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...
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...
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...
Scan posture definition and hip girth measurement: the impact on clothing design and body scanning.
Gill, Simeon; Parker, Christopher J
2017-08-01
Ergonomic measurement is central to product design and development; especially for body worn products and clothing. However, there is a large variation in measurement definitions, complicated by new body scanning technology that captures measurements in a posture different to traditional manual methods. Investigations of hip measurement definitions in current clothing measurement practices supports analysis of the effect of scan posture and hip measurement definition on the circumferences of the hip. Here, the hip girth is a key clothing measurement that is not defined in current body scanning measurement standards. Sixty-four participants were scanned in the standard scan posture of a [TC] 2 body scanner, and also in a natural posture similar to that of traditional manual measurement collection. Results indicate that scan posture affects hip girth circumferences, and that some current clothing measurement practices may not define the largest lower body circumference. Recommendations are made concerning how the hip is defined in measurement practice and within body scanning for clothing product development. Practitioner Summary: The hip girth is an important measurement in garment design, yet its measurement protocol is not currently defined. We demonstrate that body posture during body scanning affects hip circumferences, and that current clothing measurement practices may not define the largest lower body circumference. This paper also provides future measurement practice recommendations.
Cover crops in vegetable production systems
USDA-ARS?s Scientific Manuscript database
Current vegetable production systems require an intensive amount Current vegetable production systems require an intensive amount of work and inputs, and if not properly managed could have detrimental effects on soil and the environment. Practices such as intensive tillage, increased herbicide use, ...
ERIC Educational Resources Information Center
Freudenberg, Nicholas; Picard Bradley, Sarah; Serrano, Monica
2009-01-01
Industry practices such as advertising, production of unsafe products, and efforts to defeat health legislation play a major role in current patterns of U.S. ill health. Changing these practices may be a promising strategy to promote health. The authors analyze 12 campaigns designed to modify the health-related practices of U.S. corporations in…
The Future of Pork Production in the World: Towards Sustainable, Welfare-Positive Systems
McGlone, John J.
2013-01-01
Simple Summary More pork is eaten in the world than any other meat. Making production systems and practices more sustainable will benefit the animals, the planet and people. A system is presented by which production practices are evaluated using a sustainability matrix. The matrix shows why some practices are more common in some countries and regions and the impediments to more sustainable systems. This method can be used to assess the sustainability of production practices in the future where objective, science-based information is presented alongside ethical and economic information to make the most informed decisions. Finally, this paper points to current pork production practices that are more and less sustainable. Abstract Among land animals, more pork is eaten in the world than any other meat. The earth holds about one billion pigs who deliver over 100 mmt of pork to people for consumption. Systems of pork production changed from a forest-based to pasture-based to dirt lots and finally into specially-designed buildings. The world pork industry is variable and complex not just in production methods but in economics and cultural value. A systematic analysis of pork industry sustainability was performed. Sustainable production methods are considered at three levels using three examples in this paper: production system, penning system and for a production practice. A sustainability matrix was provided for each example. In a comparison of indoor vs. outdoor systems, the food safety/zoonoses concerns make current outdoor systems unsustainable. The choice of keeping pregnant sows in group pens or individual crates is complex in that the outcome of a sustainability assessment leads to the conclusion that group penning is more sustainable in the EU and certain USA states, but the individual crate is currently more sustainable in other USA states, Asia and Latin America. A comparison of conventional physical castration with immunological castration shows that the less-common immunological castration method is more sustainable (for a number of reasons). This paper provides a method to assess the sustainability of production systems and practices that take into account the best available science, human perception and culture, animal welfare, the environment, food safety, worker health and safety, and economics (including the cost of production and solving world hunger). This tool can be used in countries and regions where the table values of a sustainability matrix change based on local conditions. The sustainability matrix can be used to assess current systems and predict improved systems of the future. PMID:26487410
21 CFR 211.111 - Time limitations on production.
Code of Federal Regulations, 2010 CFR
2010-04-01
... (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and... completion of each phase of production shall be established to assure the quality of the drug product...
21 CFR 211.111 - Time limitations on production.
Code of Federal Regulations, 2011 CFR
2011-04-01
... (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and... completion of each phase of production shall be established to assure the quality of the drug product...
Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing.
Burcham, Christopher L; Florence, Alastair J; Johnson, Martin D
2018-06-07
The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development. The transformation has been encouraged by regulatory bodies as well as driven by cost reduction, decreased development cycles, access to new chemistries not practical in batch, improved safety, flexible manufacturing platforms, and improved product quality assurance. The transformation from batch to continuous manufacturing processing is the focus of this review. The review is limited to small, chemically synthesized organic molecules and encompasses the manufacture of both active pharmaceutical ingredients (APIs) and the subsequent drug product. Continuous drug product is currently used in approved processes. A few examples of production of APIs under current good manufacturing practice conditions using continuous processing steps have been published in the past five years, but they are lagging behind continuous drug product with respect to regulatory filings.
Faculty Productivity: Practice and Policy.
ERIC Educational Resources Information Center
Quigley, E. James
Information was obtained on current or recently proposed legislation, administrative regulations, policies, practices, reports or studies on any aspect of faculty productivity, faculty workload or teaching load, or faculty activity analysis. Responses were obtained from 34 states. Responses for the 14 states that provided reference material are…
1993-08-03
The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human and veterinary drug products to revise certain labeling control provisions. Specifically, the final rule defines the term "gang-printed labeling," specifies conditions for the use of gang-printed or cut labeling, exempts manufacturers that employ automated 100-percent labeling inspection systems from CGMP labeling reconciliation requirements, and requires manufacturers to identify filled drug product containers that are set aside and held in an unlabeled condition for future labeling operations. These changes are intended to reduce the frequency of drug product mislabeling and associated drug product recalls.
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...
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...
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...
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...
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...
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...
There is currently a dearth of data characterizing best management practice impacts on runoff production at the parcel-level. This data is of critical importance insofar as judging the effectiveness and reliability of on-site stormwater BMPs, with significant implications for bot...
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...
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...
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...
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...
77 FR 75885 - Control of Communicable Diseases: Foreign; Scope and Definitions
Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-26
... primary authority supporting this rulemaking is section 361 of the Public Health Service Act (42 U.S.C... the scope and definitions to part 71 to reflect modern science and current practices. HHS/CDC has... products'' in subpart F. This revision more adequately reflects modern science and current practice which...
Bhosle, Monali; Klingman, David; Aagren, Mark; Wisniewski, Tami; Lee, Won Chan
2011-01-01
To synthesize current literature on recombinant human growth hormone (rhGH) use and to identify areas of research that have received little to no attention in light of administration practice and patient perception/behavior. Relevant articles for a systematic review were identified through PubMed. A total of 43 articles were identified: 9 (15.9%) studies on product administration practices and 34 (84.1%) on patient behavior patterns. Patients primarily preferred simple, convenient, and easy-to-use delivery devices. However, literature addressing the effect of convenient product administration practices on treatment outcomes using real-world patient/caregiver data is lacking. Better understanding of real-world product administration practices will help nurses identify areas of improvement in patient education and training. © 2010, Wiley Periodicals, Inc.
Automotive Marketing Methods and Practice
DOT National Transportation Integrated Search
1979-09-01
The report is a comprehensive examination of the current marketing practices, marketing methodologies, and decision-making processes utilized by the domestic automotive industry. The various marketing elements, such as products, consumer behavior, sa...
ERIC Educational Resources Information Center
Sugar, William A.; Luterbach, Kenneth J.
2016-01-01
Through consideration of critical incidents, this study analyzed 106 effective, ineffective and extraordinary instructional design and multimedia production (MP) activities discussed by 36 instructional design professionals. This evaluation provided insights into these professionals' best and not so best practices during the past 6 months.…
Evangelinos, Konstantinos I; Allan, Stuart; Jones, Keith; Nikolaou, Ioannis E
2014-04-01
Current literature describes a number of environmental management practices and cleaner production methods that facilitate different industrial sectors to address their various environmental impacts. The high number of present practices makes their use especially difficult and complicated. This paper aims to shed light on this field by providing a typology of those environmental management practices (such as environmental management systems, environmental indicators assessment methodologies, and cleaner productions methods) and their limitations. It also describes the strengths and weaknesses of using such tools and thoughts for future research. © 2013 SETAC.
ERIC Educational Resources Information Center
Hamlett, Peggy J.
A study was conducted to identify and compare livestock production and range management practices currently in use in the Texas/Mexico border corridor, and to determine the acceptance of selected innovative practices among cattle ranchers in the State of Sonora, Mexico. Information was collected from private livestock producers who were members of…
Croney, C C; Apley, M; Capper, J L; Mench, J A; Priest, S
2012-05-01
Contemporary animal agriculture is increasingly criticized on ethical grounds. Consequently, current policy and legislative discussions have become highly controversial as decision makers attempt to reconcile concerns about the impacts of animal production on animal welfare, the environment, and on the efficacy of antibiotics required to ensure human health with demands for abundant, affordable, safe food. Clearly, the broad implications for US animal agriculture of what appears to be a burgeoning movement relative to ethical food production must be understood by animal agriculture stakeholders. The potential effects of such developments on animal agricultural practices, corporate marketing strategies, and public perceptions of the ethics of animal production must also be clarified. To that end, it is essential to acknowledge that people's beliefs about which food production practices are appropriate are tied to diverse, latent value systems. Thus, relying solely on scientific information as a means to resolve current debates about animal agriculture is unlikely to be effective. The problem is compounded when scientific information is used inappropriately or strategically to advance a political agenda. Examples of the interface between science and ethics in regards to addressing currently contentious aspects of food animal production (animal welfare, antimicrobial use, and impacts of animal production practices on the environment) are reviewed. The roles of scientists and science in public debates about animal agricultural practices are also examined. It is suggested that scientists have a duty to contribute to the development of sound policy by providing clear and objectively presented information, by clarifying misinterpretations of science, and by recognizing the differences between presenting data vs. promoting their own value judgments in regard to how and which data should be used to establish policy. Finally, the role of the media in shaping public opinions on key issues pertaining to animal agriculture is also discussed.
Expanded function allied dental personnel and dental practice productivity and efficiency.
Beazoglou, Tryfon J; Chen, Lei; Lazar, Vickie F; Brown, L Jackson; Ray, Subhash C; Heffley, Dennis R; Berg, Rob; Bailit, Howard L
2012-08-01
This study examined the impact of expanded function allied dental personnel on the productivity and efficiency of general dental practices. Detailed practice financial and clinical data were obtained from a convenience sample of 154 general dental practices in Colorado. In this state, expanded function dental assistants can provide a wide range of reversible dental services/procedures, and dental hygienists can give local anesthesia. The survey identified practices that currently use expanded function allied dental personnel and the specific services/procedures delegated. Practice productivity was measured using patient visits, gross billings, and net income. Practice efficiency was assessed using a multivariate linear program, Data Envelopment Analysis. Sixty-four percent of the practices were found to use expanded function allied dental personnel, and on average they delegated 31.4 percent of delegatable services/procedures. Practices that used expanded function allied dental personnel treated more patients and had higher gross billings and net incomes than those practices that did not; the more services they delegated, the higher was the practice's productivity and efficiency. The effective use of expanded function allied dental personnel has the potential to substantially expand the capacity of general dental practices to treat more patients and to generate higher incomes for dental practices.
ERIC Educational Resources Information Center
Grapragasem, Selvaraj; Krishnan, Anbalagan; Mansor, Azlin Norhaini
2014-01-01
Malaysia has evolved from a production-based to knowledge-based economy in order to stay relevant and compete in the global marketplace. Thus, the purpose of this article is to discuss current trends in Malaysian higher education and how these affect education policies and practices. Four main trends are discussed in this study: Globalization,…
Protocols for sagebrush seed processing and seedling production at the Lucky Peak Nursery
Clark D. Fleege
2010-01-01
This paper presents the production protocols currently practiced at the USDA Forest Service Lucky Peak Nursery (Boise, ID) for seed processing and bareroot and container seedling production for three subspecies of big sagebrush (Artemisia tridentata).
Olsen, Kim Rose; Gyrd-Hansen, Dorte; Sørensen, Torben Højmark; Kristensen, Troels; Vedsted, Peter; Street, Andrew
2013-04-01
Shortage of general practitioners (GPs) and an increased political focus on primary care have enforced the interest in efficiency analysis in the Danish primary care sector. This paper assesses the association between organisational factors of general practices and production and efficiency. We assume that production and efficiency can be modelled using a behavioural production function. We apply the Battese and Coelli (Empir Econ 20:325-332, 1995) estimator to accomplish a decomposition of exogenous variables to determine the production frontier and variables determining the individual GPs distance to this frontier. Two different measures of practice outputs (number of office visits and total production) were applied and the results compared. The results indicate that nurses do not substitute GPs in the production. The production function exhibited constant returns to scale. The mean level of efficiency was between 0.79 and 0.84, and list size was the most important determinant of variation in efficiency levels. Nurses are currently undertaking other tasks than GPs, and larger practices do not lead to increased production per GP. However, a relative increase in list size increased the efficiency. This indicates that organisational changes aiming to increase capacity in general practice should be carefully designed and tested.
21 CFR 225.202 - Formula, production, and distribution records.
Code of Federal Regulations, 2014 CFR
2014-04-01
... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Records § 225.202 Formula, production, and distribution records. Records shall be maintained identifying the... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Formula, production, and distribution records. 225...
21 CFR 225.202 - Formula, production, and distribution records.
Code of Federal Regulations, 2012 CFR
2012-04-01
... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Records § 225.202 Formula, production, and distribution records. Records shall be maintained identifying the... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Formula, production, and distribution records. 225...
21 CFR 225.202 - Formula, production, and distribution records.
Code of Federal Regulations, 2013 CFR
2013-04-01
... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Records § 225.202 Formula, production, and distribution records. Records shall be maintained identifying the... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Formula, production, and distribution records. 225...
21 CFR 225.202 - Formula, production, and distribution records.
Code of Federal Regulations, 2011 CFR
2011-04-01
... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Records § 225.202 Formula, production, and distribution records. Records shall be maintained identifying the... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Formula, production, and distribution records. 225...
Chapter 9. Sanitation for Management of Florists' Crops Diseases
USDA-ARS?s Scientific Manuscript database
Sanitation involves efforts aimed to prevent entrance of pathogens into production areas, eliminate pathogens from production areas, and reduce production and spread of pathogen propagules to limit disease damage in a current crop. Sanitation includes many practices such as purchasing disease-free c...
Nationwide Survey of Local Emergency Planning Committees
These 2008 and 1999 surveys track the progress of LEPCs by assessing their current activity; and probe current practices and preferences regarding issues such as communication, accident prevention, and Office of Emergency Management products and services.
Nursery practices in western Canada
Eric van Steenis
2002-01-01
Forest seedling production in British Columbia began with bareroot production in the 1930s and has evolved to be 95'/0+ containerized entering the new millennium. Until the late 1970s most production was limited to government facilities. Currently private industry produces 85% of seedlings planted in British Columbia. Production levels are at approximately 300+...
21 CFR 211.111 - Time limitations on production.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Time limitations on production. 211.111 Section 211.111 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and...
21 CFR 211.111 - Time limitations on production.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Time limitations on production. 211.111 Section 211.111 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and...
21 CFR 211.111 - Time limitations on production.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Time limitations on production. 211.111 Section 211.111 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and...
Toward a New Industrial America.
ERIC Educational Resources Information Center
Berger, Suzanne; And Others
1989-01-01
Summarizes the positive and negative sides of American industrial practices determined by the Commission on Industrial Productivity at the Massachusetts Institute of Technology. Describes five imperatives recommended by the commission based on its study of current weakness and best practices in American industry. (YP)
Distribution and longevity of Pratylenchus penetrans in the red raspberry production system
USDA-ARS?s Scientific Manuscript database
One of the major production constraints on the production of red raspberries in the Pacific Northwest is the presence of the root lesion nematode Pratylenchus penetrans. Current management of this nematode relies heavily on pre-plant soil fumigation, however regulations have made the practice more d...
21 CFR 226.40 - Production and control procedures.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Production and control procedures. 226.40 Section 226.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control...
ERIC Educational Resources Information Center
Danish, Joshua Adam; Phelps, David
2011-01-01
A productive approach to studying the role of representations in supporting students' learning of science content is to examine their actions from a practice perspective. The current study examines kindergarten and first-grade students' representational practices across a consistent context--the creation of storyboards--both before and after a…
Survey of Sterile Admixture Practices in Canadian Hospital Pharmacies: Part 1. Methods and Results
Warner, Travis; Nishi, Cesilia; Checkowski, Ryan; Hall, Kevin W.
2009-01-01
Background: The 1996 Guidelines for Preparation of Sterile Products in Pharmacies of the Canadian Society of Hospital Pharmacists (CSHP) represent the current standard of practice for sterile compounding in Canada. However, these guidelines are practice recommendations, not enforceable standards. Previous surveys of sterile compounding practices have shown that actual practice deviates markedly from voluntary practice recommendations. In 2004, the United States Pharmacopeia (USP) published its “General Chapter <797> Pharmaceutical Compounding—Sterile Preparations”, which set a more rigorous and enforceable standard for sterile compounding in the United States. Objectives: To assess sterile compounding practices in Canadian hospital pharmacies and to compare them with current CSHP recommendations and USP chapter <797> standards. Methods: An online survey, based on previous studies of sterile compounding practices, the CSHP guidelines, and the chapter <797> standards, was created and distributed to 193 Canadian hospital pharmacies. Results: A total of 133 pharmacies completed at least part of the survey, for a response rate of 68.9%. All respondents reported the preparation of sterile products. Various degrees of deviation from the practice recommendations were noted for virtually all areas of the CSHP guidelines and the USP standards. Low levels of compliance were most notable in the areas of facilities and equipment, process validation, and product testing. Availability in the central pharmacy of a clean room facility meeting or exceeding the criteria of International Organization for Standardization (ISO) class 8 is a requirement of the chapter <797> standards, but more than 40% of responding pharmacies reported that they did not have such a facility. Higher levels of compliance were noted for policies and procedures, garbing requirements, aseptic technique, and handling of hazardous products. Part 1 of this series reports the survey methods and results relating to policies, personnel, raw materials, storage and handling, facilities and equipment, and garments. Part 2 will report results relating to preparation of aseptic products, expiry dating, labelling, process validation, product testing and release, documentation, records, and disposal of hazardous pharmaceuticals. It will also highlight some of the key areas where there is considerable opportunity for improvement. Conclusion: This survey identified numerous deficiences in sterile compounding practices in Canadian hospital pharmacies. Awareness of these deficiencies may create an impetus for critical assessment and improvements in practice. PMID:22478875
Warner, Travis; Nishi, Cesilia; Checkowski, Ryan; Hall, Kevin W
2009-01-01
Background: The 1996 Guidelines for Preparation of Sterile Products in Pharmacies of the Canadian Society of Hospital Pharmacists (CSHP) represent the current standard of practice for sterile compounding in Canada. However, these guidelines are practice recommendations, not enforceable standards. Previous surveys of sterile compounding practices have shown that actual practice deviates markedly from voluntary practice recommendations. In 2004, the United States Pharmacopeia (USP) published its “General Chapter <797> Pharmaceutical Compounding—Sterile Preparations”, which set a more rigorous and enforceable standard for sterile compounding in the United States. Objectives: To assess sterile compounding practices in Canadian hospital pharmacies and to compare them with current CSHP recommendations and USP chapter <797> standards. Methods: An online survey, based on previous studies of sterile compounding practices, the CSHP guidelines, and the chapter <797> standards, was created and distributed to 193 Canadian hospital pharmacies. Results: A total of 133 pharmacies completed at least part of the survey, for a response rate of 68.9%. All respondents reported the preparation of sterile products. Various degrees of deviation from the practice recommendations were noted for virtually all areas of the CSHP guidelines and the USP standards. Low levels of compliance were most notable in the areas of facilities and equipment, process validation, and product testing. Availability in the central pharmacy of a clean room facility meeting or exceeding the criteria of International Organization for Standardization (ISO) class 8 is a requirement of the chapter <797> standards, but more than 40% of responding pharmacies reported that they did not have such a facility. Higher levels of compliance were noted for policies and procedures, garbing requirements, aseptic technique, and handling of hazardous products. The survey methods for this study and results relating to policies, personnel, raw materials, storage and handling, facilities and equipment, and garments were reported in Part 1. Part 2 reports results relating to preparation of aseptic products, expiry dating, labelling, process validation, product testing and release, documentation, records, and disposal of hazardous pharmaceuticals. It also highlights some of the key areas where there is considerable opportunity for improvement. Conclusion: This survey identified numerous deficiencies in sterile compounding practices in Canadian hospital pharmacies. Awareness of these deficiencies may create an impetus for critical assessment and improvements in practice. PMID:22478890
Warner, Travis; Nishi, Cesilia; Checkowski, Ryan; Hall, Kevin W
2009-05-01
The 1996 Guidelines for Preparation of Sterile Products in Pharmacies of the Canadian Society of Hospital Pharmacists (CSHP) represent the current standard of practice for sterile compounding in Canada. However, these guidelines are practice recommendations, not enforceable standards. Previous surveys of sterile compounding practices have shown that actual practice deviates markedly from voluntary practice recommendations. In 2004, the United States Pharmacopeia (USP) published its "General Chapter <797> Pharmaceutical Compounding-Sterile Preparations", which set a more rigorous and enforceable standard for sterile compounding in the United States. To assess sterile compounding practices in Canadian hospital pharmacies and to compare them with current CSHP recommendations and USP chapter <797> standards. An online survey, based on previous studies of sterile compounding practices, the CSHP guidelines, and the chapter <797> standards, was created and distributed to 193 Canadian hospital pharmacies. A total of 133 pharmacies completed at least part of the survey, for a response rate of 68.9%. All respondents reported the preparation of sterile products. Various degrees of deviation from the practice recommendations were noted for virtually all areas of the CSHP guidelines and the USP standards. Low levels of compliance were most notable in the areas of facilities and equipment, process validation, and product testing. Availability in the central pharmacy of a clean room facility meeting or exceeding the criteria of International Organization for Standardization (ISO) class 8 is a requirement of the chapter <797> standards, but more than 40% of responding pharmacies reported that they did not have such a facility. Higher levels of compliance were noted for policies and procedures, garbing requirements, aseptic technique, and handling of hazardous products. The survey methods for this study and results relating to policies, personnel, raw materials, storage and handling, facilities and equipment, and garments were reported in Part 1. Part 2 reports results relating to preparation of aseptic products, expiry dating, labelling, process validation, product testing and release, documentation, records, and disposal of hazardous pharmaceuticals. It also highlights some of the key areas where there is considerable opportunity for improvement. This survey identified numerous deficiencies in sterile compounding practices in Canadian hospital pharmacies. Awareness of these deficiencies may create an impetus for critical assessment and improvements in practice.
Survey of sterile admixture practices in canadian hospital pharmacies: part 1. Methods and results.
Warner, Travis; Nishi, Cesilia; Checkowski, Ryan; Hall, Kevin W
2009-03-01
The 1996 Guidelines for Preparation of Sterile Products in Pharmacies of the Canadian Society of Hospital Pharmacists (CSHP) represent the current standard of practice for sterile compounding in Canada. However, these guidelines are practice recommendations, not enforceable standards. Previous surveys of sterile compounding practices have shown that actual practice deviates markedly from voluntary practice recommendations. In 2004, the United States Pharmacopeia (USP) published its "General Chapter <797> Pharmaceutical Compounding-Sterile Preparations", which set a more rigorous and enforceable standard for sterile compounding in the United States. To assess sterile compounding practices in Canadian hospital pharmacies and to compare them with current CSHP recommendations and USP chapter <797> standards. An online survey, based on previous studies of sterile compounding practices, the CSHP guidelines, and the chapter <797> standards, was created and distributed to 193 Canadian hospital pharmacies. A total of 133 pharmacies completed at least part of the survey, for a response rate of 68.9%. All respondents reported the preparation of sterile products. Various degrees of deviation from the practice recommendations were noted for virtually all areas of the CSHP guidelines and the USP standards. Low levels of compliance were most notable in the areas of facilities and equipment, process validation, and product testing. Availability in the central pharmacy of a clean room facility meeting or exceeding the criteria of International Organization for Standardization (ISO) class 8 is a requirement of the chapter <797> standards, but more than 40% of responding pharmacies reported that they did not have such a facility. Higher levels of compliance were noted for policies and procedures, garbing requirements, aseptic technique, and handling of hazardous products. Part 1 of this series reports the survey methods and results relating to policies, personnel, raw materials, storage and handling, facilities and equipment, and garments. Part 2 will report results relating to preparation of aseptic products, expiry dating, labelling, process validation, product testing and release, documentation, records, and disposal of hazardous pharmaceuticals. It will also highlight some of the key areas where there is considerable opportunity for improvement. This survey identified numerous deficiences in sterile compounding practices in Canadian hospital pharmacies. Awareness of these deficiencies may create an impetus for critical assessment and improvements in practice.
Small Business and Defense Acquisitions: A Review of Policies and Current Practices
2011-01-01
Office of Management and Budget xviii Small Business and Defense Acquisitions: A Review of Policies and Current Practices PSC Product and Service Code...themselves as minority-owned, women-owned, veteran- owned, or small disadvantaged businesses . The resulting database gives sourcing managers a tool for...REPORT DATE 2011 2. REPORT TYPE 3. DATES COVERED 00-00-2011 to 00-00-2011 4. TITLE AND SUBTITLE Small Business and Defense Acquisitions: A
An Independent Scientific Assessment of Well Stimulation in California Volume I
DOE Office of Scientific and Technical Information (OSTI.GOV)
Jane C.S. Long; Laura C. Feinstein; Birkholzer, Jens
In 2013, the California Legislature passed Senate Bill 4 (SB 4), setting the framework for regulation of well stimulation technologies in California, including hydraulic fracturing. SB 4 also requires the California Natural Resources Agency to conduct an independent scientific study of well stimulation technologies in California to assess current and potential future practices, including the likelihood that well stimulation technologies could enable extensive new petroleum production in the state, evaluate the impacts of well stimulation technologies and the gaps in data that preclude this understanding, identify risks associated with current practices, and identify alternative practices which might limit these risks.more » The study is issued in three volumes. This document, Volume I, provides the factual basis describing well stimulation technologies, how and where operators deploy these technologies for oil and gas production in California, and where they might enable production in the future. Volume II discusses how well stimulation affects water, the atmosphere, seismic activity, wildlife and vegetation, traffic, light and noise levels; it will also explore human health hazards, and identify data gaps and alternative practices. Volume III presents case studies to assess environmental issues and qualitative« less
Green polymer chemistry: biocatalysis and biomaterials
USDA-ARS?s Scientific Manuscript database
This overview briefly surveys the practice of green chemistry in polymer science. Eight related themes can be discerned from the current research activities: 1) biocatalysis, 2) bio-based building blocks and agricultural products, 3) degradable polymers, 4) recycling of polymer products and catalys...
The Business Practices Course: Self-Study Learning Reengineered.
ERIC Educational Resources Information Center
Acovelli, Marianne; Nowakowski, Alan
1994-01-01
Describes an interactive multimedia Business Practices Course, developed to help reengineer point-of-need training for professional development, in which the learner conducts a business review of a company's current operations and makes recommendations to improve productivity and increase customer satisfaction. (six references) (LRW)
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.
Research on the Use of Educational Products: (4) Marketing Research: At What Prices?
ERIC Educational Resources Information Center
Rosenau, Fred S.
The production and distribution of educational materials developed by researchers is considered. The current practice of turning over federally or foundation funded products to commercial producers raises the question of pricing policies of these firms as compared to the policies of nonprofit development agencies. Comparative costs of producing…
Code of Federal Regulations, 2010 CFR
2010-07-01
... best practicable control technology currently available. (a) By-product cokemaking—iron and steel... for by-product coke plants which have wet desulfurization systems but only to the extent such systems... limitations, are allowed for by-product coke plants which include indirect ammonia recovery systems but only...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-20
... ``cut'' from a sheet or roll of labels--is used. Persistent problems with drug product mislabeling and... believe that development and use of advanced code scanning equipment has made many current electronic... and other advanced scanning techniques have made current electronic systems reliable to the 100...
ERIC Educational Resources Information Center
Kahney, Jon
2017-01-01
Teacher grading practices commonly do not align with the grading practices recommended by leading grading authorities in the field of education. The experts advocate for grades to be determined solely from measures of product criteria that represent a students current level of knowledge and what they can do. Most teachers, however, still use a mix…
76 FR 56145 - Clearwater National Forest; ID; Upper Lochsa Land Exchange EIS
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-12
... for timber production. For the most part these lands currently meet State Best Management Practices... River drainage to provide more efficient and effective resource management. This purpose can be achieved... years, differing management practices on the private lands has influenced resource management decision...
Managing Productive Schools: Toward an Ecology.
ERIC Educational Resources Information Center
Snyder, Karolyn J.; Anderson, Robert H.
Intended for use by graduate students in educational administration and supervision as well as by practicing school administrators, this book is a guide to the most effective practices surrounding the school principalship. Ideas in the book reflect current views of good management, including systems approaches, participative and collaborative…
16 CFR 1027.4 - Notice requirements before offset.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Notice requirements before offset. 1027.4 Section 1027.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL SALARY OFFSET § 1027.4... debt by deducting from the employee's current disposable pay account; (3) The amount, frequency...
40 CFR 430.01 - General definitions.
Code of Federal Regulations, 2011 CFR
2011-07-01
... that are representative of the application of the best practicable control technology currently available, the best conventional pollutant control technology, or new source performance standards in lieu... production at unbleached kraft mills including linerboard or bag paper and other mixed products, and to pulp...
40 CFR 430.01 - General definitions.
Code of Federal Regulations, 2010 CFR
2010-07-01
... that are representative of the application of the best practicable control technology currently available, the best conventional pollutant control technology, or new source performance standards in lieu... production at unbleached kraft mills including linerboard or bag paper and other mixed products, and to pulp...
The hierarchy of environmental health and safety practices in the U.S. nanotechnology workplace.
Engeman, Cassandra D; Baumgartner, Lynn; Carr, Benjamin M; Fish, Allison M; Meyerhofer, John D; Satterfield, Terre A; Holden, Patricia A; Harthorn, Barbara Herr
2013-01-01
Manufacturing of nanoscale materials (nanomaterials) is a major outcome of nanotechnology. However, the potential adverse human health effects of manufactured nanomaterial exposure are not yet fully understood, and exposures in humans are mostly uncharacterized. Appropriate exposure control strategies to protect workers are still being developed and evaluated, and regulatory approaches rely largely on industry self-regulation and self-reporting. In this context of soft regulation, the authors sought to: 1) assess current company-reported environmental health and safety practices in the United States throughout the product life cycle, 2) consider their implications for the manufactured nanomaterial workforce, and 3) identify the needs of manufactured nanomaterial companies in developing nano-protective environmental health and safety practices. Analysis was based on the responses of 45 U.S.-based company participants in a 2009-2010 international survey of private companies that use and/or produce nanomaterials. Companies reported practices that span all aspects of the current government-recommended hierarchical approach to manufactured nanomaterials' exposure controls. However, practices that were tailored to current manufactured nanomaterials' hazard and exposure knowledge, whether within or outside the hierarchical approach, were reported less frequently than general chemical hygiene practices. Product stewardship and waste management practices-the influences of which are substantially downstream-were reported less frequently than most other environmental health and safety practices. Larger companies had more workers handling nanomaterials, but smaller companies had proportionally more employees handling nanomaterials and more frequently identified impediments to implementing nano-protective practices. Company-reported environmental health and safety practices suggest more attention to environmental health and safety is necessary, especially with regard to practices that can cause external effects. Given reported impediments, smaller companies may especially benefit from more attention. However, the manufactured nanomaterial workforce within smaller companies is particularly difficult to identify and hence locate, posing challenges to developing and enforcing appropriate workplace environmental health and safety. [Supplementary materials are available for this article. Go to the publisher's online edition of Journal of Occupational and Environmental Hygiene for the following free supplemental resource: a file containing Survey of Current Health and Safety Practices in the Nanomaterial Industry and a file containing figures.].
Biofuels in Oregon and Washington: A Business Case Analysis of Opportunities and Challenges
DOE Office of Scientific and Technical Information (OSTI.GOV)
Stiles, Dennis L.; Jones, Susan A.; Orth, Rick J.
The purpose of this report is to assemble the information needed to estimate the significance of the opportunity for producing biofuels in the region as well as the associated challenges. The report reviews the current state of the industry, the biomass resources that are available within current production practices, and the biofuels production technology that is available within the marketplace. The report also identifys the areas in which alternative approaches or strategies, or technologoical advances, might offer an opportunity to expand the Nortwest biofuels industry beyond its current state.
Eisenberg, Joseph N.S.; Trueba, Gabriel; Zhang, Lixin; Johnson, Timothy J.
2017-01-01
Summary: Small-scale food animal production is widely practiced around the globe, yet it is often overlooked in terms of the environmental health risks. Evidence suggests that small-scale food animal producers often employ the use of antimicrobials to improve the survival and growth of their animals, and that this practice leads to the development of antimicrobial resistance (AMR) that can potentially spread to humans. The nature of human–animal interactions in small-scale food animal production systems, generally practiced in and around the home, likely augments spillover events of AMR into the community on a scale that is currently unrecognized and deserves greater attention. https://doi.org/10.1289/EHP2116 PMID:29038091
Academic or community practice? What is driving decision-making and career choices.
Goudreau, Bernadette J; Hassinger, Taryn E; Hedrick, Traci L; Slingluff, Craig L; Schroen, Anneke T; Dengel, Lynn T
2018-06-18
Identifying factors that impact progression of surgery trainees into academic versus non-academic practices may permit tailoring residency experiences to promote academic careers in institutions charged with the training of future surgeon scientists. The aim of this study was to identify factors associated with progression of surgery trainees into academic versus non-academic practice. A survey was distributed to 135 surgeons graduating from the University of Virginia residency program from 1964-2016, a single academic institution. Questions addressed practice type, research productivity, work/life balance, mentorship, and overall sentiment toward research and academic surgery. A 5-point Likert scale measured career satisfaction and influence of factors in practice setting choice. Of the 135 surveys that were electronically distributed, 69 participants responded (response rate: 51%). Of the 54 with known current practice types, 34 (63%) were academic and 20 (37%) non-academic. Academic surgeons reported more publications by the conclusion of surgery training (56% vs 25% with >10 publications, P = .02). More academic surgeons reported >$100,000 in student debt at graduation (44% vs 25%, P < .05). Factors encouraging an academic career were similar for both types of surgeons, including involvement in education of trainees and access to mentorship. Both groups were discouraged from an academic practice by requirements of grant-writing and funding responsibilities. Surgeons in academic practice were more likely to recommend surgery as a career to a current medical student (100% vs 70%, P = .001). This knowledge may help to tailor training experiences to promote academic careers. By supporting funding mechanisms and grant-writing programs, while encouraging mentorship and productive research experiences, current surgical trainees may be more enthusiastic about a career in academic practice. Copyright © 2018 Elsevier Inc. All rights reserved.
"My Feelings": Power, Politics and Childhood Subjectivities
ERIC Educational Resources Information Center
Tesar, Marek
2014-01-01
This article focuses on the production of children's literature in New Zealand. It problematizes the current practices of releasing and distributing children's literature, and explores these practices as technologies of control through processes of censorship and classification set by government agencies such as the Office for Film and Literature.…
Efficient silvicultural practices for eastern hardwood management
Gary W. Miller; John E. Baumgras
1994-01-01
Eastern hardwood forests are now managed to meet a wide range of objectives, resulting in the need for silvicultural alternatives that provide timber, wildlife, aesthetics, recreation, and other benefits. However, forest management practices must continue to be efficient in terms of profiting from current harvests, protecting the environment, and sustaining production...
Code of Federal Regulations, 2010 CFR
2010-07-01
... degree of effluent reduction attainable by the application of the best practicable control technology... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS TIMBER PRODUCTS PROCESSING POINT SOURCE CATEGORY Wood Furniture... best practicable control technology currently available (BPT). Except as provided in 40 CFR 125.30...
Code of Federal Regulations, 2010 CFR
2010-07-01
... degree of effluent reduction attainable by the application of the best practicable control technology... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS TIMBER PRODUCTS PROCESSING POINT SOURCE CATEGORY Wood Furniture... application of the best practicable control technology currently available (BPT). Except as provided in 40 CFR...
21 CFR 225.65 - Equipment cleanout procedures.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.65 Equipment cleanout procedures. (a) Adequate cleanout procedures for all equipment used in the manufacture... sequential production of feeds. (2) If flushing is utilized, the flush material shall be properly identified...
Processing of Brassica seeds for feedstock in biofuels production
USDA-ARS?s Scientific Manuscript database
Several Brassica species are currently being evaluated to develop regionalized production systems based on their suitability to the environment and with the prevailing practices of growing commodity food crops like wheat, corn, and soybeans. This integrated approach to farming will provide high qual...
Alternatives to current fumigation practices in western states raspberry
USDA-ARS?s Scientific Manuscript database
Red raspberry production systems in the western United States are heavily reliant on preplant soil fumigation to ensure the successful establishment and productivity of a planting. However, due to issues related to the regulation, availability, and economics of soil fumigation alternatives are need ...
Dissemination 2.0: closing the gap between knowledge and practice with new media and marketing.
Bernhardt, Jay M; Mays, Darren; Kreuter, Matthew W
2011-01-01
Despite substantial investments in public health and clinical research at the national level, and significant advancements in these areas of science, few evidence-based programs and services are rapidly implemented in health care or public health practice as a result of failures of dissemination. A significant gap in current processes to disseminate and implement effective programs relates to the lack of systems and infrastructure to facilitate distribution of scientific research products to potential end users, including clinicians and other practitioners. In this article, the authors assert that Web 2.0 technologies can be leveraged to enhance dissemination efforts and increase the implementation of evidence-based programs and services in everyday practice. The authors describe the research-to-practice delivery process and highlight gaps in the supply chain necessary to translate research findings into evidence-based practice. The authors critically evaluate the 4 most prominent strategies currently used to promote dissemination and implementation of research evidence in practice, and they detail how each can be improved by leveraging Web 2.0 technologies to enhance dissemination of research evidence. Last, the authors provide examples and suggestions for capitalizing on Web 2.0 technologies to enhance dissemination efforts and ensure that evidence-based research products reach intended end users and are implemented in clinical practice.
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.
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
Technical feasibility and carbon footprint of biochar co-production with tomato plant residue.
Llorach-Massana, Pere; Lopez-Capel, Elisa; Peña, Javier; Rieradevall, Joan; Montero, Juan Ignacio; Puy, Neus
2017-09-01
World tomato production is in the increase, generating large amounts of organic agricultural waste, which are currently incinerated or composted, releasing CO 2 into the atmosphere. Organic waste is not only produced from conventional but also urban agricultural practices due recently gained popularity. An alternative to current waste management practices and carbon sequestration opportunity is the production of biochar (thermally converted biomass) from tomato plant residues and use as a soil amendment. To address the real contribution of biochar for greenhouse gas mitigation, it is necessary to assess the whole life cycle from the production of the tomato biomass feedstock to the actual distribution and utilisation of the biochar produced in a regional context. This study is the first step to determine the technical and environmental potential of producing biochar from tomato plant (Solanum lycopersicum arawak variety) waste biomass and utilisation as a soil amendment. The study includes the characterisation of tomato plant residue as biochar feedstock (cellulose, hemicellulose, lignin and metal content); feedstock thermal stability; and the carbon footprint of biochar production under urban agriculture at pilot and small-scale plant, and conventional agriculture at large-scale plant. Tomato plant residue is a potentially suitable biochar feedstock under current European Certification based on its lignin content (19.7%) and low metal concentration. Biomass conversion yields of over 40%, 50% carbon stabilization and low pyrolysis temperature conditions (350-400°C) would be required for biochar production to sequester carbon under urban pilot scale conditions; while large-scale biochar production from conventional agricultural practices have not the potential to sequestrate carbon because its logistics, which could be improved. Therefore, the diversion of tomato biomass waste residue from incineration or composting to biochar production for use as a soil amendment would environmentally be beneficial, but only if high biochar yields could be produced. Copyright © 2017 Elsevier Ltd. All rights reserved.
Life cycle assessment part 2: current impact assessment practice.
Pennington, D W; Potting, J; Finnveden, G; Lindeijer, E; Jolliet, O; Rydberg, T; Rebitzer, G
2004-07-01
Providing our society with goods and services contributes to a wide range of environmental impacts. Waste generation, emissions and the consumption of resources occur at many stages in a product's life cycle-from raw material extraction, energy acquisition, production and manufacturing, use, reuse, recycling, through to ultimate disposal. These all contribute to impacts such as climate change, stratospheric ozone depletion, photooxidant formation (smog), eutrophication, acidification, toxicological stress on human health and ecosystems, the depletion of resources and noise-among others. The need exists to address these product-related contributions more holistically and in an integrated manner, providing complimentary insights to those of regulatory/process-oriented methodologies. A previous article (Part 1, Rebitzer et al., 2004) outlined how to define and model a product's life cycle in current practice, as well as the methods and tools that are available for compiling the associated waste, emissions and resource consumption data into a life cycle inventory. This article highlights how practitioners and researchers from many domains have come together to provide indicators for the different impacts attributable to products in the life cycle impact assessment (LCIA) phase of life cycle assessment (LCA).
Computer-aided documentation. Quality, productivity, coding, and enhanced reimbursement.
Foxlee, R H
1993-10-01
Physicians currently use technology, where appropriate, to improve patient care, for example, MRI and three-dimensional radiotherapy dose planning. One area that has seen limited benefit from current technology is in documenting of medical information. Review of related literature and directed interviews. Technology is available to assist in documenting the initial patient encounter. Patient care, quality of practice, and reimbursement may be improved with careful implementation. It will be worthwhile for practices to examine how to implement this technology to obtain the potential benefits.
Newell, Sue; Edelman, Linda; Scarbrough, Harry; Swan, Jacky; Bresnen, Mike
2003-02-01
A core prescription from the knowledge management movement is that the successful management of organizational knowledge will prevent firms from 'reinventing the wheel', in particular through the transfer of 'best practices'. Our findings challenge this logic. They suggest instead that knowledge is emergent and enacted in practice, and that normally those involved in a given practice have only a partial understanding of the overall practice. Generating knowledge about current practice is therefore a precursor to changing that practice. In this sense, knowledge transfer does not occur independently of or in sequence to knowledge generation, but instead the process of knowledge generation and its transfer are inexorably intertwined. Thus, rather than transferring 'product' knowledge about the new 'best practice' per se, our analysis suggests that it is more useful to transfer 'process' knowledge about effective ways to generate the knowledge of existing practice, which is the essential starting point for attempts to change that practice.
Complementary and alternative medicine: a survey of its use in pediatric cardiology.
Adams, Denise; Whidden, Ashley; Honkanen, Meeri; Dagenais, Simon; Clifford, Tammy; Baydala, Lola; King, W James; Vohra, Sunita
2014-10-01
The use of complementary and alternative medicine is high among children and youth with chronic illnesses, including patients with cardiac conditions. Our goal was to assess the prevalence and patterns of such use among patients presenting to academic pediatric cardiology clinics in Canada. A survey instrument was developed to inquire about current or previous use of complementary and alternative medicine products and practices, including indications, beliefs, sources of information and whether this use was discussed with physicians. Between February and July 2007, the survey was administered to patients (or their parents/guardians) presenting to 2 hospital-based cardiology clinics: the Stollery Children's Hospital in Edmonton, Alberta, and the Children's Hospital of Eastern Ontario in Ottawa, Ontario. At the Stollery Children's Hospital, 64.1% of the 145 respondents had used complementary and alternative medicine compared with 35.5% of the 31 respondents at the Children's Hospital of Eastern Ontario (p = 0.003). Overall, the most common products in current use were multivitamins (70.6%), vitamin C (22.1%), calcium (13.2%), unspecified "cold remedies" (11.8%) and fish oil or omega-3 fatty acids (11.8%). The most common practices in current use were massage (37.5%), faith healing (25.0%), chiropractic (20.0%), aromatherapy (15.0%) and Aboriginal healing (7.5%). Many patients (44.9%) used complementary and alternative medicine products at the same time as conventional prescription drugs. Concurrent use was discussed with physicians or pharmacists by 64.3% and 31.3% of respondents, respectively. Use of complementary and alternative medicine products and practices was high among patients seen in the pediatric cardiology clinics in our study. Most respondents believed that the use of these products and practices was helpful; few reported harms and many did not discuss this use with their physicians, increasing the potential for interactions with prescribed medications.
Complementary and alternative medicine: a survey of its use in pediatric cardiology
Adams, Denise; Whidden, Ashley; Honkanen, Meeri; Dagenais, Simon; Clifford, Tammy; Baydala, Lola; King, W. James
2014-01-01
Background The use of complementary and alternative medicine is high among children and youth with chronic illnesses, including patients with cardiac conditions. Our goal was to assess the prevalence and patterns of such use among patients presenting to academic pediatric cardiology clinics in Canada. Methods A survey instrument was developed to inquire about current or previous use of complementary and alternative medicine products and practices, including indications, beliefs, sources of information and whether this use was discussed with physicians. Between February and July 2007, the survey was administered to patients (or their parents/guardians) presenting to 2 hospital-based cardiology clinics: the Stollery Children’s Hospital in Edmonton, Alberta, and the Children’s Hospital of Eastern Ontario in Ottawa, Ontario. Results At the Stollery Children’s Hospital, 64.1% of the 145 respondents had used complementary and alternative medicine compared with 35.5% of the 31 respondents at the Children’s Hospital of Eastern Ontario (p = 0.003). Overall, the most common products in current use were multivitamins (70.6%), vitamin C (22.1%), calcium (13.2%), unspecified “cold remedies” (11.8%) and fish oil or omega-3 fatty acids (11.8%). The most common practices in current use were massage (37.5%), faith healing (25.0%), chiropractic (20.0%), aromatherapy (15.0%) and Aboriginal healing (7.5%). Many patients (44.9%) used complementary and alternative medicine products at the same time as conventional prescription drugs. Concurrent use was discussed with physicians or pharmacists by 64.3% and 31.3% of respondents, respectively. Interpretation Use of complementary and alternative medicine products and practices was high among patients seen in the pediatric cardiology clinics in our study. Most respondents believed that the use of these products and practices was helpful; few reported harms and many did not discuss this use with their physicians, increasing the potential for interactions with prescribed medications. PMID:25485246
Production of Ac-225 for cancer therapy by photon-induced transmutation of Ra-226.
Melville, G; Meriarty, H; Metcalfe, P; Knittel, T; Allen, B J
2007-09-01
The increasing application of Ac-225 for cancer therapy indicates the potential need for its increased production and availability. The production of Ac-225 has been achieved using bremsstrahlung photons from an 18 MV medical linear accelerator (linac) to bombard a Ra-226 target. A linac dose of 2800 Gy produced about 64 microCi of Ra-225, which decays to Ac-225. This result, while consistent with the theoretical calculations, is far too low to be of practical use. A more powerful linac is required that runs at a higher current, longer pulse length and higher frequency for practical production. This process could also lead to the reduction of the nuclear waste product Ra-226.
21 CFR 211.134 - Drug product inspection.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drug product inspection. 211.134 Section 211.134 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...
Current status of practical applications: Probiotics in dairy cattle
USDA-ARS?s Scientific Manuscript database
The gastrointestinal microbial population of dairy cattle is dense and diverse, and can be utilized to reduce pathogenic bacterial populations as well as improve animal productivity and environmental impacts. Because of the nature of the dairy industry, probiotic products have been widely used to e...
21 CFR 211.208 - Drug product salvaging.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drug product salvaging. 211.208 Section 211.208 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...
21 CFR 211.204 - Returned drug products.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...
21 CFR 211.204 - Returned drug products.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...
21 CFR 211.208 - Drug product salvaging.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drug product salvaging. 211.208 Section 211.208 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...
21 CFR 211.204 - Returned drug products.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...
21 CFR 211.204 - Returned drug products.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...
21 CFR 211.208 - Drug product salvaging.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drug product salvaging. 211.208 Section 211.208 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...
21 CFR 211.208 - Drug product salvaging.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drug product salvaging. 211.208 Section 211.208 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...
Code of Federal Regulations, 2011 CFR
2011-04-01
... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and...
Code of Federal Regulations, 2012 CFR
2012-04-01
... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and...
Code of Federal Regulations, 2014 CFR
2014-04-01
... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and...
Code of Federal Regulations, 2013 CFR
2013-04-01
... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and...
21 CFR 211.204 - Returned drug products.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...
21 CFR 211.103 - Calculation of yield.
Code of Federal Regulations, 2011 CFR
2011-04-01
...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls... at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of...
21 CFR 211.103 - Calculation of yield.
Code of Federal Regulations, 2010 CFR
2010-04-01
...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls... at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of...
Protein Aggregation and Its Impact on Product Quality
Roberts, Christopher J.
2014-01-01
Protein pharmaceutical products are typically active as folded monomers that are composed of one or more protein chains, such as the heavy and light chains in monoclonal antibodies that are a mainstay of current drug pipelines. There are numerous possible aggregated states for a given protein, some of which are potentially useful, while most of which are considered deleterious from the perspective of pharmaceutical product quality and performance. This review provides an overview of how and why different aggregated states of proteins occur, how this potentially impacts product quality and performance, fundamental approaches to control aggregate formation, and the practical approaches that are currently used in the pharmaceutical industry. PMID:25173826
Accounting for biodiversity in the dairy industry.
Sizemore, Grant C
2015-05-15
Biodiversity is an essential part of properly functioning ecosystems, yet the loss of biodiversity currently occurs at rates unparalleled in the modern era. One of the major causes of this phenomenon is habitat loss and modification as a result of intensified agricultural practices. This paper provides a starting point for considering biodiversity within dairy production, and, although focusing primarily on the United States, findings are applicable broadly. Biodiversity definitions and assessments (e.g., indicators, tools) are proposed and reviewed. Although no single indicator or tool currently meets all the needs of comprehensive assessment, many sustainable practices are readily adoptable as ways to conserve and promote biodiversity. These practices, as well as potential funding opportunities are identified. Given the state of uncertainty in addressing the complex nature of biodiversity assessments, the adoption of generally sustainable environmental practices may be the best currently available option for protecting biodiversity on dairy lands. Copyright © 2015 Elsevier Ltd. All rights reserved.
Wastes and by-products - alternatives for agricultural use
DOE Office of Scientific and Technical Information (OSTI.GOV)
Boles, J.L.; Craft, D.J.; Parker, B.R.
1994-10-01
Top address a growing national problem with generation of wastes and by-products, TVA has been involved for several years with developing and commercializing environmentally responsible practices for eliminating, minimizing, or utilizing various wastes/by-products. In many cases, reducing waste generation is impractical, but the wastes/by-products can be converted into other environmentally sound products. In some instances, conversion of safe, value-added agricultural products in the best or only practical alternative. TVA is currently involved with a diversity of projects converting wastes/by-products into safe, economical, and agriculturally beneficial products. Environmental improvement projects have involved poultry litter, cellulosic wastes, used battery acid, ammonium sulfatemore » fines, lead smelting effluents, deep-welled sulfuric acid/ammonium bisulfate solutions, wood ash, waste magnesium ammonium sulfate slurry from recording tape production, and ammunition plant waste sodium nitrate/ammonium nitrate streams.« less
ERIC Educational Resources Information Center
Glick, Phillip Ray
1980-01-01
Veterinary education must re-establish its teaching objectives. Students need practical knowledge in areas such as business management, communications, marketing, public relations, facility management, and personnel management. Industry must also meet its obligations to continue to provide safe, dependable products that fill a practice need. (MLW)
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-20
... Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food; Correction AGENCY... manufacturing, packing, or holding human food (CGMPs) to modernize it and to add requirements for domestic and... ``food-production purposes (i.e., manufacturing, processing, packing, and holding) to consistently use...
Feeding nine billion: the challenge to sustainable crop production.
Gregory, Peter J; George, Timothy S
2011-11-01
In the recent past there was a widespread working assumption in many countries that problems of food production had been solved, and that food security was largely a matter of distribution and access to be achieved principally by open markets. The events of 2008 challenged these assumptions, and made public a much wider debate about the costs of current food production practices to the environment and whether these could be sustained. As in the past 50 years, it is anticipated that future increases in crop production will be achieved largely by increasing yields per unit area rather than by increasing the area of cropped land. However, as yields have increased, so the ratio of photosynthetic energy captured to energy expended in crop production has decreased. This poses a considerable challenge: how to increase yield while simultaneously reducing energy consumption (allied to greenhouse gas emissions) and utilizing resources such as water and phosphate more efficiently. Given the timeframe in which the increased production has to be realized, most of the increase will need to come from crop genotypes that are being bred now, together with known agronomic and management practices that are currently under-developed.
21 CFR 211.192 - Production record review.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Production record review. 211.192 Section 211.192 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.192...
21 CFR 211.89 - Rejected components, drug product containers, and closures.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Rejected components, drug product containers, and closures. 211.89 Section 211.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS...
21 CFR 211.192 - Production record review.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Production record review. 211.192 Section 211.192 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.192...
21 CFR 211.89 - Rejected components, drug product containers, and closures.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Rejected components, drug product containers, and closures. 211.89 Section 211.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS...
21 CFR 211.89 - Rejected components, drug product containers, and closures.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Rejected components, drug product containers, and closures. 211.89 Section 211.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS...
21 CFR 211.94 - Drug product containers and closures.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...
21 CFR 211.89 - Rejected components, drug product containers, and closures.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Rejected components, drug product containers, and closures. 211.89 Section 211.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS...
21 CFR 211.192 - Production record review.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Production record review. 211.192 Section 211.192 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.192...
21 CFR 211.94 - Drug product containers and closures.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...
21 CFR 211.94 - Drug product containers and closures.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...
21 CFR 211.89 - Rejected components, drug product containers, and closures.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Rejected components, drug product containers, and closures. 211.89 Section 211.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS...
21 CFR 211.94 - Drug product containers and closures.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...
21 CFR 211.192 - Production record review.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Production record review. 211.192 Section 211.192 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.192...
21 CFR 211.192 - Production record review.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Production record review. 211.192 Section 211.192 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.192...
Collaborative Practitioner Research: Opening a Third Space for Local Knowledge Production
ERIC Educational Resources Information Center
Skattebol, Jen; Arthur, Leonie Maree
2014-01-01
Early childhood education and care is currently experiencing unprecedented policy interest and expansion. This policy and practice landscape requires new forms of adaptive leadership, new spaces for production of the knowledge necessary for this changing context, and tools that can support the development of leadership qualities. This paper…
21 CFR 211.94 - Drug product containers and closures.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...
21 CFR 211.105 - Equipment identification.
Code of Federal Regulations, 2010 CFR
2010-04-01
...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls... all times to indicate their contents and, when necessary, the phase of processing of the batch. (b...
21 CFR 211.188 - Batch production and control records.
Code of Federal Regulations, 2010 CFR
2010-04-01
... (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and... percentage of theoretical yield at appropriate phases of processing; (8) Complete labeling control records...
21 CFR 211.105 - Equipment identification.
Code of Federal Regulations, 2011 CFR
2011-04-01
...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls... all times to indicate their contents and, when necessary, the phase of processing of the batch. (b...
21 CFR 211.188 - Batch production and control records.
Code of Federal Regulations, 2011 CFR
2011-04-01
... (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and... percentage of theoretical yield at appropriate phases of processing; (8) Complete labeling control records...
Hawkes, Corinna
2007-06-01
Diet-related chronic diseases are now a serious global public health problem. Public health groups are calling for the agricultural sector to play a greater role in tackling the threat. To identify potential points of policy intervention in the agricultural sector that could be leveraged to promote healthy diets and tackle obesity and diet-related chronic diseases. A review of the literature on the dietary implications of agriculture, a conceptual analysis of the issues, and the identification of relevant examples. There are two main potential points of intervention in the agricultural sector that could be leveraged to promote healthy diets: agricultural policies and agricultural production practices. Agricultural policies and practices affect diet through their influence on food availability, price, and nutrient quality, which in turn affects food choices available to consumers. Agricultural policies amenable to intervention include input, production, and trade policies; agricultural production practices amenable to intervention include crop breeding, crop fertilization practices, livestock-feeding practices, and crop systems diversity. It is well-known that agricultural policies and production practices influence what farmers choose to grow. Agricultural policies and production practices could also play a role in influencing what consumers choose to eat. To identify how agricultural policies and practices can usefully contribute toward promoting healthy diets and tackling obesity and diet-related chronic diseases, health policymakers need to examine whether current agricultural policies and production practices are contributing to-or detracting from-efforts to attain dietary goals; where and how could agricultural intervention help achieve dietary goals; and whether there are trade-offs between these interventions and other important concerns, such as undernutrition and the livelihoods of agricultural producers. Given the potential of agriculture to contribute to large-scale, population-level dietary improvements, these questions warrant closer attention from health policymakers.
Chekaroua, K; Delay, E
2005-10-01
In the framework of the 2005 report on mammary implants prepared by the Société française de chirurgie plastique reconstructrice et esthétique (SOF.CPRE), we conducted a survey among french plastic surgeons involved in the field. We elaborated a questionnaire that we distributed twice to the 600 members of the society; a total of 261 responded. Analysis of the data collected provides information on the socioprofessional characteristics of the responding surgeons, and on the devices, products and techniques they use. Finally, the survey has permitted to identify their qualitative perception of breast implant products currently available. Ranking these items by order of frequency provides a snapshot of the current procedures and practices in use for breast augmentation surgery in France.
Evaluating best practices for Campylobacter and Salmonella reduction in poultry processing plants.
Wideman, N; Bailey, M; Bilgili, S F; Thippareddi, H; Wang, L; Bratcher, C; Sanchez-Plata, M; Singh, M
2016-02-01
Poultry processing plants in the United States were surveyed on their current Campylobacter and Salmonella control practices. Following surveys, data were collected to develop a baseline for prevalence rates of Salmonella and Campylobacter; then changes in practices were implemented and evaluated for improvements in pathogen control. Surveys were sent to the plant Quality Assurance managers to determine production levels, antimicrobial interventions, and current pathogen testing practices. Initial sampling was performed at 6 plants with similar production volumes, at sites that included carcass samples before any pre-evisceration intervention, after exiting the inside-outside bird washer (IOBW), after exiting the pre-chiller, after exiting the primary chiller, and after exiting any post-chill intervention, as well as a water sample from each scalder, pre-chiller, primary chiller, and post-chill dip tank or finishing chiller. Enumerations and enrichments were performed for Campylobacter and Salmonella. Following the baseline sampling, changes in practices were suggested for each plant and a second sampling was conducted to determine their effectiveness. Results demonstrated that peracetic acid (PAA) was the most effective (P < 0.05) antimicrobial currently in use. The use of a post-chill antimicrobial immersion tank and/or use of a cetylpyridinium chloride (CPC) spray cabinet also displayed a further reduction in microbial levels (P < 0.05) when the primary chiller was not sufficient (P > 0.05). Microbial buildup in the immersion tanks demonstrates the need for effective cleaning, sanitation practices, and chiller maintenance to reduce contamination of poultry with Campylobacter and Salmonella. © 2015 Poultry Science Association Inc.
Assessment of Peruvian biofuel resources and alternatives
DOE Office of Scientific and Technical Information (OSTI.GOV)
Harper, J.P.; Smith, W.; Mariani, E.
1979-08-01
Comprehensive assessment of the biofuel potential of Peru is based on: determination of current biofuel utilization practices, evauation of Peruvian biomass productivity, identification of Peruvian agricultural and forestry resources, assessment of resource development and management concerns, identification of market considerations, description of biofuel technological options, and identification of regional biofuel technology applications. Discussion of current biofuel utilization centers on a qualitative description of the main conversion approaches currently being practiced in Peru. Biomass productivity evaluations consider the terrain and soil, and climatic conditions found in Peru. The potential energy from Peruvian agricultural and forestry resources is described quantitatively. Potental regionalmore » production of agricultural residues and forest resources that could supply energy are identified. Assessment of resource development and management concerns focuses on harvesting, reforestation, training, and environmental consequences of utilization of forest resources. Market factors assessed include: importation, internal market development, external market development, energy policy and pricing, and transportation. Nine biofuel technology options for Peru are identified: (1) small-to-medium-scale gasification, (2) a wood waste inventory, (3) stationary and mobile charcoal production systems, (4) wood distillation, (5) forest resource development and management, (6) electrical cogeneration, (7) anaerobic digestion technology, (8) development of ethanol production capabilities, and (9) agricultural strategies for fuel production. Applications of these biofuel options are identified for each of the three major regions - nine applications for the Costa Region, eight for the Sierra Region, and ten for the Selva Region.« less
ERIC Educational Resources Information Center
He, Wu
2014-01-01
Currently, a work breakdown structure (WBS) approach is used as the most common cost estimation approach for online course production projects. To improve the practice of cost estimation, this paper proposes a novel framework to estimate the cost for online course production projects using a case-based reasoning (CBR) technique and a WBS. A…
A Comparison of the Greenhouse Impacts of Magnesium Produced By Electrolytic and Pidgeon Processes
NASA Astrophysics Data System (ADS)
Ramakrishnan, Subramania; Koltun, Paul
With a focus on the global warming impact, this paper deals with the cradle-to-gate life cycle study of the following two practical production systems for producing magnesium ingots: (i) Magnesite ore is processed using the Australian Magnesium process to produce anhydrous magnesium chloride, which is then electrolysed to produce magnesium; and (ii) Dolomite ore is calcined to produce magnesium oxide, which is then thermally reduced with ferrosilicon using the Pidgeon process, based on the current practice used in China for magnesium production
21 CFR 225.102 - Master record file and production records.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Master record file and production records. 225.102 Section 225.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Records and Reports § 225...
21 CFR 225.102 - Master record file and production records.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Master record file and production records. 225.102 Section 225.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Records and Reports § 225...
21 CFR 225.102 - Master record file and production records.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Master record file and production records. 225.102 Section 225.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Records and Reports § 225...
21 CFR 225.102 - Master record file and production records.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Master record file and production records. 225.102 Section 225.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Records and Reports § 225...
ERIC Educational Resources Information Center
Carlhed, Carina
2017-01-01
The article is a critical sociological analysis of current transnational practices on creating comparable measurements of dropout and completion in higher education and the consequences for the conditions of scientific knowledge production on the topic. The analysis revolves around questions of epistemological, methodological and symbolic types…
USDA-ARS?s Scientific Manuscript database
Drip fumigation is commonly used for controlling soilborne pests in raised-bed strawberry production systems in California. However, the high emission loss and poor pest control indicate that the current fumigation practice with two drip tapes and polyethylene film (PE) covering need to be improved....
USDA-ARS?s Scientific Manuscript database
In the current walnut drying practice, dryers comingle nuts with varying moisture contents (MC) which results in over drying of nuts with low MC and thereby decrease product quality. The objectives of this research were to investigate correlations among near infrared (NIR) spectral data and MC of fr...
21 CFR 225.102 - Master record file and production records.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Master record file and production records. 225.102 Section 225.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Records and Reports § 225...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-25
... Network A and Network B data feeds. Consistent with current practice, within each of a firm's billable... fee schedules by compressing the current 14-tier Network A device rate schedule into four tiers, by... products, unprecedented levels of trading, internationalization and developments in portfolio analysis and...
21 CFR 26.10 - Regulatory authorities not listed as currently equivalent.
Code of Federal Regulations, 2010 CFR
2010-04-01
... SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE...
Volmer, Daisy; Sokirskaja, Aleksandra; Laaksonen, Raisa; Vainio, Kirsti; Sandler, Niklas; Halvorsen, Kjell H; Kjome, Reidun Lisbet Skeide; Gizurarson, Sveinbjörn; Muceniece, Ruta; Maurina, Baiba; Dauksiene, Jurgita; Ruuben, Lilian; Björnsdottir, Ingunn; Ratassepp, Tagne; Heinämäki, Jyrki
2016-10-13
With increased development of medical technology (MT), new challenges emerge related to education and training of pharmacists and other healthcare specialists. Currently, only a few universities in the EU promote MT education and research. The aim of this study was to evaluate the current status, views on, and need for the education on MT for the pharmacy students and practicing pharmacists in the Baltic and Nordic countries. The representatives of higher education institutions and community/hospital pharmacists from six Baltic and Nordic countries participated in a qualitative cross-sectional exploratory internet-based study from May to October 2014. Approximately two-third of the respondents considered professional knowledge about MT products important for pharmacists, but half of them had never participated in any MT courses. More practicing pharmacists than representatives of academia underlined the need for increased MT education for pharmacy students in the future. The pharmacists in the Baltic and Nordic countries consider the professional knowledge about MT as pertinent in their education and work. The limited number and status of MT courses available today, however, is a major concern among both pharmacy students and practicing pharmacists in these countries. In the future, increasing education combining theory and practice about MT products would be one possible solution to overcome this challenge.
Volmer, Daisy; Sokirskaja, Aleksandra; Laaksonen, Raisa; Vainio, Kirsti; Sandler, Niklas; Halvorsen, Kjell H.; Kjome, Reidun Lisbet Skeide; Gizurarson, Sveinbjörn; Muceniece, Ruta; Maurina, Baiba; Dauksiene, Jurgita; Ruuben, Lilian; Björnsdottir, Ingunn; Ratassepp, Tagne; Heinämäki, Jyrki
2016-01-01
With increased development of medical technology (MT), new challenges emerge related to education and training of pharmacists and other healthcare specialists. Currently, only a few universities in the EU promote MT education and research. Objectives: The aim of this study was to evaluate the current status, views on, and need for the education on MT for the pharmacy students and practicing pharmacists in the Baltic and Nordic countries. Methods: The representatives of higher education institutions and community/hospital pharmacists from six Baltic and Nordic countries participated in a qualitative cross-sectional exploratory internet-based study from May to October 2014. Results: Approximately two-third of the respondents considered professional knowledge about MT products important for pharmacists, but half of them had never participated in any MT courses. More practicing pharmacists than representatives of academia underlined the need for increased MT education for pharmacy students in the future. Conclusions: The pharmacists in the Baltic and Nordic countries consider the professional knowledge about MT as pertinent in their education and work. The limited number and status of MT courses available today, however, is a major concern among both pharmacy students and practicing pharmacists in these countries. In the future, increasing education combining theory and practice about MT products would be one possible solution to overcome this challenge. PMID:28970402
El-Shahawy, Omar; Brown, Richard; Elston Lafata, Jennifer
2016-04-26
We explored primary care physicians' (PCPs') beliefs and practices about e-cigarettes. Cross-sectional, semi-structured interviews with PCPs in 2014 were conducted and audio-recorded. Participants were 15 general internal and family medicine physicians practicing in two settings in Virginia, USA. Interview recordings were transcribed, and the content analyzed using the Constant Comparative Method to identify key themes regarding PCPs' reported current practices and beliefs. Five themes were identified: (1) existing clinic processes do not include mechanisms to screen for noncombustible tobacco products (such as e-cigarettes); (2) e-cigarette discussions are becoming commonplace with patients initiating the discussions and seeking physician guidance regarding e-cigarette use; (3) a lack of knowledge regarding the potential harms and benefits of e-cigarettes, yet a willingness to support their patients' desire to use e-cigarettes (4) believing e-cigarettes are a safer alternative to smoking combustible tobacco products; and (5) abandoning concerns regarding the potential harms of e-cigarettes in the context of highly addicted patients and those with extensive comorbidities. Despite acknowledging limited knowledge regarding e-cigarettes, findings suggest that some PCPs are currently recommending e-cigarettes to their patients for smoking cessation and relative harm reduction, often personalizing recommendations based on the patient's perceived addiction level and current health status. Physicians need to be informed about the evolving evidence regarding the risks and benefits of e-cigarettes.
Research gaps related to forest management and stream sediment in the United States.
Anderson, Christopher J; Lockaby, B Graeme
2011-02-01
Water quality from forested landscapes tends to be very high but can deteriorate during and after silvicultural activities. Practices such as forest harvesting, site preparation, road construction/use, and stream crossings have been shown to contribute sediment, nutrients, and other pollutants to adjacent streams. Although advances in forest management accompanied with Best Management Practices (BMPs) have been very effective at reducing water quality impacts from forest operations, projected increases in demand for forest products may result in unintended environmental degradation. Through a review of the pertinent literature, we identified several research gaps related to water yield, aquatic habitat, sediment source and delivery, and BMP effectiveness that should be addressed for streams in the United States to better understand and address the environmental ramifications of current and future levels of timber production. We explored the current understanding of these topics based on relevant literature and the possible implications of increased demand for forest products in the United States.
The slippery difficulty of ever containing drug resistance with current practices.
Fullybright, R
2017-04-01
It has previously been shown that the rate of drug resistance emergence in medicine is exponential, while we have been producing drugs at a much lower rate. Our ability to successfully contain resistance at any one time is function of how many drugs we have at our disposal to counter new resistances from pathogens. Here, we assess our level of preparedness through a mathematical comparison of the drug manufacture rate by the pharmaceutical industry with the resistance emergence rate in pathogens. To that effect, changes in the rates of growth of the drugs production and resistance emergence processes are computed over multiple time segments and compared. It is found that new resistance emergence rate in infectious diseases medicine remains mathematically and permanently ahead of the drugs production rate by the pharmaceutical industry. Consequently, we are not in a position to ever contain current or future strengths of resistance from pathogens. A review of current practices is called for.
NASA Astrophysics Data System (ADS)
Elliott, R.; Coley, K.; Mostaghel, S.; Barati, M.
2018-02-01
The increasing demand for high-performance steel alloys has led to development of transformation-induced plasticity (TRIP) and twinning-induced plasticity (TWIP) alloys over the past three decades. These alloys offer exceptional combinations of high tensile strength and ductility. Thus, the mechanical behavior of these alloys has been a subject of significant work in recent years. However, the challenge of economically providing Mn in the quantity and purity required by these alloys has received considerably less attention. To enable commercial implementation of ultrahigh-Mn alloys, it is desirable to lower the high material costs associated with their production. Therefore, the present work reviews Mn processing routes in the context of the chemical requirements of these alloys. The aim of this review is to assess the current state of the art regarding reduction of manganese ores and provide a comprehensive reference for researchers working to mitigate material processing costs associated with Mn production. The review is presented in two parts: Part 1 introduces TRIP and TWIP alloys, current industrial practice, and pertinent thermodynamic fundamentals; Part 2 addresses available literature regarding reduction of Mn ores and oxides, and seeks to identify opportunities for future process development.
Rhinology fellowship training and its scholarly impact.
Svider, Peter F; Blake, Danielle M; Setzen, Michael; Folbe, Adam J; Baredes, Soly; Eloy, Jean Anderson
2013-01-01
Previous examination of the impact of fellowship training on scholarly productivity among otolaryngologists found that head and neck surgeons and otologists had a higher mean h-index than fellowship-trained rhinologists. Because fellowship training in rhinology is a historically newer trend, the objectives of the present analysis were to further characterize research productivity among fellowship-trained academic rhinologists, including geographic and temporal trends, to gain insight into the future direction of scholarly pursuits within the field. Fellowship-trained rhinologists in academic practices were identified from the American Rhinologic Society online listings and organized by academic rank, number of years in practice, location, and h-index, as calculated using the Scopus database. Mean h-index rose with increasing years in practice after fellowship. The h-index, number of publications, and the E-factor (a newly described bibliometric) increased with successive academic rank. The E-factor for rhinologists in this current analysis was not statistically different from the values calculated for other otolaryngology subspecialties (p > 0.05). Fellowship-training in rhinology is a relatively recent development, with half of the academic rhinologists included in this analysis having completed fellowship training within the past 5 years. Scholarly productivity among academic rhinologists increases with academic seniority. As the current cohort of fellowship-trained rhinologists progress in their academic careers, previously described deficits in scholarly productivity relative to other subspecialties are expected to diminish.
Longer Lasting Bridge Deck Overlays
DOT National Transportation Integrated Search
2018-04-01
The objective of this report is to determine the most effective method for bridge deck overlay construction and repair by assessing current practices; examining new products and technologies; and reviewing NCHRP (National Cooperative Highway Research...
The Future of Pork Production in the World: Towards Sustainable, Welfare-Positive Systems.
McGlone, John J
2013-05-15
Among land animals, more pork is eaten in the world than any other meat. The earth holds about one billion pigs who deliver over 100 mmt of pork to people for consumption. Systems of pork production changed from a forest-based to pasture-based to dirt lots and finally into specially-designed buildings. The world pork industry is variable and complex not just in production methods but in economics and cultural value. A systematic analysis of pork industry sustainability was performed. Sustainable production methods are considered at three levels using three examples in this paper: production system, penning system and for a production practice. A sustainability matrix was provided for each example. In a comparison of indoor vs. outdoor systems, the food safety/zoonoses concerns make current outdoor systems unsustainable. The choice of keeping pregnant sows in group pens or individual crates is complex in that the outcome of a sustainability assessment leads to the conclusion that group penning is more sustainable in the EU and certain USA states, but the individual crate is currently more sustainable in other USA states, Asia and Latin America. A comparison of conventional physical castration with immunological castration shows that the less-common immunological castration method is more sustainable (for a number of reasons). This paper provides a method to assess the sustainability of production systems and practices that take into account the best available science, human perception and culture, animal welfare, the environment, food safety, worker health and safety, and economics (including the cost of production and solving world hunger). This tool can be used in countries and regions where the table values of a sustainability matrix change based on local conditions. The sustainability matrix can be used to assess current systems and predict improved systems of the future.
Manufacturing waste disposal practices of the chemical propulsion industry
NASA Technical Reports Server (NTRS)
Goldberg, Benjamin E.; Adams, Daniel E.; Schutzenhofer, Scott A.
1995-01-01
The waste production, mitigation and disposal practices of the United States chemical propulsion industry have been investigated, delineated, and comparatively assessed to the U.S. industrial base. Special emphasis has been placed on examination of ozone depleting chemicals (ODC's). The research examines present and anticipated future practices and problems encountered in the manufacture of solid and liquid propulsion systems. Information collected includes current environmental laws and regulations that guide the industry practices, processes in which ODC's are or have been used, quantities of waste produced, funding required to maintain environmentally compliant practices, and preventive efforts.
ERIC Educational Resources Information Center
Fissore, Cinzia; Duran, Daniel F.; Russell, Robert
2015-01-01
This article describes current practices and needs associated with water and gas conservation among Southern California greenhouse growers, Post-Harvest Processors (PHPs), and agricultural associations. Two communication forums were held with the goal of educating the local gas company and small growers and PHPs on the most compelling needs and…
ERIC Educational Resources Information Center
Johnson, Maggie; Senges, Max
2010-01-01
Purpose: This paper seeks to analyse the effectiveness and impact of how Google currently trains its new software engineers ("Nooglers") to become productive in the software engineering community. The research focuses on the institutions and support for practice-based learning and cognitive apprenticeship in the Google environment.…
Marketing your equine practice.
Magnus, Robert P
2009-12-01
The take-home message in marketing your equine practice is simple: understand your position in the target market and the buying behavior of your current and prospective customers. Time well spent on analysis and evaluation of options can maximize customer value in the services and products you offer. This allows you to capture profit and to attain your personal and professional goals as an equine practitioner.
Rural veterinary services in Western Australia: Part B. Rural practice.
Maxwell, J A L; Costa, N D; Layman, L L; Robertson, I D
2008-03-01
To determine the current status of rural veterinary services in Western Australia. A questionnaire was sent to all eligible rural practitioners registered in 2006 and the replies were transferred to Microsoft Excel for analysis. Of the rural practitioners invited to participate in the survey replies were received from 67%. There were equal numbers of females and males. Their mean age was 44 years. Ninety per cent of respondents considered knowledge gained as an undergraduate was sufficient to equip them for practice, but only 60% considered their practical skills adequate. Thirteen per cent of those in rural practices in 2005 had left by 2006. Eighty-nine per cent of respondents were in mixed practice, the balance in specific species practice, such as equine, large animal and production animal consultancy. The majority of rural practitioners relied on servicing companion animals for their viability; 7% earned their income from servicing production animals only. Seventy per cent utilised merchandising and the sale of pet foods to supplement the income received from the traditional veterinary services and 34% found it necessary to earn an independent income. A quarter considered that rural practice did not have a future. The majority of rural practitioners in Western Australia depend on companion animals, not production animals, to remain viable, with very few operating production animal services. Poor remuneration is a major reason why veterinarians leave rural practice, and many find it necessary to supplement their income or develop an independent income.
GREEN CHEMISTRY. Shape-selective zeolite catalysis for bioplastics production.
Dusselier, Michiel; Van Wouwe, Pieter; Dewaele, Annelies; Jacobs, Pierre A; Sels, Bert F
2015-07-03
Biodegradable and renewable polymers, such as polylactic acid, are benign alternatives for petrochemical-based plastics. Current production of polylactic acid via its key building block lactide, the cyclic dimer of lactic acid, is inefficient in terms of energy, time, and feedstock use. We present a direct zeolite-based catalytic process, which converts lactic acid into lactide. The shape-selective properties of zeolites are essential to attain record lactide yields, outperforming those of the current multistep process by avoiding both racemization and side-product formation. The highly productive process is strengthened by facile recovery and practical reactivation of the catalyst, which remains structurally fit during at least six consecutive reactions, and by the ease of solvent and side-product recycling. Copyright © 2015, American Association for the Advancement of Science.
Kudzu-Goat Interactions--A Pilot Study
C. Bonsi; E. Rhoden; A. Woldeghebriel; P. Mount; S. Solaiman; R. Noble; G. Paris; Charles McMahon; H. Pearson; B. Cash
1992-01-01
The production and processing of forest products is a major industry in the State of Alabama. Current weed management and control practices rely heavily on the use of herbicides. With the risk of soil and water pollution associated with the use of some agricultural chemicals, the continuing use of such chemicals may become hazardous to human health. The need for...
21 CFR 212.110 - How must I maintain records of my production of PET drugs?
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false How must I maintain records of my production of PET drugs? 212.110 Section 212.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON...
21 CFR 212.110 - How must I maintain records of my production of PET drugs?
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false How must I maintain records of my production of PET drugs? 212.110 Section 212.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON...
21 CFR 111.255 - What is the requirement to establish a batch production record?
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What is the requirement to establish a batch production record? 111.255 Section 111.255 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...
21 CFR 111.255 - What is the requirement to establish a batch production record?
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What is the requirement to establish a batch production record? 111.255 Section 111.255 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...
21 CFR 111.255 - What is the requirement to establish a batch production record?
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What is the requirement to establish a batch production record? 111.255 Section 111.255 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...
21 CFR 111.255 - What is the requirement to establish a batch production record?
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What is the requirement to establish a batch production record? 111.255 Section 111.255 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...
21 CFR 111.255 - What is the requirement to establish a batch production record?
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 2 2014-04-01 2014-04-01 false What is the requirement to establish a batch production record? 111.255 Section 111.255 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...
21 CFR 211.86 - Use of approved components, drug product containers, and closures.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...
21 CFR 211.86 - Use of approved components, drug product containers, and closures.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...
21 CFR 211.86 - Use of approved components, drug product containers, and closures.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...
21 CFR 211.86 - Use of approved components, drug product containers, and closures.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...
21 CFR 211.86 - Use of approved components, drug product containers, and closures.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...
USDA-ARS?s Scientific Manuscript database
One of our three program goals for this USDA-ARS-CRIS project is to determine the effects of vineyard and vine microclimate (sunlight, temperature, humidity, etc) upon fruit development, vine productivity, and fruit quality, particularly phenolic compounds. Plant phenolics are important due to their...
21 CFR 211.82 - Receipt and storage of untested components, drug product containers, and closures.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Receipt and storage of untested components, drug product containers, and closures. 211.82 Section 211.82 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...
21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...
21 CFR 184.1697 - Riboflavin-5′-phosphate (sodium).
Code of Federal Regulations, 2014 CFR
2014-04-01
... limitation other 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... § 170.3(o)(20) of this chapter. (2) The ingredient is used in milk products, as defined in § 170.3(n)(31...
Automated Chromium Plating Line for Gun Barrels
1979-09-01
consistent pretreatments and bath dwell times. Some of the advantages of automated processing include increased productivity (average of 20^) due to...when automated processing procedures’ are used. The current method of applying chromium electrodeposits to gun tubes is a manual, batch operation...currently practiced with rotary swaged gun tubes would substantially reduce the difficulties in automated processing . RECOMMENDATIONS
ERIC Educational Resources Information Center
Hickey, Will
2001-01-01
Describes a study that surveyed current and perceived future employer-provided training practices among multinational corporations manufacturing companies in the Tianjin Economic Development Area (T.E.D.A.) of China. Highlights include labor market; human resources management in China; workforce productivity; and return on investment. (Author/LRW)
NASA Astrophysics Data System (ADS)
Hussain, Azham; Mkpojiogu, Emmanuel O. C.; Abdullah, Inam
2016-08-01
Requirements Engineering (RE) is a systemic and integrated process of eliciting, elaborating, negotiating, validating and managing of the requirements of a system in a software development project. UUM has been supported by various systems developed and maintained by the UUM Information Technology (UUMIT) Centre. The aim of this study was to assess the current requirements engineering practices at UUMIT. The main problem that prompted this research is the lack of studies that support software development activities at the UUMIT. The study is geared at helping UUMIT produce quality but time and cost saving software products by implementing cutting edge and state of the art requirements engineering practices. Also, the study contributes to UUM by identifying the activities needed for software development so that the management will be able to allocate budget to provide adequate and precise training for the software developers. Three variables were investigated: Requirement Description, Requirements Development (comprising: Requirements Elicitation, Requirements Analysis and Negotiation, Requirements Validation), and Requirement Management. The results from the study showed that the current practice of requirement engineering in UUMIT is encouraging, but still need further development and improvement because a few RE practices were seldom practiced.
The feminisation of Canadian medicine and its impact upon doctor productivity.
Weizblit, Nataly; Noble, Jason; Baerlocher, Mark Otto
2009-05-01
We examined the differences in work patterns between female and male doctors in Canada to gain insight into the effect of an increased number of female doctors on overall doctor productivity. Data on the practice profiles of female and male doctors across Canada were extracted from the 2007 National Physician Survey. A doctor productivity measure, 'work hours per week per population' (WHPWPP), was created, based on the number of weekly doctor hours spent providing direct patient care per 100,000 citizens. The predicted WHPWPP was calculated for a hypothetical time-point when the female and male doctor populations reach equilibrium. The differences in current and predicted WHPWPP were then analysed. Female medical students currently (2007) outnumber male medical students (at 57.8% of the medical student population). The percentage of practising doctors who are women is highest in the fields of paediatrics, obstetrics and gynaecology, psychiatry and family practice. Female doctors work an average of 47.5 hours per week (giving 30.0 hours of direct patient care), compared with 53.8 hours worked by male doctors (35.0 hours of direct patient care) (P < 0.01, chi(2) test). Female doctors tend to work less on call hours per week and see fewer patients while on-call. Female doctors are also more likely to take parental leave or a leave of absence (P < 0.01, chi(2) test). The difference in current and predicted WHPWPP was found to be 2.6%, equivalent to 1853 fewer full-time female doctors or 1588 fewer full-time male doctors. Gender appears to have a significant influence on the practice patterns of doctors in Canada. If the gender-specific work patterns described in the present study persist, an overall decrease in doctor productivity is to be anticipated.
Evaluating group purchasing organizations.
Kaldor, Dennis C; Kowalski, Jamie C; Tankersley, Mark A
2003-01-01
A formal evaluation process can help healthcare organizations assess the current and/or potential value of a group purchasing organization (GPO). Healthcare organizations should approach a GPO evaluation as if they were entering into a new relationship. The evaluation should include purchasing and financial services, value-added services, and corporate relations/business practices. Healthcare organizations should consider the potential economies of scale and other services offered by a GPO. Healthcare organizations should consider using acceptable substitutes for products currently used or seeking products through alternative sources if doing so achieves greater value.
Good manufacturing practices for medicinal products for human use.
Gouveia, Bruno G; Rijo, Patrícia; Gonçalo, Tânia S; Reis, Catarina P
2015-01-01
At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability.
Good manufacturing practices for medicinal products for human use
Gouveia, Bruno G.; Rijo, Patrícia; Gonçalo, Tânia S.; Reis, Catarina P.
2015-01-01
At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability. PMID:25883511
Code of Federal Regulations, 2014 CFR
2014-07-01
... SOURCE CATEGORY Lithium Carbonate Production Subcategory § 415.452 Effluent limitations guidelines... application of the best practicable control technology currently available (BPT): Subpart AS—Lithium Carbonate...
Code of Federal Regulations, 2010 CFR
2010-07-01
... SOURCE CATEGORY Lithium Carbonate Production Subcategory § 415.452 Effluent limitations guidelines... application of the best practicable control technology currently available (BPT): Subpart AS—Lithium Carbonate...
Code of Federal Regulations, 2012 CFR
2012-07-01
... SOURCE CATEGORY Lithium Carbonate Production Subcategory § 415.452 Effluent limitations guidelines... application of the best practicable control technology currently available (BPT): Subpart AS—Lithium Carbonate...
Code of Federal Regulations, 2011 CFR
2011-07-01
... SOURCE CATEGORY Lithium Carbonate Production Subcategory § 415.452 Effluent limitations guidelines... application of the best practicable control technology currently available (BPT): Subpart AS—Lithium Carbonate...
Code of Federal Regulations, 2013 CFR
2013-07-01
... SOURCE CATEGORY Lithium Carbonate Production Subcategory § 415.452 Effluent limitations guidelines... application of the best practicable control technology currently available (BPT): Subpart AS—Lithium Carbonate...
Creative employee scheduling in the health information management department.
Hyde, C S
1998-02-01
What effect do schedules have on employees and department activities? Negative effects such as backlogs, poor employee morale, and absenteeism may be due to scheduling practices currently in place. The value of effective employee scheduling practices may be seen in areas of improved productivity. The process of developing schedules should include assessing department areas, understanding operational needs, choosing an option, and implementation. Finding a schedule that meets the needs of managers as well as those of the employees is rewarding. It is a win-win situation, and the benefits can yield increased productivity, decreased turnover, and higher morale.
Vaginal health and hygiene practices and product use in Canada: a national cross-sectional survey.
Crann, Sara E; Cunningham, Shannon; Albert, Arianne; Money, Deborah M; O'Doherty, Kieran C
2018-03-23
The vaginal microbiome influences quality of life and health. The composition of vaginal microbiota can be affected by various health behaviors, such as vaginal douching. The purpose of this study was to examine the types and prevalence of diverse vaginal/genital health and hygiene behaviors among participants living in Canada and to examine associations between behavioral practices and adverse gynecological health conditions. An anonymous online survey, available in English and French, was distributed across Canada. The sample consisted of 1435 respondents, 18 years or older, living in Canada. Respondents reported engaging in diverse vaginal/genital health and hygiene behavioral practices, including the use of commercially manufactured products and homemade and naturopathic products and practices. Over 95% of respondents reported using at least one product in or around the vaginal area. Common products and practices included vaginal/genital moisturizers, anti-itch creams, feminine wipes, washes, suppositories, sprays, powders, and waxing and shaving pubic hair. The majority of the sample (80%) reported experiencing one or more adverse vaginal/genital symptom in their lifetime. Participants who had used any vaginal/genital product(s) had approximately three times higher odds of reporting an adverse health condition. Several notable associations between specific vaginal/genital health and hygiene products and adverse health conditions were identified. This study is the first of its kind to identify the range and prevalence of vaginal/genital health and hygiene behaviors in Canada. Despite a lack of credible information about the impact of these behaviors on women's health, the use of commercially manufactured and homemade products for vaginal/genital health and hygiene is common. Future research can extend the current exploratory study by identifying causal relationships between vaginal/genital health and hygiene behaviors and changes to the vaginal microbiome.
Papadimitriou, Christina; Magasi, Susan; Frank, Gelya
2012-01-01
In this introduction to the special issue on current thinking in qualitative research and occupational therapy and science, the authors focus on the importance of rigorous qualitative research to inform occupational therapy practice. The authors chosen for this special issue reflect a "second generation of qualitative researchers" who are critical, theoretically sophisticated, methodologically productive, and politically relevant to show that working with disabled clients is political work. Three themes emerged across the articles included in this special issue: (1) recognizing and addressing social justice issues; (2) learning from clients' experiences; and (3) critically reframing occupational therapy's role. These themes can inform occupational therapy practice, research, and education to reflect a more client-centered and politically engaging approach. Copyright 2012, SLACK Incorporated.
Vending machine assessment methodology. A systematic review.
Matthews, Melissa A; Horacek, Tanya M
2015-07-01
The nutritional quality of food and beverage products sold in vending machines has been implicated as a contributing factor to the development of an obesogenic food environment. How comprehensive, reliable, and valid are the current assessment tools for vending machines to support or refute these claims? A systematic review was conducted to summarize, compare, and evaluate the current methodologies and available tools for vending machine assessment. A total of 24 relevant research studies published between 1981 and 2013 met inclusion criteria for this review. The methodological variables reviewed in this study include assessment tool type, study location, machine accessibility, product availability, healthfulness criteria, portion size, price, product promotion, and quality of scientific practice. There were wide variations in the depth of the assessment methodologies and product healthfulness criteria utilized among the reviewed studies. Of the reviewed studies, 39% evaluated machine accessibility, 91% evaluated product availability, 96% established healthfulness criteria, 70% evaluated portion size, 48% evaluated price, 52% evaluated product promotion, and 22% evaluated the quality of scientific practice. Of all reviewed articles, 87% reached conclusions that provided insight into the healthfulness of vended products and/or vending environment. Product healthfulness criteria and complexity for snack and beverage products was also found to be variable between the reviewed studies. These findings make it difficult to compare results between studies. A universal, valid, and reliable vending machine assessment tool that is comprehensive yet user-friendly is recommended. Copyright © 2015 Elsevier Ltd. All rights reserved.
Implementing the Use of Chemical-Free Products in a Perinatal Unit.
Brower, Anne; Trefz, Lisa; Burns, Catherine
2015-01-01
To develop a process to identify, adopt, and increase individual awareness of the use of chemical-free products in perinatal hospital units and to develop leadership skills of the fellow/mentor pair through the Sigma Theta Tau International Maternal-Child Health Nurse Leadership Academy (STTI MCHNLA). Pretest/posttest quality improvement project. Tertiary care 80-bed perinatal unit. Mothers and newborns on perinatal unit. The chemical hazard ratings of products currently in use and new products were examined and compared. Chemical-free products were selected and introduced to the hospital system, and education programs were provided for staff and patients. We implemented leadership tools taught at the STTI MCHNLA to facilitate project success. Pre- and postproject evaluations were used to determine interest in the use of chemical-free products and satisfaction with use of the new products. Cost savings were measured. Products currently in use contained potentially harmful chemicals. New, chemical-free products were identified and adopted into practice. Participants were interested in using chemical-free products. Once new products were available, 71% of participants were positive about using them. The fellow and mentor experienced valuable leadership growth throughout the project. The change to chemical-free products has positioned the organization and partner hospitals as community leaders that set a health standard to reduce environmental exposure for patients, families, and staff. The fellow and mentor learned new skills to assist in practice changes in a large organization by using the tools shared in the STTI MCHNLA. © 2015 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses.
Current clinical research in orthodontics: a perspective.
Baumrind, Sheldon
2006-10-01
This essay explores briefly the approach of the Craniofacial Research Instrumentation Laboratory to the systematic and rigorous investigation of the usual outcome of orthodontic treatment in the practices of experienced clinicians. CRIL's goal is to produce a shareable electronic database of reliable, valid, and representative data on clinical practice as an aid in the production of an improved environment for truly evidence-based orthodontic treatment.
Cell Therapy Regulation in Taiwan
Chen, Yuan-Chuan; Cheng, Hwei-Fang; Yeh, Ming-Kung
2017-01-01
Cell therapy is not only a novel medical practice but also a medicinal product [cell therapy product (CTP)]. More and more CTPs are being approved for marketing globally because of the rapid development of bio-medicine in cell culture, preservation, and preparation. However, regulation is the most important criterion for the development of CTPs. Regulations must be flexible to expedite the process of marketing for new CTPs. Recently, the Taiwan Food and Drug Administration (TFDA) updated the related regulations such as regulation of development, current regulatory framework and process, and the application and evaluation processes. When the quality of CTPs has been improved significantly, their safety and efficacy are further ensured. The treatment protocol, a new design for adaptive licensing to current clinical practice, is a rapid process for patients with life-threatening diseases or serious conditions for which there are no suitable drugs, medical devices, or other therapeutic methods available. The hospital can submit the treatment protocol to apply for cell therapy as a medical practice, which may result in easier and faster cell therapy development, and personalized treatment for individual patients will evolve quickly. PMID:27697103
Animal Health and Welfare Issues Facing Organic Production Systems.
Sutherland, Mhairi A; Webster, Jim; Sutherland, Ian
2013-10-31
The demand for organically-grown produce is increasing worldwide, with one of the drivers being an expectation among consumers that animals have been farmed to a high standard of animal welfare. This review evaluates whether this expectation is in fact being met, by describing the current level of science-based knowledge of animal health and welfare in organic systems. The primary welfare risk in organic production systems appears to be related to animal health. Organic farms use a combination of management practices, alternative and complementary remedies and convenional medicines to manage the health of their animals and in many cases these are at least as effective as management practices employed by non-organic producers. However, in contrast to non-organic systems, there is still a lack of scientifically evaluated, organically acceptable therapeutic treatments that organic animal producers can use when current management practices are not sufficient to maintain the health of their animals. The development of such treatments are necessary to assure consumers that organic animal-based food and fibre has not only been produced with minimal or no chemical input, but under high standards of animal welfare.
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A Standard of Knowledge for the Professional Practice of Toxicology.
Hulla, Janis E; Kinter, Lewis B; Kelman, Bruce
2015-08-01
Employers, courts, and the general public judge the credibility of professionals based on credentials such as academic degrees, publications, memberships in professional organizations, board certifications, and professional registrations. However, the relevance and merit of these credentials can be difficult to determine objectively. Board certification can be a reliable indicator of proficiency if the certifying organization demonstrates, through regularly scheduled independent review, that its processes meet established standards and when a certificate holder is required to periodically demonstrate command of a body of knowledge that is essential to current professional practice. We report herein a current Standard of Knowledge in general toxicology compiled from the experience and opinions of 889 certified practicing professional toxicologists. An examination is the most commonly used instrument for testing a certification candidate's command of the body of knowledge. However, an examination-based certification is only creditable when the body of knowledge, to which a certification examination tests, is representative of the current knowledge, skills, and capabilities needed to effectively practice at the professional level. Thus, that body of knowledge must be the current "Standard of Knowledge" for the profession, compiled in a transparent fashion from current practitioners of the profession. This work was conducted toward ensuring the scientific integrity of the products produced by professional toxicologists.
Measuring and mitigating agricultural greenhouse gas production in the US Great Plains, 1870-2000.
Parton, William J; Gutmann, Myron P; Merchant, Emily R; Hartman, Melannie D; Adler, Paul R; McNeal, Frederick M; Lutz, Susan M
2015-08-25
The Great Plains region of the United States is an agricultural production center for the global market and, as such, an important source of greenhouse gas (GHG) emissions. This article uses historical agricultural census data and ecosystem models to estimate the magnitude of annual GHG fluxes from all agricultural sources (e.g., cropping, livestock raising, irrigation, fertilizer production, tractor use) in the Great Plains from 1870 to 2000. Here, we show that carbon (C) released during the plow-out of native grasslands was the largest source of GHG emissions before 1930, whereas livestock production, direct energy use, and soil nitrous oxide emissions are currently the largest sources. Climatic factors mediate these emissions, with cool and wet weather promoting C sequestration and hot and dry weather increasing GHG release. This analysis demonstrates the long-term ecosystem consequences of both historical and current agricultural activities, but also indicates that adoption of available alternative management practices could substantially mitigate agricultural GHG fluxes, ranging from a 34% reduction with a 25% adoption rate to as much as complete elimination with possible net sequestration of C when a greater proportion of farmers adopt new agricultural practices.
Measuring and mitigating agricultural greenhouse gas production in the US Great Plains, 1870–2000
Parton, William J.; Gutmann, Myron P.; Merchant, Emily R.; Hartman, Melannie D.; Adler, Paul R.; McNeal, Frederick M.; Lutz, Susan M.
2015-01-01
The Great Plains region of the United States is an agricultural production center for the global market and, as such, an important source of greenhouse gas (GHG) emissions. This article uses historical agricultural census data and ecosystem models to estimate the magnitude of annual GHG fluxes from all agricultural sources (e.g., cropping, livestock raising, irrigation, fertilizer production, tractor use) in the Great Plains from 1870 to 2000. Here, we show that carbon (C) released during the plow-out of native grasslands was the largest source of GHG emissions before 1930, whereas livestock production, direct energy use, and soil nitrous oxide emissions are currently the largest sources. Climatic factors mediate these emissions, with cool and wet weather promoting C sequestration and hot and dry weather increasing GHG release. This analysis demonstrates the long-term ecosystem consequences of both historical and current agricultural activities, but also indicates that adoption of available alternative management practices could substantially mitigate agricultural GHG fluxes, ranging from a 34% reduction with a 25% adoption rate to as much as complete elimination with possible net sequestration of C when a greater proportion of farmers adopt new agricultural practices. PMID:26240366
Regulation of Cell and Gene Therapy Medicinal Products in Taiwan.
Lin, Yi-Chu; Wang, Po-Yu; Tsai, Shih-Chih; Lin, Chien-Liang; Tai, Hsuen-Yung; Lo, Chi-Fang; Wu, Shiow-Ing; Chiang, Yu-Mei; Liu, Li-Ling
2015-01-01
Owing to the rapid and mature development of emerging biotechnology in the fields of cell culture, cell preservation, and recombinant DNA technology, more and more cell or gene medicinal therapy products have been approved for marketing, to treat serious diseases which have been challenging to treat with current medical practice or medicine. This chapter will briefly introduce the Taiwan Food and Drug Administration (TFDA) and elaborate regulation of cell and gene therapy medicinal products in Taiwan, including regulatory history evolution, current regulatory framework, application and review procedures, and relevant jurisdictional issues. Under the promise of quality, safety, and efficacy of medicinal products, it is expected the regulation and environment will be more flexible, streamlining the process of the marketing approval of new emerging cell or gene therapy medicinal products and providing diverse treatment options for physicians and patients.
Li, Xiwen; Chen, Yuning; Yang, Qing; Wang, Yitao
2015-01-01
The usage amount of medicinal plant rapidly increased along with the development of traditional Chinese medicine industry. The higher market demand and the shortage of wild herbal resources enforce us to carry out large-scale introduction and cultivation. Herbal cultivation can ease current contradiction between medicinal resources supply and demand while they bring new problems such as pesticide residues and plant disease and pests. Researchers have recently placed high hopes on the application of natural fostering, a new method incorporated herbal production and diversity protecting practically, which can solve the problems brought by artificial cultivation. However no modes can solve all problems existing in current herbal production. This study evaluated different production modes including cultivation, natural fostering, and wild collection to guide the traditional Chinese medicine production for sustainable utilization of herbal resources. PMID:26074987
Animal Health and Welfare Issues Facing Organic Production Systems
Sutherland, Mhairi A.; Webster, Jim; Sutherland, Ian
2013-01-01
Simple Summary The demand for organically grown, animal derived produce is increasing due to a growing desire for consumer products that have minimal chemical inputs and high animal welfare standards. Evaluation of the scientific literature suggests that a major challenge facing organic animal production systems is the management and treatment of health-related issues. However, implementation of effective management practices can help organic animal producers achieve and maintain high standards of health and welfare, which is necessary to assure consumers that organic animal-based food and fibre has not only been produced with minimal or no chemical input, but under high standards of animal welfare. Abstract The demand for organically-grown produce is increasing worldwide, with one of the drivers being an expectation among consumers that animals have been farmed to a high standard of animal welfare. This review evaluates whether this expectation is in fact being met, by describing the current level of science-based knowledge of animal health and welfare in organic systems. The primary welfare risk in organic production systems appears to be related to animal health. Organic farms use a combination of management practices, alternative and complementary remedies and convenional medicines to manage the health of their animals and in many cases these are at least as effective as management practices employed by non-organic producers. However, in contrast to non-organic systems, there is still a lack of scientifically evaluated, organically acceptable therapeutic treatments that organic animal producers can use when current management practices are not sufficient to maintain the health of their animals. The development of such treatments are necessary to assure consumers that organic animal-based food and fibre has not only been produced with minimal or no chemical input, but under high standards of animal welfare. PMID:26479750
Reilly, Kevin J.; Spencer, Kristie A.
2013-01-01
The current study investigated the processes responsible for selection of sounds and syllables during production of speech sequences in 10 adults with hypokinetic dysarthria from Parkinson’s disease, five adults with ataxic dysarthria, and 14 healthy control speakers. Speech production data from a choice reaction time task were analyzed to evaluate the effects of sequence length and practice on speech sound sequencing. Speakers produced sequences that were between one and five syllables in length over five experimental runs of 60 trials each. In contrast to the healthy speakers, speakers with hypokinetic dysarthria demonstrated exaggerated sequence length effects for both inter-syllable intervals (ISIs) and speech error rates. Conversely, speakers with ataxic dysarthria failed to demonstrate a sequence length effect on ISIs and were also the only group that did not exhibit practice-related changes in ISIs and speech error rates over the five experimental runs. The exaggerated sequence length effects in the hypokinetic speakers with Parkinson’s disease are consistent with an impairment of action selection during speech sequence production. The absent length effects observed in the speakers with ataxic dysarthria is consistent with previous findings that indicate a limited capacity to buffer speech sequences in advance of their execution. In addition, the lack of practice effects in these speakers suggests that learning-related improvements in the production rate and accuracy of speech sequences involves processing by structures of the cerebellum. Together, the current findings inform models of serial control for speech in healthy speakers and support the notion that sequencing deficits contribute to speech symptoms in speakers with hypokinetic or ataxic dysarthria. In addition, these findings indicate that speech sequencing is differentially impaired in hypokinetic and ataxic dysarthria. PMID:24137121
Causarano, H J; Franzluebbers, A J; Reeves, D W; Shaw, J N
2006-01-01
Past agricultural management practices have contributed to the loss of soil organic carbon (SOC) and emission of greenhouse gases (e.g., carbon dioxide and nitrous oxide). Fortunately, however, conservation-oriented agricultural management systems can be, and have been, developed to sequester SOC, improve soil quality, and increase crop productivity. Our objectives were to (i) review literature related to SOC sequestration in cotton (Gossypium hirsutum L.) production systems, (ii) recommend best management practices to sequester SOC, and (iii) outline the current political scenario and future probabilities for cotton producers to benefit from SOC sequestration. From a review of 20 studies in the region, SOC increased with no tillage compared with conventional tillage by 0.48 +/- 0.56 Mg C ha(-1) yr(-1) (H(0): no change, p < 0.001). More diverse rotations of cotton with high-residue-producing crops such as corn (Zea mays L.) and small grains would sequester greater quantities of SOC than continuous cotton. No-tillage cropping with a cover crop sequestered 0.67 +/- 0.63 Mg C ha(-1) yr(-1), while that of no-tillage cropping without a cover crop sequestered 0.34 +/- 47 Mg C ha(-1) yr(-1) (mean comparison, p = 0.04). Current government incentive programs recommend agricultural practices that would contribute to SOC sequestration. Participation in the Conservation Security Program could lead to government payments of up to Dollars 20 ha(-1). Current open-market trading of C credits would appear to yield less than Dollars 3 ha(-1), although prices would greatly increase should a government policy to limit greenhouse gas emissions be mandated.
Berger, M; Kooyman, P J; Makkee, M; van der Zee, J S; Sterk, P J; van Dijk, J; Kemper, E M
2016-08-19
Clinical studies investigating medicinal products need to comply with laws concerning good clinical practice (GCP) and good manufacturing practice (GMP) to guarantee the quality and safety of the product, to protect the health of the participating individual and to assure proper performance of the study. However, there are no specific regulations or guidelines for non-Medicinal Investigational Products (non-MIPs) such as allergens, enriched food supplements, and air pollution components. As a consequence, investigators will avoid clinical research and prefer preclinical models or in vitro testing for e.g. toxicology studies. 1) briefly review the current guidelines and regulations for Investigational Medicinal Products; 2) present a standardised approach to ensure the quality and safety of non-MIPs in human in vivo research; and 3) discuss some lessons we have learned. We propose a practical line of approach to compose a clarifying product dossier (PD), comprising the description of the production process, the analysis of the raw and final product, toxicological studies, and a thorough risk-benefit-analysis. This is illustrated by an example from a human in vivo research model to study exposure to air pollutants, by challenging volunteers with a suspension of carbon nanoparticles (the component of ink cartridges for laser printers). With this novel risk-based approach, the members of competent authorities are provided with standardised information on the quality of the product in relation to the safety of the participants, and the scientific goal of the study.
Dixon, Anthony S.
1980-01-01
Recent reports from the Canadian Pediatric Society's Nutrition Committee1-5 have re-examined issues concerning the feeding of infants, and recommendations have been presented. In an article reviewing a similar report by the Nutrition Committee of the American Academy of Pediatrics, Woodruff6 refers to the art of infant feeding and the science of infant nutrition—the former being the practical application of the latter. The distinction is important. While the science of infant nutrition is obviously a complex area of expertise appropriate to pediatricians, factors affecting the art of infant feeding—the interplay between the needs of the infant and the community's current social and cultural beliefs and practices, between the recommendations of professional groups and food manufacturers' products and advertising—fall very definitely within the purview of the family physician. These two papers examine some of the current Canadian recommendations, their rationale and the practical problems they pose from a family practice viewpoint. Imagesp1191-ap1193-a PMID:21293682
Long-term prospects for the environmental profile of advanced sugar cane ethanol.
da Silva, Cinthia R U; Franco, Henrique Coutinho Junqueira; Junqueira, Tassia Lopes; van Oers, Lauran; van der Voet, Ester; Seabra, Joaquim E A
2014-10-21
This work assessed the environmental impacts of the production and use of 1 MJ of hydrous ethanol (E100) in Brazil in prospective scenarios (2020-2030), considering the deployment of technologies currently under development and better agricultural practices. The life cycle assessment technique was employed using the CML method for the life cycle impact assessment and the Monte Carlo method for the uncertainty analysis. Abiotic depletion, global warming, human toxicity, ecotoxicity, photochemical oxidation, acidification, and eutrophication were the environmental impacts categories analyzed. Results indicate that the proposed improvements (especially no-til farming-scenarios s2 and s4) would lead to environmental benefits in prospective scenarios compared to the current ethanol production (scenario s0). Combined first and second generation ethanol production (scenarios s3 and s4) would require less agricultural land but would not perform better than the projected first generation ethanol, although the uncertainties are relatively high. The best use of 1 ha of sugar cane was also assessed, considering the displacement of the conventional products by ethanol and electricity. No-til practices combined with the production of first generation ethanol and electricity (scenario s2) would lead to the largest mitigation effects for global warming and abiotic depletion. For the remaining categories, emissions would not be mitigated with the utilization of the sugar cane products. However, this conclusion is sensitive to the displaced electricity sources.
ERIC Educational Resources Information Center
American Association of Advertising Agencies Educational Foundation, New York, NY.
This set of papers represents the written record of the 1973 national conference for advertising educators held at Arizona State University in March. The conference focus was on current developments in the practice and teaching of advertising. The purpose of the conference was to bring insights about current advertising developments to the…
Waste-handling practices at red meat abattoirs in South Africa.
Roberts, Hester; de Jager, Linda; Blight, Geoffrey
2009-02-01
Abattoir waste disposal must be carefully managed because the wastes can be a source of food-borne diseases (Nemerow & Dasgupta Industrial and Hazardous Waste Treatment, p. 284, Van Nostrand Reinhold, New York, 1991; Bradshaw et al. The Treatment and Handling of Wastes, p. 183, The Royal Society, Chapman & Hall, London, 1992). Disposal of food that has been condemned because it is known to be diseased is of particular concern, and this paper looks at current disposal methods for such waste in the light of new scientific developments and waste-management strategies. Questionnaires were presented to management and workers at low- and high-throughput red meat abattoirs in the Free State Province, South Africa to determine current waste-handling procedures for condemned products. The waste-handling practices, almost without exception, did not fully comply with the requirements of the South African Red Meat Regulations of 2004, framed under the Meat Safety Act (Act 40 of 2000). The survey highlighted the need to improve current waste-handling strategies to prevent condemned products from re-entering the food chain and contributing to environmental pollution.
NASA Astrophysics Data System (ADS)
Lambert, Jean-Christopher
As a contribution to the implementation of the Global Earth Observation System of Systems (GEOSS), the Committee on Earth Observation Satellites (CEOS) is developing a data quality strategy for satellite measurements. To achieve GEOSS requirements of consistency and interoperability (e.g. for comparison and for integrated interpretation) of the measurements and their derived data products, proper uncertainty assessment is essential and needs to be continuously monitored and traceable to standards. Therefore, CEOS has undertaken the task to establish a set of best practices and guidelines for satellite validation, starting with current practices that could be improved with time. Best practices are not intended to be imposed as firm requirements, but rather to be suggested as a baseline for comparing against, which could be used by the widest community and provide guidance to newcomers. The present paper reviews the current development of best practices and guidelines for the validation of atmospheric composition satellites. Terminologies and general principles of validation are reminded. Going beyond elementary definitions of validation like the assessment of uncertainties, the specific GEOSS context calls also for validation of individual service components and against user requirements. This paper insists on two important aspects. First one, the question of the "collocation". Validation generally involves comparisons with "reference" measurements of the same quantities, and the question of what constitutes a valid comparison is not the least of the challenges faced. We present a tentative scheme for defining the validity of a comparison and of the necessary "collocation" criteria. Second focus of this paper: the information content of the data product. Validation against user requirements, or the verification of the "fitness for purpose" of both the data products and their validation, needs to identify what information, in the final product, is contributed really by the measurement, as opposed to what is contributed by a priori constraints imposed by the retrieval.
Styles, David; Schoenberger, Harald; Galvez-Martos, Jose-Luis
2012-11-15
Retailers are strategically positioned to leverage environmental improvement over product supply chains through actions targeted at suppliers and consumers. Informed by scientific evidence on environmental hotspots and control points across 14 priority product groups, and a review of 25 major European retailers' actions, this paper proposes a framework to guide and assess retailer best practice in supply chain environmental improvement. Commonly used product standards and improvement measures are classified into "basic" or "good" levels of environmental protection. A hierarchy of eight Best Environmental Management Practices (BEMPs) is proposed to systematically identify and improve the most environmentally damaging supply chains across retail assortments. Widespread third party environmental certification is the most transparent and verifiable mechanism of improvement but may not be appropriate for some supply chains. The enforcement of retailer-defined environmental requirements, and supplier improvement programmes based on performance benchmarking and dissemination of better management practices, are alternative BEMPs that may be used in combination with third party certification. Facilitating consumer selection of frontrunner ecological products is a lower priority BEMP owing to the well documented limitations of this approach. From available data, the highest current or credible-target sales shares of products improved according to the highest priority BEMP and environmental protection level were used to derive "benchmarks of excellence" for each of the 14 product groups. The assessment framework is demonstrated through application to three retailers. Copyright © 2012 Elsevier Ltd. All rights reserved.
The future of sustainable food production.
Ronald, Pamela; Adamchak, Raoul
2010-03-01
By the year 2050, the number of people on Earth is expected to increase from the current 6.7 to 9.2 billion. What is the best way to produce enough food to feed all these people? If we continue with current farming practices, vast amounts of wilderness will be lost, millions of birds and billions of insects will die, farm workers will be at increased risk for disease, and the public will lose billions of dollars as a consequence of environmental degradation. Clearly, there must be a better way to resolve the need for increased food production with the desire to minimize its impact.
Natural Products for Cancer Prevention: Clinical Update 2016.
Sanders, Kathleen; Moran, Zelda; Shi, Zaixing; Paul, Rachel; Greenlee, Heather
2016-08-01
To present a clinical update of natural products for cancer prevention and provide oncology nurses with an evidence-based review of natural products for patient counseling and education. Clinical trials published in PubMed. In the past 4 years since the publication of the original review there have been minimal changes in the conclusions of the published literature on the use of natural products for cancer prevention. To date, clinical trials have not demonstrated conclusive benefit of using natural products for cancer prevention, and current guidelines do not recommend their use. This review provides an update on published and ongoing trials and can serve as an updated resource for nurses. Evidence-based natural products databases can help nurses stay current with the scientific literature and be effective educators and health coaches for their patients, who can be influenced by marketing of unregulated products. Patients often discuss the use of natural products with nurses. Nurses have an opportunity to educate and coach patients in effective preventive lifestyle practices. Copyright © 2016 Elsevier Inc. All rights reserved.
Yacobi, Avraham; Shah, Vinod P; Bashaw, Edward D; Benfeldt, Eva; Davit, Barbara; Ganes, Derek; Ghosh, Tapash; Kanfer, Isadore; Kasting, Gerald B; Katz, Lindsey; Lionberger, Robert; Lu, Guang Wei; Maibach, Howard I; Pershing, Lynn K; Rackley, Russell J; Raw, Andre; Shukla, Chinmay G; Thakker, Kailas; Wagner, Nathalie; Zovko, Elizabeta; Lane, Majella E
2014-04-01
This paper summarises the proceedings of a recent workshop which brought together pharmaceutical scientists and dermatologists from academia, industry and regulatory agencies to discuss current regulatory issues and industry practices for establishing therapeutic bioequivalence (BE) of dermatologic topical products. The methods currently available for assessment of BE were reviewed as well as alternatives and the advantages and disadvantages of each method were considered. Guidance on quality and performance of topical products was reviewed and a framework to categorise existing and alternative methods for evaluation of BE was discussed. The outcome of the workshop emphasized both a need for greater attention to quality, possibly, via a Quality-By-Design (QBD) approach and a need to develop a "whole toolkit" approach towards the problem of determination of rate and extent in the assessment of topical bioavailability. The discussion on the BE and clinical equivalence of topical products revealed considerable concerns about the variability present in the current methodologies utilized by the industry and regulatory agencies. It was proposed that academicians, researchers, the pharmaceutical industry and regulators work together to evaluate and validate alternative methods that are based on both the underlying science and are adapted to the drug product itself instead of single "universal" method.
[Eye cosmetics--the beauty and the beast].
Blumenfeld, Oren; Nathansohn, Nir; Yeshurun, Itamar; Ashkenazi, Isaac
2005-05-01
The use of eye cosmetics is a popular practice in modern times that dates back to ancient civilizations. This practice, however, is not without hazards. The most common adverse effect of eye cosmetics is eyelid dermatitis, although an array of other adverse effects has been reported. This article reviews the different types of eye cosmetics in current use, their composition and the adverse effects of both commercial and traditional products.
Hori, Katsuhito; Yoshida, Naoko; Okumura, Tomonori; Okamura, Yasufumi; Kawakami, Junichi
2010-08-01
Orally disintegrating (OD) tablets are widely used in clinical practice. However, drug information on the choice and dispensing based on their stability after opening packages and usability in patients and dispensaries is not sufficient. The aim of this study was to investigate possible evaluation methods of the stability and usability of amlodipine OD tablets. Additives of the brand were changed in April 2009, and therefore the previous and current forms and two generics, current and newly marketed (in November 2009) products of different firms, were used. OD tablets were stored at 25 degrees C and 75% relative humidity for 3 months after opening the packages, and their physicochemical properties were evaluated. Their weight, diameter, thickness, and color difference increased slightly from the initial state. The extent of the change in their hardness, disintegration time, and friability was different among products. These physicochemical changes were acceptable in dispensary practice. Storage after opening the packages did not affect their dissolution rate. The dissolution rate at the initial state of the current brand was slower than that of the previous one. All products used were able to be dispensed by an automatic tablet-packing machine and applied to the so-called simple suspension method for intubational administration. Sensory evaluation tests revealed no major difference in the oral disintegration time, taste, impression, and preference among products. In conclusion, the stability and usability of amlodipine OD tablets used in this study were examined using several methods, and they can be used equivalently from the stability and usability viewpoints.
The reliability-quality relationship for quality systems and quality risk management.
Claycamp, H Gregg; Rahaman, Faiad; Urban, Jason M
2012-01-01
Engineering reliability typically refers to the probability that a system, or any of its components, will perform a required function for a stated period of time and under specified operating conditions. As such, reliability is inextricably linked with time-dependent quality concepts, such as maintaining a state of control and predicting the chances of losses from failures for quality risk management. Two popular current good manufacturing practice (cGMP) and quality risk management tools, failure mode and effects analysis (FMEA) and root cause analysis (RCA) are examples of engineering reliability evaluations that link reliability with quality and risk. Current concepts in pharmaceutical quality and quality management systems call for more predictive systems for maintaining quality; yet, the current pharmaceutical manufacturing literature and guidelines are curiously silent on engineering quality. This commentary discusses the meaning of engineering reliability while linking the concept to quality systems and quality risk management. The essay also discusses the difference between engineering reliability and statistical (assay) reliability. The assurance of quality in a pharmaceutical product is no longer measured only "after the fact" of manufacturing. Rather, concepts of quality systems and quality risk management call for designing quality assurance into all stages of the pharmaceutical product life cycle. Interestingly, most assays for quality are essentially static and inform product quality over the life cycle only by being repeated over time. Engineering process reliability is the fundamental concept that is meant to anticipate quality failures over the life cycle of the product. Reliability is a well-developed theory and practice for other types of manufactured products and manufacturing processes. Thus, it is well known to be an appropriate index of manufactured product quality. This essay discusses the meaning of reliability and its linkages with quality systems and quality risk management.
The Changing Tobacco Landscape: What Dental Professionals Need To Know
Couch, Elizabeth T.; Chaffee, Benjamin W.; Gansky, Stuart A.; Walsh, Margaret M.
2016-01-01
Background Recently, the range of tobacco products available in the United States and the patterns of tobacco product use have changed. While cigarette smoking prevalence has declined, dental professionals are likely to encounter many more users of new and alternative tobacco products among their patients. Approach This paper reviews conventional and new tobacco products currently available, their adverse oral and systemic health effects, and their prevalence of use in the US. Results Tobacco products other than cigarettes currently account for a substantial portion of tobacco use. For this reason, tobacco prevention and cessation counseling provided by dental professionals must address all tobacco products, including cigarettes, cigars, waterpipes (hookahs), and electronic cigarettes, as well as conventional and new smokeless tobacco products. Cigarette smoking and smokeless tobacco use are associated with immediate and long-term adverse health effects, including nicotine addiction, oral and systemic disease, and death. Novel products may attract new tobacco users, potentially leading to addiction that results in enduring tobacco product use and associated adverse health effects. Practical Implications Dental professionals regularly treat patients who use tobacco or who are at risk of initiating use. Therefore, it is essential that dental professionals are knowledgeable about tobacco products currently available and are able to answer patients' questions and to provide them with evidence-based tobacco-related counseling. PMID:26988178
A Standard of Knowledge for the Professional Practice of Toxicology
Kinter, Lewis B.; Kelman, Bruce
2015-01-01
Background Employers, courts, and the general public judge the credibility of professionals based on credentials such as academic degrees, publications, memberships in professional organizations, board certifications, and professional registrations. However, the relevance and merit of these credentials can be difficult to determine objectively. Board certification can be a reliable indicator of proficiency if the certifying organization demonstrates, through regularly scheduled independent review, that its processes meet established standards and when a certificate holder is required to periodically demonstrate command of a body of knowledge that is essential to current professional practice. Objective We report herein a current Standard of Knowledge in general toxicology compiled from the experience and opinions of 889 certified practicing professional toxicologists. Discussion An examination is the most commonly used instrument for testing a certification candidate’s command of the body of knowledge. However, an examination-based certification is only creditable when the body of knowledge, to which a certification examination tests, is representative of the current knowledge, skills, and capabilities needed to effectively practice at the professional level. Thus, that body of knowledge must be the current “Standard of Knowledge” for the profession, compiled in a transparent fashion from current practitioners of the profession. Conclusion This work was conducted toward ensuring the scientific integrity of the products produced by professional toxicologists. Citation Hulla JE, Kinter LB, Kelman B. 2015. A Standard of Knowledge for the professional practice of toxicology. Environ Health Perspect 123:743–748; http://dx.doi.org/10.1289/ehp.1408643 PMID:25782181
The Elements of an Effective Software Development Plan - Software Development Process Guidebook
2011-11-11
standards and practices required for all XMPL software development. This SDP implements the <corporate> Standard Software Process (SSP). as tailored...Developing and integrating reusable software products • Approach to managing COTS/Reuse software implementation • COTS/Reuse software selection...final selection and submit to change board for approval MAINTENANCE Monitor current products for obsolescence or end of support Track new
ERIC Educational Resources Information Center
National Academy of Sciences - National Research Council, Washington, DC.
Publication of conference presentations include--(1) a brief review of current modular standard development, (2) the statistical status of modular practice, (3) availability of modular products, and (4) educational programs on modular coordination. Included are--(1) explanatory diagrams, (2) text of an open panel discussion, and (3) a list of…
Voice recognition software for clinical use.
Korn, K
1998-11-01
The current generation voice recognition products truly offer the promise of voice recognition systems, that are financially and operationally acceptable for use in a health care facility. Although the initial capital outlay for the purchase of such equipment may be substantial, the long-term benefit is felt to outweigh the expense. The ability to utilize computer equipment for educational purposes and information management alone helps to rationalize the cost. In addition, it is important to remember that the Internet has become a substantial source of information which provides another functional use for this equipment. Although one can readily see the implication for such a program in clinical practice, other uses for the program should not be overlooked. Uses far beyond the writing of clinic notes and correspondence can be easily envisioned. Utilization of voice recognition software offers clinical practices the ability to produce quality printed records in a timely and cost-effective manner. After learning procedures for the selected product and appropriately formatting word processing software and printers, printed progress notes should be able to be produced in less time than traditional dictation and transcription methods. Although certain procedures and practices may need to be altered, or may preclude optimal utilization of this type of system, many advantages are apparent. It is recommended that facilities consider utilization of Voice Recognition products such as Dragon Systems Naturally Speaking Software, or at least consider a trial of this method with one of the limited-feature products, if current dictation practices are unsatisfactory or excessively costly. Free downloadable trial software or single user software can provide a reduced-cost method for trial evaluation of such products if a major commitment is not felt to be desired. A list of voice recognition software manufacturer web sites may be accessed through the following: http://www.dragonsys.com/ http://www.software.ibm/com/is/voicetype/ http://www.lhs.com/
Probabilistic framework for product design optimization and risk management
NASA Astrophysics Data System (ADS)
Keski-Rahkonen, J. K.
2018-05-01
Probabilistic methods have gradually gained ground within engineering practices but currently it is still the industry standard to use deterministic safety margin approaches to dimensioning components and qualitative methods to manage product risks. These methods are suitable for baseline design work but quantitative risk management and product reliability optimization require more advanced predictive approaches. Ample research has been published on how to predict failure probabilities for mechanical components and furthermore to optimize reliability through life cycle cost analysis. This paper reviews the literature for existing methods and tries to harness their best features and simplify the process to be applicable in practical engineering work. Recommended process applies Monte Carlo method on top of load-resistance models to estimate failure probabilities. Furthermore, it adds on existing literature by introducing a practical framework to use probabilistic models in quantitative risk management and product life cycle costs optimization. The main focus is on mechanical failure modes due to the well-developed methods used to predict these types of failures. However, the same framework can be applied on any type of failure mode as long as predictive models can be developed.
Proactive detection of bones in poultry processing
NASA Astrophysics Data System (ADS)
Daley, W. D. R.; Stewart, John
2009-05-01
Bones continue to be a problem of concern for the poultry industry. Most further processed products begin with the requirement for raw material with minimal bones. The current process for generating deboned product requires systems for monitoring and inspecting the output product. The current detection systems are either people palpitating the product or X-ray systems. The current performance of these inspection techniques are below the desired levels of accuracies and are costly. We propose a technique for monitoring bones that conduct the inspection operation in the deboning the process so as to have enough time to take action to reduce the probability that bones will end up in the final product. This is accomplished by developing active cones with built in illumination to backlight the cage (skeleton) on the deboning line. If the bones of interest are still on the cage then the bones are not in the associated meat. This approach also allows for the ability to practice process control on the deboning operation to keep the process under control as opposed to the current system where the detection is done post production and does not easily present the opportunity to adjust the process. The proposed approach shows overall accuracies of about 94% for the detection of the clavicle bones.
21 CFR 110.80 - Processes and controls.
Code of Federal Regulations, 2010 CFR
2010-04-01
... HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD Production and Process Controls § 110.80 Processes and controls. All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in...
AN HISTORICAL PERSPECTIVE ON LIFE CYCLE MANAGEMENT AND CURRENT PRACTICES WORLDWIDE
Environmental life cycle management looks at products, processes, and activities by recognizing all the "cradle to grave" stages that are involved and identifying where potential environmental and economic impacts occur. Government, industry and non-governmental organizations can...
Phase I: Evaluation of Low Flexural Strength for Northern Nevada Concrete Paving Mixtures
DOT National Transportation Integrated Search
2017-07-01
Production paving grade concrete in Northern Nevada having acceptable strength is universally acknowledged to be difficult; however understanding why this is true remains elusive. Current practice is to meet flexural strength requirements by using mi...
Code of Federal Regulations, 2012 CFR
2012-04-01
... CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.48 Plumbing. (a) Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. Potable water shall meet the...
Code of Federal Regulations, 2014 CFR
2014-04-01
... CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.48 Plumbing. (a) Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. Potable water shall meet the...
Code of Federal Regulations, 2013 CFR
2013-04-01
... CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.48 Plumbing. (a) Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. Potable water shall meet the...
Code of Federal Regulations, 2011 CFR
2011-04-01
... CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.48 Plumbing. (a) Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. Potable water shall meet the...
Microalgal cultivation with biogas slurry for biofuel production.
Zhu, Liandong; Yan, Cheng; Li, Zhaohua
2016-11-01
Microalgal growth requires a substantial amount of chemical fertilizers. An alternative to the utilization of fertilizer is to apply biogas slurry produced through anaerobic digestion to cultivate microalgae for the production of biofuels. Plenty of studies have suggested that anaerobic digestate containing high nutrient contents is a potentially feasible nutrient source to culture microalgae. However, current literature indicates a lack of review available regarding microalgal cultivation with biogas slurry for the production of biofuels. To help fill this gap, this review highlights the integration of digestate nutrient management with microalgal production. It first unveils the current status of microalgal production, providing basic background to the topic. Subsequently, microalgal cultivation technologies using biogas slurry are discussed in detail. A scale-up scheme for simultaneous biogas upgrade and digestate application through microalgal cultivation is then proposed. Afterwards, several uncertainties that might affect this practice are explored. Finally, concluding remarks are put forward. Copyright © 2016 Elsevier Ltd. All rights reserved.
Influence of manufacturing practices on quality of pharmaceutical products manufactured in Kenya.
Orwa, J A; Keter, L K; Ouko, S P A; Kibwage, I O; Rukunga, G M
2004-06-01
To establish the quality of pharmaceutical products manufactured by the respective industries in Kenya and determine the effect of manufacturing practices on the quality of these products. Cross-sectional study. Industries examined are in Nairobi, Kenya. Laboratory analysis was carried out using available facilities at Kenya Medical Research Institute and University of Nairobi, Faculty of Pharmacy. Structured Questionnaires were administered to examine how the code of good manufacturing practices has been used in the production of each pharmaceutical product by respective companies. Questionnaires designed to evaluate the distribution and carry out limited post-market surveillance study were administered to community pharmacy outlets. Drugs were sampled and analyzed for their quality according to the respective monographs. The questionnaires administered to the industry included the source of raw materials, quarantine procedure before and after manufacture, manufacturing procedure, quality audit, quality assurance procedure, equipment, and staff. That administered to the pharmacy outlet included availability, affordability and acceptability of locally manufactured pharmaceutical products. Quality analysis of products involved the establishment of the chemical content, dissolution profile, friability, uniformity of weight and identity. For antibiotic suspensions the stability after reconstitution was also determined. There were 15 respondents and two non-respondents from the industry and six out of nine respondents from the pharmacy outlets. The ratio of qualified staff to product range produced seemed to influence product quality. Industries producing several products with only limited number of pharmaceutical staff had more products failing to comply with pharmacopoeia specifications compared to those producing only few products. Nevertheless, all companies are well equipped with quality control equipment, in accordance with type of product manufactured. Private pharmacies stocked few of the locally manufactured products. The reason, they said, was due to low doctor and/or patient acceptance. Compliance with quality specifications as set out in respective monographs was overall 76%. Although the local pharmaceutical industries have adopted good manufacturing practices leading to many good quality products currently in commerce, these manufacturing practices are not comprehensive and measures need to be taken to continue improving them.
Li, Zhaoyang; Easton, Rachael
2018-01-01
The development of an injectable drug-device combination (DDC) product for biologics is an intricate and evolving process that requires substantial investments of time and money. Consequently, the commercial dosage form(s) or presentation(s) are often not ready when pivotal trials commence, and it is common to have drug product changes (manufacturing process or presentation) during clinical development. A scientifically sound and robust bridging strategy is required in order to introduce these changes into the clinic safely. There is currently no single developmental paradigm, but a risk-based hierarchical approach has been well accepted. The rigor required of a bridging package depends on the level of risk associated with the changes. Clinical pharmacokinetic/pharmacodynamic comparability or outcome studies are only required when important changes occur at a late stage. Moreover, an injectable DDC needs to be user-centric, and usability assessment in real-world clinical settings may be required to support the approval of a DDC. In this review, we discuss the common issues during the manufacturing process and presentation development of an injectable DDC and practical considerations in establishing a clinical strategy to address these issues, including key elements of clinical studies. We also analyze the current practice in the industry and review relevant and status of regulatory guidance in the DDC field.
Easton, Rachael
2018-01-01
ABSTRACT The development of an injectable drug-device combination (DDC) product for biologics is an intricate and evolving process that requires substantial investments of time and money. Consequently, the commercial dosage form(s) or presentation(s) are often not ready when pivotal trials commence, and it is common to have drug product changes (manufacturing process or presentation) during clinical development. A scientifically sound and robust bridging strategy is required in order to introduce these changes into the clinic safely. There is currently no single developmental paradigm, but a risk-based hierarchical approach has been well accepted. The rigor required of a bridging package depends on the level of risk associated with the changes. Clinical pharmacokinetic/pharmacodynamic comparability or outcome studies are only required when important changes occur at a late stage. Moreover, an injectable DDC needs to be user-centric, and usability assessment in real-world clinical settings may be required to support the approval of a DDC. In this review, we discuss the common issues during the manufacturing process and presentation development of an injectable DDC and practical considerations in establishing a clinical strategy to address these issues, including key elements of clinical studies. We also analyze the current practice in the industry and review relevant and status of regulatory guidance in the DDC field. PMID:29035675
Survey of US fuel ethanol plants.
Saunders, J A; Rosentrater, K A
2009-07-01
The ethanol industry is growing in response to increased consumer demands for fuel as well as the renewable fuel standard. Corn ethanol processing creates the following products: 1/3 ethanol, 1/3 distillers grains, and 1/3 carbon dioxide. As the production of ethanol increases so does the generation of its coproducts, and viable uses continually need to be developed. A survey was mailed to operational US ethanol plants to determine current practices. It inquired about processes, equipment used, end products, and desired future directions for coproducts. Results indicated that approximately one-third of plant managers surveyed expressed a willingness to alter current drying time and temperature if it could result in a higher quality coproduct. Other managers indicated hesitation, based on lack of economic incentives, potential cost and return, and capital required. Respondents also reported the desire to use their coproducts in some of the following products: fuels, extrusion, pellets, plastics, and human food applications. These results provide a snapshot of the industry, and indicate that operational changes to the current production of DDGS must be based upon the potential for positive economic returns.
Robotics in a controlled, ecological life support system
NASA Technical Reports Server (NTRS)
Miles, Gaines E.; Krom, Kimberly J.
1993-01-01
Controlled, Ecological Life Support Systems (CELSS) that utilize plants to provide food, water and oxygen could consume considerable amounts of labor unless crop production, recovery and processing are automated. Robotic manipulators equipped with special end-effectors and programmed to perform the sensing and materials handling tasks would minimize the amount of astronaut labor required. The Human Rated Test Facility (HRTF) planned for Johnson Space Center could discover and demonstrate techniques of crop production which can be reliably integrated with machinery to minimize labor requirements. Before the physical components (shelves, lighting fixtures, etc.) can be selected, a systems analysis must be performed to determine which alternative processes should be followed and how the materials handling tasks should be automated. Given that the current procedures used to grow crops in a CELSS may not be the best methods to automate, then what are the alternatives? How may plants be grown, harvested, processed for food, and the inedible components recycled? What commercial technologies current exist? What research efforts are underway to develop new technologies which might satisfy the need for automation in a CELSS? The answers to these questions should prove enlightening and provide some of the information necessary to perform the systems analysis. The planting, culturing, gathering, threshing and separation, food processing, and recovery of inedible portions of wheat were studied. The basic biological and materials handling processes of each task are defined and discussed. Current practices at Johnson Space Center and other NASA centers are described and compared to common production practices in the plant production industry. Technologies currently being researched which might be applicable are identified and illustrated. Finally, based on this knowledge, several scenarios are proposed for automating the tasks for wheat.
Changing corporate practices to reduce cancer disparities.
Freudenberg, Nicholas; Galea, Sandro; Fahs, Marianne
2008-02-01
While reducing racial/ethnic and socioeconomic disparities in cancer mortality has been identified as a national goal, current policies are unlikely to achieve it. In order to advance the development of policies for the primary prevention of cancer and cancer disparities, we propose that the practices of the tobacco, alcohol, and food industries be considered as modifiable social determinants of health. We review evidence that the practices of these industries in product design, marketing, retail distribution, and pricing contribute to cancer risk behavior, incidence, and disparities, then examine public health strategies designed to reduce health-damaging practices of these industries and encourage healthier alternatives. We conclude with recommendations for research, practice, and policy that could contribute to the development of less carcinogenic corporate practices.
Code of Federal Regulations, 2010 CFR
2010-04-01
... CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Construction and Maintenance of Facilities and Equipment § 225.20 Buildings. (a) The location, design, construction, and physical size of the buildings and other production facilities are factors important to the manufacture of medicated feed. The features of...
Seed production areas for the global restoration challenge
USDA-ARS?s Scientific Manuscript database
Seed availability of wild species is fundamental to the conservation of biodiversity and the achievement of global ecosystem restoration or reforestation targets. The current and future demands for seeds for restoration and reforestation far exceed what can be practically, economically, and ethicall...
A landscape vision for integrating industrial crops into biofuel systems
USDA-ARS?s Scientific Manuscript database
Achieving energy independence and security through domestic production of renewable biofuels is feasible but will require a different landscape than we have with current agricultural practices. Integrating industrial crops such as Canola, Camelina, or Cuphea could offer many opportunities to enhance...
Suliman, Shireen; Al-Mohammed, Ahmed; Al Mohanadi, Dabia; Allen, Margaret; Bylund, Carma L
2018-01-01
Purpose Mentoring plays a vital role in academic productivity, personal development, and career guidance for students, residents, fellows, and junior faculty. A culture of mentoring is spreading across residency and fellowship training programs in Hamad Medical Corporation, the main teaching tertiary care facility in Qatar. However, there is insufficient knowledge about the current practice of mentoring in these programs. Methods We conducted a cross-sectional study by surveying all faculty and trainees in all residency and fellowship training programs in Qatar. Each completed a web-based questionnaire that asked about the current experience, self-efficacy and measures of improvement of the current practice of mentoring across training programs. Results A total of 393/650 faculty members (61%), 187/250 fellows (74%), and 405/650 residents (62%) responded to the two surveys. Most (74% of faculty members) reported being current mentors, while 67% of residents and fellows reported that they currently have mentors. Faculty who received training in mentoring and those who had an established formal mentoring program in their departments were more likely to enroll in mentoring than others (86%, P<0.01; 71%, P<0.05%, respectively). Trainees suggested that the two main areas to improve the current mentoring initiative in their departments were to develop a structured mentoring program and to train the mentors. Content analysis revealed participants’ confusion differentiating between the terms mentoring and supervision. Conclusion Based on the current study, many existing mentoring relationships have an evident confusion between supervision and mentoring roles. Developing structured mentoring program and training both faculty and trainees in mentoring is recommended to improve the current practice of mentoring within the training programs. PMID:29416385
Overview of cleaner production as a result of clean technology research in Vietnam
DOE Office of Scientific and Technical Information (OSTI.GOV)
Sam, D.V.; Nhan, T.V.; Lan, N.N.
Vietnam is beginning its industrialization process, and it currently lacks the capital necessary for expensive pollution control and treatment systems. Pollution strategies are critical for the country. This study evaluates the present status of industry and the pollution problems associated with industrial development in Vietnam. The purpose of the study is to identify sectors that may have potential for promoting cleaner production practices. 4 refs.
2011-11-01
fusion energy -production processes of the particular type of reactor using a lithium (Li) blanket or related alloys such as the Pb-17Li eutectic. As such, tritium breeding is intimately connected with energy production, thermal management, radioactivity management, materials properties, and mechanical structures of any plausible future large-scale fusion power reactor. JASON is asked to examine the current state of scientific knowledge and engineering practice on the physical and chemical bases for large-scale tritium
Real-time yield estimation based on deep learning
NASA Astrophysics Data System (ADS)
Rahnemoonfar, Maryam; Sheppard, Clay
2017-05-01
Crop yield estimation is an important task in product management and marketing. Accurate yield prediction helps farmers to make better decision on cultivation practices, plant disease prevention, and the size of harvest labor force. The current practice of yield estimation based on the manual counting of fruits is very time consuming and expensive process and it is not practical for big fields. Robotic systems including Unmanned Aerial Vehicles (UAV) and Unmanned Ground Vehicles (UGV), provide an efficient, cost-effective, flexible, and scalable solution for product management and yield prediction. Recently huge data has been gathered from agricultural field, however efficient analysis of those data is still a challenging task. Computer vision approaches currently face diffident challenges in automatic counting of fruits or flowers including occlusion caused by leaves, branches or other fruits, variance in natural illumination, and scale. In this paper a novel deep convolutional network algorithm was developed to facilitate the accurate yield prediction and automatic counting of fruits and vegetables on the images. Our method is robust to occlusion, shadow, uneven illumination and scale. Experimental results in comparison to the state-of-the art show the effectiveness of our algorithm.
The implementation of tissue banking experiences for setting up a cGMP cell manufacturing facility.
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.
Supporting Worth Mapping with Sentence Completion
NASA Astrophysics Data System (ADS)
Cockton, Gilbert; Kujala, Sari; Nurkka, Piia; Hölttä, Taneli
Expectations for design and evaluation approaches are set by the development practices within which they are used. Worth-Centred Development (WCD) seeks to both shape and fit such practices. We report a study that combined two WCD approaches. Sentence completion gathered credible quantitative data on user values, which were used to identify relevant values and aversions of two player groups for an on-line gambling site. These values provided human value elements for a complementary WCD approach of worth mapping. Initial worth maps were extended in three workshops, which focused on outcomes and user experiences that could be better addressed in the current product and associated marketing materials. We describe how worth maps were prepared for, and presented in, workshops, and how product owners and associated business roles evaluated the combination of WCD approaches. Based on our experiences, we offer practical advice on this combinination.
Where Does Homeopathy Fit in Pharmacy Practice?
Johnson, Teela
2007-01-01
Homeopathy has been the cause of much debate in the scientific literature with respect to the plausibility and efficacy of homeopathic preparations and practice. Nonetheless, many consumers, pharmacists, physicians, and other health care providers continue to use or practice homeopathic medicine and advocate its safety and efficacy. As drug experts, pharmacists are expected to be able to counsel their patients on how to safely and effectively use medications, which technically includes homeopathic products. Yet many pharmacists feel that the homeopathic system of medicine is based on unscientific theories that lack supporting evidence. Since consumers continue to use homeopathic products, it is necessary for pharmacists to have a basic knowledge of homeopathy and to be able to counsel patients about its general use, the current state of the evidence and its use in conjunction with other medications. PMID:17429507
Kashima, Koji; Yuki, Yoshikazu; Mejima, Mio; Kurokawa, Shiho; Suzuki, Yuji; Minakawa, Satomi; Takeyama, Natsumi; Fukuyama, Yoshiko; Azegami, Tatsuhiko; Tanimoto, Takeshi; Kuroda, Masaharu; Tamura, Minoru; Gomi, Yasuyuki; Kiyono, Hiroshi
2016-03-01
The first Good Manufacturing Practices production of a purification-free rice-based oral cholera vaccine (MucoRice-CTB) from transgenic plants in a closed cultivation system yielded a product meeting regulatory requirements. Despite our knowledge of their advantages, plant-based vaccines remain unavailable for human use in both developing and industrialized countries. A leading, practical obstacle to their widespread use is producing plant-based vaccines that meet governmental regulatory requirements. Here, we report the first production according to current Good Manufacturing Practices of a rice-based vaccine, the cholera vaccine MucoRice-CTB, at an academic institution. To this end, we established specifications and methods for the master seed bank (MSB) of MucoRice-CTB, which was previously generated as a selection-marker-free line, evaluated its propagation, and given that the stored seeds must be renewed periodically. The production of MucoRice-CTB incorporated a closed hydroponic system for cultivating the transgenic plants, to minimize variations in expression and quality during vaccine manufacture. This type of molecular farming factory can be operated year-round, generating three harvests annually, and is cost- and production-effective. Rice was polished to a ratio of 95 % and then powdered to produce the MucoRice-CTB drug substance, and the identity, potency, and safety of the MucoRice-CTB product met pre-established release requirements. The formulation of MucoRice-CTB made by fine-powdering of drug substance and packaged in an aluminum pouch is being evaluated in a physician-initiated phase I study.
Boar taint compound levels in back fat versus meat products: Do they correlate?
Wauters, Jella; Vercruysse, Vicky; Aluwé, Marijke; Verplanken, Kaat; Vanhaecke, Lynn
2016-09-01
Surgical castration of male pigs will soon be abandoned, turning a major advantage of this practice, the elimination of boar taint, into the biggest challenge for pig industry when raising intact male pigs becomes common practice. To map the (economical) consequences in relation to boar-taint consumer acceptance, as well as offer a processing strategy for tainted carcasses to stockholders, the current study investigated not only back fat boar taint levels, but additionally generated information on the levels of boar taint compounds recovered after the production of commercially relevant meat products using UHPLC-HRMS laboratory analysis. Our results demonstrate that levels of androstenone, skatole and indole in back fat and meat products tend to correlate strongly, particularly in fatty meat products (generally r>0.80). Concentration values in the edible (lean) meat fraction were significantly lower compared to back fat and fat sampled from fresh or processed meat (p<0.05). Copyright © 2016 Elsevier Ltd. All rights reserved.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
1979-08-01
A comprehensive assessment of the biofuel potential of Peru is presented. Topics discussed cover current biofuel utilization practices; evaluation of Peruvian biomass productivity; identification of Peruvian agricultural and forestry resources; assessment of resource development and management concerns; identification of market considerations; description of biofuel technological options; and regional identification of biofuel technology applications. The discussion of current biofuel utilization centers on a qualitative description of the main conversion approaches now being practiced in Peru. Biomass productivity is evaluated in the context of the terrain, soil, and climatic conditions found in Peru. A quantitative description of the energy potential that couldmore » be realized from agricultural and forestry resources of Peru follows. A regional picture is given for the production of agricultural residues and forest resources that could potentially supply energy. The assessment of resource development and management concerns focuses on harvesting, reforestation, training, and the environmental consequences of utilization of forest resources. Market factors assessed include: importation, internal market development, external market development, energy policy and pricing, and transportation. Ten biofuel technology options for Peru were identified: small- to medium-scale gasification, a wood waste inventory, stationary and mobile charcoal production systems, wood distillation, forest resource development and management, electrical cogeneration, anaerobic digestion technology, development of ethanol production capabilities, and agricultural strategies for fuel production.Based upon these biofuel options, nine applications were identified for the Costa Region, eight for the Sierra Region, and ten for the Selva Region.« less
Sorice, Michael G; Kreuter, Urs P; Wilcox, Bradford P; Fox, William E
2014-01-15
Motivations for owning rural land are shifting from an agricultural-production orientation to a preference for natural and cultural amenities. Resultant changes in land management have significant implications for the type and distribution of landscape-level disturbances that affect the delivery of ecosystem services. We examined the relationship between motivations for owning land and the implementation of conservation land management practices by landowners in the Southern Great Plains of the United States. Using a mail survey, we classified landowners into three groups: agricultural production, multiple-objective, and lifestyle-oriented. Cross tabulations of landowner group with past, current, and future use of 12 different land management practices (related to prescribed grazing, vegetation management, restoration, and water management) found that lifestyle-oriented landowners were overall less likely to adopt these practices. To the degree that the cultural landscape of rural lands transitions from production-oriented to lifestyle-oriented landowners, the ecological landscape and the associated flow of ecosystem services will likely change. This poses new challenges to natural resource managers regarding education, outreach, and policy; however, a better understanding about the net ecological consequences of lower rates of adoption of conservation management practices requires consideration of the ecological tradeoffs associated with the changing resource dependency of rural landowners. Copyright © 2013 Elsevier Ltd. All rights reserved.
21 CFR 211.115 - Reprocessing.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...
21 CFR 211.115 - Reprocessing.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...
21 CFR 211.105 - Equipment identification.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Equipment identification. 211.105 Section 211.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...
21 CFR 211.115 - Reprocessing.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...
21 CFR 211.105 - Equipment identification.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Equipment identification. 211.105 Section 211.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...
21 CFR 211.115 - Reprocessing.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...
21 CFR 211.115 - Reprocessing.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...
21 CFR 211.105 - Equipment identification.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Equipment identification. 211.105 Section 211.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...
78 FR 22263 - Agency Information Collection Activities; Proposed Collection; Comment Request
Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-15
... produce effectiveness and comparative effectiveness research. The Effective Health Care Program also... materials and translation products that are currently available are designed to help practicing clinicians... started developing some tools, such as faculty slide sets based on comparative effectiveness reviews of...
21 CFR 211.68 - Automatic, mechanical, and electronic equipment.
Code of Federal Regulations, 2010 CFR
2010-04-01
... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS... satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such... designed to assure proper performance. Written records of those calibration checks and inspections shall be...
Narratives of Menstrual Product Consumption: Convenience, Culture, or Commoditization?
ERIC Educational Resources Information Center
Davidson, Anna
2012-01-01
The environmental and social costs of consumer societies have increasingly been recognized. Achieving sustainable household consumption requires an understanding of the underlying roots of current consumption levels. Using the case study of menstrual care practices, different theoretical frameworks--or narratives--for understanding household…
Is the Classroom Obsolete in the Twenty-First Century?
ERIC Educational Resources Information Center
Benade, Leon
2017-01-01
Lefebvre's triadic conception of "spatial practice, representations of space and representational spaces" provides the theoretical framework of this article, which recognises a productive relationship between space and social relations. Its writing stems from a current and ongoing qualitative study of innovative teaching and learning…
Design criteria monograph for liquid propellant gas generators
NASA Technical Reports Server (NTRS)
1974-01-01
Monograph reviews and assesses current design practices, and from them establishes firm guidance for achieving greater consistency in design, increased reliability in end product, and greater efficiency in design effort. Main emphasis of monograph is on bipropellant gas generators using hydrogen peroxide and hydrazine monopropellants.
Best Practices in Online Conference Moderation
ERIC Educational Resources Information Center
De Schutter, Adrienne; Fahrni, Patricia; Rudolph, Jim
2004-01-01
Facilitation by a moderator is crucial to a purposeful and productive conference. The moderator keeps the session focused, and ensures that all participants receive feedback regarding their contributions to the discussion. These functions are particularly important in the otherwise impersonal context of online discussion. The current report…
Product-based Safety Certification for Medical Devices Embedded Software.
Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael
2015-01-01
Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).
Arenas, Nelson E; Abril, Diego A; Valencia, Paola; Khandige, Surabhi; Soto, Carlos Yesid; Moreno-Melo, Vilma
2017-04-01
Hazardous practices regarding antibiotics misuse, unsanitary milking procedures, and the commercial sales of raw milk and unpasteurized dairy products are currently being practiced by livestock farmers in the Sumapaz region (Colombia). The purpose of this study was to screen for food-borne and zoonotic pathogens associated with local livestock practices. We evaluated 1098 cows from 46 livestock farms in the Sumapaz region that were selected by random. Of the total population of cattle, 962 animals (88%) were tested for bovine TB using a caudal-fold tuberculin test and 546 (50%) for brucellosis by a competitive ELISA. In the population tested, 23 cows were positive for Brucella sp. representing a 4.2% seroprevalence and no cases of bovine tuberculosis were found. In addition, food-borne contamination with Escherichia coli and Staphylococcus aureus was assessed together with antibiotic susceptibility for ten different antibiotics in milk samples from 16 livestock farms. We found that 12 of the farms (75%) were contaminated with these food-borne pathogens. Noteworthy, all of the isolated pathogenic strains were resistant to multiple antibiotics, primarily to oxytetracycline and erythromycin. Our findings suggest that livestock products could be a source of exposure to Brucella and multidrug-resistant E. coli and S. aureus strains as a result of unhygienic livestock practices in the Sumapaz region. Training in good farming practices is the key to improving safety in food production.
Review article: practical current issues in perioperative patient safety.
Eichhorn, John H
2013-02-01
This brief review provides an overview and, importantly, a context perspective of relevant current practical issues in perioperative patient safety. The dramatic improvement in anesthesia patient safety over the last 30 years was not initiated by electronic monitors but, rather, largely by a set of behaviours known as "safety monitoring" that were then made decidedly more effective by extending the human senses through electronic monitoring, for example, capnography and pulse oximetry. In the highly developed world, this current success is threatened by complacency and production pressure. In some areas of the developing/underdeveloped world, the challenge is implementing the components of anesthesia practice that will bring safety improvements to parallel the overall current success, for instance, applying the World Federation of Societies of Anaesthesiologists (WFSA) "International Standards for A Safe Practice of Anaesthesia". Generally, expanding the current success in safety involves many practical issues. System issues involve research, effective reporting mechanisms and analysis/broadcasting of results, perioperative communication (including "speaking up to power"), and checklists. Monitoring issues involve enforcing existing published monitoring standards and also recognizing the risk of danger to the patient from hypoventilation during procedural sedation and from postoperative intravenous pain medications. Issues of clinical care include medication errors in the operating room, cerebral hypoperfusion (especially in the head-up position), dangers of airway management, postoperative residual weakness from muscle relaxants, operating room fires, and risks specific in obstetric anesthesia. Recognition of the issues outlined here and empowerment of all anesthesia professionals, from the most senior professors and administrators to the newest practitioners, should help maintain, solidify, and expand the improvements in anesthesia and perioperative patient safety.
Correlation between solar flare productivity and photospheric vector magnetic fields
NASA Astrophysics Data System (ADS)
Cui, Yanmei; Wang, Huaning
2008-11-01
Studying the statistical correlation between the solar flare productivity and photospheric magnetic fields is very important and necessary. It is helpful to set up a practical flare forecast model based on magnetic properties and improve the physical understanding of solar flare eruptions. In the previous study ([Cui, Y.M., Li, R., Zhang, L.Y., He, Y.L., Wang, H.N. Correlation between solar flare productivity and photospheric magnetic field properties 1. Maximum horizontal gradient, length of neutral line, number of singular points. Sol. Phys. 237, 45 59, 2006]; from now on we refer to this paper as ‘Paper I’), three measures of the maximum horizontal gradient, the length of the neutral line, and the number of singular points are computed from 23990 SOHO/MDI longitudinal magnetograms. The statistical relationship between the solar flare productivity and these three measures is well fitted with sigmoid functions. In the current work, the three measures of the length of strong-shear neutral line, total unsigned current, and total unsigned current helicity are computed from 1353 vector magnetograms observed at Huairou Solar Observing Station. The relationship between the solar flare productivity and the current three measures can also be well fitted with sigmoid functions. These results are expected to be beneficial to future operational flare forecasting models.
Reducing human nitrogen use for food production
NASA Astrophysics Data System (ADS)
Liu, Junguo; Ma, Kun; Ciais, Philippe; Polasky, Stephen
2016-07-01
Reactive nitrogen (N) is created in order to sustain food production, but only a small fraction of this N ends up being consumed as food, the rest being lost to the environment. We calculated that the total N input (TN) of global food production was 171 Tg N yr-1 in 2000. The production of animal products accounted for over 50% of the TN, against 17% for global calories production. Under current TN per unit of food production and assuming no change in agricultural practices and waste-to-food ratios, we estimate that an additional TN of 100 Tg N yr-1 will be needed by 2030 for a baseline scenario that would meet hunger alleviation targets for over 9 billion people. Increased animal production will have the largest impact on increasing TN, which calls for new food production systems with better N-recycling, such as cooperation between crop and livestock producing farms. Increased N-use efficiency, healthier diet and decreased food waste could mitigate this increase and even reduce TN in 2030 by 8% relative to the 2000 level. Achieving a worldwide reduction of TN is a major challenge that requires sustained actions to improve nitrogen management practices and reduce nitrogen losses into the environment.
Reducing human nitrogen use for food production.
Liu, Junguo; Ma, Kun; Ciais, Philippe; Polasky, Stephen
2016-07-22
Reactive nitrogen (N) is created in order to sustain food production, but only a small fraction of this N ends up being consumed as food, the rest being lost to the environment. We calculated that the total N input (TN) of global food production was 171 Tg N yr(-1) in 2000. The production of animal products accounted for over 50% of the TN, against 17% for global calories production. Under current TN per unit of food production and assuming no change in agricultural practices and waste-to-food ratios, we estimate that an additional TN of 100 Tg N yr(-1) will be needed by 2030 for a baseline scenario that would meet hunger alleviation targets for over 9 billion people. Increased animal production will have the largest impact on increasing TN, which calls for new food production systems with better N-recycling, such as cooperation between crop and livestock producing farms. Increased N-use efficiency, healthier diet and decreased food waste could mitigate this increase and even reduce TN in 2030 by 8% relative to the 2000 level. Achieving a worldwide reduction of TN is a major challenge that requires sustained actions to improve nitrogen management practices and reduce nitrogen losses into the environment.
Reducing human nitrogen use for food production
Liu, Junguo; Ma, Kun; Ciais, Philippe; Polasky, Stephen
2016-01-01
Reactive nitrogen (N) is created in order to sustain food production, but only a small fraction of this N ends up being consumed as food, the rest being lost to the environment. We calculated that the total N input (TN) of global food production was 171 Tg N yr−1 in 2000. The production of animal products accounted for over 50% of the TN, against 17% for global calories production. Under current TN per unit of food production and assuming no change in agricultural practices and waste-to-food ratios, we estimate that an additional TN of 100 Tg N yr−1 will be needed by 2030 for a baseline scenario that would meet hunger alleviation targets for over 9 billion people. Increased animal production will have the largest impact on increasing TN, which calls for new food production systems with better N-recycling, such as cooperation between crop and livestock producing farms. Increased N-use efficiency, healthier diet and decreased food waste could mitigate this increase and even reduce TN in 2030 by 8% relative to the 2000 level. Achieving a worldwide reduction of TN is a major challenge that requires sustained actions to improve nitrogen management practices and reduce nitrogen losses into the environment. PMID:27445108
A review of the use of engineered nanomaterials to suppress plant disease and enhance crop yield
NASA Astrophysics Data System (ADS)
Servin, Alia; Elmer, Wade; Mukherjee, Arnab; De la Torre-Roche, Roberto; Hamdi, Helmi; White, Jason C.; Bindraban, Prem; Dimkpa, Christian
2015-02-01
Nanotechnology has the potential to play a critical role in global food production, food security, and food safety. The applications of nanotechnology in agriculture include fertilizers to increase plant growth and yield, pesticides for pest and disease management, and sensors for monitoring soil quality and plant health. Over the past decade, a number of patents and products incorporating nanomaterials into agricultural practices (e.g., nanopesticides, nanofertilizers, and nanosensors) have been developed. The collective goal of all of these approaches is to enhance the efficiency and sustainability of agricultural practices by requiring less input and generating less waste than conventional products and approaches. This review evaluates the current literature on the use of nanoscale nutrients (metals, metal oxides, carbon) to suppress crop disease and subsequently enhance growth and yield. Notably, this enhanced yield may not only be directly linked to the reduced presence of pathogenic organisms, but also to the potential nutritional value of the nanoparticles themselves, especially for the essential micronutrients necessary for host defense. We also posit that these positive effects are likely a result of the greater availability of the nutrients in the "nano" form. Last, we offer comments on the current regulatory perspective for such applications.
Review of musculoskeletal injuries and prevention in the endoscopy practitioner.
Harvin, Glenn
2014-08-01
Practitioners of endoscopy often experience musculoskeletal pain and injury (most often in the back, neck, shoulders, hands, wrists, and thumbs) that are associated with the minute and repetitive strain that is placed on these areas during endoscopic procedures. This review of the current documentation of endoscopy-related pain and injuries among practitioners finds that such problems are widespread and specific in kind as well as strongly correlated with high procedure volume and procedure duration. Research on the nature and impact of cumulative trauma and overuse syndromes in other professions such as dentistry, pianists, production labor, and athletics is brought to bear on the work of the endoscopist. A more thorough understanding of the nature and prevalence of work-related pain and injury sustained by endoscopists should inform further development of ergonomic practices and equipment design. This article reviews current recommendations for ergonomic design in the endoscopy procedure space and finds that reported compliance with those recommendations is quite low. Strategies for the management of the risk of musculoskeletal injuries related to the practice of endoscopy include compliance with currently recommended ergonomic practices, education of trainees in ergonomic technique when practicing endoscopy, and research toward the modification and development of more ergonomic endoscopes and procedure spaces.
NASA Astrophysics Data System (ADS)
Rigby, J.; Reba, M.
2011-12-01
The Lower Mississippi River Alluvial Plain is a highly productive agricultural region for rice, soy beans, and cotton that depends heavily on irrigation. Development of the Mississippi River Alluvial Aquifer (MRAA), one of the more prolific agricultural aquifers in the country, has traditionally been the primary source for irrigation in the region yielding over 1,100 Mgal/day to irrigation wells. Increasingly, the realities of changing climate and rapidly declining water tables have highlighted the necessity for new water management practices. Tail-water recovery and reuse is a rapidly expanding practice due in part to the efforts and cost-sharing of the NRCS, but regional studies of the potential for such practices to alleviate groundwater mining under current and future climate are lacking. While regional studies of aquifer geology have long been available, including assessments of regional groundwater flow, much about the aquifer is still not well understood including controls on recharge rates, a crucial component of water management design. We review the trends in regional availability of surface and groundwater resources, their current status, and the effects of recent changes in management practices on groundwater decline in Mississippi and Arkansas. Global and regional climate projections are used to assess scenarios of sustainable aquifer use under current land use and management along with the potential for more widely practiced surface water capture and reuse to alleviate groundwater decline. Finally, we highlight crucial knowledge gaps and challenges associated with the development of water management practices for sustainable agricultural use in the region.
Transfusion in critically ill children: indications, risks, and challenges.
Parker, Robert I
2014-03-01
To provide a concise review of transfusion-related issues and practices in the pediatric patient population, with a focus on those issues of particular importance to the care of critically ill children. Electronic search of the PubMed database using the search terms "pediatric transfusion," "transfusion practices," "transfusion risks," "packed red blood cell transfusion," "white blood cell transfusion," "platelet transfusion," "plasma transfusion," and "massive transfusion" either singly or in combination. All identified articles published since 2000 were manually reviewed for study design, content, and support for indicated conclusions, and the bibliographies were scrutinized for pertinent references not identified in the PubMed search. Selected studies from this group were then manually reviewed for possible inclusion in this review. Well-designed studies have demonstrated the benefit of "restrictive" transfusion practices across the entire age spectrum of pediatric patients across a wide spectrum of pediatric illness. However, clinician implementation of the more restrictive transfusion practices supported by these studies is variable. Additionally, the utilization of both platelet and plasma transfusions in either a "prophylactic" or "therapeutic" setting appears to be greater than that supported by published data. The preponderance of prospective, randomized trials and retrospective analyses support the use of a restrictive packed RBC transfusion policy in most clinical conditions in children. Neonatal transfusions guidelines rely largely on "expert opinion" rather than experimental data. Current transfusion practices for both platelets and coagulant products (e.g., fresh-frozen plasma and recombinant-activated factor VII) are poorly aligned with recommended transfusion guidelines. As with adults, current transfusion practices in children often do not reflect implementation of our current knowledge on the need for transfusion. Greater efforts to implement current evidence-based transfusion practices are needed.
Terminal Area Productivity Program: Dynamic Spacing Human Factors
NASA Technical Reports Server (NTRS)
Kanki, Barbara G.
1997-01-01
Dynamic spacing human factors deals with the following human factors issues: define controller limits to incorporating dynamic changes in separation standards; identify timing, planning, and coordination strategies; and consider consistency with current practices, policies, and regulations. The AVOSS technologies will make it possible to reduce separation standards in the terminal area under certain meteorological conditions. This paper contains the following sections: Dynamic space human factors overview, Preliminary tests, and current research status & plans.
21 CFR 211.103 - Calculation of yield.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Calculation of yield. 211.103 Section 211.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...
21 CFR 211.103 - Calculation of yield.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Calculation of yield. 211.103 Section 211.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...
21 CFR 211.103 - Calculation of yield.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Calculation of yield. 211.103 Section 211.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...
21 CFR 211.196 - Distribution records.
Code of Federal Regulations, 2011 CFR
2011-04-01
...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.196 Distribution records. Distribution records shall contain the name and strength of the product and description... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Distribution records. 211.196 Section 211.196 Food...
21 CFR 211.196 - Distribution records.
Code of Federal Regulations, 2013 CFR
2013-04-01
...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.196 Distribution records. Distribution records shall contain the name and strength of the product and description... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Distribution records. 211.196 Section 211.196 Food...
21 CFR 211.196 - Distribution records.
Code of Federal Regulations, 2014 CFR
2014-04-01
...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.196 Distribution records. Distribution records shall contain the name and strength of the product and description... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Distribution records. 211.196 Section 211.196 Food...
21 CFR 211.196 - Distribution records.
Code of Federal Regulations, 2012 CFR
2012-04-01
...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.196 Distribution records. Distribution records shall contain the name and strength of the product and description... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Distribution records. 211.196 Section 211.196 Food...
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...
Current Fault Management Trends in NASA's Planetary Spacecraft
NASA Technical Reports Server (NTRS)
Fesq, Lorraine M.
2009-01-01
The key product of this three-day workshop is a NASA White Paper that documents lessons learned from previous missions, recommended best practices, and future opportunities for investments in the fault management domain. This paper summarizes the findings and recommendations that are captured in the White Paper.
Soil quality impacts of current South American agricultural practices
USDA-ARS?s Scientific Manuscript database
Increasing global demand for oil seeds and cereals during the past 50 years has caused an expansion in the cultivated areas and resulted in major soil management and crop production changes throughout Bolivia, Paraguay, Uruguay, Argentina and southern Brazil. Unprecedented adoption of no-tillage as ...
Characterizing body temperature and activity changes at the onset of estrus in replacement gilts
USDA-ARS?s Scientific Manuscript database
Accurate estrus detection can improve sow conception rates and increase swine production efficiency. Unfortunately, current estrus detection practices based on individual animal behavior may be inefficient due to large sow populations at commercial farms and the associated labor required. Therefore,...
Food, Feed, and Fuel: Integrating Energy Double Crops in Conventional Farming Systems
USDA-ARS?s Scientific Manuscript database
The increasing demand for renewable energy, coupled with global demand for agricultural products and a range of environmental constraints, requires a re-thinking of current agricultural practices. Growing markets for cellulosic and other biomass feedstocks create new opportunities for farmers to div...
Optimizing fluctuating thermal regime storage of developing Megachile rotundata
USDA-ARS?s Scientific Manuscript database
The alfalfa leafcutting bee, Megachile rotundata, is the primary pollinator for alfalfa seed production in North America. Under current management practice developing pupae are incubated at 29ºC until the adults emerge for pollination. If unfavorable spring weather delays peak alfalfa bloom, bee m...
Transit Marketing : Review of the State-of-the-Art and a Handbook of Current Practice
DOT National Transportation Integrated Search
1985-04-01
Over the past decade, marketing has been given increased emphasis as a way to improve both transit rideship and productivity. While there is near universal agreement among transit managers that some level of marketing is necessary, there is far from ...
21 CFR 226.58 - Laboratory controls.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test...
21 CFR 226.58 - Laboratory controls.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test...
21 CFR 226.58 - Laboratory controls.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test...
21 CFR 211.113 - Control of microbiological contamination.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Control of microbiological contamination. 211.113 Section 211.113 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and...
21 CFR 225.165 - Equipment cleanout procedures.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Equipment cleanout procedures. 225.165 Section 225.165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Assurance § 225...
Cell Engineering and Molecular Pharming for Biopharmaceuticals
Abdullah, M.A; Rahmah, Anisa ur; Sinskey, A.J; Rha, C.K
2008-01-01
Biopharmaceuticals are often produced by recombinant E. coli or mammalian cell lines. This is usually achieved by the introduction of a gene or cDNA coding for the protein of interest into a well-characterized strain of producer cells. Naturally, each recombinant production system has its own unique advantages and disadvantages. This paper examines the current practices, developments, and future trends in the production of biopharmaceuticals. Platform technologies for rapid screening and analyses of biosystems are reviewed. Strategies to improve productivity via metabolic and integrated engineering are also highlighted. PMID:19662143
The universal applications of microtubes and microtube composites
NASA Technical Reports Server (NTRS)
Hoffman, Wesley P.; Upadhya, Kamleshwar
1994-01-01
Microtubes are a basic component for a myriad of potential products. They are very small tubes (hundreds can fit in a human hair) that can be made from practically any material. Tubes larger than 1 micron diameter can be made with any cross-sectional shape desired. The significance of microtubes and microtube composites is that they provide the opportunity to miniaturize (even to the nanoscale) numerous products and devices that are currently in existence as well as allowing the fabrication of products that have to date been impossible to produce.
Bejaei, M; Cheng, K M
2014-02-01
Appropriate management of an ostrich's exposure to stressors during preslaughter handling and transport practices can improve its well-being and product quality. Because of the lack of information about ostrich farming and transportation in North America and lack of developed Codes of Practice for ratite transport in Canada and the United States, the first objective of our research was to identify current preslaughter handling and transport practices of the ostrich industry in Canada and the United States, and to identify potential welfare issues based on the current practices. The second objective of this research was to review ostrich transport welfare standards and guidelines from Australia, European Union, New Zealand, and South Africa to investigate if those guidelines are applicable to Canadian and American ostrich production systems. Preliminary producer interviews, on-farm visits, and literature review information sources were used to design a producer questionnaire that was used to survey producers by Internet and mail surveying methods to identify existing ostrich transport norms in Canada and the United States. Based on the results of our producer survey and review of the transport standards and guidelines, we conclude that following factors are potential ostrich handling and transport welfare issues in Canada and the United States: lack of scientific information about welfare of ostriches during handling and transport; unfamiliarity of handlers and birds with handling and transport practices; not considering birds' social bounds, sex, behavior, and physical state in mixing them during handling and transport process; lack of an established specific maximum water and feed withdrawal duration for ostrich transport in Canada and the United States; lack of a specific vehicle designed for ratite transportation in Canada and the United States considering different physical body characteristics of ostriches compared with other species; exposure of birds to natural light during transport inside the trailer; overcrowding; and long transportation in Canada and the United States. Results of this research will contribute toward developing Codes of Practice for preslaughter handling, transportation, and slaughter of ostriches in Canada and the United States.
[Oxidative stress. Should it be measured in the diabetic patient?].
Villa-Caballero, L; Nava-Ocampo, A A; Frati-Munari, A C; Ponce-Monter, H
2000-01-01
Oxidative stress has been defined as a loss of counterbalance between free radical or reactive oxygen species production and the antioxidant systems, with negative effects on carbohydrates, lipids, and proteins. It is also involved in the progression of different chronic diseases and apoptosis. Diabetes mellitus is associated to a high oxidative stress level through different biochemical pathways, i.e. protein glycosylation, glucose auto-oxidation, and the polyol pathway, mainly induced by hyperglycemia. Oxidative stress could also be involved in the pathogenesis of atherosclerotic lesions and other chronic diabetic complications. Measurement of oxidative stress could be useful to investigate its role in the initiation and development processes of chronic diabetic complications and also to evaluate preventive actions, including antioxidative therapy. Different attempts have been made to obtain a practical, accurate, specific, and sensitive method to evaluate oxidative stress in clinical practice. However, this ideal method is not currently available to date and the usefulness of the current methods needs to be confirmed in daily practice. We suggest quantifying oxidated and reduced glutation (GSSG/GSH) and the thiobarbituric reactive substances (TBARS) with currently alternatives. Currently available alternative methods while we await better options.
Genaidy, A M; Sequeira, R; Tolaymat, T; Kohler, J; Rinder, M
2009-05-01
An evidence-based methodology was adopted in this research to establish strategies to increase lead recovery and recycling via a systematic review and critical appraisal of the published literature. In particular, the research examines pollution prevention and waste minimization practices and technologies that meet the following criteria: (a) reduce/recover/recycle the largest quantities of lead currently being disposed of as waste, (b) technically and economically viable, that is, ready to be diffused and easily transferable, and (c) strong industry interest (i.e., industry would consider implementing projects with higher payback periods). The following specific aims are designed to achieve the study objectives: Aim 1 - To describe the recycling process of recovering refined lead from scrap; Aim 2 - To document pollution prevention and waste management technologies and practices adopted by US stakeholders along the trajectory of LAB and lead product life cycle; Aim 3 - To explore improved practices and technologies which are employed by other organizations with an emphasis on the aforementioned criteria; Aim 4 - To demonstrate the economic and environmental costs and benefits of applying improved technologies and practices to existing US smelting operations; and Aim 5 - To evaluate improved environmental technologies and practices using an algorithm that integrates quantitative and qualitative criteria. The process of identifying relevant articles and reports was documented. The description of evidence was presented for current practices and technologies used by US smelters as well as improved practices and technologies. Options for integrated environmental solutions for secondary smelters were introduced and rank ordered on the basis of costs (i.e., capital investment) and benefits (i.e., production increases, energy and flux savings, and reduction of SO(2) and slag). An example was provided to demonstrate the utility of the algorithm by detailing the costs and benefits associated with different combinations of practices and technologies. The evidence-based methodology documented in this research reveals that it is technically and economically feasible to implement integrated environmental solutions to increase lead recovery and recycling among US smelters. The working example presented in this research can be confirmed with US stakeholders and form the basis for implementable solutions in the lead smelter and product industries to help reverse the overall trend of declining life-cycle recycling rates.
The ultrasound unit and infection control – Are we on the right track?
Westerway, Susan C
2017-01-01
Best practice guidelines for the disinfection of ultrasound transducers and infection prevention in ultrasound departments are generally recommended by either government health groups or the ultrasound societies of individual countries. The literature shows a wide variance in not only transducer cleaning methods but basic hygiene practices in the ultrasound workplace. This paper describes results from a UK survey of disinfection of ultrasound transducers and hygiene practice in the workplace. The survey revealed that some ultrasound practitioners did not follow current guidelines with regard to the correct disinfection method of transducers, cords or ultrasound machine keyboards. Furthermore, the survey exposed the lack of training from the product manufacturers on how to use the disinfection product appropriately. These inconsistencies may be responsible for compliance issues and highlight the need for an awareness campaign and a unified approach to infection control by ultrasound practitioners. PMID:28228825
Jacobson, Christine C; Resneck, Jack S; Kimball, Alexa Boer
2004-12-01
To examine the effect of age and other demographic factors on dermatologists' practice characteristics. Anonymous practice profile survey. Dermatologist members of the American Academy of Dermatology Association. Analyzed survey questions included information about legal practice entity, geographic area served, weekly patient care hours, patients seen per hour, and scope of patient care activities. Of 4090 surveys sent, 1425 (35%) were returned. As the age of the cohorts increased, the percentage practicing in solo practices increased (range, 21%-39%), as did the percentage serving urban areas (range, 31%-46%). Measures of physician productivity increased in the older age cohorts; however, age was not a significant factor after controlling for other variables. More patient-hours per week were associated with male sex (P < .001), solo practices (P < .001), and non-urban-based practices (P = .04), whereas a greater number of patients per hour was associated with non-rural-based practices (P = .02) and male sex (P = .03). As the cohorts progressed in age, more time was spent practicing medical dermatology. The number of hours spent practicing cosmetic dermatology peaked in the 41- to 50-year-old cohort (P = .03). Practice patterns differ significantly among dermatologists of different ages. As the current cohorts age and new dermatologists emerge from training, changes in scope of practice and generational differences in productivity are likely to cause a contraction in the effective supply of dermatologists, which has important implications for dermatology workforce planning.
Exposure data for cosmetic products: lipstick, body lotion, and face cream.
Loretz, L J; Api, A M; Barraj, L M; Burdick, J; Dressler, W E; Gettings, S D; Han Hsu, H; Pan, Y H L; Re, T A; Renskers, K J; Rothenstein, A; Scrafford, C G; Sewall, C
2005-02-01
Accurate exposure information for cosmetic products and ingredients is needed in order to conduct safety assessments. Essential information includes both the amount of cosmetic product applied, and the frequency of use. To obtain current data, a study to assess consumer use practices was undertaken. The study included three widely used cosmetic product types: lipstick, body lotion, and face cream. Three hundred and sixty women, ages 19-65 years, who regularly use the products of interest, were recruited at ten different geographical locations within the US. The number of recruits was chosen to ensure a minimum of 300 completes per product type. Subjects were provided with prototype test products, and kept diaries and recorded detailed daily usage information over a two week period. Products were weighed at the start and completion of the study in order to determine the total amount of product used. Statistical analysis of the data was conducted to derive summary distribution of use patterns. The mean and median usage per application, respectively, for the three products was: face cream, 1.22 g and 0.84 g; lipstick, 10 mg and 5 mg; and body lotion, 4.42 g and 3.45 g. The mean and median usage per day for the three products was: face cream, 2.05 g and 1.53 g; lipstick, 24 mg and 13 mg; and body lotion, 8.70 g and 7.63 g. The mean number of applications per day for face cream and lipstick was 1.77 and 2.35, respectively. For body lotion, the mean number of applications per day was dependent on body area, and was 2.12, 1.52, 1.11, 0.95, 0.43, 0.26, and 0.40 for hands, arms, legs, feet, neck and throat, back, and other body areas, respectively. The effect of product preference on use practices was also investigated. This study provides current cosmetic exposure information for commonly used products which will be useful for risk assessment purposes.
USDA-ARS?s Scientific Manuscript database
To address the multiple challenges to food security posed by global climate change, population growth and rising incomes, plant breeders are developing new crop varieties that can enhance both agricultural productivity and environmental sustainability. Current breeding practices, however, are unable...
21 CFR 211.101 - Charge-in of components.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Charge-in of components. 211.101 Section 211.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...
21 CFR 211.101 - Charge-in of components.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Charge-in of components. 211.101 Section 211.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...
21 CFR 211.101 - Charge-in of components.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Charge-in of components. 211.101 Section 211.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...
21 CFR 211.101 - Charge-in of components.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Charge-in of components. 211.101 Section 211.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...
21 CFR 211.101 - Charge-in of components.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Charge-in of components. 211.101 Section 211.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...
Code of Federal Regulations, 2011 CFR
2011-07-01
... best practicable control technology currently available (BPT): Subpart AD—Calcium Carbonate Milk of... SOURCE CATEGORY Calcium Carbonate Production Subcategory § 415.302 Effluent limitations guidelines... point source subject to this subpart and using the milk of lime process must achieve the following...
Code of Federal Regulations, 2011 CFR
2011-07-01
... SOURCE CATEGORY Titanium Dioxide Production Subcategory § 415.222 Effluent limitations guidelines... point source subject to this subpart and producing titanium dioxide by the sulfate process must achieve... application of the best practicable control technology currently available (BPT): Subpart V—Titanium Dioxide...
Code of Federal Regulations, 2010 CFR
2010-07-01
... SOURCE CATEGORY Titanium Dioxide Production Subcategory § 415.222 Effluent limitations guidelines... point source subject to this subpart and producing titanium dioxide by the sulfate process must achieve... application of the best practicable control technology currently available (BPT): Subpart V—Titanium Dioxide...
Code of Federal Regulations, 2014 CFR
2014-07-01
... SOURCE CATEGORY Titanium Dioxide Production Subcategory § 415.222 Effluent limitations guidelines... point source subject to this subpart and producing titanium dioxide by the sulfate process must achieve... application of the best practicable control technology currently available (BPT): Subpart V—Titanium Dioxide...
Code of Federal Regulations, 2013 CFR
2013-07-01
... SOURCE CATEGORY Titanium Dioxide Production Subcategory § 415.222 Effluent limitations guidelines... point source subject to this subpart and producing titanium dioxide by the sulfate process must achieve... application of the best practicable control technology currently available (BPT): Subpart V—Titanium Dioxide...
Code of Federal Regulations, 2012 CFR
2012-07-01
... SOURCE CATEGORY Titanium Dioxide Production Subcategory § 415.222 Effluent limitations guidelines... point source subject to this subpart and producing titanium dioxide by the sulfate process must achieve... application of the best practicable control technology currently available (BPT): Subpart V—Titanium Dioxide...
School Executive Website Study
ERIC Educational Resources Information Center
Thiede, Robert
2009-01-01
The School Executive Website will be a one-stop, online site for officials who are looking for educational data, best practices, product reviews, school documents, professional opinions, and/or job-related networking. The format of the website is designed in certain sections similar to other current and popular websites, such as Angie's List.com,…
The Role of Public Extension in Introducing Environment-Friendly Farming Methods in Turkey.
ERIC Educational Resources Information Center
Kumuk, T.; Akgungor, S.
1995-01-01
Currently, the Turkish extension service plays a minimal role in reducing adverse environmental effects of farming methods. Public investment in research and extension on sustainable agriculture is needed to ensure long-term production practices that maintain the food supply without damaging the environment. (SK)
Designing and establishing a fine hardwood timber plantation
James R. McKenna; Lenny D. Farlee
2013-01-01
Today, new tools and lessons learned from established plantations of black walnut and other fine hardwoods can provide landowners with guidelines to design and establish successful plantations to produce quality timber for the future. From earlier plantations now maturing, we can recognize design features critical during establishment. Current production practices...
What is the current state of management practices for biosolids production and application, and how can those be made more effective? How effective are Class B disinfection and vector attraction processes, and public access and harvesting restrictions at reducing the public's exp...
Using Performance-Based Pay to Improve the Quality of Teachers
ERIC Educational Resources Information Center
Lavy, Victor
2007-01-01
Tying teachers' pay to their classroom performance should, says Victor Lavy, improve the current educational system both by clarifying teaching goals and by attracting and retaining the most productive teachers. But implementing pay for performance poses many practical challenges, because measuring individual teachers' performance is difficult.…
Current best management practices for harvesting and storing dry hay: a research review
USDA-ARS?s Scientific Manuscript database
The production of high-quality grass or legume hays in humid environments is complicated by slower drying rates, and increased probability of rainfall events compared to hay produced under arid climatic conditions. As a result, hay producers in humid environments often face the management dilemma of...
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...
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...
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...
21 CFR 225.58 - Laboratory controls.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure of...
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...
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...
21 CFR 225.58 - Laboratory controls.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure of...
21 CFR 225.58 - Laboratory controls.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure of...
The Wisdom of Scientific Inquiry on Education
ERIC Educational Resources Information Center
Glass, Gene V.
1972-01-01
Under current conditions evaluative research based on curriculum products of master teachers using basic knowledge from the social and natural sciences is more likely to contribute to the improvement of educational practice than is an attempt to build theories of teaching based upon rapidly changing philosophy and technique. (AL)
Mapping and monitoring potato cropping systems in Maine: geospatial methods and land use assessments
USDA-ARS?s Scientific Manuscript database
Geospatial frameworks and GIS-based approaches were used to assess current cropping practices in potato production systems in Maine. Results from the geospatial integration of remotely-sensed cropland layers (2008-2011) and soil datasets for Maine revealed a four-year potato systems footprint estima...
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...
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...
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...
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...
The effects of mulching, tillage, and herbicides on weed control and watermelon yield
USDA-ARS?s Scientific Manuscript database
Currently few producers in the Southeast US have adopted conservation tillage practices in specialty crop production. The lack of conservation adoption is likely due to the added challenges in producing vegetables in cover crop residues, especially high biomass cover crop systems. The objective of t...
Rewards for Inventors: A Review of Current Practice in UK Universities.
ERIC Educational Resources Information Center
Handscombe, R. D.
1996-01-01
Since the British government began allowing universities to exploit the products of their research, universities have developed cash reward systems for inventors. For many researchers, job satisfaction and peer recognition appear more important than monetary rewards. The money is often reinvested in further research. (SK)
Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-17
... for Preventing Cross- Contamination; Availability AGENCY: Food and Drug Administration, HHS. ACTION... require separation of manufacturing facilities to avoid cross-contamination, the only class of products... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0104...
Hybrid Practices? Contributions to the Debate on the Mutation of Science and University
ERIC Educational Resources Information Center
Tuunainen, Juha
2005-01-01
This article reflects on current debate over transformations of scientific research and universities. Four well-known mutation theories (Mode-2 knowledge production, triple helix of university-industry-government relations, academic capitalism and enterprise university), and their recent critiques, are reviewed. It is suggested that a better…
NASA Technical Reports Server (NTRS)
1974-01-01
Monograph reviews and assesses current design practices, and from them establishes firm guidance for achieving greater consistency in design, increased reliability in end product, and greater efficiency in design effort. Five devices are treated separately. Guides to aid in configuration selection are outlined.
Design criteria monograph on centrifugal flow turbopumps
NASA Technical Reports Server (NTRS)
1974-01-01
Monograph reviews and assesses current design practices, and from them establishes firm guidance for achieving greater consistency in design, increased reliability in end product, and greater efficiency in design effort. Review should be of interest to manufacturers and users of pumps, power drives, turbine drives, and rotary equipment in general.
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...
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...
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...
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...
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...
ERIC Educational Resources Information Center
Palmer, Zsuzsanna Bacsa
2013-01-01
The effects of globalization on communication products and processes have resulted in document features and interactional practices that are sometimes difficult to describe within current theoretical frameworks of inter/transcultural technical communication. Although it has been recognized in our field that the old theoretical frameworks and…
Managing soil microbial communities in grain production systems through cropping practices
NASA Astrophysics Data System (ADS)
Gupta, Vadakattu
2013-04-01
Cropping practices can significantly influence the composition and activity of soil microbial communities with consequences to plant growth and production. Plant type can affect functional capacity of different groups of biota in the soil surrounding their roots, rhizosphere, influencing plant nutrition, beneficial symbioses, pests and diseases and overall plant health and crop production. The interaction between different players in the rhizosphere is due to the plethora of carbon and nutritional compounds, root-specific chemical signals and growth regulators that originate from the plant and are modulated by the physico-chemical properties of soils. A number of plant and environmental factors and management practices can influence the quantity and quality of rhizodeposition and in turn affect the composition of rhizosphere biota communities, microbe-fauna interactions and biological processes. Some of the examples of rhizosphere interactions that are currently considered important are: proliferation of plant and variety specific genera or groups of microbiota, induction of genes involved in symbiosis and virulence, promoter activity in biocontrol agents and genes correlated with root adhesion and border cell quality and quantity. The observation of variety-based differences in rhizodeposition and associated changes in rhizosphere microbial diversity and function suggests the possibility for the development of varieties with specific root-microbe interactions targeted for soil type and environment i.e. designer rhizospheres. Spatial location of microorganisms in the heterogeneous field soil matrix can have significant impacts on biological processes. Therefore, for rhizosphere research to be effective in variable seasonal climate and soil conditions, it must be evaluated in the field and within a farming systems context. With the current focus on security of food to feed the growing global populations through sustainable agricultural production systems there is a need to develop innovative cropping systems that are both economically and environmentally sustainable.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Seeley, E.J.
An apple orchard can be a very efficient mechanism for harvesting and storing energy in a usable form. The challenge is to define how the genetic, microclimatic, soil, water and cultural practice interactions limit the productive potential of apple plantings and at the same time to look ahead toward increasing the efficiency of the plant to assume continued increases in productivity for the future. Five papers were presented as summaries of some of the current and past research efforts into the factors affecting apple tree photosynthesis. (DP).
Colbach, Nathalie; Darmency, Henri; Fernier, Alice; Granger, Sylvie; Le Corre, Valérie; Messéan, Antoine
2017-05-01
Overreliance on the same herbicide mode of action leads to the spread of resistant weeds, which cancels the advantages of herbicide-tolerant (HT) crops. Here, the objective was to quantify, with simulations, the impact of glyphosate-resistant (GR) weeds on crop production and weed-related wild biodiversity in HT maize-based cropping systems differing in terms of management practices. We (1) simulated current conventional and probable HT cropping systems in two European regions, Aquitaine and Catalonia, with the weed dynamics model FLORSYS; (2) quantified how much the presence of GR weeds contributed to weed impacts on crop production and biodiversity; (3) determined the effect of cultural practices on the impact of GR weeds and (4) identified which species traits most influence weed-impact indicators. The simulation study showed that during the analysed 28 years, the advent of glyphosate resistance had little effect on plant biodiversity. Glyphosate-susceptible populations and species were replaced by GR ones. Including GR weeds only affected functional biodiversity (food offer for birds, bees and carabids) and weed harmfulness when weed effect was initially low; when weed effect was initially high, including GR weeds had little effect. The GR effect also depended on cultural practices, e.g. GR weeds were most detrimental for species equitability when maize was sown late. Species traits most harmful for crop production and most beneficial for biodiversity were identified, using RLQ analyses. None of the species presenting these traits belonged to a family for which glyphosate resistance was reported. An advice table was built; the effects of cultural practices on crop production and biodiversity were synthesized, explained, quantified and ranked, and the optimal choices for each management technique were identified.
The Doctor-Patient Relationship: A Model for Senior Leaders
1994-04-21
accessible, high quality, affordable health care. In working towards this goal, to ignore or discount the contributions from the dynamics of the model is a...order to stay current in practice. Another source of pressure to stay current is working along side fellow physicians. The expectations of peers can...candidate in the served patient population. P t the case of pressure for income production, if a patient can benefit from a procedure even when less
Laboratory and Field Evaluation of Rapid Setting Cementitious Materials for Large Crater Repair
2010-05-01
frame used within which to complete the repair was the current NATO standard of 4 hr. A total of 6 simulated craters were prepared, with each repair...Combat Command 129 Andrews Street Langley Air Force Base, VA 23665 ERDC TR-10-4 ii Abstract: Current practice for expedient runway repair...penalty. Numerous commercial products are available. A full-scale field test was conducted using rapid setting materials to repair simulated bomb craters
The Food and Drug Administration and pragmatic clinical trials of marketed medical products
Anderson, Monique L; Griffin, Joseph; Goldkind, Sara F; Zeitler, Emily P; Wing, Liz; Al-Khatib, Sana M; Sherman, Rachel E
2015-01-01
Pragmatic clinical trials (PCTs) can help answer questions of comparative effectiveness for interventions routinely used in medical practice. PCTs may examine outcomes of one or more marketed medical products, and they are heterogeneous in design and risk. The Food and Drug Administration (FDA) is charged with protecting the rights, safety, and welfare of individuals enrolled in clinical investigations, as well as assuring the integrity upon which approval of medical products are made. The FDA has broad jurisdiction over drugs and medical devices (whether or not they are approved for marketing), and as such, clinical investigations of these products are subject to applicable FDA regulations. While many PCTs will meet the criteria for an exemption from the requirements for an investigational new drug application (IND) or investigational device exemption (IDE), in general all clinical investigations of medical products that fall under FDA jurisdiction must adhere to regulations for informed consent and review by an institutional review board (IRB). We are concerned that current FDA requirements for obtaining individual informed consent may deter or delay the conduct of PCTs intended to develop reliable evidence of comparative safety and effectiveness of approved medical products that are regulated by the FDA. Under current regulations, there are no described mechanisms to alter or waive informed consent to make it less burdensome or more practicable for low-risk PCTs. We recommend that the FDA establish a risk-based approach to obtaining informed consent in PCTs that would facilitate the conduct of PCTs without compromising the protection of enrolled individuals or the integrity of the resulting data. PMID:26374684
The commercial sector: marketing diet and fitness responsibly.
Conley, R
1998-08-01
The commercial sector, through a range of products and services, is already heavily involved in the weight loss industry. Because of its capability to access millions of people, it has great potential for promoting public health through dietary and exercise practices. However, an absence of controls or advertising standards, safety and quality, currently threatens its credibility. This paper draws from my own experience developing a now well-established diet and fitness organisation. It makes the case that the best quality products and practice arise from close collaboration with scientific experts in the field. Effectiveness is increased through the distribution of sound educational messages, through an array of commercial options that include books, magazines, videos, television and diet and exercise clubs.
Evaluating How to Alter Design Processes to Consider Sustainable Practices
NASA Astrophysics Data System (ADS)
Liew, V.
2017-12-01
The Design Cycle is a well established design methodology featuring four major criterion (Investigating, Planning, Creating, and Evaluating), adopted by International Baccalaureate education foundation. However, as sustainability has become an alarmingly relevant issue, the Design Cycle is not a sufficient guide in its current form. With the the excessive quantities of waste entering Hong Kong's landfills as well as the worldwide issue of rapidly depleting resources, it is imperative that products reduce waste via adaptive or mitigative methods, and that an environmental sector be integrated into the existing Design Cycle. In this piece of research, sustainable design practices will be evaluated to form a list of specifications that products can be assessed against to reduce waste and repurpose materials.
Preston, Sarah Jane Margaret; Sandeman, Mark; Gonzalez, Jorge; Piedrafita, David
2014-01-01
Gastrointestinal nematode (GIN) parasites pose a significant economic burden particularly in small ruminant production systems. Anthelmintic resistance is a serious concern to the effective control of GIN parasites and has fuelled the focus to design and promote sustainable control of practices of parasite control. Many facets of sustainable GIN parasite control programs rely on the ability to diagnose infection both qualitatively and quantitatively. Diagnostics are required to determine anthelmintic efficacies, for targeted treatment programs and selection of animals for parasite resistant breeding. This review describes much of the research investigated to date to improve the current diagnostic for the above practices which is based on counting the number of parasite eggs in faeces.
Radiological health risk evaluation of radium contaminated land: a real life implementation.
Paridaens, J
2005-01-01
A plot of land, currently used for dairy farming, has been contaminated over the years with radium due to the operation of one of the world's largest radium production plants. Within the framework of a global remediation approach for the plant surroundings, the land owner needed advice for a future destination of the land. Therefore, the radium contamination was accurately mapped, and on the basis of its severity a practically feasible subdivision of the land into four plots was proposed. For all four plots, the radiological risk was evaluated for the current type of land use and for possible alternative types. Hence a clear and useable advice could be formulated to the authorities reconciling public health, economic and practical issues.
The current status of vital tooth whitening techniques.
Blankenau, R; Goldstein, R E; Haywood, V B
1999-08-01
Tooth whitening of vital teeth continues to have a major impact on the practice of dentistry. The growing public interest in having whiter, brighter teeth is clearly evident in the advertisements from toothpaste manufacturers on "whitening" formulations of their products and by the number of individuals seeking whitening procedures from their dentists. In addition, new over-the-counter whitening products continue to emerge in a marketplace that cannot seem to get teeth white enough, bright enough, fast enough. What new products and procedures have evolved over the past decade to whiten teeth? Are they better, safer, faster, and more effective now? Are dentists meeting public demand for whiter teeth and is this quest having a positive or negative impact on the practice of dentistry or the patient's dental health? I posed these questions to a group of experts on whitening procedures to get their opinions and recommendations.
Current challenges in European oncology pharmacy practice.
Hoppe-Tichy, Torsten
2010-03-01
The demand for pharmacy cancer services is expected to at least double over the next 10 years, as the population ages and new treatments are introduced. Safe and efficient handling of cytotoxic products minimises risks to staff and reduces medication errors. To identify and describe strategies for coping safely and effectively with heavier workloads in the hospital oncology pharmacy, currently and in the future. The PubMed database was searched for literature on approaches to safe handling of antineoplastic agents and to decreasing medication errors in the hospital pharmacy. Articles that were judged to be of prime importance to the hospital oncologist were reviewed. These safety concepts are put into the context of contemporary hospital oncology pharmacy practice through discussion of key issues, including increased demand, the role of the pharmacist in determining the hospital formulary, and growth in patient preferences for oral chemotherapy. Recommendations on best practices are also provided, based on relevant literature and author experience. Efficient, safe hospital pharmacy operations can be aided by capacity planning, dose banding, and knowledge of novel products and procedures that can reduce risks to health while increasing the number of patients who are safely treated. Consideration may also be given to the economic role of oncology pharmacists in formulary development.
Current and future risks of asbestos exposure in the Australian community
2016-01-01
Background Australia mined asbestos for more than 100 years and manufactured and imported asbestos products. There is a legacy of in situ asbestos throughout the built environment. Methods The aim of this study was to identify the possible sources of current and future asbestos exposure from the built environment. Telephone interviews with environmental health officers, asbestos removalists, and asbestos assessors in Australia sought information about common asbestos scenarios encountered. Results There is a considerable amount of asbestos remaining in situ in the Australian built environment. Potential current and future sources of asbestos exposure to the public are from asbestos-containing roofs and fences, unsafe asbestos removal practices, do-it-yourself home renovations and illegal dumping. Conclusion This research has highlighted a need for consistent approaches in the regulation and enforcement of safe practices for the management and removal of asbestos to ensure that in situ asbestos in the built environment is managed appropriately. PMID:27611196
Current and future risks of asbestos exposure in the Australian community.
Gray, Corie; Carey, Renee N; Reid, Alison
2016-10-01
Australia mined asbestos for more than 100 years and manufactured and imported asbestos products. There is a legacy of in situ asbestos throughout the built environment. The aim of this study was to identify the possible sources of current and future asbestos exposure from the built environment. Telephone interviews with environmental health officers, asbestos removalists, and asbestos assessors in Australia sought information about common asbestos scenarios encountered. There is a considerable amount of asbestos remaining in situ in the Australian built environment. Potential current and future sources of asbestos exposure to the public are from asbestos-containing roofs and fences, unsafe asbestos removal practices, do-it-yourself home renovations and illegal dumping. This research has highlighted a need for consistent approaches in the regulation and enforcement of safe practices for the management and removal of asbestos to ensure that in situ asbestos in the built environment is managed appropriately.
Current status of production and market of human vaccine products in Korea.
Kim, So Youn; Cho, Jahyang; Cha, Sung-Ho; Bae, Chong-Woo
2013-07-01
The goal of this study was to build basic information related to the production and market of human vaccine products in Korea, which can be an important indicator to provide basic data in practical use. Statistical data were obtained from the Bank of Korea, Korea Health Industry Development Institute, Korea Pharmaceutical Traders Association, and Korea Pharmaceutical Manufacturers Association. Vaccines are the 10th ranked drugs in the classification of whole complete preparated drugs. The production output of vaccines in Korea was 392.2 billion KRW in 2011, comprising 2.83% of complete preparated drug production output (13 trillion 880.8 billion KRW) and 2.54% of medical-pharmaceutical product output (15 trillion 440.3 billion KRW). The market scale of vaccines in Korea was 710 billion KRW in 2011, with an annual average growth rate of 11% in the past 6 years, comprising 2% of vaccine market in the world. There was also a significant increase in essential vaccines and other preventive vaccines in a global scale. Vaccines have the potential of becoming an emerging attractive industry. Based on the current analysis about the production of vaccine products and market scale, further development of the vaccine industry is expected in Korea.
Negative emissions from stopping deforestation and forest degradation, globally.
Houghton, Richard A; Nassikas, Alexander A
2018-01-01
Forest growth provides negative emissions of carbon that could help keep the earth's surface temperature from exceeding 2°C, but the global potential is uncertain. Here we use land-use information from the FAO and a bookkeeping model to calculate the potential negative emissions that would result from allowing secondary forests to recover. We find the current gross carbon sink in forests recovering from harvests and abandoned agriculture to be -4.4 PgC/year, globally. The sink represents the potential for negative emissions if positive emissions from deforestation and wood harvest were eliminated. However, the sink is largely offset by emissions from wood products built up over the last century. Accounting for these committed emissions, we estimate that stopping deforestation and allowing secondary forests to grow would yield cumulative negative emissions between 2016 and 2100 of about 120 PgC, globally. Extending the lifetimes of wood products could potentially remove another 10 PgC from the atmosphere, for a total of approximately 130 PgC, or about 13 years of fossil fuel use at today's rate. As an upper limit, the estimate is conservative. It is based largely on past and current practices. But if greater negative emissions are to be realized, they will require an expansion of forest area, greater efficiencies in converting harvested wood to long-lasting products and sources of energy, and novel approaches for sequestering carbon in soils. That is, they will require current management practices to change. © 2017 John Wiley & Sons Ltd.
Gnoth, S; Jenzsch, M; Simutis, R; Lübbert, A
2007-10-31
The Process Analytical Technology (PAT) initiative of the FDA is a reaction on the increasing discrepancy between current possibilities in process supervision and control of pharmaceutical production processes and its current application in industrial manufacturing processes. With rigid approval practices based on standard operational procedures, adaptations of production reactors towards the state of the art were more or less inhibited for long years. Now PAT paves the way for continuous process and product improvements through improved process supervision based on knowledge-based data analysis, "Quality-by-Design"-concepts, and, finally, through feedback control. Examples of up-to-date implementations of this concept are presented. They are taken from one key group of processes in recombinant pharmaceutical protein manufacturing, the cultivations of genetically modified Escherichia coli bacteria.
NASA Astrophysics Data System (ADS)
Spellerberg, S.; Scholten, B.; Spahn, I.; Felden, O.; Gebel, R.; Qaim, S. M.; Bai, M.; Neumaier, B.
2017-05-01
An essential basis for research and development work on radiopharmaceuticals is the efficient production of radionuclides of high quality. In this process research-oriented studies aiming for elucidation of biochemical processes require novel products. The radionuclide development at INM-5 entails basic research, e.g. the determination of nuclear reaction data, as well as technical aspects of practical production, such as high-current targetry, chemical separation, formulation and quality control. In this work developments, adaptation and optimization of irradiation facilities at the BC 1710, JULIC as Injector of COSY and COSY itself are summarized, which shall allow the extension of radionuclide production possibilities, aiming at innovations in medical applications.
Kentucky pharmacists' opinions of the potential reclassification of pseudoephedrine as a legend drug
Monson, Kathleen E.; Freeman, Patricia R.; Goodin, Amie J.; Talbert, Jeffery; Blumenschein, Karen
2015-01-01
Objectives To collect and analyze Kentucky pharmacists' opinions of the effectiveness of current methamphetamine precursor controls, to analyze proposed legislation to make pseudoephedrine (PSE) a legend drug, and to analyze the potential impact of such legislation on pharmacy practice and patients. Design Descriptive, nonexperimental survey study. Setting Kentucky; June through October 2012. Participants 431 Kentucky community pharmacists. Intervention Mailed survey. Main outcome measures Perceived efficacy of current methamphetamine precursor controls, anticipated impact on individual pharmacy practices and patients of proposed legislation to make PSE available by prescription only, and current opinions about the proposed legislation. Results Analysis of 431 community pharmacists showed that approximately 77% believed proposed legislation to make PSE available by prescription only would be effective in reducing methamphetamine abuse and methamphetamine-related laboratory incidents, with 56.2% indicating support for the proposed legislation. Pharmacists practicing in chain pharmacies were 2.9 times more likely to support the legislation than pharmacists practicing in independent pharmacies. Additional factors influencing pharmacist support included Kentucky region of practice, anticipated impact on time spent on PSE activities, pharmacy profit, methamphetamine abuse, and methamphetamine-related laboratory incidents. Pharmacists practicing in regions of Kentucky associated with higher methamphetamine abuse appear to more strongly support the proposed legislation. Conclusion Pharmacists are at the frontline of PSE distribution. Gaining a better understanding of issues surrounding the distribution of PSE will enhance the likelihood that future legislation may be crafted to reduce methamphetamine production, laboratory incidents, and abuse while minimizing inconvenience and cost. PMID:25063261
Monson, Kathleen E; Freeman, Patricia R; Goodin, Amie J; Talbert, Jeffery; Blumenschein, Karen
2014-01-01
To collect and analyze Kentucky pharmacists' opinions of the effectiveness of current methamphetamine precursor controls, to analyze proposed legislation to make pseudoephedrine (PSE) a legend drug, and to analyze the potential impact of such legislation on pharmacy practice and patients. Descriptive, nonexperimental survey study. Kentucky; June through October 2012. 431 Kentucky community pharmacists. Mailed survey. Perceived efficacy of current methamphetamine precursor controls, anticipated impact on individual pharmacy practices and patients of proposed legislation to make PSE available by prescription only, and current opinions about the proposed legislation. Analysis of 431 community pharmacists showed that approximately 77% believed proposed legislation to make PSE available by prescription only would be effective in reducing methamphetamine abuse and methamphetamine-related laboratory incidents, with 56.2% indicating support for the proposed legislation. Pharmacists practicing in chain pharmacies were 2.9 times more likely to support the legislation than pharmacists practicing in independent pharmacies. Additional factors influencing pharmacist support included Kentucky region of practice, anticipated impact on time spent on PSE activities, pharmacy profit, methamphetamine abuse, and methamphetamine-related laboratory incidents. Pharmacists practicing in regions of Kentucky associated with higher methamphetamine abuse appear to more strongly support the proposed legislation. Pharmacists are at the frontline of PSE distribution. Gaining a better understanding of issues surrounding the distribution of PSE will enhance the likelihood that future legislation may be crafted to reduce methamphetamine production, laboratory incidents, and abuse while minimizing inconvenience and cost.
Okumu, Mitchel Otieno; Ochola, Francis Okumu; Onyango, Allan Odhiambo; Mbaria, James Mucunu; Gakuya, Daniel Waweru; Kanja, Laetitia Wakonyu; Kiama, Stephen Gitahi; Onyango, Mary Atieno
2017-01-01
Complementary and alternative medicine is an integral component of primary healthcare in Kenya. This is because the infrastructural health setup in the country is inadequate in catering for all the medical needs of the population. This particularly holds true in the rural areas where many rural folk rely on products of herbal origin to offset their healthcare needs. More often than not these products are an elaborate cacophony of several different substances of biological origin and thus need personnel adept in their preparation. Sadly, due to loopholes in legislation and regulation, quacks have a field day in the practice. Moreover, the process of planting, harvesting, preparation and storage of herbs and related products dictates that a significant number of people will ultimately be involved in the whole process. This is likely to set the stage for manipulation and compromise of the safety, quality and efficacy of these products. This state of affairs appears unabated especially in the context of the current legal and regulatory framework governing herbal medicine use and practice in Kenya. Not only are these laws inadequate, they are shrouded in ambiguity, open to interpretation and the authorities mandated to implement them often end up performing duplicate roles. The aim of this review is to critique the legal and regulatory provisions governing herbal medicine use and practice in Kenya. In conclusion, laws and regulations meant to control herbal medicine use and practice in Kenya are wanting. Clear and definitive legislation on herbal medicine use and practice coupled with effective implementation by mandated institutions will go a long way in inspiring confidence to all stakeholders of herbal medicine.
Okumu, Mitchel Otieno; Ochola, Francis Okumu; Onyango, Allan Odhiambo; Mbaria, James Mucunu; Gakuya, Daniel Waweru; Kanja, Laetitia Wakonyu; Kiama, Stephen Gitahi; Onyango, Mary Atieno
2017-01-01
Complementary and alternative medicine is an integral component of primary healthcare in Kenya. This is because the infrastructural health setup in the country is inadequate in catering for all the medical needs of the population. This particularly holds true in the rural areas where many rural folk rely on products of herbal origin to offset their healthcare needs. More often than not these products are an elaborate cacophony of several different substances of biological origin and thus need personnel adept in their preparation. Sadly, due to loopholes in legislation and regulation, quacks have a field day in the practice. Moreover, the process of planting, harvesting, preparation and storage of herbs and related products dictates that a significant number of people will ultimately be involved in the whole process. This is likely to set the stage for manipulation and compromise of the safety, quality and efficacy of these products. This state of affairs appears unabated especially in the context of the current legal and regulatory framework governing herbal medicine use and practice in Kenya. Not only are these laws inadequate, they are shrouded in ambiguity, open to interpretation and the authorities mandated to implement them often end up performing duplicate roles. The aim of this review is to critique the legal and regulatory provisions governing herbal medicine use and practice in Kenya. In conclusion, laws and regulations meant to control herbal medicine use and practice in Kenya are wanting. Clear and definitive legislation on herbal medicine use and practice coupled with effective implementation by mandated institutions will go a long way in inspiring confidence to all stakeholders of herbal medicine. PMID:29629018
O'Donovan, A; Coleman, M; Harris, R; Herst, P
2015-05-01
Radiation-induced toxicity is a common adverse side effect of radiation therapy. Previous studies have demonstrated a lack of evidence to support common skincare advice for radiotherapy patients. The aim of the current study was to investigate the management of radiation-induced skin toxicity across Europe and the USA. Where previous surveys have focused on national practice or treatment of specific sites, the current study aimed to gain a broader representation of skincare practice. An anonymous online survey investigating various aspects of radiotherapy skincare management was distributed to departments across Europe and the USA (n = 181/737 responded i.e. 25%). The UK was excluded as a similar survey was carried out in 2011. The results highlight the lack of consistency in both the prevention and management of radiation-induced skin toxicity. Recommended products are often not based on evidence-based practice. Examples include the continued use of aqueous cream and gentian violet, as well as the recommendations on washing restrictions during treatment. To our knowledge, this is the most extensive survey to date on the current management of radiation-induced skin toxicity. This study highlights significant disparities between clinical practice and research-based evidence published in recent systematic reviews and guidelines. Ongoing large prospective randomised trials are urgently needed. © 2014 John Wiley & Sons Ltd.
A Roundtable Discussion: Combination Products: Twice the Challenge?
Baird, Nolan; Binion, Steven B; Cammack, Jon; Paine, Stephanie Del; Gonzales, Rosemary; Passut, Jena; Weiner, John Barlow Barr
2015-01-01
Combination products are therapeutic or diagnostic medical products that combine drugs, devices, and/or biological products with one another. FDA developed a regulation (final rule) on Current Good Manufacturing Practices (CGMP) for combination products that became effective July 22, 2013 (21 CFR Part 4). AAMI recently developed a technical information report (TIR) that provides information on how to effectively implement FDA's regulation. The overall goal of the TIR is to aid informed, risk-based decisions in establishing CGMP operating systems that support development, manufacture, premarket regulatory evaluation, and ultimately commercialization of combination products. This article, a result of an discussion with industry and FDA representatives, explores the landscape of combination products, highlights important considerations in developing and seeking marketing clearance for these innovative products, and provides insight on trends in the area.
ESIP Information Quality Cluster (IQC)
NASA Technical Reports Server (NTRS)
Ramapriyan, H. K.; Peng, Ge; Moroni, David F.
2016-01-01
The Information Quality Cluster (IQC) within the Federation of Earth Science Information Partners (ESIP) was initially formed in 2011 and has evolved significantly over time. The current objectives of the IQC are to: 1. Actively evaluate community data quality best practices and standards; 2. Improve capture, description, discovery, and usability of information about data quality in Earth science data products; 3. Ensure producers of data products are aware of standards and best practices for conveying data quality, and data providers distributors intermediaries establish, improve and evolve mechanisms to assist users in discovering and understanding data quality information; and 4. Consistently provide guidance to data managers and stewards on how best to implement data quality standards and best practices to ensure and improve maturity of their data products. The activities of the IQC include: 1. Identification of additional needs for consistently capturing, describing, and conveying quality information through use case studies with broad and diverse applications; 2. Establishing and providing community-wide guidance on roles and responsibilities of key players and stakeholders including users and management; 3. Prototyping of conveying quality information to users in a more consistent, transparent, and digestible manner; 4. Establishing a baseline of standards and best practices for data quality; 5. Evaluating recommendations from NASA's DQWG in a broader context and proposing possible implementations; and 6. Engaging data providers, data managers, and data user communities as resources to improve our standards and best practices. Following the principles of openness of the ESIP Federation, IQC invites all individuals interested in improving capture, description, discovery, and usability of information about data quality in Earth science data products to participate in its activities.
Lefèvre, P-A; Audat, F; Giraud, C; Roussel, P
2010-04-01
Hemapheresis is made up of a set of essential methods for modern medical practices. Applicated to donors, they allow production of labile blood products as well as raw material for plasma products industrial manufacturing; applicated to patients, they are indispensable for the treatment of many pathologies. Conditions for their implementation are very variable according to the teams who have few tools at their disposal to access, standardize and make reliable their activity. Therefore, an approach has been initiated by the Institut National de la Transfusion Sanguine and the Hemapheresis French Society to develop a guide which primary goal is to help teams evaluate themselves in different areas of their responsibilities. The generalization of the evaluation of professional practices in all activities and specialties required recently by the third iteration of the certification procedure of health institutions and a new law about French health system reinforce us in our approach. Finally, hemapheresis is not without risks, neither for donors nor for patients, which now encourages us to analyze sharply our procedures, to identify risk situations and develop means of prevention. This second step is already a current news for us. Copyright 2010 Elsevier Masson SAS. All rights reserved.
Review of Musculoskeletal Injuries and Prevention in the Endoscopy Practitioner
2014-01-01
Practitioners of endoscopy often experience musculoskeletal pain and injury (most often in the back, neck, shoulders, hands, wrists, and thumbs) that are associated with the minute and repetitive strain that is placed on these areas during endoscopic procedures. This review of the current documentation of endoscopy-related pain and injuries among practitioners finds that such problems are widespread and specific in kind as well as strongly correlated with high procedure volume and procedure duration. Research on the nature and impact of cumulative trauma and overuse syndromes in other professions such as dentistry, pianists, production labor, and athletics is brought to bear on the work of the endoscopist. A more thorough understanding of the nature and prevalence of work-related pain and injury sustained by endoscopists should inform further development of ergonomic practices and equipment design. This article reviews current recommendations for ergonomic design in the endoscopy procedure space and finds that reported compliance with those recommendations is quite low. Strategies for the management of the risk of musculoskeletal injuries related to the practice of endoscopy include compliance with currently recommended ergonomic practices, education of trainees in ergonomic technique when practicing endoscopy, and research toward the modification and development of more ergonomic endoscopes and procedure spaces. PMID:24798940
Status and prospects for renewable energy using wood pellets from the southeastern United States
Dale, Virginia H.; Kline, Keith L.; Parish, Esther S.; ...
2017-04-20
The ongoing debate about costs and benefits of wood-pellet based bioenergy production in the southeastern United States (SE USA) requires an understanding of the science and context influencing market decisions associated with its sustainability. Production of pellets has garnered much attention as US exports have grown from negligible amounts in the early 2000s to 4.6 million metric tonnes in 2015. Currently, 98% of these pellet exports are shipped to Europe to displace coal in power plants. We ask, 'How is the production of wood pellets in the SE USA affecting forest systems and the ecosystem services they provide?' To addressmore » this question, we review current forest conditions and the status of the wood products industry, how pellet production affects ecosystem services and biodiversity, and what methods are in place to monitor changes and protect vulnerable systems. Scientific studies provide evidence that wood pellets in the SE USA are a fraction of total forestry operations and can be produced while maintaining or improving forest ecosystem services. Ecosystem services are protected by the requirement to utilize loggers trained to apply scientifically based best management practices in planning and implementing harvest for the export market. Bioenergy markets supplement incomes to private rural landholders and provide an incentive for forest management practices that simultaneously benefit water quality and wildlife and reduce risk of fire and insect outbreaks. Bioenergy also increases the value of forest land to landowners, thereby decreasing likelihood of conversion to nonforest uses. Monitoring and evaluation are essential to verify that regulations and good practices are achieving goals and to enable timely responses if problems arise. Conducting rigorous research to understand how conditions change in response to management choices requires baseline data, monitoring, and appropriate reference scenarios. Furthermore, long-term monitoring data on forest conditions should be publicly accessible and utilized to inform adaptive management.« less
Status and prospects for renewable energy using wood pellets from the southeastern United States
DOE Office of Scientific and Technical Information (OSTI.GOV)
Dale, Virginia H.; Kline, Keith L.; Parish, Esther S.
The ongoing debate about costs and benefits of wood-pellet based bioenergy production in the southeastern United States (SE USA) requires an understanding of the science and context influencing market decisions associated with its sustainability. Production of pellets has garnered much attention as US exports have grown from negligible amounts in the early 2000s to 4.6 million metric tonnes in 2015. Currently, 98% of these pellet exports are shipped to Europe to displace coal in power plants. We ask, 'How is the production of wood pellets in the SE USA affecting forest systems and the ecosystem services they provide?' To addressmore » this question, we review current forest conditions and the status of the wood products industry, how pellet production affects ecosystem services and biodiversity, and what methods are in place to monitor changes and protect vulnerable systems. Scientific studies provide evidence that wood pellets in the SE USA are a fraction of total forestry operations and can be produced while maintaining or improving forest ecosystem services. Ecosystem services are protected by the requirement to utilize loggers trained to apply scientifically based best management practices in planning and implementing harvest for the export market. Bioenergy markets supplement incomes to private rural landholders and provide an incentive for forest management practices that simultaneously benefit water quality and wildlife and reduce risk of fire and insect outbreaks. Bioenergy also increases the value of forest land to landowners, thereby decreasing likelihood of conversion to nonforest uses. Monitoring and evaluation are essential to verify that regulations and good practices are achieving goals and to enable timely responses if problems arise. Conducting rigorous research to understand how conditions change in response to management choices requires baseline data, monitoring, and appropriate reference scenarios. Furthermore, long-term monitoring data on forest conditions should be publicly accessible and utilized to inform adaptive management.« less
Mdege, Noreen Dadirai; Chevo, Tafadzwa; Toner, Paul
There is increasing recognition of the potential significant contribution that pharmacy personnel can make to improve the public's health. However, there is an evidence gap in developing countries on the public health role of pharmacy personnel. This study aimed to explore the current public health activities that pharmacy professionals in Zimbabwe are currently involved in, and the potential of expanding this role. The study utilized individual, face-to-face, semi-structured qualitative interviews with 9 key informants. The sample reflected the diversity of pharmacy practice groups and levels as well as professional experience, and included a representative from a patient group, and a non-pharmacist national level public health expert. Data collection and analysis was an iterative process informed both by the currently available literature on the topic, as well as themes emerging from the data. Framework analysis was utilized with two independent analyses performed. There was a general consensus among participants that pharmacy practice in Zimbabwe was mainly focused on curative services, with very limited involvement in public health oriented activities. The following were identified as pharmacists' current public health activities: supply chain management of pharmaceutical products, provision of medications and other pharmaceutical products to patients, therapy monitoring, identification and monitoring of chronic illnesses, information provision and training of pharmacists. Nevertheless, there were concerns regarding the quality of some of these services, and lack of consistency in provision across pharmacies. Other potential areas for pharmacists' public health practice were identified as emergency response, drug abuse, addressing social determinants of health particularly promoting healthy lifestyles, applied health research, counterfeit and substandard medicines, and advocacy. There is perceived potential for Zimbabwean pharmacists to become more involved in public health oriented services. However, concerns regarding the quality of services and lack of consistency in provision need to be addressed. Copyright © 2015 Elsevier Inc. All rights reserved.
WHO Expert Committee on Specifications for Pharmaceutical Preparations.
2009-01-01
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 standards and guidelines were adopted and recommended for use: the current list of available International Chemical Reference Substances and International Infrared Reference Spectra; guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products; procedure for prequalification of pharmaceutical products; and the procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products.
Hu, ChunSheng; Cheng, XiaoChen; Lu, YuXin; Wu, ZuZe; Zhang, QingLin
2016-11-16
The demand of a plasmid encoding human hepatocyte growth factor gene (pUDK-HGF) in large quantities at high purity and concentration has increased for gene therapy of critical limb ischemia (CLI) in clinical trials. In this article, we produced pUDK-HGF in compliance with current good manufacturing practices at gram scale. The process included a 50-L batch fermentation, continuous alkaline lysis, and integrated three-step chromatography on Sepharose 6 Fast Flow, PlasmidSelect Xtra, and Source 15Q. The production process has been scaled up to yield 4.24 ± 0.41 g of pharmaceutical pUDK-HGF from 1.0 kg bacterial cell paste and the overall yield reached range from 58.37 to 66.70%. The final pUDK-HGF product exhibited high purity with supercoiled percentage of > 95.8% and undetectable residual RNA, contaminated protein, and bacterial endotoxin. The phase I clinical study indicates that intramuscular injection of pUDK-HGF is safe, well tolerated, and may provide symptomatic relief to CLI patients. These results show that our manufacturing process of pUDK-HGF is efficient in producing pharmaceutical-grade plasmid DNA and is safe for clinical applications.
Advancing Scholarship and Intellectual Productivity: An Interview with Clifford A. Lynch
ERIC Educational Resources Information Center
Hawkins, Brian L.
2006-01-01
In this article, Brian L. Hawkins, President of EDUCAUSE, interviews Clifford A. Lynch, Executive Director of the Coalition for Networked Information (CNI), and the recipient of the 2005 EDUCAUSE Award for Leadership in Public Policy and Practice, about, among other things, the current CNI initiatives, digital assets preservation, e-science,…
USDA-ARS?s Scientific Manuscript database
Manure spills into streams are an all too common byproduct of animal production. With greater numbers of animals raised on fewer farms, manure spills become greater problems due to the volume of manure spilled into aquatic ecosystems. This book chapter reviews why manure spills occur, and the curren...
The Role of the Home Environment in the Transmission of Infectious Diseases.
ERIC Educational Resources Information Center
Kagan, Lori J.; Aiello, Allison E.; Larson, Elaine
2002-01-01
Examines current health care literature on the microbiology of the home environment, summarizing evidence of transmission within the home and assessing the effectiveness of cleaning practices and products. The article focuses on the kitchen, bathroom, and laundry room, then looks at routes of transmission of infection within the home and discusses…
Effective Teaching of Reading: Research and Practice.
ERIC Educational Resources Information Center
Hoffman, James V., Ed.
Distilling and interpreting past and current research on the effective teaching of reading is the focus of this volume. The titles and authors are as follows: "Research in Effective Teaching: An Overview of Its Development" (William H. Rupley, Beth S. Wise, and John W. Logan); "Process-Product Research on Effective Teaching: A Primer for a…
Stormwater filtration of a municipal detention pond
James S. Han; Ernest S. Miyashita; Yi-yu Lin; Alcardo Roa
1999-01-01
Wood- and nonwood-based fibers have been found to have a significant sorption capacity for ionized copper, a heavy metal commonly found in stormwater. The USDA-FS Forest Products Laboratory (Madison, WI) is conducting research on the potential of utilizing natural wood- and nonwood-based fibers in stormwater treatment. The problem with the current practice of...
USDA-ARS?s Scientific Manuscript database
Cottonseed meal-based products show promise in serving as environment-friendly wood adhesives. However, their practical utilization is currently limited due to low durability and water resistant properties. In this research, we tested the improvement of adhesion strength and water resistance of cott...
USDA-ARS?s Scientific Manuscript database
Consolidated bioprocessing (CBP), in which anaerobic bacteria produce their own cellulolytic enzymes and ferment the products of cellulose hydrolysis to ethanol in a single reactor, is regarded as a promising future route to cellulosic ethanol. Some of the current limitations to practical use of thi...
USDA-ARS?s Scientific Manuscript database
The Ogallala aquifer region (OAR) currently accounts for 30% of total crop and animal production in the U.S. More than 90% of the water pumped from the Ogallala aquifer is used for irrigated agriculture in this region. Consequently, groundwater levels in the Ogallala aquifer are rapidly declining. H...
Issues in Educating Students with Disabilities. The LEA Series on Special Education and Disability.
ERIC Educational Resources Information Center
Lloyd, John Wills, Ed.; Kameenui, Edward J., Ed.; Chard, David, Ed.
This book is designed to reaffirm the value of special instruction and to provide information on current research and practice which shows productive and successful outcomes. It addresses the definition of disabilities, the assessment of disabilities, instruction, special populations, special education legislation and policy, and integration.…
Social Media in VET Courses. Good Practice Guide
ERIC Educational Resources Information Center
National Centre for Vocational Education Research (NCVER), 2017
2017-01-01
The use of various forms of social media for individuals, groups and organisations is now commonplace. Individuals use it to update friends and family on their experiences, groups use it to inform their members of relevant information, and organisations use it to market their services and products. With many current and future students already…
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...
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...
ERIC Educational Resources Information Center
Rosenblum, L. Penny; Lewis, Sandra; D'Andrea, Frances Mary
2010-01-01
University instructors were surveyed to determine the requirements for their literary braille courses. Twenty-one instructors provided information on the textbooks they used; how they determined errors; reading proficiency requirements; and other pertinent information, such as methods of assessing mastery of the production of braille using a…
ERIC Educational Resources Information Center
Pickering, Catherine; Grignon, Julien; Steven, Rochelle; Guitart, Daniela; Byrne, Jason
2015-01-01
Current understandings suggest that three aspects of writing practice underpin the research student publication process: knowledge creation, text production and identity formation. Publishing a literature review is the first opportunity most students have to publish. This article compares the pedagogical benefits of different literature review…
Unitizing goods on pallets and slipsheets
J. F. Laundrie
1986-01-01
Packaging, handling, and shipping methods and facilities have changed drastically since World War II. Today, most products are individually packaged and then combined into unitized loads for more efficient handling, storage, and shipping. The purpose of this manual is to promote the most effective use of wood and wood fiber in current packaging and shipping practices...
21 CFR 184.1676 - Pyridoxine hydrochloride.
Code of Federal Regulations, 2014 CFR
2014-04-01
... exceed current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter...)(31) of this chapter; plant protein products as defined in § 170.3(n)(33) of this chapter; and snack... 21 Food and Drugs 3 2014-04-01 2014-04-01 false Pyridoxine hydrochloride. 184.1676 Section 184...
2008-07-15
The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.
Jin, Xiaoning; Siegel, David; Weiss, Brian A; Gamel, Ellen; Wang, Wei; Lee, Jay; Ni, Jun
A research study was conducted (1) to examine the practices employed by US manufacturers to achieve productivity goals and (2) to understand what level of intelligent maintenance technologies and strategies are being incorporated into these practices. This study found that the effectiveness and choice of maintenance strategy were strongly correlated to the size of the manufacturing enterprise; there were large differences in adoption of advanced maintenance practices and diagnostics and prognostics technologies between small and medium-sized enterprises (SMEs). Despite their greater adoption of maintenance practices and technologies, large manufacturing organizations have had only modest success with respect to diagnostics and prognostics and preventive maintenance projects. The varying degrees of success with respect to preventative maintenance programs highlight the opportunity for larger manufacturers to improve their maintenance practices and use of advanced prognostics and health management (PHM) technology. The future outlook for manufacturing PHM technology among the manufacturing organizations considered in this study was overwhelmingly positive; many manufacturing organizations have current and planned projects in this area. Given the current modest state of implementation and positive outlook for this technology, gaps, future trends, and roadmaps for manufacturing PHM and maintenance strategy are presented.
The present status and future growth of maintenance in US manufacturing: results from a pilot survey
Jin, Xiaoning; Siegel, David; Weiss, Brian A.; Gamel, Ellen; Wang, Wei; Lee, Jay; Ni, Jun
2016-01-01
A research study was conducted (1) to examine the practices employed by US manufacturers to achieve productivity goals and (2) to understand what level of intelligent maintenance technologies and strategies are being incorporated into these practices. This study found that the effectiveness and choice of maintenance strategy were strongly correlated to the size of the manufacturing enterprise; there were large differences in adoption of advanced maintenance practices and diagnostics and prognostics technologies between small and medium-sized enterprises (SMEs). Despite their greater adoption of maintenance practices and technologies, large manufacturing organizations have had only modest success with respect to diagnostics and prognostics and preventive maintenance projects. The varying degrees of success with respect to preventative maintenance programs highlight the opportunity for larger manufacturers to improve their maintenance practices and use of advanced prognostics and health management (PHM) technology. The future outlook for manufacturing PHM technology among the manufacturing organizations considered in this study was overwhelmingly positive; many manufacturing organizations have current and planned projects in this area. Given the current modest state of implementation and positive outlook for this technology, gaps, future trends, and roadmaps for manufacturing PHM and maintenance strategy are presented. PMID:27525253
Koski, Sari M; Laitinen-Parkkonen, Pirjo; Airaksinen, Marja
2015-01-01
The study aim was to explore the progress of legislation relating to herbal medicinal products in the European Union and compare it with the corresponding progress of the legislation in Finland in 1965-2007. The study was carried out using content analysis. Data were searched from publicly available European Union directives and national acts. All definitions and safety-related requirements for herbal medicinal products were identified. The transposition of safety-related requirements into the national legislation was studied. Medicinal products from plant origins have been part of the European Union legislation since 1965. Most plant-based products have not initially been regarded as medicinal products but rather as some kind of medicine-like products. The official definition of herbal medicinal products was introduced in Directive 2004/24/EC and implemented into the Finnish legislation with the terminology to recognise herbal medicinal products as part of medicinal products. The current safety-related requirements of medicinal products concern analogously herbal medicinal products. Herbal medicinal products have had different definitions in pharmaceutical legislation over the study period in the European Union and Finland. The current definition places herbal medicinal products more clearly under the medicinal products' legislation. Safety-related requirements are now practically identical for all medicinal products. Transposition of the European Union legislation into the national legislation in Finland is apparent. Copyright © 2013 John Wiley & Sons, Ltd.
Security Personnel Practices and Policies in U.S. Hospitals: Findings From a National Survey.
Schoenfisch, Ashley L; Pompeii, Lisa A
2016-06-27
Concerns of violence in hospitals warrant examination of current hospital security practices. Cross-sectional survey data were collected from members of a health care security and safety association to examine the type of personnel serving as security in hospitals, their policies and practices related to training and weapon/restraint tool carrying/use, and the broader context in which security personnel work to maintain staff and patient safety, with an emphasis on workplace violence prevention and mitigation. Data pertaining to 340 hospitals suggest security personnel were typically non-sworn officers directly employed (72%) by hospitals. Available tools included handcuffs (96%), batons (56%), oleoresin capsicum products (e.g., pepper spray; 52%), hand guns (52%), conducted electrical weapons (e.g., TASERs®; 47%), and K9 units (12%). Current workplace violence prevention policy components, as well as recommendations to improve hospital security practices, aligned with Occupational Safety and Health Administration guidelines. Comprehensive efforts to address the safety and effectiveness of hospital security personnel should consider security personnel's relationships with other hospital work groups and hospitals' focus on patients' safety and satisfaction. © 2016 The Author(s).
Challenges for Product Roadmapping in Inter-company Collaboration
NASA Astrophysics Data System (ADS)
Suomalainen, Tanja; Tihinen, Maarit; Parviainen, Päivi
Product roadmapping is a critical activity in product development, as it provides a link between business aspects and requirements engineering and thus helps to manage a high-level view of the company’s products. Nowadays, inter-company collaboration, such as outsourcing, is a common way of developing software products, as through collaboration, organisations gain advantages, such as flexibility with in-house resources, savings in product development costs and gain a physical presence in important markets. The role of product roadmapping becomes even more critical in collaborative settings, since different companies need to align strategies and work together to create products. In order to support companies in improving their own product roadmapping processes, this paper first gives an overview of product roadmapping and then discusses in detail an empirical study of the current practices in industry. The presented results particularly focus on the most challenging and important activities of product roadmapping in collaboration.
The maturing of the quality improvement paradigm in the SEL
NASA Technical Reports Server (NTRS)
Basili, Victor R.
1993-01-01
The Software Engineering Laboratory uses a paradigm for improving the software process and product, called the quality improvement paradigm. This paradigm has evolved over the past 18 years, along with our software development processes and product. Since 1976, when we first began the SEL, we have learned a great deal about improving the software process and product, making a great many mistakes along the way. Quality improvement paradigm, as it is currently defined, can be broken up into six steps: characterize the current project and its environment with respect to the appropriate models and metrics; set the quantifiable goals for successful project performance and improvement; choose the appropriate process model and supporting methods and tools for this project; execute the processes, construct the products, and collect, validate, and analyze the data to provide real-time feedback for corrective action; analyze the data to evaluate the current practices, determine problems, record findings, and make recommendations for future project improvements; and package the experience gained in the form of updated and refined models and other forms of structured knowledge gained from this and prior projects and save it in an experience base to be reused on future projects.
Benchmarks in Clinical Productivity: A National Comprehensive Cancer Network Survey
Stewart, F. Marc; Wasserman, Robert L.; Bloomfield, Clara D.; Petersdorf, Stephen; Witherspoon, Robert P.; Appelbaum, Frederick R.; Ziskind, Andrew; McKenna, Brian; Dodson, Jennifer M.; Weeks, Jane; Vaughan, William P.; Storer, Barry; Perkel, Sara; Waldinger, Marcy
2007-01-01
Purpose Oncologists in academic cancer centers usually generate professional fees that are insufficient to cover salaries and other expenses, despite significant clinical activity; therefore, supplemental funding is frequently required in order to support competitive levels of physician compensation. Relative value units (RVUs) allow comparisons of productivity across institutions and practice locations and provide a reasonable point of reference on which funding decisions can be based. Methods We reviewed the clinical productivity and other characteristics of oncology physicians practicing in 13 major academic cancer institutions with membership or shared membership in the National Comprehensive Cancer Network (NCCN). The objectives of this study were to develop tools that would lead to better-informed decision making regarding practice management and physician deployment in comprehensive cancer centers and to determine benchmarks of productivity using RVUs accrued by physicians at each institution. Three hundred fifty-three individual physician practices across the 13 NCCN institutions in the survey provided data describing adult hematology/medical oncology and bone marrow/stem-cell transplantation programs. Data from the member institutions participating in the survey included all American Medical Association Current Procedural Terminology (CPT®) codes generated (billed) by each physician during each organization's fiscal year 2003 as a measure of actual clinical productivity. Physician characteristic data included specialty, clinical full-time equivalent (CFTE) status, faculty rank, faculty track, number of years of experience, and total salary by funding source. The average adult hematologist/medical oncologist in our sample would produce 3,745 RVUs if he/she worked full-time as a clinician (100% CFTE), compared with 4,506 RVUs for a 100% CFTE transplant oncologist. Results and Conclusion Our results suggest specific clinical productivity targets for academic oncologists and provide a methodology for analyzing potential factors associated with clinical productivity and developing clinical productivity targets specific for physicians with a mix of research, administrative, teaching, and clinical salary support. PMID:20859362
Benchmarks in clinical productivity: a national comprehensive cancer network survey.
Stewart, F Marc; Wasserman, Robert L; Bloomfield, Clara D; Petersdorf, Stephen; Witherspoon, Robert P; Appelbaum, Frederick R; Ziskind, Andrew; McKenna, Brian; Dodson, Jennifer M; Weeks, Jane; Vaughan, William P; Storer, Barry; Perkel, Sara; Waldinger, Marcy
2007-01-01
Oncologists in academic cancer centers usually generate professional fees that are insufficient to cover salaries and other expenses, despite significant clinical activity; therefore, supplemental funding is frequently required in order to support competitive levels of physician compensation. Relative value units (RVUs) allow comparisons of productivity across institutions and practice locations and provide a reasonable point of reference on which funding decisions can be based. We reviewed the clinical productivity and other characteristics of oncology physicians practicing in 13 major academic cancer institutions with membership or shared membership in the National Comprehensive Cancer Network (NCCN). The objectives of this study were to develop tools that would lead to better-informed decision making regarding practice management and physician deployment in comprehensive cancer centers and to determine benchmarks of productivity using RVUs accrued by physicians at each institution. Three hundred fifty-three individual physician practices across the 13 NCCN institutions in the survey provided data describing adult hematology/medical oncology and bone marrow/stem-cell transplantation programs. Data from the member institutions participating in the survey included all American Medical Association Current Procedural Terminology (CPT®) codes generated (billed) by each physician during each organization's fiscal year 2003 as a measure of actual clinical productivity. Physician characteristic data included specialty, clinical full-time equivalent (CFTE) status, faculty rank, faculty track, number of years of experience, and total salary by funding source. The average adult hematologist/medical oncologist in our sample would produce 3,745 RVUs if he/she worked full-time as a clinician (100% CFTE), compared with 4,506 RVUs for a 100% CFTE transplant oncologist. Our results suggest specific clinical productivity targets for academic oncologists and provide a methodology for analyzing potential factors associated with clinical productivity and developing clinical productivity targets specific for physicians with a mix of research, administrative, teaching, and clinical salary support.
Needs assessment for business strategies of anesthesiology groups' practices.
Scurlock, Corey; Dexter, Franklin; Reich, David L; Galati, Maria
2011-07-01
Progress has been made in understanding strategic decision making influencing anesthesia groups' operating room business practices. However, there has been little analysis of the remaining gaps in our knowledge. We performed a needs assessment to identify unsolved problems in anesthesia business strategy based on Porter's Five Forces Analysis. The methodology was a narrative literature review. We found little previous investigation for 2 of the 5 forces (threat of new entrants and bargaining power of suppliers), modest understanding for 1 force (threat of substitute products or services), and substantial understanding for 2 forces (bargaining power of customers and jockeying for position among current competitors). Additional research in strategic decisions influencing anesthesia groups should focus on the threat of new entrants, bargaining power of suppliers, and the threat of substitute products or services.
Prince, Roger C; Kheshgi, Haroon S
2005-01-01
Photosynthetic microorganisms can produce hydrogen when illuminated, and there has been considerable interest in developing this to a commercially viable process. Its appealing aspects include the fact that the hydrogen would come from water, and that the process might be more energetically efficient than growing, harvesting, and processing crops. We review current knowledge about photobiological hydrogen production, and identify and discuss some of the areas where scientific and technical breakthroughs are essential for commercialization. First we describe the underlying biochemistry of the process, and identify some opportunities for improving photobiological hydrogen production at the molecular level. Then we address the fundamental quantum efficiency of the various processes that have been suggested, technological issues surrounding large-scale growth of hydrogen-producing microorganisms, and the scale and efficiency on which this would have to be practiced to make a significant contribution to current energy use.
Passport-PeopleSoft integration for HANDI 2000 business management system
DOE Office of Scientific and Technical Information (OSTI.GOV)
Wilson, D.
The integration between the PeopleSoft applications and Passport modules are accomplished with an off the shelf package developed by lNDUS. The product was updated to the PeopleSoft Release 7.O. The Integration product interacts with data from multiple products within Passport and PeopleSoft. For 10/l/98 the Integration will interlace between the following: (1) PassPort Accounts Payable, Contract Management, Inventory Management, Purchasing; and (2) PeopleSoft General Ledger, Project Costing, Human Resources, Payroll. The current supply systems and financial systems interact with each other via multiple custom interfaces. Data integrity and Y2K issues were some of the driving factors in replacement of thesemore » systems. The new systems allow FDH the opportunity to change the current business processes to go to a best business practice that the commercial off the shelf software was adopted.« less
Electronic Nicotine Delivery Systems (ENDS): What Nurses Need to Know.
Essenmacher, Carol; Naegle, Madeline; Baird, Carolyn; Vest, Bridgette; Spielmann, Rene; Smith-East, Marie; Powers, Leigh
Efforts to decrease adverse effects of tobacco use are affected by emergence of new nicotine delivery products. Advertising, product promotion, and social media promote use of these products, yet a lack of evidence regarding safety leaves nurses unprepared to counsel patients. To critically evaluate current research, reviews of literature, expert opinion, and stakeholder policy proposals on use and safety of electronic nicotine delivery systems (ENDS). A targeted examination of literature generated by key stakeholders and subject matter experts was conducted using key words, modified by risk factors, and limited to the past 8 years. Current knowledge gaps in research literature and practice implications of the literature are discussed. The safety of ENDS is questionable and unclear. There are clear health risks of nicotine exposure to developing brains. Potential health risks of ENDS secondhand emissions exposure exist. Using ENDS to facilitate total tobacco cessation is not proven.
Environmental release of living modified organisms: current approaches and case studies.
Thomas, E; Nickson, Ph D
2005-01-01
Agricultural biotechnology is being rapidly adopted as evidenced by the acreage of genetically modified (GM) crops planted and tonnes of product (grain and fiber) harvested. Concurrent with this technological progress, is a growing concern that the worlds biological diversity is coming under increasing threat from human activities. As such, ecological risk assessment approaches are being developed for GM crop plants as international agreements regulating the transboundary movements of these products are being implemented. This paper reviews the ecological risk assessment approach that has been used to date to approve GM crops to date. The process has been case-by-case, using a comparative, science-based approach balancing the potential risks and benefits of the new technology versus those present with the currently accepted practices. The approach used to evaluate and approve these products is consistent with the conditions and requirements outlined in the Cartagena Protocol.
NASA Astrophysics Data System (ADS)
Amin, M. A. Mohd; Abas, N. H.; Shahidan, S.; Rahmat, M. H.; Suhaini, N. A.; Nagapan, S.; Rahim, R. Abdul
2017-11-01
Malaysia considers the construction industry as one of the main contributors to its Gross Domestic Product (GDP). However, there are some unresolved issues arising from the ongoing and widespread adoption of the conventional method of construction such as the resultant fragmentation of the industry itself; delays in production and delivery time of unnecessary wastages and lack of sustainability practice. Malaysian Government has been continuously encouraging the industry to use, partly or if not wholly, the Industrialized Building System (IBS), which is considered to be an important part of sustainable construction initiative. IBS was introduced to Malaysia as the solution to issues related to dependencies of foreign workers, raising demand for affordable accommodations and improving image, quality and productivity of construction industry. However, the IBS adoption in Malaysia remains low. This paper presents the review of the current issues and barriers of IBS adoption in Malaysian construction industry.
Best Practices for Robotic Surgery Programs
Goldenberg, David; Winder, Joshua S.; Juza, Ryan M.; Lyn-Sue, Jerome R.
2017-01-01
Background and Objectives: Robotic surgical programs are increasing in number. Efficient methods by which to monitor and evaluate robotic surgery teams are needed. Methods: Best practices for an academic university medical center were created and instituted in 2009 and continue to the present. These practices have led to programmatic development that has resulted in a process that effectively monitors leadership team members; attending, resident, fellow, and staff training; credentialing; safety metrics; efficiency; and case volume recommendations. Results: Guidelines for hospitals and robotic directors that can be applied to one's own robotic surgical services are included with examples of management of all aspects of a multispecialty robotic surgery program. Conclusion: The use of these best practices will ensure a robotic surgery program that is successful and well positioned for a safe and productive environment for current clinical practice. PMID:28729780
Canadian community pharmacists' use of digital health technologies in practice.
Leung, Valerie; Tharmalingam, Sukirtha; Cooper, Janet; Charlebois, Maureen
2016-01-01
In 2010, a pan-Canadian study on the current state and benefits of provincial drug information systems (DIS) found that substantial benefits were being realized and that pharmacists perceived DIS to be a valuable tool in the evolving models of pharmacy practice. To understand changes in digital health and the impact on practice since that time, a survey of community pharmacists in Canada was conducted. In 2014, Canada Health Infoway (Infoway) and the Canadian Pharmacists Association (CPhA) invited community pharmacists to participate in a Web-based survey to understand their use and perceived benefits of digital health in practice. The survey was open from April 15 to May 12, 2014. Of the 447 survey responses, almost all used some form of digital health in practice. Those with access to DIS and provincial laboratory information systems (LIS) reported increased productivity and better quality of care. Those without access to these systems would overwhelmingly like access. There have been significant advances in digital health and community pharmacy practice over the past several years. In addition to digital health benefits in the areas of productivity and quality of care, pharmacists are also experiencing substantial benefits in areas related to recently expanded scope of practice activities such as ordering lab tests. Community pharmacists frequently use digital health in practice and recognize the benefits of these technologies. Digital health is, and will continue to be, a key enabler for practice transformation and improved quality of care. Can Pharm J (Ott) 2016;149:xx-xx.
Current Impact and Application of Abuse-Deterrent Opioid Formulations in Clinical Practice.
Lee, Ya-Han; Brown, Daniel L; Chen, Hsiang-Yin
2017-11-01
Abuse-deterrent formulations (ADFs) represent one novel strategy for curbing the potential of opioid abuse. We aim to compare and contrast the characteristics and applications of current abuse-deterrent opioid products in clinical practice. Literature searches were conducted in databases (Pubmed Medline, International Pharmaceutical Abstracts, Google Scholar) and official reports. Relevant data were screened and organized into: 1) epidemiology of opioid abuse, 2) mitigation strategies for reducing opioid abuse, 3) development of ADFs, and 4) clinical experience with these formulations. Increasing trends of opioid abuse and misuse have been reported globally. There are 5 types of abuse-deterrent opioid products: physical chemical barrier, combined agonist/antagonist, sequestered aversive agent, prodrug, and novel delivery system. The advantages and disadvantages of the 5 options are discussed in this review. A total of 9 products with abuse-deterrent labels have been approved by the Food and Drug Administration (FDA). The rates of abuse, diversion, and overdose deaths of these new products are also discussed. A framework for collecting in-time data on the efficacy, benefit and risk ratio, and cost-effectiveness of these new products is suggested to facilitate their optimal use. The present review did not utilize systematic review standards or meta-analytic techniques, given the large heterogeneity of data and outcomes reviewed. ADFs provide an option for inhibiting the abuse or misuse of oral opioid products by hindering extraction of the active ingredient, preventing alternative routes of administration, or causing aversion. Their relatively high costs, uncertain insurance policies, and limited data on pharmacoeconomics warrant collaborative monitoring and assessment by government agencies, pharmaceutical manufacturers, and data analysis services to define their therapeutic role in the future. Opioid abuse, abuse-deterrent formulations, ADF, post-marketing, FDA guidance, cost impact, abuse liking, physician attitude, generic abuse-deterrent formulation, clinical application.
An operational amplifier B1404UD1A-1 in the patch-clamp current-to-voltage converter.
Korzun, A M; Rozinov, S V; Abashin, G I
1997-01-01
The applicability of the home-made operational amplifier B1404UD1A-1 in a patch-clamp current-to-voltage converter was analyzed. Its parameters (background noise, input bias current, and gain-bandwidth product) were estimated. Schematic solutions and practical recommendations for the use of this amplifier in a current-to-voltage converter were given. Based on the background noise and frequency parameters of the converter, we found that this device can be used for measuring ion channel currents with a high sensitivity and within a broad frequency range (0.055 pA, to 1 kHz; 0.4 pA, to 10 kHz). An example of the converter application in experiments is given.
Chasing helminths and their economic impact on farmed ruminants.
Charlier, Johannes; van der Voort, Mariska; Kenyon, Fiona; Skuce, Philip; Vercruysse, Jozef
2014-07-01
Global agriculture will be required to intensify production from a shrinking natural resource base. Helminth infections of ruminants are a major constraint on efficient livestock production. The current challenge is to develop diagnostic methods that detect the production impact of helminth infections on farms in order to target control measures and contribute to the global challenge of preserving food security. We review here our understanding of the effects of helminth infections and control practices on productivity and the diagnostic tools that can inform on this. By combining advances in helminth laboratory diagnostics and animal health economics, sustainable management of helminth infections can be integrated into the whole-farm economic context. Copyright © 2014 Elsevier Ltd. All rights reserved.
Research of cement mixtures with additions of industrial by-products
NASA Astrophysics Data System (ADS)
Papesch, R.; Klus, L.; Svoboda, J.; Zajac, R.
2017-10-01
The main goal of the article is the comparison of the possible use of secondary energy products. Used fly ashes, respectively steel dusts in cement mixes derive from production in Moravian-Silesian Region. The research focused on their influence on the chemical and physico-mechanical characteristics of the fresh and solid mixture. The aim was to find suitable formulations for grouting works, highway construction possibly rehabilitation of underground cavities created by mining activities. The introduction is mentioned the history of waste utilization up to current use as a product and the overall state of the problem. The conclusion is an evaluation of possible use in practice, including recommendations to carry out further tests.
Fernandes, Rômulo Araújo; Zanesco, Angelina
2015-01-01
Early sport practice prevents development of diseases in children/adolescents, but still unclear its effect over health in adulthood. Therefore, the purpose of this study was to analyze the association between sport practice in early life and chronic diseases in adulthood. A retrospective population-based survey carried out in eight Brazilian cities with adults of both genders. Throughout a multistage random process 2720 adults (1096 male and 1624 female) were selected and interviewed. Type 2 diabetes mellitus and arterial hypertension were assessed in a face-to-face interview through a self-report, which was necessarily based on previous medical diagnosis. Early sport practice was assessed in childhood (7-10 years old) and adolescence (11-17 years old). Current physical activity and body mass index were assessed in adulthood throughout a face-to-face interview. Type 2 diabetes mellitus and arterial hypertension were identified in 8.1% (95% CI, 7.1-9.2) and 23.5% (95% CI, 21.9-25.1) of the sample, respectively. Early sport practice during childhood and adolescence was associated with lower occurrence of arterial hypertension (OR, 0.49; 95% CI, 0.33-0.73) and type 2 diabetes (OR, 0.46; 95% CI, 0.24-0.88) in adulthood. Independently of obesity and current physical activity, early sport practice in early life was positively associated with lower occurrence of chronic diseases in adulthood. Copyright © 2015 Lithuanian University of Health Sciences. Production and hosting by Elsevier Urban & Partner Sp. z o.o. All rights reserved.
Centanni, N; Monroe, M; White, L; Larson, R
1999-01-01
The service sector within the biopharmaceutical industry has experienced phenomenal growth over the past decade. In the highly regulated Good Laboratory Practices environment, the need for timely, high-quality service, accurate results, and on-time deliverables becomes paramount for the success and profitability of biopharmaceutical companies. The quality assurance process is a vital component of this drug product-development cycle and ensures compliance to the highest domestic and international regulatory standards. Quality-assurance professionals historically have held the role of independent auditors of the processes, who certify that results meet current standards of practice. Covance, a contract research organization that includes Good Laboratory Practices laboratories, reorganized and expanded the functional responsibilities of its quality assurance team in 1997. Auditors and quality assurance professionals have assumed roles beyond traditional compliance auditing and are forging new leadership and mentoring roles as process-improvement specialists. The results have been tangible, measurable benefits for clients and the Covance organization. This article provides an overview of this cultural change and the processes put in place to improve efficiency, productivity, and customer and employee satisfaction.
Review of Virtual Reality Treatment in Psychiatry: Evidence Versus Current Diffusion and Use.
Mishkind, Matthew C; Norr, Aaron M; Katz, Andrea C; Reger, Greg M
2017-09-18
This review provides an overview of the current evidence base for and clinical applications of the use of virtual reality (VR) in psychiatric practice, in context of recent technological developments. The use of VR in psychiatric practice shows promise with much of the research demonstrating clinical effectiveness for conditions including post-traumatic stress disorder, anxiety and phobias, chronic pain, rehabilitation, and addictions. However, more research is needed before the use of VR is considered a clinical standard of practice in some areas. The recent release of first generation consumer VR products signals a change in the viability of further developing VR systems and applications. As applications increase so will the need for good quality research to best understand what makes VR effective, and when VR is not appropriate for clinical services. As the field progresses, it is hopeful that the flexibility afforded by this technology will yield superior outcomes and a better understanding of the underlying mechanisms impacting those outcomes.
Achieving competitive advantage through strategic human resource management.
Fottler, M D; Phillips, R L; Blair, J D; Duran, C A
1990-01-01
The framework presented here challenges health care executives to manage human resources strategically as an integral part of the strategic planning process. Health care executives should consciously formulate human resource strategies and practices that are linked to and reinforce the broader strategic posture of the organization. This article provides a framework for (1) determining and focusing on desired strategic outcomes, (2) identifying and implementing essential human resource management actions, and (3) maintaining or enhancing competitive advantage. The strategic approach to human resource management includes assessing the organization's environment and mission; formulating the organization's business strategy; assessing the human resources requirements based on the intended strategy; comparing the current inventory of human resources in terms of numbers, characteristics, and human resource management practices with respect to the strategic requirements of the organization and its services or product lines; formulating the human resource strategy based on the differences between the assessed requirements and the current inventory; and implementing the appropriate human resource practices to reinforce the strategy and attain competitive advantage.
NASA Astrophysics Data System (ADS)
Jain, A. K.; Lin, T. S.; Lawrence, P.; Kheshgi, H. S.
2017-12-01
Environmental factors - characterized by increasing levels of CO2, and changes in temperature and precipitation patterns - present potential risks to global food supply. To date, understanding of environmental factors' effects on crop production remains uncertain due to (1) uncertainties in projected trends of these factors and their spatial and temporal variability; (2) uncertainties in the physiological, genetic and molecular basis of crop adaptation to adaptive management practices (e.g. change in planting time, irrigation and N fertilization etc.) and (3) uncertainties in current land surface models to estimate the response of crop production to changes in environmental factors and management strategies. In this study we apply a process-based land surface model, the Integrated Science Assessment model (ISAM), to assess the impact of various environmental factors and management strategies on the production of row crops (corn, soybean and wheat) at regional and global scales. Results are compared to corresponding simulations performed with the crop model in the Community Land Model (CLM4.5). Each model is driven with historical atmospheric forcing data (1901-2005), and projected atmospheric forcing data under RCP 4.5 or RCP 8.5 (2006-2100) from CESM CMIP5 simulations to estimate the effects of different climate change projections on potential productivity of food crops at a global scale. For each set of atmospheric forcing data, production of each crop is simulated with and without inclusion of adaptive management practices (e.g. application of irrigation, N fertilization, change in planting time and crop cultivars etc.) to assess the effect of adaptation on projected crop production over the 21st century. In detail, three questions are addressed: (1) what is the impact of different climate change projections on global crop production; (2) what is the effect of adaptive management practices on projected crop production; and (3) how do differences in model mechanisms in ISAM and CLM4.5 impact projected global crop production and adaptive management practices (irrigation and N fertilizer) over the 21st century. The major outcomes of this study will help to understand the uncertainties in potential productivity of food crops under different environmental conditions and management practices.
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.
Off-label use of medicines: The need for good practice guidelines.
Dooms, Marc; Killick, James
2017-01-01
'Off-label use' is the term used for the prescription and dispensing of a medicinal product for any indication, patient group, route of administration, dosage or treatment regimen other than that listed in the Summary of Product Characteristics. In this article the authors present a brief overview of current practices of off-label use in Europe and the applicable European law and jurisprudence. They then go on to present a set of guidelines for best practice in off-label use which underlines the need for guidance on prescription to be firmly rooted in the need to ensure patient safety above all other concerns. The article was written from desk research and expert engagement, including a presentation and Q&A in the European Parliament. This article intends to demonstrate that off-label use entails increased risks for patients, especially when it is not underpinned by rigorous clinical studies or the reporting routes for use are not well defined. Europe is seeing a growing trend the promotion of off-label prescription of medicinal products for reasons other than pure medical need, including motives such as cost-containment. This poses a numer of questions for the ethical and legal framework for medicine prescription and dispensing in Europe.
NASA Astrophysics Data System (ADS)
Lambert, Jean-Christopher; Bojkov, Bojan
The Committee on Earth Observation Satellites (CEOS)/Working Group on Calibration and Validation (WGCV) is developing a global data quality strategy for the Global Earth Obser-vation System of Systems (GEOSS). In this context, CEOS WGCV elaborated the GEOSS Quality Assurance framework for Earth Observation (QA4EO, http://qa4eo.org). QA4EO en-compasses a documentary framework and a set of ten guidelines, which describe the top-level approach of QA activities and key requirements that drive the QA process. QA4EO is appli-cable virtually to all Earth Observation data. Calibration and validation activities are a cornerstone of the GEOSS data quality strategy. Proper uncertainty assessment of the satellite measurements and their derived data products is essential, and needs to be continuously monitored and traceable to standards. As a practical application of QA4EO, CEOS WGCV has undertaken to establish a set of best practices, methodologies and guidelines for satellite calibration and validation. The present paper reviews current developments of best practices and guidelines for the vali-dation of atmospheric composition satellites. Aimed as a community effort, the approach is to start with current practices that could be improved with time. The present review addresses current validation capabilities, achievements, caveats, harmonization efforts, and challenges. Terminologies and general principles of validation are reminded. Going beyond elementary def-initions of validation like the assessment of uncertainties, the specific GEOSS context requires considering also the validation of individual service components and against user requirements.
Jacobs, Carmel; Graham, Ian D; Makarski, Julie; Chassé, Michaël; Fergusson, Dean; Hutton, Brian; Clemons, Mark
2014-01-01
Consensus statements and clinical practice guidelines are widely available for enhancing the care of cancer patients. Despite subtle differences in their definition and purpose, these terms are often used interchangeably. We systematically assessed the methodological quality of consensus statements and clinical practice guidelines published in three commonly read, geographically diverse, cancer-specific journals. Methods Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents. Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents. Thirty-four consensus statements and 67 clinical practice guidelines were evaluated. The rigour of development score for consensus statements over the three journals was 32% lower than that of clinical practice guidelines. The editorial independence score was 15% lower for consensus statements than clinical practice guidelines. One journal scored consistently lower than the others over both domains. No journals adhered to all the items related to the transparency of document development. One journal's consensus statements endorsed a product made by the sponsoring pharmaceutical company in 64% of cases. Guidance documents are an essential part of oncology care and should be subjected to a rigorous and validated development process. Consensus statements had lower methodological quality than clinical practice guidelines using AGREE II. At a minimum, journals should ensure that that all consensus statements and clinical practice guidelines adhere to AGREE II criteria. Journals should consider explicitly requiring guidelines to declare pharmaceutical company sponsorship and to identify the sponsor's product to enhance transparency.
The British National Formulary: Checking, medicines and clinicians.
Dickson, Jane
2015-01-01
The British National Formulary underpins the way medical practice is made safe in the UK. Its move from book to digital product has been identified as welcome but with problematic aspects. This chapter describes and investigates the current use of the formulary in order to examine how a rapid, well-targeted project is designed and executed.
Elements and rationale for a common approach to assess and report soil disturbance.
Mike Curran; Doug Maynard; Ron Heninger; Tom Terry; Steve Howes; Doug Stone; Tom Niemann; Richard E. Miller
2008-01-01
Soil disturbance from forest practices ranges from barely perceptible to very obvious, and from positive to nil to negative effects on forest productivity and 1 or hydrologic function. Currently, most public and private landholders and various other interested parties have different approaches to describing this soil disturbance. More uniformity is needed to describe,...
Measuring the mechanical behavior of paperboard in a changing humidity environment
Dennis E. Gunderson; John M. Considine
1986-01-01
âBoth the strength and stability of compressively loaded paperboard are known to be adversely affected by cyclic changes in relative humidity. Current research at the Forest Products Laboratory (FPL) seeks to observe and explain this phenomenon and to develop a simple, practical test to determine allowable "working loads" in cyclicmoisture environments. A new...
Evidence-Based Systematic Review: Effects of Nonspeech Oral Motor Exercises on Speech
ERIC Educational Resources Information Center
McCauley, Rebecca J.; Strand, Edythe; Lof, Gregory L.; Schooling, Tracy; Frymark, Tobi
2009-01-01
Purpose: The purpose of this systematic review was to examine the current evidence for the use of oral motor exercises (OMEs) on speech (i.e., speech physiology, speech production, and functional speech outcomes) as a means of supporting further research and clinicians' use of evidence-based practice. Method: The peer-reviewed literature from 1960…
Iris B. Montague
2011-01-01
Many obstacles may deter hardwood manufacturers from obtaining chain-of-custody certification. Because the hardwood and softwood forest products industries have many differences between them, current certification systems may not fit the unique demographics of the hardwood industry. For this reason, it is important to understand chain-of-custody certification as it...
21 CFR 184.1372 - Insoluble glucose isomerase enzyme preparations.
Code of Federal Regulations, 2014 CFR
2014-04-01
... isomerase enzyme preparations are used in the production of high fructose corn syrup described in § 184.1866... defined in § 170.3(o)(9) of this chapter, to convert glucose to fructose. (2) The ingredient is used in high fructose corn syrup, at levels not to exceed current good manufacturing practice. [48 FR 5720, Feb...
NASA Technical Reports Server (NTRS)
Mccullough, R. A.; Pinelli, T. E.; Pilley, D. D.; Stohrer, F. F.
1982-01-01
Current practice and usage using selected technical reports; literature relative to the sequential, language, and presentation components of technical reports; and NASA technical report publications standards are discussed. The effctiveness of the technical report as a product for information dissemination is considered.
Feed Efficiency: An Assessment of Current Knowledge from a Voluntary Subsample of the Swine Industry
ERIC Educational Resources Information Center
Flohr, Josh R.; Tokach, Mike D.; DeRouchey, Joel M.; Goodband, Robert D.; Dritz, Steve S.; Nelssen, Jim L.; Patience, John F.
2014-01-01
A voluntary sample of pork producers and advisers to the swine industry were surveyed about feed efficiency. The questionnaire was designed to accomplish three objectives: (a) determine the level of knowledge related to feed efficiency topics, (b) identify production practices used that influence feed efficiency, and (c) identify information gaps…
Are current efforts sufficient to ensure healthy fish populations?
Bob Danehy; Andy Dolloff
2013-01-01
The maintenance and conservation of fish and wildlife populations in landscapes managed for timber production is a contemporary stewardship requirement and a challenge for forest managers. Best management practices (BMPs) have been developed to meet these challenges. Most BMPs were developed starting in the 1970s so the full impact and the success of those BMPs are not...
Identifying Governance Best Practices in Systems-of-Systems Acquisition
2014-02-08
Acquisition Governance ................................................ 28 Figure 3. Harvest Hercules Airborne Weapons Kit System Components ...... 39 ...acquisition poses considerable challenges that the current Department of Defense (DoD) acquisition governance structure was not necessarily designed to...specify the warship it needed along with the design , construction, and outfitting of the ship. The Navy managed and performed production operations and
Ho, Mei Mei; Baca-Estrada, Maria; Conrad, Christoph; Karikari-Boateng, Eric; Kang, Hye-Na
2015-08-26
The current World Health Organization (WHO) guidelines on the quality, safety and efficacy of recombinant malaria vaccines targeting the pre-erythrocytic and blood stages of Plasmodium falciparum were adopted by the WHO Expert Committee on Biological Standardization in 2012 to provide guidance on the quality, nonclinical and clinical aspects of recombinant malaria vaccines. A WHO workshop was organised to facilitate implementation into African (national/regional) regulatory practices, of the regulatory evaluation principles outlined in the guidelines regarding quality aspects. The workshop was used also to share knowledge and experience on regulatory topics of chemistry, manufacturing and control with a focus on vaccines through presentations and an interactive discussion using a case study approach. The basic principles and concepts of vaccine quality including consistency of production, quality control and manufacturing process were presented and discussed in the meeting. By reviewing and practicing a case study, better understanding on the relationship between consistency of production and batch release tests of an adjuvanted pre-erythrocytic recombinant malaria vaccine was reached. The case study exercise was considered very useful to understand regulatory evaluation principles of vaccines and a suggestion was made to WHO to provide such practices also through its Global Learning Opportunities for Vaccine Quality programme. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.
Current prevalence rate of latex allergy: Why it remains a problem?
Wu, Miaozong; McIntosh, James; Liu, Jian
2016-01-01
Objectives: This article aims to review the current prevalence rate of latex allergy among healthcare workers, susceptible patients, and the general public, and to investigate why latex is still a ubiquitous occupational health hazard. Methods: Scientific publications on PubMed, particularly those published within the last five years, and current regulations from agencies such as Food and Drug Administration (FDA) were reviewed. Consumer and commercial products that may contain latex were also surveyed. Results: Approximately 12 million tons of natural rubber latex is produced annually and is widely used to manufacture millions of consumer and commercial products. Only limited number of latex-derived products have been approved and regulated by government agencies, such as FDA, whereas the majority of finished products do not label whether they contain latex. Owing to millions of unidentifiable products containing latex and many routes for exposure to latex, preventing contact with latex allergens and reducing the prevalence of latex allergy are more difficult than expected. Reported data suggest that the average prevalence of latex allergy worldwide remains 9.7%, 7.2%, and 4.3% among healthcare workers, susceptible patients, and general population, respectively. Conclusions: Latex-derived products are ubiquitous, and latex allergy remains a highly prevalent health risk in many occupations and to the general population. Developing alternative materials and increasing the ability to identify and label latex-derived products will be practicable approaches to effectively control the health risks associated with latex. PMID:27010091
Advanced lighting guidelines: 1993. Final report
DOE Office of Scientific and Technical Information (OSTI.GOV)
Eley, C.; Tolen, T.M.; Benya, J.R.
1993-12-31
The 1993 Advanced Lighting Guidelines document consists of twelve guidelines that provide an overview of specific lighting technologies and design application techniques utilizing energy-efficient lighting practice. Lighting Design Practice assesses energy-efficient lighting strategies, discusses lighting issues, and explains how to obtain quality lighting design and consulting services. Luminaires and Lighting Systems surveys luminaire equipment designed to take advantage of advanced technology lamp products and includes performance tables that allow for accurate estimation of luminaire light output and power input. The additional ten guidelines -- Computer-Aided Lighting Design, Energy-Efficient Fluorescent Ballasts, Full-Size Fluorescent Lamps, Compact Fluorescent Lamps, Tungsten-Halogen Lamps, Metal Halidemore » and HPS Lamps, Daylighting and Lumen Maintenance, Occupant Sensors, Time Scheduling Systems, and Retrofit Control Technologies -- each provide a product technology overview, discuss current products on the lighting equipment market, and provide application techniques. This document is intended for use by electric utility personnel involved in lighting programs, lighting designers, electrical engineers, architects, lighting manufacturers` representatives, and other lighting professionals.« less
Regulatory aspects of diets, supplements, and nutraceuticals.
Dzanis, D A
1998-11-01
The number of pet foods commercially available for veterinary use, both complete diets and dietary supplements, has been rapidly expanding in recent years. Veterinarians use and recommend nutritional products in their daily practice, and this use should meet the ethical constraints of veterinary medical practice and be based on scientifically sound premises. However, it is also important to be aware that nutritional products intended to treat or prevent disease or to affect the structure or function of the body in a manner apart from what is normally ascribed for food are considered "drugs" under the law. Most of the "veterinary medical foods" and "nutraceuticals" on the market bear claims on the labels or in promotional literature that would establish intent as drugs, but under the current regulatory conditions, they have done so without meeting the criteria needed for most drugs. Thus, the lack of government oversight of therapeutic claims places the burden onto the veterinarian to carefully scrutinize products for safety and efficacy.
Understanding medical practice team roles.
Hills, Laura
2015-01-01
Do you believe that the roles your employees play on your medical practice team are identical to their job titles or job descriptions? Do you believe that team roles are determined by personality type? This article suggests that a more effective way to build and manage your medical practice team is to define team roles through employee behaviors. It provides 10 rules of behavioral team roles that can help practice managers to select and build high-performing teams, build more productive team relationships, improve the employee recruitment process, build greater team trust and understanding; and increase their own effectiveness. This article describes in detail Belbin's highly regarded and widely used team role theory and summarizes four additional behavioral team role theories and systems. It offers lessons learned when applying team role theory to practice. Finally, this article offers an easy-to-implement method for assessing current team roles. It provides a simple four-question checklist that will help practice managers balance an imbalanced medical practice team.
2012-03-20
The Food and Drug Administration (FDA) is amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons. FDA is also permitting the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. This action is intended to protect consumers from labeling errors more likely to cause adverse health consequences, while eliminating the regulatory burden of applying the rule to labeling unlikely to reach or adversely affect consumers. This action is also intended to permit manufacturers to use a broader range of error prevention and labeling control techniques than permitted by current CGMPs.
Medicare managed care. How physicians can make it better.
Roggin, G M
1997-12-01
The federal government is attempting to control anticipated, increased Medicare health care costs by providing the senior population with incentives to encourage their movement into managed care programs. For-profit corporate HMOs that currently dominate the managed care arena are coming under increased competitive pressure at a time when their perception of profiteering is undergoing increased public scrutiny. If physicians are to take advantage of this window of opportunity and successfully enter the Medicare managed care marketplace, they must identify the major deficiencies existing in the current model, and fashion a new product that divests itself of the profit orientation of current corporate HMOs. A nonprofit version of a highly integrated, multispecialty provider service organization (PSO) provides an appropriate model to effectively compete with the corporate HMO. The ideal physician-controlled managed care model must: develop a responsive policy board structure; create practice guidelines that decrease variation in physician practice; achieve an appropriate balance between primary and specialty medical care; and adopt a quality-assurance program that effectively addresses both process and outcome data.
Clinical Space Medicine Products as Developed by the Medical Operations Support Team (MOST)
NASA Technical Reports Server (NTRS)
Polk, James D.; Doerr, Harold K.; Hurst, Victor W., IV; Schmid, Josef
2007-01-01
Medical Operations Support Team (MOST) is introducing/integrating teaching practices associated with high fidelity human patient simulation into the NASA culture, in particular, into medical training sessions and medical procedure evaluations. Current/Future Products iclude: a) Development of Sub-optimal Airway Protocols for the International Space Station (ISS) using the ILMA; b) Clinical Core Competency Training for NASA Flight Surgeons (FS); c) Post-Soyuz Landing Clinical Training for NASA FS; d) Experimental Integrated Training for Astronaut Crew Medical Officers and NASA FS; and e) Private Clinical Refresher Training.
Boland, Michael V; Chiang, Michael F; Lim, Michele C; Wedemeyer, Linda; Epley, K David; McCannel, Colin A; Silverstone, David E; Lum, Flora
2013-08-01
To assess the current state of electronic health record (EHR) use by ophthalmologists, including adoption rate, user satisfaction, functionality, benefits, barriers, and knowledge of meaningful use criteria. Population-based, cross-sectional study. A total of 492 members of the American Academy of Ophthalmology (AAO). A random sample of 1500 AAO members were selected on the basis of their practice location and solicited to participate in a study of EHR use, practice management, and image management system use. Participants completed the survey via the Internet, phone, or fax. The survey included questions about the adoption of EHRs, available functionality, benefits, barriers, satisfaction, and understanding of meaningful use criteria and health information technology concepts. Current adoption rate of EHRs, user satisfaction, benefits and barriers, and availability of EHR functionality. Overall, 32% of the practices surveyed had already implemented an EHR, 15% had implemented an EHR for some of their physicians or were in the process of implementation, and another 31% had plans to do so within 2 years. Among those with an EHR in their practice, 49% were satisfied or extremely satisfied with their system, 42% reported increased or stable overall productivity, 19% reported decreased or stable overall costs, and 55% would recommend an EHR to a fellow ophthalmologist. For those with an electronic image management system, only 15% had all devices integrated, 33% had images directly uploaded into their system, and 12% had electronic association of patient demographics with the image. The adoption of EHRs by ophthalmology practices more than doubled from 2007 to 2011. The satisfaction of ophthalmologists with their EHR and their perception of beneficial effects on productivity and costs were all lower in 2011 than in 2007. Knowledge about meaningful use is high, but the percentage of physicians actually receiving incentive payments is relatively low. Given the importance of imaging in ophthalmology, the shortcomings in current image management systems need to be addressed. The author(s) have no proprietary or commercial interest in any materials discussed in this article. Copyright © 2013 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
Clinicians and product sales representatives: developing a relationship that works.
Harbit, Maryanne Drake; Driggers, Zola S
2002-02-01
In today's healthcare climate, clinicians in any specialty may be required to make product selections for their practice. The skills necessary to negotiate the world of sales include information about how sales relationships are conducted, product evaluations, negotiation management, and time management. Because these skills are not taught in traditional healthcare training programs, clinicians often learn these skills through trial and error. Credible and resourceful clinical experts have current information and a working knowledge about products that are available for patients. An excellent resource for this information is the product sales representative. Literature providing information for clinicians on how to establish and maintain productive relationships with medical product representatives is scarce. This article will explain what issues to address in discussions and negotiations with product representatives. Common pitfalls that often result from not understanding the agenda of the sales representative are identified. By employing the suggested strategies, a mutually beneficial relationship can be fostered.
Environmental and economic analyses of waste disposal options for traditional markets in Indonesia.
Aye, Lu; Widjaya, E R
2006-01-01
Waste from traditional markets in Indonesia is the second largest stream of municipal solid waste after household waste. It has a higher organic fraction and may have greater potential to be managed on a business scale compared to household wastes. The attributed reason is that in general the wastes generated from traditional markets are more uniform, more concentrated and less hazardous than waste from other sources. This paper presents the results of environmental and economic assessments to compare the options available for traditional market waste disposal in Indonesia. The options compared were composting in labour intensive plants, composting in a centralised plant that utilised a simple wheel loader, centralised biogas production and landfill for electricity production. The current open dumping practice was included as the baseline case. A life cycle assessment (LCA) was used for environmental analysis. All options compared have lower environmental impacts than the current practice of open dumping. The biogas production option has the lowest environmental impacts. A cost-benefit analysis, which considered greenhouse gas savings, was used for the economic assessment. It was found that composting at a centralised plant is the most economically feasible option under the present Indonesian conditions. The approach reported in this study could be applied for 'a pre-feasibility first cut comparison' that includes environmental aspects in a decision-making framework for developing countries even though European emission factors were used.
Current and Future Greenhouse Gas Emissions from Global Crop Intensification and Expansion
NASA Astrophysics Data System (ADS)
Carlson, K. M.; Gerber, J. S.; Mueller, N. D.; O'Connell, C.; West, P. C.
2014-12-01
Food systems currently contribute up to one-third of total anthropogenic greenhouse gas emissions, and these emissions are expected to rise as demand for agricultural products increases. Thus, improving the greenhouse gas emissions efficiency of agriculture - the tons or kilocalories of production per ton of CO2 equivalent emissions - will be critical to support a resilient future global system. Here, we model and evaluate global, 2000-era, spatially explicit relationships between a suite of greenhouse gas emissions from various agronomic practices (i.e., fertilizer application, peatland draining, and rice cultivation) and crop yields. Then, we predict potential emissions from future crop production increases achieved through intensification and extensification, including CO2 emissions from croplands replacing non-urban land cover. We find that 2000-era yield-scaled agronomic emissions are highly heterogeneous across crops types, crop management practices, and regions. Rice agriculture produces more total CO2-equivalent emissions than any other crop. Moreover, inundated rice in just a few countries contributes the vast majority of these rice emissions. Crops such as sunflower and cotton have low efficiency on a caloric basis. Our results suggest that intensification tends to be a more efficient pathway to boost greenhouse gas emissions efficiency than expansion. We conclude by discussing potential crop- and region-specific agricultural development pathways that may boost the greenhouse gas emissions efficiency of agriculture.
Zimmermann, Wes O; Helmhout, P H; Beutler, A
2017-04-01
Overuse injuries of the leg are a common problem for young soldiers. This article reviews the literature concerning the prevention and treatment of exercise related leg pain in military settings and presents the latest developments in proposed mechanisms and treatments. Current practice and treatment protocols from the Dutch Armed Forces are reviewed, with an emphasis on the most prevalent conditions of medial tibial stress syndrome and chronic exertional compartment syndrome. The conclusion is that exercise related leg pain in the military is an occupational problem that deserves further study. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...
Modern sanitary practices result in large volumes of human waste, as well as domestic and industrial sewage, being collected and treated at common collection points, wastewater treatment plants (WWTP). In recognition of the growing use of sewage sludges as a fertilizers and as soilamendments, and the scarcity of current data regarding the chemical constituents in sewage sludges, the United States National Research Council (NRC) in 2002 produced a report on sewage sludges. Among the NRC's recommendations was the need for investigating the occurrence of pharmaceuticals and personal care products (PPCPs) in sewage sludges. PPCPsare a diverse array of non-regulated contaminants that had not been studied in previous sewage sludges surveys but which are likely to be present. The focus of this paper will be to review the current analytical methodologies available for investigating whether pharmaceuticals are present in WWTP-produced sewage sludges, to summarize current regulatory practices regarding sewage sludges, and to report on the presence of pharmaceuticals in sewage sludges. The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth coverage of each project. Briefly, each project's objective is stated below.Subta
Basso, Bruno; Giola, Pietro; Dumont, Benjamin; Migliorati, Massimiliano De Antoni; Cammarano, Davide; Pruneddu, Giovanni; Giunta, Francesco
2016-01-01
Future climatic changes may have profound impacts on cropping systems and affect the agronomic and environmental sustainability of current N management practices. The objectives of this work were to i) evaluate the ability of the SALUS crop model to reproduce experimental crop yield and soil nitrate dynamics results under different N fertilizer treatments in a farmer’s field, ii) use the SALUS model to estimate the impacts of different N fertilizer treatments on NO3- leaching under future climate scenarios generated by twenty nine different global circulation models, and iii) identify the management system that best minimizes NO3- leaching and maximizes yield under projected future climate conditions. A field experiment (maize-triticale rotation) was conducted in a nitrate vulnerable zone on the west coast of Sardinia, Italy to evaluate N management strategies that include urea fertilization (NMIN), conventional fertilization with dairy slurry and urea (CONV), and no fertilization (N0). An ensemble of 29 global circulation models (GCM) was used to simulate different climate scenarios for two Representative Circulation Pathways (RCP6.0 and RCP8.5) and evaluate potential nitrate leaching and biomass production in this region over the next 50 years. Data collected from two growing seasons showed that the SALUS model adequately simulated both nitrate leaching and crop yield, with a relative error that ranged between 0.4% and 13%. Nitrate losses under RCP8.5 were lower than under RCP6.0 only for NMIN. Accordingly, levels of plant N uptake, N use efficiency and biomass production were higher under RCP8.5 than RCP6.0. Simulations under both RCP scenarios indicated that the NMIN treatment demonstrated both the highest biomass production and NO3- losses. The newly proposed best management practice (BMP), developed from crop N uptake data, was identified as the optimal N fertilizer management practice since it minimized NO3- leaching and maximized biomass production over the long term. PMID:26784113
Koerbin, Gus; Liu, Jiakai; Eigenstetter, Alex; Tan, Chin Hon; Badrick, Tony; Loh, Tze Ping
2018-02-15
A product recall was issued for the Roche/Hitachi Cobas Gentamicin II assays on 25 th May 2016 in Australia, after a 15 - 20% positive analytical shift was discovered. Laboratories were advised to employ the Thermo Fisher Gentamicin assay as an alternative. Following the reintroduction of the revised assay on 12 th September 2016, a second reagent recall was made on 20 th March 2017 after the discovery of a 20% negative analytical shift due to erroneous instrument adjustment factor. The practices of an index laboratory were examined to determine how the analytical shifts evaded detection by routine internal quality control (IQC) and external quality assurance (EQA) systems. The ability of the patient result-based approaches, including moving average (MovAvg) and moving sum of outliers (MovSO) approaches in detecting these shifts were examined. Internal quality control data of the index laboratory were acceptable prior to the product recall. The practice of adjusting IQC target following a change in assay method resulted in the missed negative shift when the revised Roche assay was reintroduced. While the EQA data of the Roche subgroup showed clear negative bias relative to other laboratory methods, the results were considered as possible 'matrix effect'. The MovAvg method detected the positive shift before the product recall. The MovSO did not detect the negative shift in the index laboratory but did so in another laboratory 5 days before the second product recall. There are gaps in current laboratory quality practices that leave room for analytical errors to evade detection.
Socio-economic impacts of irrigated agriculture in Mbarali District of south west Tanzania
NASA Astrophysics Data System (ADS)
Mwakalila, Shadrack
Irrigation has been found to be central in curbing food scarcity not only in Tanzania but also in many other developing countries. It has been proved that continued reliability on rainfall in agriculture cannot sustain the increase in population. This study examines the impacts of smallholder irrigated agriculture in improving social and economic benefits in Igurusi Ward of Mbarali District which is located in the southern-western part of Tanzania. The study applies the Participatory Rural Appraisal Framework for data collection. The study was confined to five villages in Igurusi ward which are Majenje, Igurusi, Chamoto, Uhambule and Mahango. The study examined critically paddy production for smallholder farmers that practice irrigation and those who cultivates rain-fed paddy. The study examined both existing traditional and modern irrigation systems. It was found that, most of the respondents (79%) practice irrigated agriculture in paddy production while the remaining 21% practice rain-fed agriculture. Forty percent of households that practice irrigated agriculture harvest paddy two seasons per year. The return to labour in paddy production for smallholder farmers who irrigate their paddy fields is about US 2.5/manday which is above the poverty line of US 1.0/day. The smallest return to labour (US $ 0.85/manday) is obtained by an average smallholder farmer who cultivates rain-fed paddy using hand hoe and family labour. The potential implication of the current irrigation systems is that if irrigation is managed properly it may lead to sustainable increases in small farmer’s productivity and income, thus alleviating rural poverty.
Karriker, Locke A; Ramirez, Alejandro; Leuschen, Bruce; Halbur, Pat
2008-01-01
Recent trends in urbanization of the population, increased need for bio-security on large farms, and more food-animal or mixed-animal practitioners approaching retirement age are forcing a renewed focus on recruiting and training veterinary students with an interest in production-animal medicine. The increasing number of veterinary students coming from urban backgrounds has led to a need to expose these students to standard animal-production practices and to interest them in a career involving food animals. This article describes one such program developed at Iowa State University, in which 14 students obtained hands-on experience in all aspects of swine and dairy production across a wide sampling of herd size, housing style, bio-security levels, and production phases. The participating students, ranging from senior undergraduates to third-year veterinary students, gained valuable insight not only into daily farming practices but also the knowledge and skills necessary to provide quality veterinary care to these clients. The first year of this program has yielded positive feedback from all participants, including the veterinary practices, private producers, corporate sponsors, and students. Current applicants cite positive comments from past participants as motivating their interest in the program. This program has the potential to expand as an opportunity to educate selected students in the field of food-supply veterinary medicine and to help fill the anticipated void in this area.
Use of DNA barcoding to reveal species composition of convenience seafood.
Huxley-Jones, Elizabeth; Shaw, Jennifer L A; Fletcher, Carly; Parnell, Juliette; Watts, Phillip C
2012-04-01
Increased education of consumers can be an effective tool for conservation of commercially harvested marine species when product labeling is accurate and allows an informed choice. However, generic labeling (e.g., as white fish or surimi) and mislabeling of seafood prevents this and may erode consumer confidence in seafood product labels in general. We used DNA barcoding to identify the species composition of two types of convenience seafood (i.e., products processed for ease of consumption): fish fingers (long pieces of fish covered with bread crumbs or batter, n = 241) and seafood sticks (long pieces of cooked fish, n = 30). In products labeled as either white fish or surimi, four teleost species were present. Less than 1.5% of fish fingers with species-specific information were mislabeled. Results of other studies show substantially more mislabeling (e.g., >25%) of teleost products, which likely reflects the lower economic gains associated with mislabeling of convenience seafood compared with whole fillets. In addition to species identification, seafood product labels should be required to contain information about, for example, harvesting practices, and our data indicate that consumers can have reasonable confidence in the accuracy of the labels of convenience seafood and thus select brands on the basis of information about current fisheries practice. ©2012 Society for Conservation Biology.
Pedersen, Line Bjørnskov; Gyrd-Hansen, Dorte
2014-07-01
This study examines the preferences of general practitioners (GPs) in training for organizational characteristics in general practice with focus on aspects that can mitigate problems with GP shortages. A discrete choice experiment was used to investigate preferences for the attributes practice type, number of GPs in general practice, collaboration with other practices, change in weekly working hours (administrative versus patient related), and change in yearly surplus. In May 2011, all doctors actively engaged in the family medicine program in Denmark were invited to participate in a web-based survey. A total of 485 GPs in training responded to the questionnaire, resulting in a response rate of 56%. A mixed logit model showed that GPs in training prefer to work in smaller shared practices (2 GPs). This stands in contrast to the preferences of current GPs. Hence, a generational change in the GP population is likely to introduce more productive practice forms, and problems with GP shortages are likely to be mitigated over the coming years. Results further showed that a majority of the respondents are willing to work in larger shared practices (with 3-4 GPs) if they receive an increase in surplus (approximately 50,000 DKK/6,719 EUR per year) and that they may be willing to take in more patient-related work if the increase in surplus is sufficient (approximately 200,000 DKK/26,875 EUR per year for 5 extra hours per week). Monetary incentives may therefore be an effective tool for further improving productivity.
USDA-ARS?s Scientific Manuscript database
Current knowledge of yield potential and best agronomic management practices for perennial bioenergy grasses is primarily derived from small-scale and short-term studies, yet these studies inform policy at the national scale. In an effort to learn more about how bioenergy grasses perform at the farm...
Composite materials from forest biomass : a review of current practices, science, and technology
Roger M. Rowell
2007-01-01
Renewable and sustainable composite materials can be produced using forest biomass if we maintain healthy forests. Small diameter trees and other forest biomass can be processed in the forest into small solid wood pieces, sliced veneers, strands, flakes, chips, particles and fiber that can be used to make construction composite products such as glued-laminated lumber,...
USDA-ARS?s Scientific Manuscript database
The effect dirt-floored broiler houses have on the underlying native soil and the potential for contamination of the ground water by leaching under the foundation of these houses is an understudied area. No research could be found in the literature which followed alterations in soil parameters from...
Measuring Academic Productivity and Changing Definitions of Scientific Impact
Sarli, Cathy C.; Carpenter, Christopher R.
2016-01-01
This manuscript provides a brief overview of the history of communication of scientific research and reporting of scientific research impact outcomes. Current day practices are outlined along with examples of how organizations and libraries are providing tools to evaluate and document the impact of scientific research to provide a meaningful narrative suitable for a variety of purposes and audiences. PMID:25438359
ERIC Educational Resources Information Center
Hellawell, Beate
2017-01-01
This article contributes a current thematic review of literature about the challenges of productive parent-professional partnership working relating to children and young people with special educational needs and disabilities (SEND). It also reports on an empirical project which explored early experiences of professionals working under the newly…
Matching physician compensation plans to capitation levels.
Kennedy, K M; Buckley, M P
1997-09-01
As managed care penetration increases, physician compensation plans need to reflect the current transition from fee-for-service to capitated payment. In choosing the compensation structure that will be most beneficial to the success of the group practice and secure physician buy-in, practices need to assess their mission, goals, and corporate culture. They also need to assess their percentage of capitation to total revenues and develop, when necessary, new compensation pools that reward physicians for a variety of behaviors, such as increased productivity and utilization control. Compensation plans should be fair, flexible, and simple to understand and administer.
Education evolution: a historical perspective of associate degree nursing.
Orsolini-Hain, Liana; Waters, Verle
2009-05-01
Exploring the inception and growth of associate degree nursing education informs our understanding of what led to such explosive growth so that most of the nursing workforce is currently educated at the associate degree level. The success of associate degree nursing programs led to many divisive years in nursing education of differentiation of practice debates that were hardly productive. Work world practices and patient needs are creating pressures on community colleges to join forces with universities to increase the percentage of baccalaureate-educated nurses. Associate degree nursing education continues to evolve to meet the demands of a higher educated nursing workforce.
Current good manufacturing practice regulation and investigational new drugs. Direct final rule.
2006-01-17
The Food and Drug Administration (FDA) is amending its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational "Phase 1" drugs from complying with the requirements in FDA's regulations. FDA will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application (IND) authority. In addition, FDA is making available simultaneously with the publication of this direct final rule, a guidance document setting forth recommendations on approaches to CGMP compliance for the exempted Phase 1 drugs. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled "INDs--Approaches to Complying With CGMP During Phase 1" to provide further guidance on the subject.
Steel, Christopher C; Blackman, John W; Schmidtke, Leigh M
2013-06-05
Bunch rot of grape berries causes economic loss to grape and wine production worldwide. The organisms responsible are largely filamentous fungi, the most common of these being Botrytis cinerea (gray mold); however, there are a range of other fungi responsible for the rotting of grapes such as Aspergillus spp., Penicillium spp., and fungi found in subtropical climates (e.g., Colletotrichum spp. (ripe rot) and Greeneria uvicola (bitter rot)). A further group more commonly associated with diseases of the vegetative tissues of the vine can also infect grape berries (e.g., Botryosphaeriaceae, Phomopsis viticola ). The impact these fungi have on wine quality is poorly understood as are remedial practices in the winery to minimize wine faults. Compounds found in bunch rot affected grapes and wine are typically described as having mushroom, earthy odors and include geosmin, 2-methylisoborneol, 1-octen-3-ol, 2-octen-1-ol, fenchol, and fenchone. This review examines the current state of knowledge about bunch rot of grapes and how this plant disease complex affects wine chemistry. Current wine industry practices to minimize wine faults and gaps in our understanding of how grape bunch rot diseases affect wine production and quality are also identified.
Keeping soil in the field - runoff and erosion management in asparagus crops
NASA Astrophysics Data System (ADS)
Niziolomski, Joanna; Simmons, Robert; Rickson, Jane; Hann, Mike
2016-04-01
Row crop production (including potatoes, onions, carrots, asparagus, bulbs and lettuce) is regarded as one of the most erosive agricultural cropping systems. This is a result of the many practices involved that increase erosion risk including: fine seedbed preparation, a typically short growing season where adequate ground cover protects the soil, permanent bare soil areas between crops, and often intensive harvesting methods that can damage soil structure and result in soil compaction. Sustained exposure of bare soil coupled with onsite compaction on slightly sloping land results in soil and water issues in asparagus production. Asparagus production is a growing British industry covering > 2000 ha and is worth approximately £30 million yr-1. However, no tried and tested erosion control measurements currently exist to manage associated problems. Research has recently been undertaken investigating the effectiveness of erosion control measures suitable for asparagus production systems. These consisted of surface applied wheat straw mulch and shallow soil disturbance (< 350 mm) using several tine configurations: a currently adopted winged tine, a narrow with two shallow leading tines, and a modified para-plough. These treatments were tested individually and in combination (straw mulch with each shallow soil disturbance tine configuration) using triplicated field plots situated on a working asparagus farm in Herefordshire, UK. Testing was conducted between May and November 2013. Rainfall-event based runoff and erosion measurements were taken including; runoff volume, runoff rate and total soil loss. Runoff and soil erosion was observed from all treatments. However, the surface application of straw mulch alone out performed each shallow soil disturbance practice. This suggests that runoff and erosion from asparagus production can be reduced using the simple surface application of straw.
Dental practice websites: creating a Web presence.
Miller, Syrene A; Forrest, Jane L
2002-07-01
Web technology provides an opportunity for dentists to showcase their practice philosophy, quality of care, office setting, and staff in a creative manner. Having a Website provides a practice with innovative and cost-effective communications and marketing tools for current and potential patients who use the Internet. The main benefits of using a Website to promote one's practice are: Making office time more productive, tasks more timely, follow-up less necessary Engaging patients in an interactive and visual learning process Providing online forms and procedure examples for patients Projecting a competent and current image Tracking the usage of Web pages. Several options are available when considering the development of a Website. These options range in cost based on customization of the site and ongoing support services, such as site updates, technical assistance, and Web usage statistics. In most cases, Websites are less expensive than advertising in the phone book. Options in creating a Website include building one's own, employing a company that offers Website templates, and employing a company that offers customized sites. These development options and benefits will continue to grow as individuals access the Web and more information and sites become available.
Guidelines for computer security in general practice.
Schattner, Peter; Pleteshner, Catherine; Bhend, Heinz; Brouns, Johan
2007-01-01
As general practice becomes increasingly computerised, data security becomes increasingly important for both patient health and the efficient operation of the practice. To develop guidelines for computer security in general practice based on a literature review, an analysis of available information on current practice and a series of key stakeholder interviews. While the guideline was produced in the context of Australian general practice, we have developed a template that is also relevant for other countries. Current data on computer security measures was sought from Australian divisions of general practice. Semi-structured interviews were conducted with general practitioners (GPs), the medical software industry, senior managers within government responsible for health IT (information technology) initiatives, technical IT experts, divisions of general practice and a member of a health information consumer group. The respondents were asked to assess both the likelihood and the consequences of potential risks in computer security being breached. The study suggested that the most important computer security issues in general practice were: the need for a nominated IT security coordinator; having written IT policies, including a practice disaster recovery plan; controlling access to different levels of electronic data; doing and testing backups; protecting against viruses and other malicious codes; installing firewalls; undertaking routine maintenance of hardware and software; and securing electronic communication, for example via encryption. This information led to the production of computer security guidelines, including a one-page summary checklist, which were subsequently distributed to all GPs in Australia. This paper maps out a process for developing computer security guidelines for general practice. The specific content will vary in different countries according to their levels of adoption of IT, and cultural, technical and other health service factors. Making these guidelines relevant to local contexts should help maximise their uptake.
Career evaluation and the decision process for plastic surgery graduates.
Davison, Steven P; Clemens, Mark W
2011-08-01
National experience shows that 50 percent of physicians change positions within the first 2 years of practice. Because of market pressures, medicine in general and plastic surgery in particular are shifting away from solo practice. The authors examine the primary reasons for turnover and discuss job search priorities for recent plastic surgery graduates and established surgeons in job transition, with a current analysis of the different job opportunities available, ranging from government to private practice. The advantages and disadvantages of different positions are compared and income data are presented. Academic income is close to that of private practice at a mean of $366,141 annually but requires more work as measured by an overall higher relative value unit of productivity. The concept of creating a personal inventory before seeking the best job match is introduced.
Capper, Judith L; Bauman, Dale E
2013-01-01
The global livestock industry is charged with providing sufficient animal source foods to supply the global population while improving the environmental sustainability of animal production. Improved productivity within dairy and beef systems has demonstrably reduced resource use and greenhouse gas emissions per unit of food over the past century through the dilution of maintenance effect. Further environmental mitigation effects have been gained through the current use of technologies and practices that enhance milk yield or growth in ruminants; however, the social acceptability of continued intensification and use of productivity-enhancing technologies is subject to debate. As the environmental impact of food production continues to be a significant issue for all stakeholders within the field, further research is needed to ensure that comparisons among foods are made based on both environmental impact and nutritive value to truly assess the sustainability of ruminant products.
Global farm animal production and global warming: impacting and mitigating climate change.
Koneswaran, Gowri; Nierenberg, Danielle
2008-05-01
The farm animal sector is the single largest anthropogenic user of land, contributing to many environmental problems, including global warming and climate change. The aim of this study was to synthesize and expand upon existing data on the contribution of farm animal production to climate change. We analyzed the scientific literature on farm animal production and documented greenhouse gas (GHG) emissions, as well as various mitigation strategies. An analysis of meat, egg, and milk production encompasses not only the direct rearing and slaughtering of animals, but also grain and fertilizer production for animal feed, waste storage and disposal, water use, and energy expenditures on farms and in transporting feed and finished animal products, among other key impacts of the production process as a whole. Immediate and far-reaching changes in current animal agriculture practices and consumption patterns are both critical and timely if GHGs from the farm animal sector are to be mitigated.
Toward exascale production of recombinant adeno-associated virus for gene transfer applications.
Cecchini, S; Negrete, A; Kotin, R M
2008-06-01
To gain acceptance as a medical treatment, adeno-associated virus (AAV) vectors require a scalable and economical production method. Recent developments indicate that recombinant AAV (rAAV) production in insect cells is compatible with current good manufacturing practice production on an industrial scale. This platform can fully support development of rAAV therapeutics from tissue culture to small animal models, to large animal models, to toxicology studies, to Phase I clinical trials and beyond. Efforts to characterize, optimize and develop insect cell-based rAAV production have culminated in successful bioreactor-scale production of rAAV, with total yields potentially capable of approaching the exa-(10(18)) scale. These advances in large-scale AAV production will allow us to address specific catastrophic, intractable human diseases such as Duchenne muscular dystrophy, for which large amounts of recombinant vector are essential for successful outcome.
Dressings and Products in Pediatric Wound Care
King, Alice; Stellar, Judith J.; Blevins, Anne; Shah, Kara Noelle
2014-01-01
Significance: The increasing complexity of medical and surgical care provided to pediatric patients has resulted in a population at significant risk for complications such as pressure ulcers, nonhealing surgical wounds, and moisture-associated skin damage. Wound care practices for neonatal and pediatric patients, including the choice of specific dressings or other wound care products, are currently based on a combination of provider experience and preference and a small number of published clinical guidelines based on expert opinion; rigorous evidence-based clinical guidelines for wound management in these populations is lacking. Recent Advances: Advances in the understanding of the pathophysiology of wound healing have contributed to an ever-increasing number of specialized wound care products, most of which are predominantly marketed to adult patients and that have not been evaluated for safety and efficacy in the neonatal and pediatric populations. This review aims to discuss the available data on the use of both more traditional wound care products and newer wound care technologies in these populations, including medical-grade honey, nanocrystalline silver, and soft silicone-based adhesive technology. Critical Issues: Evidence-based wound care practices and demonstration of the safety, efficacy, and appropriate utilization of available wound care dressings and products in the neonatal and pediatric populations should be established to address specific concerns regarding wound management in these populations. Future Directions: The creation and implementation of evidence-based guidelines for the treatment of common wounds in the neonatal and pediatric populations is essential. In addition to an evaluation of currently marketed wound care dressings and products used in the adult population, newer wound care technologies should also be evaluated for use in neonates and children. In addition, further investigation of the specific pathophysiology of wound healing in neonates and children is indicated to promote the development of wound care dressings and products with specific applications in these populations. PMID:24761363
NASA Astrophysics Data System (ADS)
Matyasovszky, István; Makra, László; Csépe, Zoltán; Sümeghy, Zoltán; Deák, Áron József; Pál-Molnár, Elemér; Tusnády, Gábor
2015-10-01
After extreme dry (wet) summers or years, pollen production of different taxa may decrease (increase) substantially. Accordingly, studying effects of current and past meteorological conditions on current pollen concentrations for different taxa have of major importance. The purpose of this study is separating the weight of current and past weather conditions influencing current pollen productions of three taxa. Two procedures, namely multiple correlations and factor analysis with special transformation are used. The 11-year (1997-2007) data sets include daily pollen counts of Ambrosia (ragweed), Poaceae (grasses) and Populus (poplar), as well as daily values of four climate variables (temperature, relative humidity, global solar flux and precipitation). Multiple correlations of daily pollen counts with simultaneous values of daily meteorological variables do not show annual course for Ambrosia, but do show definite trends for Populus and Poaceae. Results received using the two methods revealed characteristic similarities. For all the three taxa, the continental rainfall peak and additional local showers in the growing season can strengthen the weight of the current meteorological elements. However, due to the precipitation, big amount of water can be stored in the soil contributing to the effect of the past climate elements during dry periods. Higher climate sensitivity (especially water sensitivity) of the herbaceous taxa ( Ambrosia and Poaceae) can be definitely established compared to the arboreal Populus. Separation of the weight of the current and past weather conditions for different taxa involves practical importance both for health care and agricultural production.
Global perspectives on ensuring the safety of pharmaceutical products in the distribution process .
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. .
Commitment to and preparedness for sustainable supply chain management in the oil and gas industry.
Wan Ahmad, Wan Nurul K; Rezaei, Jafar; Tavasszy, Lóránt A; de Brito, Marisa P
2016-09-15
Our current dependency on the oil and gas (O&G) industry for economic development and social activities necessitates research into the sustainability of the industry's supply chains. At present, studies on sustainable supply chain management (SSCM) practices in the industry do not include firm-internal factors that affect the sustainability strategies employed by different functional areas of its supply chains. Our study aims to address this gap by identifying the relevant internal factors and exploring their relationship with SSCM strategies. Specifically, we discuss the commitment to and preparedness for sustainable practices of companies that operate in upstream and downstream O&G supply chain. We study the impact of these factors on their sustainability strategies of four key supply chain functions: supplier management, production management, product stewardship and logistics management. The analyses of data collected through a survey among 81 companies show that management preparedness may enhance sustainable supply chain strategies in the O&G industry more than commitment does. Among the preparedness measures, management of supply chain operational risks is found to be vital to the sustainability of all supply chain functions except for production management practices. The findings also highlight the central importance of supplier and logistics management to the achievement of sustainable O&G supply chains. Companies must also develop an organizational culture that encourages, for example, team collaboration and proactive behaviour to finding innovative sustainability solutions in order to translate commitment to sustainable practices into actions that can produce actual difference to their SSCM practices. Copyright © 2016 Elsevier Ltd. All rights reserved.
Fernandes, G S; Sternberg, C; Lopes, G; Chammas, R; Gifoni, M A C; Gil, R A; Araujo, D V
2018-01-11
A biosimilar is a biologic product that is similar to a reference biopharmaceutical product, the manufacturing process of which hinders the ability to identically replicate the structure of the original product, and therefore, it cannot be described as an absolute equivalent of the original medication. The currently available technology does not allow for an accurate copy of complex molecules, but it does allow the replication of similar molecules with the same activity. As biosimilars are about to be introduced in oncology practice, these must be evaluated through evidence-based medicine. This manuscript is a position paper, where the Brazilian Society of Clinical Oncology (SBOC) aims to describe pertinent issues regarding the approval and use of biosimilars in oncology. As a working group on behalf of SBOC, we discuss aspects related to definition, labeling/nomenclature, extrapolation, interchangeability, switching, automatic substitution, clinical standards on safety and efficacy, and the potential impact on financial burden in healthcare. We take a stand in favor of the introduction of biosimilars, as they offer a viable, safe, and cost-effective alternative to the biopharmaceutical products currently used in cancer. We hope this document can provide valuable information to support therapeutic decisions that maximize the clinical benefit for the thousands of cancer patients in Brazil and can contribute to expedite the introduction of this new drug class in clinical practice. We expect the conveyed information to serve as a basis for further discussion in Latin America, this being the first position paper issued by a Latin American Oncology Society.
Rosecrans, Kathryn; Cruz-Martin, Gabriela; King, Ashley; Dumonteil, Eric
2014-01-01
Background Chagas disease is a vector-borne parasitic disease of major public health importance. Current prevention efforts are based on triatomine vector control to reduce transmission to humans. Success of vector control interventions depends on their acceptability and value to affected communities. We aimed to identify opportunities for and barriers to improved vector control strategies in the Yucatan peninsula, Mexico. Methodology/principal findings We employed a sequence of qualitative and quantitative research methods to investigate knowledge, attitudes and practices surrounding Chagas disease, triatomines and vector control in three rural communities. Our combined data show that community members are well aware of triatomines and are knowledgeable about their habits. However, most have a limited understanding of the transmission dynamics and clinical manifestations of Chagas disease. While triatomine control is not a priority for community members, they frequently use domestic insecticide products including insecticide spray, mosquito coils and plug-in repellents. Families spend about $32 US per year on these products. Alternative methods such as yard cleaning and window screens are perceived as desirable and potentially more effective. Screens are nonetheless described as unaffordable, in spite of a cost comparable to the average annual spending on insecticide products. Conclusion/Significance Further education campaigns and possibly financing schemes may lead families to redirect their current vector control spending from insecticide products to window screens. Also, synergism with mosquito control efforts should be further explored to motivate community involvement and ensure sustainability of Chagas disease vector control. PMID:24676038
A Review of PAT Strategies in Secondary Solid Oral Dosage Manufacturing of Small Molecules.
Laske, Stephan; Paudel, Amrit; Scheibelhofer, Otto
2017-03-01
Pharmaceutical solid oral dosage product manufacturing is a well-established, yet revolutionizing area. To this end, process analytical technology (PAT) involves interdisciplinary and multivariate (chemical, physical, microbiological, and mathematical) methods for material (e.g., materials, intermediates, products) and process (e.g., temperature, pressure, throughput, etc.) analysis. This supports rational process modeling and enhanced control strategies for improved product quality and process efficiency. Therefore, it is often difficult to orient and find the relevant, integrated aspects of the current state-of-the-art. Especially, the link between fundamental research, in terms of sensor and control system development, to the application both in laboratory and manufacturing scale, is difficult to comprehend. This review compiles a nonexhaustive overview on current approaches from the recognized academia and industrial practices of PAT, including screening, selection, and final implementations in solid oral dosage manufacturing, through a wide diversity of use cases. Finally, the authors attempt to extract a common consensus toward developing PAT application guidance for different unit operations of drug product manufacturing. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
NASA Astrophysics Data System (ADS)
Al-Jader, M. A.; Cullen, J. D.; Shaw, Andy; Al-Shamma'a, A. I.
2011-08-01
Currently there are about 4300 weld points on the average steel vehicle. Errors and problems due to tip damage and wear can cause great losses due to production line downtime. Current industrial monitoring systems check the quality of the nugget after processing 15 cars average once every two weeks. The nuggets are examined off line using a destructive process, which takes approximately 10 days to complete causing a long delay in the production process. In this paper a simulation results using software package, SORPAS, will be presented to determined the sustainability factors in spot welding process including Voltage, Current, Force, Water cooling rates, Material thicknesses and usage. The experimental results of various spot welding processes will be investigated and reported. The correlation of experimental results shows that SORPAS simulations can be used as an off line measurement to reduce factory energy usage. This paper also provides an overview of electrode current selection and its variance over the lifetime of the electrode tip, and describes the proposed analysis system for the selection of welding parameters for the spot welding process, as the electrode tip wears.
MONTANO, Diego
2016-01-01
The present study proposes a set of quality requirements to management practices by taking into account the empirical evidence on their potential effects on health, the systemic nature of social organisations, and the current conceptualisations of management functions within the framework of comprehensive quality management systems. Systematic reviews and meta-analyses focusing on the associations between leadership and/or supervision and health in occupational settings are evaluated, and the core elements of an ISO 9001 standardisation approach are presented. Six major occupational health requirements to high-quality management practices are identified pertaining to communication processes, organisational justice, role clarity, decision making, social influence processes and management support. It is concluded that the quality of management practices may be improved by developing a quality management system of management practices that ensures not only conformity to product but also to occupational safety and health requirements. Further research may evaluate the practicability of the proposed approach. PMID:26860787
Montano, Diego
2016-08-05
The present study proposes a set of quality requirements to management practices by taking into account the empirical evidence on their potential effects on health, the systemic nature of social organisations, and the current conceptualisations of management functions within the framework of comprehensive quality management systems. Systematic reviews and meta-analyses focusing on the associations between leadership and/or supervision and health in occupational settings are evaluated, and the core elements of an ISO 9001 standardisation approach are presented. Six major occupational health requirements to high-quality management practices are identified pertaining to communication processes, organisational justice, role clarity, decision making, social influence processes and management support. It is concluded that the quality of management practices may be improved by developing a quality management system of management practices that ensures not only conformity to product but also to occupational safety and health requirements. Further research may evaluate the practicability of the proposed approach.
Leyvraz, Magali; Rohner, Fabian; Konan, Amoin G; Esso, Lasme J C E; Woodruff, Bradley A; Norte, Augusto; Adiko, Adiko F; Bonfoh, Bassirou; Aaron, Grant J
2016-01-01
Poor complementary feeding practices among infants and young children in Côte d'Ivoire are major contributing factors to the country's high burden of malnutrition. As part of a broad effort to address this issue, an affordable, nutritious, and locally produced fortified complementary food product was launched in the Côte d'Ivoire in 2011. The objective of the current research was to assess various levels of coverage of the program and to identify coverage barriers. A cross-sectional household survey was conducted among caregivers of children less than 2-years of age living in Abidjan, Côte d'Ivoire. Four measures of coverage were assessed: "message coverage" (i.e., has the caregiver ever heard of the product?), "contact coverage" (i.e., has the caregiver ever fed the child the product?), "partial coverage" (i.e., has the caregiver fed the child the product in the previous month?), and "effective coverage" (i.e., has the caregiver fed the child the product in the previous 7 days?). A total of 1,113 caregivers with children between 0 and 23 months of age were interviewed. Results showed high message coverage (85.0%), moderate contact coverage (37.8%), and poor partial and effective coverages (8.8% and 4.6%, respectively). Product awareness was lower among caregivers from poorer households, but partial and effective coverages were comparable in both poor and non-poor groups. Infant and young child feeding (IYCF) practices were generally poor and did not appear to have improved since previous assessments. In conclusion, the results from the present study indicate that availability on the market and high awareness among the target population is not sufficient to achieve high and effective coverage. With market-based delivery models, significant efforts are needed to improve demand. Moreover, given the high prevalence of malnutrition and poor IYCF practices, additional modes of delivering IYCF interventions and improving IYCF practices should be considered.
The National Practice Benchmark for oncology, 2014 report on 2013 data.
Towle, Elaine L; Barr, Thomas R; Senese, James L
2014-11-01
The National Practice Benchmark (NPB) is a unique tool to measure oncology practices against others across the country in a way that allows meaningful comparisons despite differences in practice size or setting. In today's economic environment every oncology practice, regardless of business structure or affiliation, should be able to produce, monitor, and benchmark basic metrics to meet current business pressures for increased efficiency and efficacy of care. Although we recognize that the NPB survey results do not capture the experience of all oncology practices, practices that can and do participate demonstrate exceptional managerial capability, and this year those practices are recognized for their participation. In this report, we continue to emphasize the methodology introduced last year in which we reported medical revenue net of the cost of the drugs as net medical revenue for the hematology/oncology product line. The effect of this is to capture only the gross margin attributable to drugs as revenue. New this year, we introduce six measures of clinical data density and expand the radiation oncology benchmarks. Copyright © 2014 by American Society of Clinical Oncology.
Biomarkers of exposure to new and emerging tobacco delivery products.
Schick, Suzaynn F; Blount, Benjamin C; Jacob, Peyton; Saliba, Najat A; Bernert, John T; El Hellani, Ahmad; Jatlow, Peter; Pappas, R Steven; Wang, Lanqing; Foulds, Jonathan; Ghosh, Arunava; Hecht, Stephen S; Gomez, John C; Martin, Jessica R; Mesaros, Clementina; Srivastava, Sanjay; St Helen, Gideon; Tarran, Robert; Lorkiewicz, Pawel K; Blair, Ian A; Kimmel, Heather L; Doerschuk, Claire M; Benowitz, Neal L; Bhatnagar, Aruni
2017-09-01
Accurate and reliable measurements of exposure to tobacco products are essential for identifying and confirming patterns of tobacco product use and for assessing their potential biological effects in both human populations and experimental systems. Due to the introduction of new tobacco-derived products and the development of novel ways to modify and use conventional tobacco products, precise and specific assessments of exposure to tobacco are now more important than ever. Biomarkers that were developed and validated to measure exposure to cigarettes are being evaluated to assess their use for measuring exposure to these new products. Here, we review current methods for measuring exposure to new and emerging tobacco products, such as electronic cigarettes, little cigars, water pipes, and cigarillos. Rigorously validated biomarkers specific to these new products have not yet been identified. Here, we discuss the strengths and limitations of current approaches, including whether they provide reliable exposure estimates for new and emerging products. We provide specific guidance for choosing practical and economical biomarkers for different study designs and experimental conditions. Our goal is to help both new and experienced investigators measure exposure to tobacco products accurately and avoid common experimental errors. With the identification of the capacity gaps in biomarker research on new and emerging tobacco products, we hope to provide researchers, policymakers, and funding agencies with a clear action plan for conducting and promoting research on the patterns of use and health effects of these products.
Predictors of Success for Electronic Health Record Implementation in Small Physician Practices
Ancker, J.S.; Singh, M.P.; Thomas, R.; Edwards, A.; Snyder, A.; Kashyap, A.; Kaushal, R.
2013-01-01
Background The federal government is promoting adoption of electronic health records (EHRs) through financial incentives for EHR use and implementation support provided by regional extension centers. Small practices have been slow to adopt EHRs. Objectives Our objective was to measure time to EHR implementation and identify factors associated with successful implementation in small practices receiving financial incentives and implementation support. This study is unique in exploiting quantitative implementation time data collected prospectively as part of routine project management. Methods This mixed-methods study includes interviews of key informants and a cohort study of 544 practices that had worked with the Primary Care Information Project (PCIP), a publicly funded organization that since 2007 has subsidized EHRs and provided implementation support similar to that supplied by the new regional extension centers. Data from a project management database were used for a cohort study to assess time to implementation and predictors of implementation success. Results Four hundred and thirty practices (79%) implemented EHRs within the analysis period, with a median project time of 24.7 weeks (95% CI: 23.3 – 26.4). Factors associated with implementation success were: fewer providers, practice sites, and patients; fewer Medicaid and uninsured patients; having previous experience with scheduling software; enrolling in 2010 rather than earlier; and selecting an integrated EHR plus practice management product rather than two products. Interviews identified positive attitude toward EHRs, resources, and centralized leadership as additional practice-level predictors of success. Conclusions A local initiative similar to current federal programs successfully implemented EHRs in primary care practices by offsetting software costs and providing implementation assistance. Nevertheless, implementation success was affected by practice size and other characteristics, suggesting that the federal programs can reduce barriers to EHR implementation but may not eliminate them. PMID:23650484
Zadran, Sohila; Levine, Raphael D
2013-01-01
Metabolic engineering seeks to redirect metabolic pathways through the modification of specific biochemical reactions or the introduction of new ones with the use of recombinant technology. Many of the chemicals synthesized via introduction of product-specific enzymes or the reconstruction of entire metabolic pathways into engineered hosts that can sustain production and can synthesize high yields of the desired product as yields of natural product-derived compounds are frequently low, and chemical processes can be both energy and material expensive; current endeavors have focused on using biologically derived processes as alternatives to chemical synthesis. Such economically favorable manufacturing processes pursue goals related to sustainable development and "green chemistry". Metabolic engineering is a multidisciplinary approach, involving chemical engineering, molecular biology, biochemistry, and analytical chemistry. Recent advances in molecular biology, genome-scale models, theoretical understanding, and kinetic modeling has increased interest in using metabolic engineering to redirect metabolic fluxes for industrial and therapeutic purposes. The use of metabolic engineering has increased the productivity of industrially pertinent small molecules, alcohol-based biofuels, and biodiesel. Here, we highlight developments in the practical and theoretical strategies and technologies available for the metabolic engineering of simple systems and address current limitations.
Functional food. Product development, marketing and consumer acceptance--a review.
Siró, István; Kápolna, Emese; Kápolna, Beáta; Lugasi, Andrea
2008-11-01
It was mainly the advances in understanding the relationship between nutrition and health that resulted in the development of the concept of functional foods, which means a practical and new approach to achieve optimal health status by promoting the state of well-being and possibly reducing the risk of disease. Functional foods are found virtually in all food categories, however products are not homogeneously scattered over all segments of the growing market. The development and commerce of these products is rather complex, expensive and risky, as special requirements should be answered. Besides potential technological obstacles, legislative aspects, as well as consumer demands need to be taken into consideration when developing functional food. In particular, consumer acceptance has been recognized as a key factor to successfully negotiate market opportunities. This paper offers a brief overview of the current functional food market situation in USA, Japan and some European countries completed with some comments on functional food future potential. It explores the main challenges of such product development focusing on the different factors determining the acceptance of functional food. Furthermore it discusses some prominent types of these food products currently on the market.
Dubey, Manish K; Zehra, Andleeb; Aamir, Mohd; Meena, Mukesh; Ahirwal, Laxmi; Singh, Siddhartha; Shukla, Shruti; Upadhyay, Ram S; Bueno-Mari, Ruben; Bajpai, Vivek K
2017-01-01
Fungal glucose oxidase (GOD) is widely employed in the different sectors of food industries for use in baking products, dry egg powder, beverages, and gluconic acid production. GOD also has several other novel applications in chemical, pharmaceutical, textile, and other biotechnological industries. The electrochemical suitability of GOD catalyzed reactions has enabled its successful use in bioelectronic devices, particularly biofuel cells, and biosensors. Other crucial aspects of GOD such as improved feeding efficiency in response to GOD supplemental diet, roles in antimicrobial activities, and enhancing pathogen defense response, thereby providing induced resistance in plants have also been reported. Moreover, the medical science, another emerging branch where GOD was recently reported to induce several apoptosis characteristics as well as cellular senescence by downregulating Klotho gene expression. These widespread applications of GOD have led to increased demand for more extensive research to improve its production, characterization, and enhanced stability to enable long term usages. Currently, GOD is mainly produced and purified from Aspergillus niger and Penicillium species, but the yield is relatively low and the purification process is troublesome. It is practical to build an excellent GOD-producing strain. Therefore, the present review describes innovative methods of enhancing fungal GOD production by using genetic and non-genetic approaches in-depth along with purification techniques. The review also highlights current research progress in the cost effective production of GOD, including key advances, potential applications and limitations. Therefore, there is an extensive need to commercialize these processes by developing and optimizing novel strategies for cost effective GOD production.
Dubey, Manish K.; Zehra, Andleeb; Aamir, Mohd; Meena, Mukesh; Ahirwal, Laxmi; Singh, Siddhartha; Shukla, Shruti; Upadhyay, Ram S.; Bueno-Mari, Ruben; Bajpai, Vivek K.
2017-01-01
Fungal glucose oxidase (GOD) is widely employed in the different sectors of food industries for use in baking products, dry egg powder, beverages, and gluconic acid production. GOD also has several other novel applications in chemical, pharmaceutical, textile, and other biotechnological industries. The electrochemical suitability of GOD catalyzed reactions has enabled its successful use in bioelectronic devices, particularly biofuel cells, and biosensors. Other crucial aspects of GOD such as improved feeding efficiency in response to GOD supplemental diet, roles in antimicrobial activities, and enhancing pathogen defense response, thereby providing induced resistance in plants have also been reported. Moreover, the medical science, another emerging branch where GOD was recently reported to induce several apoptosis characteristics as well as cellular senescence by downregulating Klotho gene expression. These widespread applications of GOD have led to increased demand for more extensive research to improve its production, characterization, and enhanced stability to enable long term usages. Currently, GOD is mainly produced and purified from Aspergillus niger and Penicillium species, but the yield is relatively low and the purification process is troublesome. It is practical to build an excellent GOD-producing strain. Therefore, the present review describes innovative methods of enhancing fungal GOD production by using genetic and non-genetic approaches in-depth along with purification techniques. The review also highlights current research progress in the cost effective production of GOD, including key advances, potential applications and limitations. Therefore, there is an extensive need to commercialize these processes by developing and optimizing novel strategies for cost effective GOD production. PMID:28659876
Manufacture of tumor- and virus-specific T lymphocytes for adoptive cell therapies
Wang, X; Rivière, I
2015-01-01
Adoptive transfer of tumor-infiltrating lymphocytes (TILs) and genetically engineered T lymphocytes expressing chimeric antigen receptors (CARs) or conventional alpha/beta T-cell receptors (TCRs), collectively termed adoptive cell therapy (ACT), is an emerging novel strategy to treat cancer patients. Application of ACT has been constrained by the ability to isolate and expand functional tumor-reactive T cells. The transition of ACT from a promising experimental regimen to an established standard of care treatment relies largely on the establishment of safe, efficient, robust and cost-effective cell manufacturing protocols. The manufacture of cellular products under current good manufacturing practices (cGMPs) has a critical role in the process. Herein, we review current manufacturing methods for the large-scale production of clinical-grade TILs, virus-specific and genetically modified CAR or TCR transduced T cells in the context of phase I/II clinical trials as well as the regulatory pathway to get these complex personalized cellular products to the clinic. PMID:25721207
Manufacture of tumor- and virus-specific T lymphocytes for adoptive cell therapies.
Wang, X; Rivière, I
2015-03-01
Adoptive transfer of tumor-infiltrating lymphocytes (TILs) and genetically engineered T lymphocytes expressing chimeric antigen receptors (CARs) or conventional alpha/beta T-cell receptors (TCRs), collectively termed adoptive cell therapy (ACT), is an emerging novel strategy to treat cancer patients. Application of ACT has been constrained by the ability to isolate and expand functional tumor-reactive T cells. The transition of ACT from a promising experimental regimen to an established standard of care treatment relies largely on the establishment of safe, efficient, robust and cost-effective cell manufacturing protocols. The manufacture of cellular products under current good manufacturing practices (cGMPs) has a critical role in the process. Herein, we review current manufacturing methods for the large-scale production of clinical-grade TILs, virus-specific and genetically modified CAR or TCR transduced T cells in the context of phase I/II clinical trials as well as the regulatory pathway to get these complex personalized cellular products to the clinic.
An, Ning; Fan, Mingsheng; Zhang, Fusuo; Christie, Peter; Yang, Jianchang; Huang, Jianliang; Guo, Shiwei; Shi, Xiaojun; Tang, Qiyuan; Peng, Jianwei; Zhong, Xuhua; Sun, Yixiang; Lv, Shihua; Jiang, Rongfeng; Dobermann, Achim
2015-01-01
Meeting the future food security challenge without further sacrificing environmental integrity requires transformative changes in managing the key biophysical determinants of increasing agronomic productivity and reducing the environmental footprint. Here, we focus on Chinese rice production and quantitatively address this concern by conducting 403 on-farm trials across diverse rice farming systems. Inherent soil productivity, management practices and rice farming type resulted in confounded and interactive effects on yield, yield gaps and greenhouse gas (GHG) emissions (N2O, CH4 and CO2-equivalent) with both trade-offs and compensating effects. Advances in nitrogen, water and crop management (Best Management Practices-BMPs) helped closing existing yield gaps and resulted in a substantial reduction in CO2-equivalent emission of rice farming despite a tradeoff of increase N2O emission. However, inherent soil properties limited rice yields to a larger extent than previously known. Cultivating inherently better soil also led to lower GHG intensity (GHG emissions per unit yield). Neither adopting BMPs only nor improving soils with low or moderate productivity alone can adequately address the challenge of substantially increasing rice production while reducing the environmental footprint. A combination of both represents the most efficient strategy to harness the combined-benefits of enhanced production and mitigating climate change. Extrapolating from our farm data, this strategy could increase rice production in China by 18%, which would meet the demand for direct human consumption of rice by 2030. It would also reduce fertilizer nitrogen consumption by 22% and decrease CO2-equivalent emissions during the rice growing period by 7% compared with current farming practice continues. Benefits vary by rice-based cropping systems. Single rice systems have the largest food provision benefits due to its wider yield gap and total cultivated area, whereas double-rice system (especially late rice) contributes primarily to reducing GHG emissions. The study therefore provides farm-based evidence for feasible, practical approaches towards achieving realistic food security and environmental quality targets at a national scale.
PCMO L01-Setting Specifications for Biological Investigational Medicinal Products.
Krause, Stephan O
2015-01-01
This paper provides overall guidance and best practices for the setting of specifications for clinical biological drug substances and drug products within the framework of ICH guidelines on pharmaceutical development [Q8(R2) and Q11], quality risk management (Q9), and quality systems (Q10). A review is provided of the current regulatory expectations for the specification setting process as part of a control strategy during product development, pointing to existing challenges for the investigational new drug/investigational medicinal product dossier (IND/IMPD) sponsor. A case study illustrates how the investigational medicinal product specification revision process can be managed within a flexible quality system, and how specifications can be set and justified for early and late development stages. This paper provides an overview for the setting of product specifications for investigational medicinal products used in clinical trials. A case study illustrates how product specifications of investigational medicinal products can be justified and managed within a modern product quality system. © PDA, Inc. 2015.