general practice issues.

    PubMed

    Murfett, Amanda; Charman, Denise

    2006-09-01

    Studies of general practitioner wellbeing have demonstrated remarkably consistent findings. However, the implications for day-to-day general practice have been unclear. This study was based on a survey comprising items extracted from transcripts of interviews with GPs and designed to link general practice issues with self reported wellbeing. 480 GP Australian Family Physician (AFP) subscribers (2.18% response rate); aged 26-81 years (mean 45.5 years); 273 (56.9%) men and 199 (43.1%) women. A survey insert in AFP September 2003 with questions about wellbeing, demographic details and 27 items about general practice issues. Almost 15% reported poor/very poor wellbeing, 47% reported good wellbeing and 38% reported very good/excellent wellbeing. Poor wellbeing was associated with being single, divorced or widowed, and reports of being alone in an adversarial context and more negative reactions to patients. Excellent or very good wellbeing was associated with being coupled and reports of general practice as a vocation. Targeted wellbeing strategies advocating social support may ameliorate the stress of general practice, especially for those GPs who are single.

  16. Comparative evaluation of the cadaveric, radiographic and computed tomographic anatomy of the heads of green iguana (Iguana iguana), common tegu (Tupinambis merianae) and bearded dragon (Pogona vitticeps).

    PubMed

    Banzato, Tommaso; Selleri, Paolo; Veladiano, Irene A; Martin, Andrea; Zanetti, Emanuele; Zotti, Alessandro

    2012-05-11

    Radiology and computed tomography are the most commonly available diagnostic tools for the diagnosis of pathologies affecting the head and skull in veterinary practice. Nevertheless, accurate interpretation of radiographic and CT studies requires a thorough knowledge of the gross and the cross-sectional anatomy. Despite the increasing success of reptiles as pets, only a few reports over their normal imaging features are currently available. The aim of this study is to describe the normal cadaveric, radiographic and computed tomographic features of the heads of the green iguana, tegu and bearded dragon. 6 adult green iguanas, 4 tegus, 3 bearded dragons, and, the adult cadavers of: 4 green iguana, 4 tegu, 4 bearded dragon were included in the study. 2 cadavers were dissected following a stratigraphic approach and 2 cadavers were cross-sectioned for each species. These latter specimens were stored in a freezer (-20°C) until completely frozen. Transversal sections at 5 mm intervals were obtained by means of an electric band-saw. Each section was cleaned and photographed on both sides. Radiographs of the head of each subject were obtained. Pre- and post- contrast computed tomographic studies of the head were performed on all the live animals. CT images were displayed in both bone and soft tissue windows. Individual anatomic structures were first recognised and labelled on the anatomic images and then matched on radiographs and CT images. Radiographic and CT images of the skull provided good detail of the bony structures in all species. In CT contrast medium injection enabled good detail of the soft tissues to be obtained in the iguana whereas only the eye was clearly distinguishable from the remaining soft tissues in both the tegu and the bearded dragon. The results provide an atlas of the normal anatomical and in vivo radiographic and computed tomographic features of the heads of lizards, and this may be useful in interpreting any imaging modality involving these species.

  17. Comparative evaluation of the cadaveric, radiographic and computed tomographic anatomy of the heads of green iguana (Iguana iguana) , common tegu ( Tupinambis merianae) and bearded dragon ( Pogona vitticeps)

    PubMed Central

    2012-01-01

    Background Radiology and computed tomography are the most commonly available diagnostic tools for the diagnosis of pathologies affecting the head and skull in veterinary practice. Nevertheless, accurate interpretation of radiographic and CT studies requires a thorough knowledge of the gross and the cross-sectional anatomy. Despite the increasing success of reptiles as pets, only a few reports over their normal imaging features are currently available. The aim of this study is to describe the normal cadaveric, radiographic and computed tomographic features of the heads of the green iguana, tegu and bearded dragon. Results 6 adult green iguanas, 4 tegus, 3 bearded dragons, and, the adult cadavers of : 4 green iguana, 4 tegu, 4 bearded dragon were included in the study. 2 cadavers were dissected following a stratigraphic approach and 2 cadavers were cross-sectioned for each species. These latter specimens were stored in a freezer (−20°C) until completely frozen. Transversal sections at 5 mm intervals were obtained by means of an electric band-saw. Each section was cleaned and photographed on both sides. Radiographs of the head of each subject were obtained. Pre- and post- contrast computed tomographic studies of the head were performed on all the live animals. CT images were displayed in both bone and soft tissue windows. Individual anatomic structures were first recognised and labelled on the anatomic images and then matched on radiographs and CT images. Radiographic and CT images of the skull provided good detail of the bony structures in all species. In CT contrast medium injection enabled good detail of the soft tissues to be obtained in the iguana whereas only the eye was clearly distinguishable from the remaining soft tissues in both the tegu and the bearded dragon. Conclusions The results provide an atlas of the normal anatomical and in vivo radiographic and computed tomographic features of the heads of lizards, and this may be useful in interpreting any imaging modality involving these species. PMID:22578088

  18. Selective imaging of cancer cells with a pH-activatable lysosome-targeting fluorescent probe.

    PubMed

    Shi, Rongguang; Huang, Lu; Duan, Xiaoxue; Sun, Guohao; Yin, Gui; Wang, Ruiyong; Zhu, Jun-Jie

    2017-10-02

    Fluorescence imaging with tumor-specific fluorescent probe has emerged as a tool to aid surgeons in the identification and removal of tumor tissue. We report here a new lysosome-targeting fluorescent probe (NBOH) with BODIPY fluorephore to distinguish tumor tissue out of normal tissue based on different pH environment. The probe exhibited remarkable pH-dependent fluorescence behavior in a wide pH range from 3.0 to 11.0, especially a sensitive pH-dependent fluorescence change at pH range between 3.5 and 5.5, corresponding well to the acidic microenvironment of tumor cells, in aqueous solution. The response time of NBOH was extremely short and the photostability was proved to be good. Toxicity test and fluorescence cell imaging together with a sub-cellular localization study were carried out revealing its low biotoxicity and good cell membrane permeability. And NBOH was successfully applied to the imaging of tumor tissue in tumor-bearing mice suggesting potential application to surgery as a tumor-specific probe. Copyright © 2017 Elsevier B.V. All rights reserved.

  19. The hand-hold polarization-sensitive spectral domain optical coherence and its applications

    NASA Astrophysics Data System (ADS)

    Liu, Hao; Gao, Wanrong

    2017-08-01

    The polarization-sensitive spectral domain optical coherence tomography (PSOCT) has the advantages of being able to measure the polarization properties of samples, such as phase-retardation, diattenuation, depolarization, and optical axis orientation, providing a contrast to identify the diseased area and normal area in tissues in PSOCT images. Conventionally, the sample arm of PSOCT is fixed on the stage where biomedical tissues or models is placed, and the OCT images is acquired by scanning with a galvanometer-based mirror. To be applied in the practical diagnosis, a promising way is to design a hand-held device. To this end, it is required that probe is assembled with a small volume to allow for comprehensively imaging large tissues areas at a microscopic scale, and is available to move on different samples to be acquired quickly with negligible motion artifacts. Meanwhile, the probe should be manufactured wih well stability to avoid system jitter error while it is used to detect the biological tissues in vivo. In this work, a design of a hand-hold fiber-based PSOCT is described. The device is of the size of 10 cm (length) × 8 cm (width) × 6 cm (height). Both the axial resolution and the imaging depth of the system are measured and were approximately 7 μm and 2.5 mm in air, respectively, which are in good agreement with the theoretical predictions. The A-scan rate of the system is 70 kHz. The structure is compact and all the components are fixed on the shell to reduce the motion artifact, resulting in a great stability on measuring the tissues in vivo. The cross sectional images of ex vivo chicken breast, ex vivo pork cartilage and in vivo forearm skin of human wolunteer are presented to demonstrate the capability of the system.

  20. Best practice guidelines for the operation of a donor human milk bank in an Australian NICU.

    PubMed

    Hartmann, B T; Pang, W W; Keil, A D; Hartmann, P E; Simmer, K

    2007-10-01

    Until the establishment of the PREM Bank (Perron Rotary Express Milk Bank) donor human milk banking had not occurred in Australia for the past 20 years. In re-establishing donor human milk banking in Australia, the focus of the PREM Bank has been to develop a formal and consistent approach to safety and quality in processing during the operation of the human milk bank. There is currently no existing legislation in Australia that specifically regulates the operation of donor human milk banks. For this reason the PREM Bank has utilised existing and internationally recognised management practices for managing hazards during food production. These tools (specifically HACCP) have been used to guide the development of Standard Operating Procedures and Good Manufacturing Practice for the screening of donors and processing of donor human milk. Donor screening procedures are consistent with those recommended by other human milk banks operating internationally, and also consistent with the requirements for blood and tissue donation in Australia. Controlled documentation and record keep requirements have also been developed that allow complete traceability from individual donation to individual feed dispensed to recipient and maintain a record of all processing and storage conditions. These operational requirements have been developed to reduce any risk associated with feeding pasteurised donor human milk to hospitalised preterm or ill infants to acceptable levels.

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