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1

iPhone Programming Presentation: Slides  

NSDL National Science Digital Library

These are the slides from an iPhone programming presentation given by Mike Qaissaunee for the Brookdale Community College Computer Science Club. The video of the presentation and the narration of these slides are also available.

Qaissaunee, Michael

2010-05-14

2

Slide Composition for Electronic Presentations  

ERIC Educational Resources Information Center

Instructors who use computer-generated graphics in their lectures have many options to consider when developing their presentations. Experts give different advice on which typefaces, background and letter colors, and background imagery improve communications. This study attempted to resolve these controversies by examining how short-term recall of…

Larson, Ronald B.

2004-01-01

3

iPhone Programming Presentation - Slides with Narration  

NSDL National Science Digital Library

This is a video including slides with narration from an iPhone programming presentation given by Mike Qaissaunee for the Brookdale Community College Computer Science Club. The video of the presentation and the slides are also available.

Qaissaunee, Mike

2012-07-30

4

Comparing and managing multiple versions of slide presentations  

Microsoft Academic Search

Despite the ubiquity of slide presentations, managing mul- tiple presentations remains a challenge. Understanding how multiple versions of a presentation are related to one an- other, assembling new presentations from existing presenta- tions, and collaborating to create and edit presentations are difficult tasks. In this paper, we explore techniques for comparing and managing multiple slide presentations. We propose a general

Steven M. Drucker; Georg Petschnigg; Maneesh Agrawala

2006-01-01

5

Presentation video retrieval using automatically recovered slide and spoken text  

NASA Astrophysics Data System (ADS)

Video is becoming a prevalent medium for e-learning. Lecture videos contain text information in both the presentation slides and lecturer's speech. This paper examines the relative utility of automatically recovered text from these sources for lecture video retrieval. To extract the visual information, we automatically detect slides within the videos and apply optical character recognition to obtain their text. Automatic speech recognition is used similarly to extract spoken text from the recorded audio. We perform controlled experiments with manually created ground truth for both the slide and spoken text from more than 60 hours of lecture video. We compare the automatically extracted slide and spoken text in terms of accuracy relative to ground truth, overlap with one another, and utility for video retrieval. Results reveal that automatically recovered slide text and spoken text contain different content with varying error profiles. Experiments demonstrate that automatically extracted slide text enables higher precision video retrieval than automatically recovered spoken text.

Cooper, Matthew

2013-03-01

6

Slide presentation Architectures for Emotional Animals and Machines  

E-print Network

Cognition and Affect Group and many great thinkers in other places Related papers and slide presentations relate to different sorts of emotions, moods, and othr affective states and processes. The COGAFF?). Unsolved problems: where next? IK2002 / BBC02 Slide 2 Architectures for Emotions #12;"Advertisement" I use

Sloman, Aaron

7

FDA Centennial  

NSDL National Science Digital Library

On June 30th 1906, President Theodore Roosevelt signed the Food and Drugs Act, which prohibiting interstate commerce in misbranded and adulterated foods, drinks, and drugs. Broadly understood, this action was part of the Progressive Movement in the United States which brought forth a number of substantial changes in the way that government interacted with private industry and so on. 100 years on, the Food and Drug Administration (FDA) has decided to celebrate the centennial of this act by creating this site. Starting at the homepage, visitors can learn about events created to celebrate the FDA's legacy as well as read a nice feature titled "This Week in FDA History". Visitors may also want to look through a nice graphic presentation titled "FDA's Role in Protecting and Promoting Public Health". Through images and text, this presentation brings together some highlights of their work over the years, including information about the effects of the Federal Food, Drug, and Cosmetic Act of 1938. Finally, the site also contains a short quiz on FDA history.

2006-01-01

8

Zoomable user interfaces as a medium for slide show presentations  

Microsoft Academic Search

In this paper, the authors propose Zoomable User Interfaces as an alternative presentation medium to address several common presentation problems. Zoomable User Interfaces offer new techniques for managing multiple versions of a presentation, providing interactive presentation navigation, and distin- guishing levels of detail. These zoomable presentations may also offer several cognitive benefits over their commercial slide show counterparts. The authors

Lance Good; Benjamin B. Bederson

2002-01-01

9

FDA Terminology  

Cancer.gov

The FDA is working with EVS to develop and support controlled terminology in several areas. More than 10,000 FDA terms and codes are stored in NCI Thesaurus (NCIt). This and other terminology used by FDA is updated and made available for download from an NCI File Transfer Protocol (FTP) site.

10

FDA Almanac  

NSDL National Science Digital Library

The Office of Public Affairs for the Food and Drug Administration, the Public Health Service, and the Department of Health & Human Services has placed the most recent FDA Almanac online. The Almanac serves as a comprehensive starting point for information on the FDA and its subsidiary agencies. The introduction offers an overview of the FDA's organization, its mission, and its vision for the year 2000, as well as a compilation of the major laws it enforces. The Almanac itself contains information on the agency's 1999 budget and links to its major departments, such as the Center for Drug Evaluation and Research, the Center for Food Safety and Applied Nutrition, and the Office of Regulatory Affairs. Additional resources include a list of milestones in US food and drug law history, FDA-related acronyms and abbreviations, and a guide to obtaining information from the FDA.

Administration., United S.

1999-01-01

11

Optimizing Student Learning: Examining the Use of Presentation Slides  

ERIC Educational Resources Information Center

Sensory overload and split attention result in reduced learning when instructors read slides with bullet points and complex graphs during a lecture. Conversely, slides containing relevant visual elements, when accompanied by instructor narration, use both the visual and verbal channels of a student's working memory, thus improving the chances of…

Strauss, Judy; Corrigan, Hope; Hofacker, Charles F.

2011-01-01

12

Title Slide: This presentation was developed and presented on behalf of the Natural Resource Damage Assessment trustees for the  

E-print Network

the public's interest in natural resources under the Oil Pollution Act. A Natural Resource Damage AssessmentTitle Slide: This presentation was developed and presented on behalf of the Natural Resource Damage out of the Exxon Valdez spill. We are in the Restoration Planning Phase of the Natural Resource Damage

13

Slide Presentations as Speech Suppressors: When and Why Learners Miss Oral Information  

ERIC Educational Resources Information Center

The objective of this study was to test whether information presented on slides during presentations is retained at the expense of information presented only orally, and to investigate part of the conditions under which this effect occurs, and how it can be avoided. Such an effect could be expected and explained either as a kind of redundancy…

Wecker, Christof

2012-01-01

14

Discourse for slide presentation: An overview of chemical detection systems  

NASA Technical Reports Server (NTRS)

A brief overview of some of the analytical techniques currently used in monitoring and analyzing permanent gases and selected volatile organic compound in air are presented. Some of the analytical considerations in developing a specific method are discussed. Four broad groups of hardware are discussed: compound class specific personal monitors, gas chromatographic systems, infrared spectroscopic systems, and mass spectrometric residual gas analyzer systems. Three types of detectors are also discussed: catalytic sensor based systems, photoionization detectors, and wet or dry chemical reagent systems. Under gas chromatograph based systems five detector systems used in combination with a GC are covered: thermal conductivity detectors, photoionization detectors, Fourier transform infrared spectrophotometric systems, quadrapole mass spectrometric systems, and a relatively recent development, a surface acoustic wave vapor detector.

Peters, Randy Alan; Galen, Theodore J.; Pierson, Duane L.

1990-01-01

15

Integrating Annotations into a Dual-Slide PowerPoint Presentation for Classroom Learning  

ERIC Educational Resources Information Center

This study introduces a learning environment integrating annotations with a dual-slide PowerPoint presentation for classroom learning. Annotation means a kind of additional information to emphasize the explanations for the learning objects. The use of annotations is to support the cognitive process for PowerPoint presentation in a classroom. The…

Lai, Yen-Shou; Tsai, Hung-Hsu; Yu, Pao-Ta

2011-01-01

16

Automatic Color Conversion Method for Color-Defective Vision about Presentation Slides  

Microsoft Academic Search

This paper proposes the automatic color conversion method for color-defective vision persons about presentation slides. In order to set up this method, first, we defined the color combinations which are difficult to distinguish for color-defective vision persons by using the color confusion locus. Second, the function was derived which realizes the brightness difference values between strings and background. Then the

Sho Yokota; Akinori Sasaki; Hiroshi Hashimoto; Yasuhiro Ohyama

2009-01-01

17

FDA 101: Product Recalls  

MedlinePLUS Videos and Cool Tools

... Consumer Updates RSS Feed FDA 101: Product Recalls (video) Search the Consumer Updates Section Read the Consumer ... market may be necessary. In this Consumer Update video, FDA Recall Operations Team Leader Armando Zamora, explains ...

18

Reporting Problems to FDA  

MedlinePLUS Videos and Cool Tools

... Consumer Updates RSS Feed Reporting Problems to FDA (video) Search the Consumer Updates Section Get Consumer Updates ... can ultimately save lives. In this Consumer Update video, Norman Marks, FDA's MedWatch Medical Director, explains how ...

19

Is It Really FDA Approved?  

MedlinePLUS

... the same technology. back to top FDA approves additives in food for people. FDA field investigators inspect ... approval. back to top FDA approves drugs and additives in food for animals. FDA is responsible for ...

20

Drugs@FDA: FDA Approved Drug Products  

MedlinePLUS

... A to Z Index Follow FDA En Español Enter Search terms Most Popular Searches Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco ... Search by Drug Name, Active Ingredient, or Application Number Enter at least three characters: Advanced Search Browse by ...

21

Hospital incinerator operator training course. Volume 2. Presentation slides. Final report  

SciTech Connect

This document is Volume II of a three-volume training course for operators of hospital-waste incinerators. The course provides hospital waste-incinerator operators with a basic understanding of the principles of incineration and air pollution control and to identify good operation and maintenance (O M) practices. Proper O M, in addition to reducing air emissions, improves equipment reliability and performance, prolongs equipment life, and helps to ensure proper ash burnout. Volume II contains classroom materials including a copy of the presentation slides so that students can follow along during the class and worksheets that can be completed during the classroom sessions. The course includes 11 separate classroom sessions covering topics such as basic combustion principles and incinerator design; air pollution control equipment design, function, operation, and monitoring; incinerator operation; maintenance inspections; typical problems; and State regulations.

Neulicht, R.M.; Chaput, L.S.; Wallace, D.D.; Turner, M.B.; Smith, S.G.

1989-03-01

22

FDA -- Electronic Submission Process  

Cancer.gov

Food and Drug Administration – E lectronic Submission Process Stephen E. Wilson, DrPH (Biostatistics) Deputy Direct or Division of Biometrics II, CDER, FDA Member, CDER Electronic Submissions Working Group NIH Cancer Imaging Informatics Workshop Bethesda

23

FDA Authority Over Cosmetics  

MedlinePLUS

... cosmetics manufacturers? FDA can and does inspect cosmetic manufacturing facilities to assure cosmetic product safety and determine ... consumers in the United States and register their manufacturing and/or packaging facility locations in the VCRP ...

24

FDA 101: Dietary Supplements  

MedlinePLUS

... A to Z Index Follow FDA En Español Enter Search terms Home Food Drugs Medical Devices Radiation-Emitting Products ... been altered or updated since it was archived. Enter Search terms For Consumers Home For Consumers Consumer Updates Section ...

25

Abstract--This paper presents an enhanced sliding mode control for pneumatic master-slave teleoperation systems that are actuated  

E-print Network

e Abstract-- This paper presents an enhanced sliding mode control for pneumatic master pneumatic actuators have previously been modeled as having three discrete operating modes, an extension-of-freedom pneumatic teleoperation system. Experimental results demonstrate high accuracies in terms of position

Paris-Sud XI, Université de

26

An Experiment to Determine the Effectiveness of Slides and Audio-Tapes for Presenting Manipulative Demonstrations in Graphic Arts.  

ERIC Educational Resources Information Center

This study compared teacher demonstrations with a slide-tape methods of presenting demonstrations in graphic arts. It involved 134 eighth grade students and four teachers in four schools. Random assignment to treatments was made by classes. Four demonstrations randomly selected from a group were (1) composing a line of type, (2) locking-up a type…

Jenkins, John David

27

Teacher Education Students' Perceptions of the Value of Handouts Accompanying Teacher Educators' Computer-Generated Slide Presentations  

ERIC Educational Resources Information Center

This mixed-methods study used interviews and a questionnaire to investigate the perceptions of 304 teacher education students regarding the learning-related value of handouts accompanying teacher educators' computer-generated slide presentations. The extent to which graduate and undergraduate students differed in their perceptions was also…

Yilmazel-Sahin, Yesim; Oxford, Rebecca L.

2010-01-01

28

BE READY FOR COLLEGE PRESENTATION -SPEAKERS NOTES Slide #1 Be Full of Knowledge  

E-print Network

, explain consortium & why we're doing this · Poll audience ­ why do they want their children to go's going on in school, knowing the teachers, knowing what your student is doing in school Slide #8 ­ Be Prepared · Don't let finances keep your student from achieving their dreams - Range of costs · Savings

29

FDA 101: Regulating Biological Products  

MedlinePLUS

... mail Consumer Updates RSS Feed FDA 101: Regulating Biological Products Search the Consumer Updates Section Consumer Update ... friendly PDF (196 KB) On this page: What biological products does FDA regulate? How do biologics differ ...

30

FDA Kids Homepage  

NSDL National Science Digital Library

Highlight of the recently opened US Food and Drug Administration's Kids Homepage is Yorick, FDA's "favorite skeleton," which allows users to see the various medical devices and implants that can replace real body parts. Included are such items as a glass eye, a silicon cochlear implant, a hip and a knee, among others. In addition, there is a kids quiz on food safety, a medicine cabinet word find (unfortunately not interactive), a tobacco quiz, information about vaccines, and a food safety coloring book, among other features. Information is aimed mostly at young children, but Yorick should also be of interest to older users.

Center for Food Safety and Applied Nutrition (U.S.).

1998-01-01

31

FDA: CVaccines, Blood & Biologics  

NSDL National Science Digital Library

The mission of the Food and Drug Administration's (FDA) Vaccines, Blood & Biologics program is "to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies." Their mission is an important one, and consumers and scientists will want to bookmark this page and return to it on a regular basis. On the right-hand side of the page, visitors can sign up for their RSS feed, check out the "About" section, and read through their FAQ. In the center of the page, visitors can peruse the "Hot Topics", which at any given moment might include information on influenza vaccinations or product recalls or withdrawals. The site is rounded out by topical guide to the site along the left-hand side of the homepage.

2009-10-20

32

Slide 1  

Cancer.gov

Handout #1: Slides Slide 1 Needs Assessment: Getting To Know Your Audiences Better ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________

33

Slide 1  

Cancer.gov

Handout #1: Slides Slide 1 Finding an Evidence-Based Program ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________

34

A Guide to the FDA.  

ERIC Educational Resources Information Center

The United States Food and Drug Administration (FDA) collects information in seven areas: foods, cosmetics, human drugs, animal drugs and feeds, medical devices, biologics, and electronic radiological products. By using procedures outlined in the Freedom of Information Act, the public may get specific information from such FDA files as inspection…

Miller, Annetta K.

35

78 FR 19715 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...  

Federal Register 2010, 2011, 2012, 2013

...FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring...entitled ``Implementation of the FDA Food Safety Modernization Act Provision Requiring...Congress that is required by the FDA Food Safety Modernization Act (FSMA),...

2013-04-02

36

NSF/FDA Scholar-in-Residence at FDA  

NSF Publications Database

... Division of Computer-Communications Research Food and Drug Administration Center for Devices and ... and Environmental Systems (BES), and the U.S. Food and Drug Administration (FDA), through its Center ...

37

Slide 1  

Cancer.gov

Handout #1: Slides Slide 1 Making the Evidence-Based Program Fit Your Needs: Adaptation and Your Program Summary ___________________________________ ___________________________________ ___________________________________ ___________________________________

38

FDA Regulations and Definitions, FDA & HHS Similarities and Differences, Applicability of Each  

E-print Network

6/30/08 FDA Regulations and Definitions, FDA & HHS Similarities and Differences, Applicability to provide the universe of FDA. How detailed you go into it is up to you.) 1.FDA Regulations ­ overview of each regulation; (reason/rationale/intent / FDA Cosmetic Act), applicability/definitions as you

Biederman, Irving

39

Mini Lessons from FDA.  

ERIC Educational Resources Information Center

Eight self-contained lessons present information about topics of current interest in the Food and Drug Administration. Multidisciplinary in nature, the lessons can be integrated into ongoing activities in elementary or secondary level reading, math, language arts, social studies, science, art, health, consumer education, and home economics. The…

Food and Drug Administration (DHEW), Washington, DC.

40

FDA Warns About Stem Cell Claims  

MedlinePLUS

... Biologics Articulos en Espanol FDA Warns About Stem Cell Claims Search the Consumer Updates Section Researchers hope ... forming system. back to top Regulation of Stem Cells FDA regulates stem cells in the U.S. to ...

41

FDA Approves Orbactiv to Treat Skin Infections  

MedlinePLUS

... of antibacterial drugs.” Orbactiv is also the third new drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, Orbactiv ...

42

2013 FDA FOOD CODE FDA/CFSAN Retail Food Protection Team  

E-print Network

2013 FDA FOOD CODE FDA/CFSAN Retail Food Protection Team #12;The FDA Food Code: · Provides FDA's current thinking on food safety, sanitation, and fair dealing in the retail food sector · Can be uniformly adopted as a statute, regulation or ordinance for the retail, food service and vending segment of the food

Jawitz, James W.

43

FDA Guide to Dietary Supplements  

NSDL National Science Digital Library

The sale and variety of dietary supplements such as vitamins, minerals, herbal mixtures, and hormones have expanded tremendously in recent years, accounting for $6.5 billion in sales in 1996 alone. This resource will help users to understand this trend and the health claims made by supplement companies and to make educated decisions regarding their use. This site offers a revised version of an article which originally ran in the September-October 1998 FDA Consumer. The article addresses topics such as the definition of a dietary supplement, safety monitoring, understanding claims, and fraudulent products. An illustration of new requirements for dietary supplement labels and sources for more information are also provided.

Kurtzweil, Paula, 1958-.

1999-01-01

44

Pharmaceutical trademarks: navigating through the FDA's pilot program.  

PubMed

Creation and clearance of pharmaceutical trademarks continues to be one of the most difficult and challenging areas of trademark law. The Food and Drug Administration (FDA) recently initiated a 2-year Pilot Program under Prescription Drug User Fee Act (PDUFA) IV. The intent of the program is to enable participating pharmaceutical firms to evaluate proposed pharmaceutical marks and submit the data generated from those evaluations to the FDA for review. Submitting a trademark to the FDA warrants questions: What supporting data is needed and accepted when proposing a mark? What issues might arise, and how can they be averted? In a recent Thomson Reuters on-demand webinar (http://science.thomsonreuters.com/news/2010-02/8580404/), a group of renowned experts in the field of trademark development review the FDA pilot program, outline the requirements for submission and discuss what the changes will mean in clearing new pharmaceutical marks. They also present various approaches to trademark development and evaluation in light of the FDA's views. PMID:20603657

Ferrer, Elisa

2010-06-01

45

Access to F.D.A. Information.  

ERIC Educational Resources Information Center

Prior to the enactment of the Freedom of Information Act (FOIA), little of the data collected by the Food and Drug Administration (FDA) was made public or could be obtained from the agency. Although the FDA files are now open, information is considered exempt from public disclosure when it involves regulatory procedures, program guidelines, work…

Sinovic, Dianna

46

FDA’s Role in Standards Development  

Cancer.gov

Rationale behind the Vision 1. Addresses the FDA’s Performance Plan 2. Optimizes FDA and manufacturer’s resources 3. Accomplishes International Trade Commitment 4. Strengthens cooperation between governments 5. Partners with manufacturers to reduce risks 6. Enables productivity improvements 7.

47

New Antibiotic Approved by FDA  

NSDL National Science Digital Library

Last week, the FDA approved Zyvox (known generically as linezolid), the first in a new class of synthetic antibacterial drugs -- called oxazolidinones -- designed to treat a number of drug-resistant infections. Zyvox has proven effective in treatment of infections associated with vancomycin-resistant Enterococcus faecium (VREF) as well as hospital-acquired pneumonia and complicated skin and skin structure infections, including cases caused by methicillin-resistant Staphylococcus aureus (MRSA). This is the first drug to be approved in over 40 years for fighting hospital-acquired infections that are resistant to antibiotics. "It comes at a time when we were literally running out of antibiotics," said Dr. Robert C. Moellering Jr., physician-in-chief of Boston's Beth Israel-Deaconness Hospital, in a recent AP news article. In an attempt to preserve the long-term effectiveness of Zyvox and discourage microbes from developing renewed resistance, some doctors are calling for cautious use of the drug for only the worst antibiotic-resistant infections. This week's In The News takes a look at this new development and its consequences for antibiotic resistant bacteria.

Ramanujan, Krishna.

48

Opportunities at FDA: Bench Science and Regulatory Review of Science  

NSDL National Science Digital Library

This recorded presentation on "Physiologists and the FDA" is part of the EB 2010 Careers Symposium - Government Careers in Physiology Revealed. The target audience is students and postdoctoral fellows, as well as early career and established investigators seeking information on job opportunities and career development processes in the government.

PhD Kevin J Greenlees (Food and Drug Administration)

2010-04-25

49

Opportunities at FDA: Bench Science and Regulatory Review of Science  

NSDL National Science Digital Library

This powerpoint presentation file on "Physiologists and the FDA" is part of the EB 2010 Careers Symposium - Government Careers in Physiology Revealed. The target audience is students and postdoctoral fellows, as well as early career and established investigators seeking information on job opportunities and career development processes in the government.

PhD Kevin J Greenlees (Food and Drug Administration)

2010-04-25

50

Slide system for machine tools  

DOEpatents

The present invention relates to a machine tool which permits the machining of nonaxisymmetric surfaces on a workpiece while rotating the workpiece about a central axis of rotation. The machine tool comprises a conventional two-slide system (X-Y) with one of these slides being provided with a relatively short travel high-speed auxiliary slide which carries the material-removing tool. The auxiliary slide is synchronized with the spindle speed and the position of the other two slides and provides a high-speed reciprocating motion required for the displacement of the cutting tool for generating a nonaxisymmetric surface at a selected location on the workpiece.

Douglass, Spivey S. (Oak Ridge, TN); Green, Walter L. (Knoxville, TN)

1982-01-01

51

FDA Approves First Therapeutic Cancer Vaccine  

Cancer.gov

Sipuleucel-T (Provenge) is a relatively nontoxic treatment option for men with hormone-resistant or castration-resistant prostate cancer. The FDA's approval of the vaccine represented the first proof of principle that immunotherapy can work in cancer.

52

Noninvasive Devices May Help Migraines, FDA Says  

MedlinePLUS

... page, please enable JavaScript. Noninvasive Devices May Help Migraines, FDA Says New treatments might aid those who ... 22, 2014 Related MedlinePlus Pages Medical Device Safety Migraine MONDAY, Sept. 22, 2014 (HealthDay News) -- Two new ...

53

FDA Expands Advice on Statin Risks  

MedlinePLUS

... of liver damage. back to top Reports of Memory Loss FDA has been investigating reports of cognitive ... included assessments of cognitive function. The reports about memory loss, forgetfulness and confusion span all statin products ...

54

Painful decision-making at FDA.  

PubMed

The FDA is critical in ensuring that medications are safe and effective. However, the FDA's decision-making process for opioid analgesics is complicated by the need to address patients with complex clinical pain syndromes while balancing public safety concerns involving opioid misuse and abuse. Several recent regulatory decisions by FDA have exposed the complexity of this regulatory tug of war. For example, the FDA's decision to include a requirement for tamper resistance for extended-release oxycodone products but not for extended-release oxymorphone or hydrocodone preparations is concerning. Although tamper resistance is an imperfect solution, it provides a modicum of abuse prevention. Additionally, the rewording of the labeled indication (from 'moderate to severe pain' to 'severe enough pain') for extended-release opioid analgesics, in an attempt to provide clarity, resulted in an equally if not more vague statement of appropriate use. Furthermore, the postmarketing requirement for continued data regarding safety and efficacy have been affirmed by FDA but some of the proposed means to acquire those data will likely result in unclear answers and may have undesired consequences. We fully support the important role of the FDA but raise concerns about the occasional lack of consistency and transparency. PMID:24597477

Nelson, Lewis S; Perrone, Jeanmarie; Juurlink, David N

2014-04-01

55

Slide 1  

Cancer.gov

Phase 0 trials can start earlier than Phase 1 Conceived under FDA’s “Critical Path” initiative to help sponsors identify promising candidate drugs more quickly Toxicology evaluation less extensive than for traditional IND because of reduced dosing and limited exposure.

56

Epidural steroid warning controversy still dogging FDA.  

PubMed

On April 23, 2014, the Food and Drug Administration (FDA) issued a letter of warning that injection of corticosteroids into the epidural space of the spine may result in rare, but serious adverse events, including "loss of vision, stroke, paralysis, and death." The advisory also advocated that patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. In addition, the FDA stated that the effectiveness and safety of the corticosteroids for epidural use have not been established, and the FDA has not approved corticosteroids for such use. To raise awareness of the risks of epidural corticosteroid injections in the medical community, the FDA's Safe Use Initiative convened a panel of experts including pain management experts to help define the techniques for such injections with the aim of reducing preventable harm. The panel was unable to reach an agreement on 20 proposed items related to technical aspects of performing epidural injections. Subsequently, the FDA issued the above referenced warning and a notice that a panel will be convened in November 2014. This review assesses the inaccuracies of the warning and critically analyzes the available literature. The literature has been assessed in reference to alternate techniques and an understanding of the risk factors when performing transforaminal epidural injections in the cervical, thoracic, and lumbar regions, ultimately resulting in improved safety. The results of this review show the efficacy of epidural injections, with or without steroids, in a multitude of spinal ailments utilizing caudal, cervical, thoracic, and lumbar interlaminar approaches as well as lumbar transforaminal epidural injections . The evidence also shows the superiority of steroids in managing lumbar disc herniation utilizing caudal and lumbar interlaminar approaches without any significant difference as compared to transforaminal approaches, either with local anesthetic alone or local anesthetic and steroids combined. In conclusion, the authors request that the FDA modify the warning based on the evidence. PMID:25054397

Manchikanti, Laxmaiah; Candido, Kenneth D; Singh, Vijay; Gharibo, Christopher G; Boswell, Mark V; Benyamin, Ramsin M; Falco, Frank J E; Grider, Jay S; Diwan, Sudhir; Hirsch, Joshua A

2014-01-01

57

Archive: FDA/NSTA Symposium: Food Safety and Nutrition, St. Louis, MO: March 31, 2007  

NSDL National Science Digital Library

During this half-day symposium, scientists and education specialists from the FDA shared information with teachers about food science, bioscience, and the food label. The presenters also performed activities that enhanced the participants' knowledge about

Fda

1900-01-01

58

These instructions are to accompany the Power Point "Leveling the Playing Field". Make a copy of the Power Point presentation, number the slides (1) (2), and follow these instructions.  

E-print Network

These instructions are to accompany the Power Point "Leveling the Playing Field". Make a copy of the Power Point presentation, number the slides (1) (2), and follow these instructions. www, COPY and PASTE into a new Word document. You are limited to 255 characters: eliminate words that don

59

Appearance Normalization of Histology Slides  

PubMed Central

This paper presents a method for automatic color and intensity normalization of digitized histology slides stained with two different agents. In comparison to previous approaches, prior information on the stain vectors is used in the estimation process, resulting in improved stability of the estimates. Due to the prevalence of hematoxylin and eosin staining for histology slides, the proposed method has significant practical utility. In particular, it can be used as a first step to standardize appearances across slides, that is very effective at countering effects due to differing stain amounts and protocols, and to slide fading. The approach is validated using synthetic experiments and 13 real datasets.

Niethammer, Marc; Borland, David; Marron, J. S.; Woosley, John; Thomas, Nancy E.

2011-01-01

60

FDA’S food ingredient approval process  

Microsoft Academic Search

Fifty years ago, the Food and Drug Administration (FDA) began implementing new provisions of the Federal Food, Drug, and Cosmetic Act aimed at assuring the safety of new food additives before they enter the marketplace. Today, the agency’s procedures for premarket evaluation of food additive safety have evolved into a scientifically rigorous, sound and dependable system whose objective and independent

Alan M. Rulis; Joseph A. Levitt

2009-01-01

61

How FDA Evaluates Regulated Products: Cosmetics  

MedlinePLUS

... cosmetics. The Regulation of Cosmetics Under the Federal Food, Drug, and Cosmetic Act, cosmetic products and ingredients do not require FDA approval before they go on the market. The exception is color additives (other than those used in most hair dyes). Companies and individuals who market ...

62

Food and Drug Administration (FDA) History  

NSDL National Science Digital Library

On this site, visitors can learn about the origins and history of the U.S. Food and Drug Administration. The navigation menu on the left will help move around the site to areas including FDA's Origin & Functions, Milestones, Leaders and Their Deputies, and Oral Histories. There is also a page of links to other related resources elsewhere online.

2013-06-11

63

FDA panel finds mifepristone safe and effective.  

PubMed

At a July 19 hearing, the Food and Drug Administration's Advisory Committee for Reproductive Health Drugs found mifepristone to be safe and effective in inducing abortions early in pregnancy and recommended that the drug be approved for marketing in the US. With a 6-0 vote with two abstentions, the eight-member panel found that mifepristone's benefits were greater than its risks; agreed, 7-0, with one abstention, that it is safe; voted 6-2 to accept data from a French study as sufficient to recommend use in this country; and decided unanimously to reconvene if results from US clinical trials differ significantly from those from France. While the FDA is not required to follow the panel's advice, it is highly uncommon for it to do otherwise. The advisory panel scheduled the hearing in response to an application filed this spring by the Population Council, the nonprofit organization that owns the US patent rights to the drug. The meeting began with a presentation by the Population Council on the results of an American mifepristone trial that involved more than 2000 women and a discussion of the data from studies and practical use in France. The second session brought public testimony from 33 speakers, the majority of whom spoke in favor of the drug's approval. A company plans to manufacture mifepristone once it is approved but refuses to reveal its identity out of concern that it will be a target for anti-choice protests and boycotts. The drug would be marketed by Advances in Health Technology, Inc., an enterprise designated by the Population Council as the exclusive US distributor of mifepristone--the abortifacient marketed as RU486 in France and used by nearly 200,000 women in Europe and elsewhere. PMID:12347288

1996-07-26

64

Slide Whistle  

NSDL National Science Digital Library

In this activity, learners build a slide whistle using PVC pipe, bamboo skewer, and piece of foam. Construction of the instrument is relatively simple. Learners will experiment making sounds and varying the pitch (frequency). Use this activity to help learners explore sound, instruments, vibration, and frequency. Adult supervision recommended.

Workshop, Watsonville E.

2011-01-01

65

FDA Warns Consumers about Fraudulent Ebola Treatment Products  

MedlinePLUS

... 2010 FDA Statement FDA warns consumers about fraudulent Ebola treatment products For Immediate Release August 14, 2014 ... sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus ...

66

Mining FDA drug labels for medical conditions  

PubMed Central

Background Cincinnati Children’s Hospital Medical Center (CCHMC) has built the initial Natural Language Processing (NLP) component to extract medications with their corresponding medical conditions (Indications, Contraindications, Overdosage, and Adverse Reactions) as triples of medication-related information ([(1) drug name]-[(2) medical condition]-[(3) LOINC section header]) for an intelligent database system, in order to improve patient safety and the quality of health care. The Food and Drug Administration’s (FDA) drug labels are used to demonstrate the feasibility of building the triples as an intelligent database system task. Methods This paper discusses a hybrid NLP system, called AutoMCExtractor, to collect medical conditions (including disease/disorder and sign/symptom) from drug labels published by the FDA. Altogether, 6,611 medical conditions in a manually-annotated gold standard were used for the system evaluation. The pre-processing step extracted the plain text from XML file and detected eight related LOINC sections (e.g. Adverse Reactions, Warnings and Precautions) for medical condition extraction. Conditional Random Fields (CRF) classifiers, trained on token, linguistic, and semantic features, were then used for medical condition extraction. Lastly, dictionary-based post-processing corrected boundary-detection errors of the CRF step. We evaluated the AutoMCExtractor on manually-annotated FDA drug labels and report the results on both token and span levels. Results Precision, recall, and F-measure were 0.90, 0.81, and 0.85, respectively, for the span level exact match; for the token-level evaluation, precision, recall, and F-measure were 0.92, 0.73, and 0.82, respectively. Conclusions The results demonstrate that (1) medical conditions can be extracted from FDA drug labels with high performance; and (2) it is feasible to develop a framework for an intelligent database system. PMID:23617267

2013-01-01

67

FDA’S Perspectives on Cardiovascular Devices  

Microsoft Academic Search

The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a\\u000a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices\\u000a and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the\\u000a health

Eric A. Chen; Sonna M. Patel-Raman; Kathryn O’Callaghan; Matthew G. Hillebrenner

2009-01-01

68

76 FR 20588 - FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities; Public Meeting  

Federal Register 2010, 2011, 2012, 2013

...No. FDA-2011-N-0251] FDA Food Safety Modernization Act: Focus on Preventive...public meeting entitled ``FDA Food Safety Modernization Act: Focus on Preventive...provisions of the recently enacted FDA Food Safety Modernization Act (FSMA)....

2011-04-13

69

Catalog of FDA Approved Drug Products  

NSDL National Science Digital Library

The Catalog of FDA Approved Drug Products provides information on drugs approved and tentatively approved prescription, over-the-counter, and discontinued drugs. The catalog allows users to browse by drug name, quick search by drug name or active ingredient, or use their advanced search page to look up the drug they are seeking. The catalog is part of the Center fro Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration. This site would be useful for student research as well as for instructors in their classrooms and curricula.

2006-11-18

70

FDA: Center for Biologics Evaluation and Research  

NSDL National Science Digital Library

The mission of the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is "to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies." Their mission is an important one, and consumers and scientists will want to bookmark this page and return to it on a regular basis. On this page, visitors can sign up for their RSS feed and read through some key resources. Users can also browse resources on biologics depending on their needs: consumer, healthcare and industry level information is provided.

71

Presentations  

Cancer.gov

Presentations Name Position Presentation (ppt) Sudhir Srivastava, PhD, MPH Chief, Cancer Biomarkers Research Group Metabolomics: An Untapped Frontier (ppt, 161kb) John Milner, PhD Chief, Nutritional Sciences research Group Can Metabolomics

72

FDA and CPMP rulings on subgroup analyses.  

PubMed

The extent to which subgroup analyses should affect the interpretation and conclusions in a trial report is a contentious matter, and guidelines regarding this issue have been established by the US Food and Drug Administration (FDA) and the EU Committee for Proprietary Medicinal Products (CPMP). Subgroup analyses should be set out in the protocol of clinical trials. The treatment effect itself may vary within a subgroup or covariate. In some cases, interactions are anticipated or are of particular a priori interest; hence a subgroup analysis or a statistical model including interactions is part of the planned analysis. However, subgroup or interaction analyses are often merely exploratory and should be clearly identified as such in the protocol. When exploratory, these analyses should be interpreted cautiously. Market approval of a compound is based on the overall trial results, and, importantly, no drug has so far been approved or not-approved either in the US or in the EU on the basis of subgroup analysis. However, subgroup analysis can influence the approval or can even be required, and therefore it can influence the labelling of the Summary Characteristics of a Product. Two examples in heart failure are given by the Val-HeFT trial comparing valsartan to placebo and the MERIT-HF trial comparing metoprolol to placebo, from which some remarkable regulatory issues arose that were debated by the FDA and CPMP. PMID:16847375

Maggioni, Aldo P; Darne, Bernadette; Atar, Dan; Abadie, Eric; Pitt, Bertram; Zannad, Faiez

2007-01-01

73

FDA Modernization Act: implications for oncology.  

PubMed

The Food and Drug Administration (FDA) Modernization Act, signed into law on November 21, 1997, represents a sweeping review of existing standards for the approval, labeling, and promotion of prescription medicines. Certain sections of the act will influence access that oncologists and their patients have to new treatments and to information about those treatments. Major impacts of the act include: (1) continued funding of drug reviews by the FDA to assure a continuing stream of new drugs to prevent and treat disease; (2) providing greater flexibility in drug approval by permitting approval on the basis of one clinical trial and confirmatory evidence, and by instituting "fast track" designation to certain drugs that will permit approval on the basis of surrogate end points; (3) improving the access of physicians and patients to developing treatments by instituting a clinical trials databank and by authorizing the use of investigational products in emergencies; and (4) loosening restrictions on dissemination by drug companies of health, economic, and off-label use information, while maintaining incentives to investigate new uses for developing products. PMID:10028506

Morris, L

1998-11-01

74

Evaluation of efficacy of heartworm preventive products at the FDA  

Microsoft Academic Search

The Center for Veterinary Medicine, U.S. Food and Drug Administration (FDA\\/CVM) has authority under the United States Code 21 under Section 514.80 to monitor for adverse experiences of approved animal products. Although veterinarians voluntarily report suspect drug-related events to manufacturers, firms that market FDA-approved animal products must report serious events to the FDA within 15 working days of the veterinarian

Victoria A. Hampshire

2005-01-01

75

Archive: FDA/NSTA Symposium: Teach Science Concepts and Inquiry with Food, Boston, MA: March 28, 2008  

NSDL National Science Digital Library

During this half-day symposium, scientists and education specialists from the FDA shared information with teachers about food science, bioscience, and the food label. The presenters also performed activities that enhanced the participants' knowledge about

1900-01-01

76

Archive: FDA/NSTA Symposium: Teach Science Concepts and Inquiry with Food, Portland, Oregon: November 21, 2008  

NSDL National Science Digital Library

During this half-day symposium, scientists and education specialists from the FDA shared information with teachers about food science, bioscience, and the food label. The presenters also performed activities that enhanced the participants' knowledge abou

1900-01-01

77

Archive: FDA/NSTA Symposium: Teach Science Concepts and Inquiry with Food, Denver, CO: Nov 9, 2007  

NSDL National Science Digital Library

During this half-day symposium, scientists and education specialists from the FDA talked to teachers about food science, food science related careers, and the food label. The presenters also performed activities that enhanced the participants' knowledge a

Fda

1900-01-01

78

Meeting the FDA's Initiative for Protecting the US Drug Supply  

E-print Network

Meeting the FDA's Initiative for Protecting the US Drug Supply Tatsuya Inaba Research Affiliate rapidly. Demographic changes, along with a host of new drugs, are causing greater volumes of raw materials. To achieve these goals for the public good, the Food and Drug Administration (FDA) and individual States

Brock, David

79

Needs and New Policies for Medicines for Children: The FDA, United States Incentives, and International Doings  

Microsoft Academic Search

Most prescription medicines in the United States and in other countries are not labeled with sufficient information for sensible use in the pediatric population, even though many drugs are widely used for disorders present in both children and adults. The Food and Drug Administration (FDA) has launched initiatives to get pediatric use information into labeling of medicines in the United

Paula Botstein

2000-01-01

80

Biclustering of Adverse Drug Events in the FDA's Spontaneous Reporting System  

Microsoft Academic Search

In this article, we present a new pharmacovigilance data mining technique based on the biclustering paradigm, which is designed to identify drug groups that share a common set of adverse events (AEs) in the spontaneous reporting system (SRS) of the US Food and Drug Administration (FDA). A taxonomy of biclusters is developed, revealing that a significant number of bona fide

R Harpaz; H Perez; H S Chase; R Rabadan; G Hripcsak; C Friedman

2011-01-01

81

Detection of slide transition for topic indexing  

Microsoft Academic Search

This paper presents an automatic and novel approach in detecting the transitions of slides for video sequences of technical lectures. Our approach adopts a foreground vs background segmentation algorithm to separate a presenter from the projected electronic slides. Once a background template is generated, text captions are detected and analyzed. The segmented caption regions as well as background templates together

Chong-Wah Ngo; Ting-Chuen Pong; Thomas S. Huang

2002-01-01

82

Modeling and simulation for medical product development and evaluation: highlights from the FDA-C-Path-ISOP 2013 workshop.  

PubMed

Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration (FDA) described critical challenges facing medical-product development by establishing the critical path initiative [1]. Priorities identified included the need for improved modeling and simulation tools, further emphasized in FDA's 2011 Strategic Plan for Regulatory Science [Appendix]. In an effort to support and advance model-informed medical-product development (MIMPD), the Critical Path Institute (C-Path) [ www.c-path.org ], FDA, and International Society of Pharmacometrics [ www.go-isop.org ] co-sponsored a workshop in Washington, D.C. on September 26, 2013, to examine integrated approaches to developing and applying model- MIMPD. The workshop brought together an international group of scientists from industry, academia, FDA, and the European Medicines Agency to discuss MIMPD strategies and their applications. A commentary on the proceedings of that workshop is presented here. PMID:25288257

Romero, Klaus; Sinha, Vikram; Allerheiligen, Sandra; Danhof, Meindert; Pinheiro, Jose; Kruhlak, Naomi; Wang, Yaning; Wang, Sue-Jane; Sauer, John-Michael; Marier, J F; Corrigan, Brian; Rogers, James; Lambers Heerspink, H J; Gumbo, Tawanda; Vis, Peter; Watkins, Paul; Morrison, Tina; Gillespie, William; Gordon, Mark Forrest; Stephenson, Diane; Hanna, Debra; Pfister, Marc; Lalonde, Richard; Colatsky, Thomas

2014-12-01

83

Pesticides: FDA's (Food and Drug Administration's) Investigation of Imported Apple Juice Concentrate.  

National Technical Information Service (NTIS)

The report provides information on the volume of imported apple juice concentrate, FDA's testing methodology, and FDA's testing results of its special investigation on imported apple juice concentrate. All FDA district offices were instructed to sample ea...

1986-01-01

84

FDA Warns against Using Laparoscopic Power Morcellators to Treat Uterine Fibroids  

MedlinePLUS

... FDA News Release FDA warns against using laparoscopic power morcellators to treat uterine fibroids Agency recommends adding ... April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) ...

85

Discrepancies in the primary PLATO trial publication and the FDA reviews.  

PubMed

The results of major indication seeking Phase 3 clinical trials are reported at international meetings, and simultaneously published In top medical journals. However, the data presented during such dual release do not disclose all the trial findings, suffer from overoptimistic interpretations heavily favoring the study sponsor. Ironically, after the New Drug Application is submitted for regulatory approval, and when the FDA secondary reviews become available for public, the benefit/risk assessment of a new drug is usually considered much less impressive. However, the community may ignore pivotal unreported findings later outlined in the government documents taking for granted the facts presented in the primary publication. The discrepancies between initial publication and the FDA files are not only confusing to the readership, but hold additional risks for patients. Indeed, if physicians are impressed with the initial interpretation of the trial, and do not have broad access to the FDA verified facts, chances are new agents will be prescribed based on exaggerated benefit and less safety concerns. The current pattern also hurts the reputation of the journal publishers, editors and reviewers challenging their trust and credibility. We here outline the disparity between the primary PLATO trial publication in the New England Journal of Medicine against the FDA verified numbers, and discuss how to avoid such mismatches in the future. PMID:24456868

Serebruany, Victor L

2014-03-01

86

FDA Approves New Vaccine to Protect Against Meningitis  

MedlinePLUS

... JavaScript. FDA Approves New Vaccine to Protect Against Meningitis Trumenba guards against type of bacteria that is ... Wednesday, October 29, 2014 Related MedlinePlus Pages Immunization Meningitis Meningococcal Infections WEDNESDAY, Oct. 29, 2014 (HealthDay News) -- ...

87

Factors influencing FDA clearance time for medical device 510(k)  

E-print Network

Since the FDA Modernization Act of 1997, recent legislation has sought to establish performance goals and consistency in the regulatory review and clearance of new medical devices. Despite these goals, regulatory review ...

Koert, Andrew J. (Andrew James)

2010-01-01

88

Certain Meds, Driving Can Be Deadly Mix: FDA  

MedlinePLUS

... page, please enable JavaScript. Certain Meds, Driving Can Be Deadly Mix: FDA Even nonprescription drugs might bring ... drowsiness, agency warns (*this news item will not be available after 01/05/2015) By Robert Preidt ...

89

FDA LABA Warning: Is There Anything New Here?  

Microsoft Academic Search

The FDA advisory on long-acting ?-agonists (LABAs) is not based on new data but on ongoing safety concerns about this class of medication. Not to be ignored are the potential safety risks of short-acting ?-agonists (SABAs).

S T Weiss

2010-01-01

90

PHOSPHOLIPID AND FDA ACTIVITY MEASUREMENTS ADAPTED TO BIOLOGICAL GAC  

EPA Science Inventory

Established microbial ecology analytical techniques for measuring the quantity and activity of bacteria were examined for use on biological granular activated carbon (GAC). ctivity was determined using the fluorescein diacetate (FDA) assay. he assay was tested and accordingly cor...

91

Factors influencing the time for FDA review of medical devices  

E-print Network

Companies must receive marketing authorization by the Food and Drug Administration (FDA) before they can begin commercial distribution of a new type of medical device in the United States. The premarket approval application ...

Singh, Inder Raj, S.M. Massachusetts Institute of Technology

2007-01-01

92

NIH-FDA Interagency Clinical Outcome Assessments Working Group  

Cancer.gov

To increase communication between the relevant groups at FDA and the many separate efforts at NIH to advance measurement science by exchanging information about specific COA projects of common interest, thereby improving the knowledge base for COA development.

93

Developing Orphan Products: FDA and Rare Disease Day  

MedlinePLUS

... Feed Developing Orphan Products: FDA and Rare Disease Day Search the Consumer Updates Section Get Consumer Updates ... 2009, as the 2nd annual World Rare Disease Day—an important time for bringing attention to the ...

94

FDA Regulation of Stem CellâÂÂBased Products  

NSDL National Science Digital Library

In the United States, clinical trials designed to demonstrate the safety and effectiveness of stem cellâÂÂbased products are regulated by the U.S. Food and Drug Administration (FDA). To ensure that subjects enrolled in a clinical study involving stem cellâÂÂbased products are not exposed to significant and unreasonable risk, the FDA reviews medical and scientific information to determine whether there is sufficient safety assurance to permit initiation of human clinical studies.

Donald Fink (U.S. Food and Drug Administration;)

2009-06-26

95

76 FR 13643 - FDA Food Safety Modernization Act: Title III-A New Paradigm for Importers; Public Meeting  

Federal Register 2010, 2011, 2012, 2013

...and FDA-2011-N-0146] FDA Food Safety Modernization Act: Title III...public meeting entitled ``FDA Food Safety Modernization Act: Title III...provisions of the recently enacted FDA Food Safety Modernization Act (FSMA)....

2011-03-14

96

76 FR 62073 - Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety...  

Federal Register 2010, 2011, 2012, 2013

...of the Fee Provisions of the FDA Food Safety Modernization Act; Availability...Provisions of Section 107 of the FDA Food Safety Modernization Act.'' FDA is...Provisions of Section 107 of the FDA Food Safety Modernization Act.'' The...

2011-10-06

97

A Case-Study Based Course on "Device Evaluation and FDA Approval"  

NSDL National Science Digital Library

Preclinical evaluation of new devices and therapies is an integral part of research and development in the medical device industry, and the regulatory process for FDA approval is a major driving force behind much that goes on in a company setting. A large number of graduating biomedical engineers enter this medical device industry or a related environment upon graduation from our institution. Although these engineers are equipped to address many of the technical challenges that will arise, there is currently limited formal training in or exposure to the regulatory process that is required to bring new devices to market. Knowledge of the typical progression through preclinical testing, as well as an understanding of clinical trial guidelines and the FDA regulatory process would allow students to work more effectively and productively in industry or other medically-related positions. Therefore, a course has been designed entitled Device Evaluation and FDA Approval as an upper division elective at our institution. The goal of this course is to expose students to the overall process of FDA approval, including aspects of both preclinical and clinical testing, in order to prepare them to succeed in a regulatory-based environment. This is a case-study based course, where cases range from small in-class examples that facilitate active student engagement in the material, to large cases that span multiple lessons and incorporate out of class assignments and projects. Cases are selected and presented such that students gain insights into the progression and complexities of real-life devices, while learning in vitro and in vivo preclinical evaluation techniques, clinical trial guidelines, FDA processes and requirements, and overall regulatory constraints.

Cardinal, Kristen

2009-10-27

98

Sliding Pi  

NSDL National Science Digital Library

"The entrance to the Downsview subway station in Toronto presents visitors with a striking vista. A vast mosaic of square tiles sweeps across a curved wall, inviting viewers to trace its lines and ponder intriguing irregularities in its color scheme of blues, greens, roses, and other hues... The artist is Arlene Stamp, now a resident of Calgary, Alberta. In 1993, at the height of her interest in nonperiodic patterns, she was intrigued by the possibility of using such designs in public spaces for enlivening large areas, such as floors and walls, more often covered with simple, repeating motifs..."

Peterson, Ivars

2007-03-05

99

Slide structure and role of gas hydrate at the northern boundary of the Storegga Slide, offshore Norway  

Microsoft Academic Search

The Storegga Slide off the coast of Norway is one of the largest underwater slide complexes known and has been proposed as a significant source of past methane release into the atmosphere. We present pre-stack depth-migrated images from a new multi-channel seismic data set in the Storegga Slide. The northern scarp of the Storegga Slide has previously been interpreted as

Hillary E. Brown; W. Steven Holbrook; Matthew J. Hornbach; Jeffrey Nealon

2006-01-01

100

America, you are digging your grave with your spoon--should the FDA tell you that on food labels?  

PubMed

R.J. Reynolds Tobacco Co. v. Food & Drug Admin. discussed whether the FDA's promulgation of graphic images violated tobacco companies' First Amendment rights. While the tobacco companies contested the graphic images, the tobacco companies did not contest the promulgation of nine textual statements about the adverse effects of cigarettes. This uncontested mandate opens a door for the FDA to further expand its regulatory scheme. If the FDA can mandate textual statements about the adverse effects of cigarettes, can the FDA mandate textual statements about the adverse effects of sugar to combat the obesity crisis? This Article presents three textual statements about the adverse effects of sugar, to define the line between acceptable and unacceptable forms of compelled commercial speech under Central Hudson. Establishing this line ensures that the commercial speech doctrine does not deny the FDA from its authority to provide consumers with accurate information. While three textual statements are presented, this Article advocates that one of the textual statements is likely to serve as the best solution to the obesity crisis. The chosen textual statement serves as an effective solution because it presents meaningful information to the consumers enabling consumers to make healthful decisions about their food and encourages manufacturers to modify their products. PMID:24640612

Card, Melissa M

2013-01-01

101

Clarification of FDA Regulations and Guidance on "Compassionate" and "Humanitarian" Use  

E-print Network

Clarification of FDA Regulations and Guidance on "Compassionate" and "Humanitarian" Use The following FDA regulations and guidance make provision for the so-called "compassionate use in FDA regulations, and its use is actively discouraged by the FDA Center for Drug Evaluation

Puglisi, Joseph

102

Dendritic Spines and Development: Towards a Unifying Model of Spinogenesis--A Present Day Review of Cajal's Histological Slides and Drawings  

PubMed Central

Dendritic spines receive the majority of excitatory connections in the central nervous system, and, thus, they are key structures in the regulation of neural activity. Hence, the cellular and molecular mechanisms underlying their generation and plasticity, both during development and in adulthood, are a matter of fundamental and practical interest. Indeed, a better understanding of these mechanisms should provide clues to the development of novel clinical therapies. Here, we present original results obtained from high-quality images of Cajal's histological preparations, stored at the Cajal Museum (Instituto Cajal, CSIC), obtained using extended focus imaging, three-dimensional reconstruction, and rendering. Based on the data available in the literature regarding the formation of dendritic spines during development and our results, we propose a unifying model for dendritic spine development. PMID:21584262

Garcia-Lopez, Pablo; Garcia-Marin, Virginia; Freire, Miguel

2010-01-01

103

Herbaceous Ornamental Plants. Slide Script.  

ERIC Educational Resources Information Center

This slide script, part of a series of slide scripts designed for use in vocational agriculture classes, deals with commercially important herbaceous ornamental plants. Included in the script are narrations for use with a total of 338 slides illustrating 150 different plants. Generally, two slides are used to illustrate each plant: one slide shows…

Still, Steven

104

Healthy public relations: the FDA's 1930s legislative campaign.  

PubMed

In this article, I argue that the Food and Drug Administration (FDA) is an oft-overlooked government agency that acts to preserve and secure the public's health. From its early years as an agency charged with enforcement of the 1906 Pure Food and Drugs Act, the FDA not only protected the public's health but also made the public aware of its mission, using methods as diverse as displays at county fairs and at the 1933 Chicago World's Fair, radio programming, and active correspondence. The agency encouraged the public to protect itself, particularly in those arenas in which the FDA had no regulatory authority. In addition, it may have overstepped its boundaries when it actively solicited public support for a bill submitted to Congress in the early 1930s. In the dark days of the Great Depression, the FDA contended not only with limited resources and its own feelings of inadequacy in terms of what could and could not be done to protect the populace, but also with "guinea pig" books that horrified and angered many readers. By 1938, when the agency prevailed and the revisions to the 1906 Act passed Congress and were signed into law by President Franklin D. Roosevelt, the FDA had done all that a responsible public health agency should do, and more. PMID:11568487

Kay, G

2001-01-01

105

Selected case from the Arkadi M. Rywlin International Pathology Slide Series: Mitochondrial myopathy presenting with chronic progressive external ophthalmoplegia (CPEO): a case report.  

PubMed

A 43-year-old female patient diagnosed with chronic progressive external ophthalmoplegia (CPEO) because of mitochondrial myopathy documented by muscle biopsy is presented. The chief complaints were represented by blepharoptosis and ophthalmoplegia. The muscle biopsy was evaluated by histology, using the appropriate histochemical and histoenzimological stains. Ragged red fibers with Gomori trichrome stain were seen, which showed cytochrome c oxydase deficiency and abnormal succinate dehydrogenase staining in around 20% of muscle fibres. Electron microscopy was also performed which demonstrated abnormal, hyperplastic, pleomorphic, and hypertrophic mitochondria, characterized by paracrystalline inclusions arranged in parallel rows ("parking-lot" inclusions), consisting of rectangular arrays of mitochondrial membranes in a linear or grid-like pattern. In conclusion, mitochondrial myopathy was definitely diagnosed. Although molecular analysis, which was subsequently carried out, failed to reveal mutations in the mitochondrial DNA or in selected nuclear genes, the pathologic diagnosis was not changed. The differential diagnosis of CPEO with other forms of ocular myopathies as well as the possible association of CPEO with systemic syndromes is discussed. Ophtalmologists and medical internists should always suspect CPEO when dealing with patients affected by ocular myopathy, either in its pure form or in association with other myopathic or systemic signs. PMID:25299315

Bisceglia, Michele; Crociani, Paola; Fogli, Danilo; Centola, Antonio; Galliani, Carlos A; Pasquinelli, Gianandrea

2014-11-01

106

Slide2Go: A virtual slide collection for pathology education.  

PubMed

Slide2Go is a collection of digitized glass slides on the Web from a pathology departments slide set for second year medical students. The virtual slide collection can be accessed anywhere using any Web browser with Adobe Flash Player. It simulates the experience of viewing a glass slide under an optical microscope. Rare and unusual cases can be preserved and shared worldwide. Medical education can be enhanced by virtual slides. PMID:18694018

Conran, Richard; Fontelo, Paul; Liu, Fang; Fontelo, Marie; White, Elizabeth

2007-01-01

107

Update of the worldwide FDA study of the 3M diffractive multifocal intraocular lens.  

PubMed

The multifocal diffractive intraocular lens (IOL) represents a significant technological advance. Results of 671 patients with a year follow-up from a worldwide study are presented. Through this FDA study, it appears that many patients can enjoy uncompromising distance vision as well as unaided near vision. With careful surgical control of astigmatism and competent calculation of IOL power, it may be possible to reduce the post-cataract patients' dependency on glasses. PMID:1400097

Roy, F H

1992-10-01

108

From high molecular weight precursor polyrotaxanes to supramolecular sliding networks. The ‘sliding gels’  

Microsoft Academic Search

This paper presents the synthesis and characterization of an original class of supramolecular networks, the ‘sliding’ gels. In this new class of network materials the crosslink points are not fixed but sliding. The molecular structure is based on intermolecularly crosslinked ?-cyclodextrins\\/poly(ethylene-glycol) precursor polyrotaxanes. A synthetic method was developed to obtain various high molecular weight precursor polyrotaxanes with various amounts of

Guillaume Fleury; Guy Schlatter; Cyril Brochon; Georges Hadziioannou

2005-01-01

109

Slides of the Math Advisors Presentation  

E-print Network

Oct 24, 2013 ... There is a new appointment system for all students (except Stacey's advisees) ... Pre-req or test score error: contact advisor via e-mail; College or Major: ... Tips. Check Pre-requisites. If you don't meet pre-requisites after fall grades ... 201 course OR a Culture or Diversity course OR approved study abroad.

110

No Slide Title  

Cancer.gov

FDA will accept alternative, or modified, pharmacologic and toxicological studies Short-term modified toxicity or safety studies in 2 species to achieve a clinical PD endpoint Incorporate PD endpoints in toxicity studies Possible use of single, relevant species Doses based on efficacy, MED and safe BEDs, not MTDs Not a Microdose Study!

111

The US FDA and animal cloning: Risk and regulatory approach  

Microsoft Academic Search

The Food and Drug Administration's (FDA's) Center for Veterinary Medicine issued a voluntary request to producers of livestock clones not to introduce food from clones or their progeny into commerce until the agency had assessed whether production of cattle, swine, sheep, or goats by somatic cell nuclear transfer (SCNT) posed any unique risks to the animal(s) involved in the process,

Larisa Rudenko; John C. Matheson

2007-01-01

112

NCI-FDA-NIST Workshop on Standards in Molecular Diagnostics  

Cancer.gov

Meetings & Events Division of Cancer PreventionNational Cancer Institute - National Institutes of HealthU.S. Department of Health and Human ServicesNCI-FDA-NIST Workshop on Standards in Molecular Diagnostics View the Report(PDF, 794kb) Friday, December

113

FDA review of software: discussion of the proposed reviewer's guide  

Microsoft Academic Search

The widespread application of microprocessors to medical devices has led to a need by FDA for internal reviewer guidance that will establish uniform review criteria for software. A software committee in the Center for Devices and Radiological Health (CDRH) was created to establish a reviewer's guidance document for computer-controlled medical devices. A guidance document was drafted by the committee and

D. Zier

1988-01-01

114

Semantic Focusing Allows Fully Automated Single-Layer Slide Scanning of Cervical Cytology Slides  

PubMed Central

Liquid-based cytology (LBC) in conjunction with Whole-Slide Imaging (WSI) enables the objective and sensitive and quantitative evaluation of biomarkers in cytology. However, the complex three-dimensional distribution of cells on LBC slides requires manual focusing, long scanning-times, and multi-layer scanning. Here, we present a solution that overcomes these limitations in two steps: first, we make sure that focus points are only set on cells. Secondly, we check the total slide focus quality. From a first analysis we detected that superficial dust can be separated from the cell layer (thin layer of cells on the glass slide) itself. Then we analyzed 2,295 individual focus points from 51 LBC slides stained for p16 and Ki67. Using the number of edges in a focus point image, specific color values and size-inclusion filters, focus points detecting cells could be distinguished from focus points on artifacts (accuracy 98.6%). Sharpness as total focus quality of a virtual LBC slide is computed from 5 sharpness features. We trained a multi-parameter SVM classifier on 1,600 images. On an independent validation set of 3,232 cell images we achieved an accuracy of 94.8% for classifying images as focused. Our results show that single-layer scanning of LBC slides is possible and how it can be achieved. We assembled focus point analysis and sharpness classification into a fully automatic, iterative workflow, free of user intervention, which performs repetitive slide scanning as necessary. On 400 LBC slides we achieved a scanning-time of 13.9±10.1 min with 29.1±15.5 focus points. In summary, the integration of semantic focus information into whole-slide imaging allows automatic high-quality imaging of LBC slides and subsequent biomarker analysis. PMID:23585899

Lahrmann, Bernd; Valous, Nektarios A.; Eisenmann, Urs; Wentzensen, Nicolas; Grabe, Niels

2013-01-01

115

Academic Success Centre Presentation Checklist  

E-print Network

receive balanced treatment Main message is recapitulated in the conclusion Slide information is conveyed of the slides. If there is too much content (too much information or too many slides), the message will need on the presentation equipment Checked face with a mirror (e.g., no food in teeth) Checked clothing (e.g., no tags

Northern British Columbia, University of

116

Projector slides - preparation, construction and use.  

PubMed

Projector slides are used widely as visual aids in lectures and meetings. However, they are often difficult to read and to interpret, and can bring about more confusion than illumination to an audience. A framework is offered for the non-specialist in graphic design, within which the preparation, construction and presentation of projector slides may be placed in a systematic fashion. Summary recommendations are also given. PMID:15677213

Galer, I A

1976-12-01

117

Selected Landscape Plants. Slide Script.  

ERIC Educational Resources Information Center

This slide script, part of a series of slide scripts designed for use in vocational agriculture classes, deals with commercially important woody ornamental landscape plants. Included in the script are narrations for use with a total of 253 slides illustrating 92 different plants. Several slides are used to illustrate each plant: besides a view of…

McCann, Kevin

118

Learning from Slide Rules  

NSDL National Science Digital Library

This resource describes the slide rule as an analog computer, and uses the slide rule to demonstrate the concept of isomorphism, which is one of the most pervasive and important concepts in mathematics. This resource is from PUMAS - Practical Uses of Math and Science - a collection of brief examples created by scientists and engineers showing how math and science topics taught in K-12 classes have real world applications.

119

Slide Projector Activities  

NSDL National Science Digital Library

This resource contains several mini-explorations using a slide projector as a light source to investigate light and the properties of images. These activities can be used as a class demonstration or as learning stations. This guide also includes information about the "anatomy" of slide projectors and how they work. Learners and educators are encouraged to "tinker" with the equipment to find the best conditions and methods. Note: the cost of the projector is not included in the total cost of materials.

Miller, Bob

2013-01-30

120

Paleo Slide Set: Coral Paleoclimatology  

NSDL National Science Digital Library

This slide show presents information about corals, which build carbonate skeletons over many years, forming the beautiful reefs common in tropical seas. Some coral species are sensitive to water temperatures and other environmental factors, and their skeletons can record information on past climate. This slide set discusses the future implications of climate variability through the use of color photos of undersea coral, coral drilling and an accompanying text. Also included are graphic representations that discuss high-resolution paleoclimatic proxy data from corals, El Nino-Southern Oscillation (ENSO) reconstructions and the Pacific Climate System. This set can be used as a comprehensive educational tool for studying current issues in marine ecology, global warming and ENSO. Each photograph can be enlarged for better viewing.

121

77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability  

Federal Register 2010, 2011, 2012, 2013

...OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0339] Draft Guidance on Drug Safety Information--FDA's Communication...Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION:...

2012-03-09

122

76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...  

Federal Register 2010, 2011, 2012, 2013

...Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators...Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators...complying with the regulations governing financial disclosure by clinical...

2011-05-24

123

76 FR 61709 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728...  

Federal Register 2010, 2011, 2012, 2013

...Request; FDA Form 3728, Animal Generic Drug User Fee Act Cover Sheet AGENCY...collection burden of the Animal Generic Drug User Fee Cover Sheet Form FDA 3728...certain provisions of the Animal Generic Drug User Fee Act of 2008...

2011-10-05

124

How You Can Know If FDA Regulates an Over-The-Counter Test  

MedlinePLUS

... may not be regulated by FDA. - Search In Vitro Test Database IVD Over the Counter (OTC) Database - ... FDA 301-796-5450 CDRH-Office of In Vitro Diagnostics and Radiological Health Center for Devices and ...

125

76 FR 38666 - Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island...  

Federal Register 2010, 2011, 2012, 2013

...located at http://www.fda.gov/Food/NewsEvents/default.htm. (FDA has verified the Web site addresses throughout this document...Acquisition and Grant Services (OAGS), Food and Drug Administration, 5630...

2011-07-01

126

FDA/NCI Interagency Oncology Task Force (IOTF)  

Cancer.gov

Under this effort, the two agencies share knowledge and resources to facilitate the development of new cancer drugs and speed their delivery to patients. Theresa Mullin, Ph.D., Assistant Commissioner, Office of Planning, Office of Policy and Planning, FDA, and Anna Barker, Ph.D., Deputy Director for Strategic Scientific Initiatives, Office of the Director, NCI, serve as the Co-Chairs for the IOTF.

127

The PCAST report on pharmaceutical innovation: implications for the FDA.  

PubMed

In September 2012, the President's Council of Advisors on Science and Technology (PCAST) released the report "Propelling Innovation in Drug Discovery, Development and Evaluation." A product of discussions with many stakeholders, the report reiterates current problems in drug development, including diminished return on basic biomedical research. The report calls for doubling the current annual output of innovative new medicines--an ambitious goal. Recommendations and resulting initiatives will probably affect the FDA's drug regulatory programs. PMID:23963215

Woodcock, J

2013-09-01

128

January 27, 2010 CUMC Compliance Program for FDA-regulated Human Subjects Research  

E-print Network

January 27, 2010 CUMC Compliance Program for FDA-regulated Human Subjects Research The CUMC Compliance Program for FDA-regulated human subjects research (the "Program") is the responsibility. The Program is intended to ensure compliance in the conduct of all FDA-regulated human subjects research

Grishok, Alla

129

21 CFR 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food...  

... The Food and Drug Administration's (FDA's) determination that a premarket notification... The Food and Drug Administration's (FDA's) determination that a premarket notification...If data or other information available to FDA, including data not submitted by...

2014-04-01

130

21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...  

Code of Federal Regulations, 2010 CFR

...procedures apply when FDA initiates a seizure action against a detained perishable...procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a seizure action under section 304(a)...

2010-04-01

131

21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...  

Code of Federal Regulations, 2012 CFR

...procedures apply when FDA initiates a seizure action against a detained perishable...procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a seizure action under section 304(a)...

2012-04-01

132

21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...  

...procedures apply when FDA initiates a seizure action against a detained perishable...procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a seizure action under section 304(a)...

2014-04-01

133

21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...  

Code of Federal Regulations, 2011 CFR

...procedures apply when FDA initiates a seizure action against a detained perishable...procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a seizure action under section 304(a)...

2011-04-01

134

21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...  

Code of Federal Regulations, 2013 CFR

...procedures apply when FDA initiates a seizure action against a detained perishable...procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a seizure action under section 304(a)...

2013-04-01

135

No sisyphean task: how the FDA can regulate electronic cigarettes.  

PubMed

The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed "tobacco products" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009 (TCA). It examines the tumultuous history of attempts at tobacco regulation by reflecting on the history of Congressional activity to regulate tobacco sales and promotion. Furthermore, this Article suggests a feasible approach to strengthening regulation of e-cigarettes under the existing statutory framework. This approach includes increased scrutiny of manufacturer and distributor claims that trigger drug and medical device provisions, utilization of new tobacco product and modified risk tobacco product provisions, and promulgation of new FDA regulations and guidance specifically directed at e-cigarettes. PMID:24340824

Paradise, Jordan

2013-01-01

136

Application of partial sliding mode in guidance problem.  

PubMed

In this paper, the problem of 3-dimensional guidance law design is considered and a new guidance law based on partial sliding mode technique is presented. The approach is based on the classification of the state variables within the guidance system dynamics with respect to their required stabilization properties. In the proposed law by using a partial sliding mode technique, only trajectories of a part of states variables are forced to reach the partial sliding surfaces and slide on them. The resulting guidance law enables the missile to intercept highly maneuvering targets within a finite interception time. Effectiveness of the proposed guidance law is demonstrated through analysis and simulations. PMID:23260528

Shafiei, M H; Binazadeh, T

2013-03-01

137

Theory of sliding-mode triboelectric nanogenerators.  

PubMed

The triboelectric nanogenerator (TENG) is a powerful approach toward new energy technology, especially for portable electronics. A theoretical model for the sliding-mode TENG is presented in this work. The finite element method was utilized to characterize the distributions of electric potential, electric field, and charges on the metal electrodes of the TENG. Based on the FEM calculation, the semi-analytical results from the interpolation method and the analytical V-Q-x relationship are built to study the sliding-mode TENG. The analytical V-Q-x equation is validated through comparison with the semi-analytical results. Furthermore, based on the analytical V-Q-x equation, dynamic output performance of sliding-mode TENG is calculated with arbitrary load resistance, and good agreement with experimental data is achieved. The theory presented here is a milestone work for in-depth understanding of the working mechanism of the sliding-mode TENG, and provides a theoretical basis for further enhancement of the sliding-mode TENG for both energy scavenging and self-powered sensor applications. PMID:24038597

Niu, Simiao; Liu, Ying; Wang, Sihong; Lin, Long; Zhou, Yu Sheng; Hu, Youfan; Wang, Zhong Lin

2013-11-20

138

Lectin approaches for glycoproteomics in FDA-approved cancer biomarkers.  

PubMed

The nine FDA-approved protein biomarkers for the diagnosis and management of cancer are approaching maturity, but their different glycosylation compositions relevant to early diagnosis still remain practically unexplored at the sub-glycoproteome scale. Lectins generally exhibit strong binding to specific sub-glycoproteome components and this property has been quite poorly addressed as the basis for the early diagnosis methods. Here, we discuss some glycoproteome issues that make tackling the glycoproteome particularly challenging in the cancer biomarkers field and include a brief view for next generation technologies. PMID:24611567

Badr, Haitham A; Alsadek, Dina M M; Darwish, Ashraf A; Elsayed, Abdelaleim I; Bekmanov, Bakhytzhan O; Khussainova, Elmira M; Zhang, Xueji; Cho, William C S; Djansugurova, Leyla B; Li, Chen-Zhong

2014-04-01

139

Sliding and Stuttering  

NSDL National Science Digital Library

Students use a spring scale to drag an object such as a ceramic coffee cup along a table top or the floor. The spring scale allows them to measure the frictional force that exists between the moving cup and the surface it slides on. By modifying the bottom surface of the cup, students find out what kinds of surfaces generate more or less friction.

Engineering K-Phd Program

140

A High Order Sliding Mode Control with PID Sliding Surface: Simulation on a Torpedo  

E-print Network

Position and speed control of the torpedo present a real problem for the actuators because of the high level of the system non linearity and because of the external disturbances. The non linear systems control is based on several different approaches, among it the sliding mode control. The sliding mode control has proved its effectiveness through the different studies. The advantage that makes such an important approach is its robustness versus the disturbances and the model uncertainties. However, this approach implies a disadvantage which is the chattering phenomenon caused by the discontinuous part of this control and which can have a harmful effect on the actuators. This paper deals with the basic concepts, mathematics, and design aspects of a control for nonlinear systems that make the chattering effect lower. As solution to this problem we will adopt as a starting point the high order sliding mode approaches then the PID sliding surface. Simulation results show that this control strategy can attain exce...

Rhif, Ahmed

2012-01-01

141

A Simple Measurement of the Sliding Friction Coefficient  

ERIC Educational Resources Information Center

We present a simple computer-aided experiment for investigating Coulomb's law of sliding friction in a classroom. It provides a way of testing the possible dependence of the friction coefficient on various parameters, such as types of materials, normal force, apparent area of contact and sliding velocity.

Gratton, Luigi M.; Defrancesco, Silvia

2006-01-01

142

Qualification test unit slide stainer (Beckman P/N 673753)  

NASA Technical Reports Server (NTRS)

Specifications for a slide stainer unit for the Skylab program are presented. The qualification test slide stainer was designed to be a self-contained system capable of performing an eight-step Gram stain of microorganisms and a Wright's stain of blood smears.

Bernier, P. S.

1972-01-01

143

Tissue slide-based microRNA characterization of tumors: how detailed could diagnosis become for cancer medicine?  

PubMed

miRNAs are short, non-coding, regulatory RNAs that exert cell type-dependent, context-dependent, transcriptome-wide gene expression control under physiological and pathological conditions. Tissue slide-based assays provide qualitative (tumor compartment) and semi-quantitative (expression levels) information about altered miRNA expression at single-cell resolution in clinical tumor specimens. Reviewed here are key technological advances in the last 5 years that have led to implementation of fully automated, robust and reproducible tissue slide-based assays for in situ miRNA detection on US FDA-approved instruments; recent tissue slide-based discovery studies that suggest potential clinical applications of specific miRNAs in cancer medicine are highlighted; and the challenges in bringing tissue slide-based miRNA assays into the clinic are discussed, including clinical validation, biomarker performance, biomarker space and integration with other biomarkers. PMID:25090088

Sempere, Lorenzo F

2014-09-01

144

Benefit-risk paradigm for clinical trial design of obesity devices: FDA proposal.  

PubMed

Diet and exercise, except in controlled circumstances, have not been shown to provide effective and prolonged weight loss for the majority of those who are obese. Several older drugs intended to reduce weight have been withdrawn from the market, and the new drugs show only modest weight loss. Surgical intervention, specifically procedures that alter the normal gastrointestinal anatomy, does provide prolonged periods of sustained weight loss, with rebound weight gain over time. A variety of medical devices to assist in weight reduction have been studied, but only two are legally marketed devices for obesity. The authors propose a new paradigm for devices intended to treat obesity, based on a benefit-risk determination, with the hope to provide sponsors an a priori tool for systematic assessment of the risks associated with the devices intended for treatment of obesity and to suggest appropriate levels of benefit for devices with different risk levels. The paradigm is not intended to determine the class of a device from a regulatory perspective. This approach was conceived at a Food and Drug Administration (FDA) co-sponsored workshop in October, 2011 and formally presented to an FDA advisory panel for discussion in May 2012. PMID:23247746

Lerner, Herbert; Whang, Joyce; Nipper, Rebecca

2013-03-01

145

Decision tree SAR models for developmental toxicity based on an FDA/TERIS database.  

PubMed

Humans are exposed to thousands of environmental chemicals for which no developmental toxicity information is available. Structure-activity relationships (SARs) are models that could be used to efficiently predict the biological activity of potential developmental toxicants. However, at this time, no adequate SAR models of developmental toxicity are available for risk assessment. In the present study, a new developmental database was compiled by combining toxicity information from the Teratogen Information System (TERIS) and the Food and Drug Administration (FDA) guidelines. We implemented a decision tree modeling procedure, using Classification and Regression Tree software and a model ensemble approach termed bagging. We then assessed the empirical distributions of the prediction accuracy measures of the single and ensemble-based models, achieved by repeating our modeling experiment many times by repeated random partitioning of the working database. The decision tree developmental SAR models exhibited modest prediction accuracy. Bagging tended to enhance the accuracy of prediction. Also, the model ensemble approach reduced the variability of prediction measures compared to the single model approach. Further research with data derived from animal species- and endpoint-specific components of an extended and refined FDA/TERIS database has the potential to derive SAR models that would be useful in the developmental risk assessment of the thousands of untested chemicals. PMID:12747568

Sussman, N B; Arena, V C; Yu, S; Mazumdar, S; Thampatty, B P

2003-04-01

146

Reconstitution of flagellar sliding.  

PubMed

The motile structure within eukaryotic cilia and flagella is the axoneme. This structure typically consists of nine doublet microtubules arranged around a pair of singlet microtubules. The axoneme contains more than 650 different proteins that have structural, force-generating, and regulatory functions. Early studies on sea urchin sperm identified the force-generating components, the dynein motors. It was shown that dynein can slide adjacent doublet microtubules in the presence of ATP. How this sliding gives rise to the beating of the axoneme is still unknown. Reconstitution assays provide a clean system, free from cellular effects, to elucidate the underlying beating mechanisms. These assays can be used to identify the components that are both necessary and sufficient for the generation of flagellar beating. PMID:23498749

Alper, Joshua; Geyer, Veikko; Mukundan, Vikram; Howard, Jonathon

2013-01-01

147

Plasma spray processing of TiC-based coatings for sliding wear resistance  

Microsoft Academic Search

Titanium carbide-reinforced metallic coatings, produced by plasma spraying, can be used for sliding wear resistant applications. The sliding wear properties of such coatings are governed to a large extent by the strength, structure and stability of the bond interface between the carbide and the metallic phases. In the present investigation, the microstructure and sliding wear properties of plasma sprayed metal-bonded

Mahesh Mohanty

1997-01-01

148

Second-order sliding mode control for a magnetic levitation system  

Microsoft Academic Search

This paper presents a second-order sliding mode position control design for robust stabilization and disturbance rejection of the magnetic ball suspension system. With respect to conventional sliding mode control, the second-order sliding mode technique shows the same properties of robustness to uncertainties of model and external disturbances. The proposed second-order sliding mode control has the continuous control signal that improves

Huann-Keng Chiang; Chun-Chiang Fang; Wen-Bin Lin; Guan-Wei Chen

2011-01-01

149

Grain boundary sliding behaviour of copper and alpha brass at intermediate temperatures  

Microsoft Academic Search

The role of grain boundary sliding in copper and Cu-30% Zn in the temperature range 0.50 to 0.72Tm, whereTm is the absolute melting point of the material, is examined. First, sliding data obtained on these materials are presented. These results indicate that the stress exponent for sliding,ngbs, is similar to that for lattice deformation, while the activation energy for sliding,Qgbs,

S. V. Raj

1991-01-01

150

New FDA rules force drug makers to detail youth-specific effects. Food and Drug Administration.  

PubMed

The U.S. Food and Drug Administration (FDA) has issued new rules requiring pharmaceutical companies to provide doctors with information on the effects of drugs on children. In addition, rules allow the FDA to require testing of certain drugs on children under "compelling circumstances." The FDA issued the regulations after complaints from parents of HIV-positive children, because of the lack of drug studies on children under 18 years. PMID:11367188

1999-01-01

151

Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing  

Microsoft Academic Search

BackgroundPhysician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing.Methods and FindingsCross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals

Deborah Korenstein; Salomeh Keyhani; Ali Mendelson; Joseph S. Ross

2011-01-01

152

Sliding Mode Control of a Quadrotor Helicopter  

Microsoft Academic Search

In this paper, we present a new design method for the flight control of an autonomous quadrotor helicopter based on sliding mode control. Due to the under-actuated property of a quadrotor helicopter, the controller can make the helicopter move three positions (x, y, z) and the yaw angle to their desired values and stabilize the pitch and roll angles. A

Rong Xu; U. Ozguner

2006-01-01

153

Static and dynamic friction in sliding colloidal monolayers  

PubMed Central

In a pioneer experiment, Bohlein et al. realized the controlled sliding of two-dimensional colloidal crystals over laser-generated periodic or quasi-periodic potentials. Here we present realistic simulations and arguments that besides reproducing the main experimentally observed features give a first theoretical demonstration of the potential impact of colloid sliding in nanotribology. The free motion of solitons and antisolitons in the sliding of hard incommensurate crystals is contrasted with the soliton–antisoliton pair nucleation at the large static friction threshold Fs when the two lattices are commensurate and pinned. The frictional work directly extracted from particles’ velocities can be analyzed as a function of classic tribological parameters, including speed, spacing, and amplitude of the periodic potential (representing, respectively, the mismatch of the sliding interface and the corrugation, or “load”). These and other features suggestive of further experiments and insights promote colloid sliding to a unique friction study instrument. PMID:23019582

Vanossi, Andrea; Manini, Nicola; Tosatti, Erio

2012-01-01

154

Sliding lipoma: an indirect inguinal hernia without a peritoneal sac.  

PubMed

With the increasing application of endoscopic hernioplasty, surgeons have now recognized that the peritoneal sac is sometimes absent in patients who present with a reducible inguinal hernia. Sliding lipoma refers to a sliding herniation of preperitoneal fat into the inguinal canal forming a reducible indirect inguinal hernia in the absence of a peritoneal sac. In this report, we describe a patient who underwent bilateral endoscopic totally extraperitoneal inguinal hernioplasty (TEP), followed by an early recurrence of left inguinal hernia, secondary to a sliding lipoma. Sliding lipoma is a challenging condition specific to endoscopic repair of inguinal hernia. All lipomas should be reduced and excised whenever feasible. Awareness and appropriate management of the sliding lipoma will help to reduce the risk of recurrence after endoscopic hernioplasty. PMID:15035847

Lau, Hung

2004-02-01

155

Detection of felt tip markers on microscope slides  

NASA Astrophysics Data System (ADS)

Sensitivity and specificity of conventional cytological methods for cancer diagnosis can be raised significantly by applying further adjuvant cytological methods. To this end, the pathologist marks regions of interest (ROI) with a felt tip pen on the microscope slide for further analysis. This paper presents algorithms for the automated detection of these ROIs, which enables further automated processing of these regions by digital pathology solutions and image analysis. For this purpose, an overview scan is obtained at low magnification. Slides from different manufacturers need to be treated, as they might contain certain regions which need to be excluded from the analysis. Therefore the slide type is identified first. Subsequently, the felt tip marks are detected automatically, and gaps appearing in the case of ROIs which have been drawn incompletely are closed. Based on the marker detection, the ROIs are obtained. The algorithms have been optimized on a training set of 82 manually annotated images. On the test set, the slide types of all but one out of 81 slides were identified correctly. A sensitivity of 98.31% and a positive predictive value of 97.48% were reached for the detection of ROIs. In combination with a slide loader or a whole slide imaging scanner as well as automated image analysis, this enables fully automated batch processing of slides.

Friedrich, David; Meyer-Ebrecht, Dietrich; Böcking, Alfred; Merhof, Dorit

2014-03-01

156

Regulation of Animal Health Products FDA/CVM: Animal drugs, animal  

E-print Network

Regulation of Animal Health Products FDA/CVM: Animal drugs, animal feeds USDA of effectiveness.) #12;Animal Health Literacy Campaign Go to the CVM page, http://www.fda.gov/AnimalVeterinary/, then Click on Animal Health Literacy Click on Animal Health Literacy Campaign Great general references

157

Blood Donation, Deferral, and Discrimination: FDA Donor Deferral Policy for Men Who Have Sex With Men  

Microsoft Academic Search

U.S. Food and Drug Administration (FDA) policy prohibits blood donation from men who have had sex with men (MSM) even one time since 1977. Growing moral criticism claims that this policy is discriminatory, a claim rejected by the FDA. An overview of U.S. blood donation, recent donor deferral policy, and the conventional ethical debate introduce the need for a different

Charlene Galarneau

2010-01-01

158

Analyzing the Laws, Regulations, and Policies Affecting FDA-Regulated Products  

E-print Network

Analyzing the Laws, Regulations, and Policies Affecting FDA-Regulated Products FDLI FOOD AND DRUG additional regulation. As part of the National Nanotechnol- ogy Initiative (NNI) in the United States, 26 federal agencies, including the Food and Drug Administration (FDA), contributed to the development

Kokkoli, Efie

159

FDA regulation of invasive neural recording electrodes: a daunting task for medical innovators.  

PubMed

The U.S. Food and Drug Administration (FDA) is charged with assuring the safety and effectiveness of medical devices. Before any medical device can be brought to market, it must comply with all federal regulations regarding FDA processes for clearance or approval. Navigating the FDA regulatory process may seem like a daunting task to the innovator of a novel medical device who has little experience with the FDA regulatory process or device commercialization. This review introduces the basics of the FDA regulatory premarket process, with a focus on issues relating to chronically implanted recording devices in the central or peripheral nervous system. Topics of device classification and regulatory pathways, the use of standards and guidance documents, and optimal time lines for interaction with the FDA are discussed. Additionally, this article summarizes the regulatory research on neural implant safety and reliability conducted by the FDA's Office of Science and Engineering Laboratories (OSEL) in collaboration with Defense Advanced Research Projects Agency (DARPA) Reliable Neural Technology (RE-NET) Program. For a more detailed explanation of the medical device regulatory process, please refer to several excellent reviews of the FDA's regulatory pathways for medical devices [1]-[4]. PMID:22481744

Welle, Cristin; Krauthamer, Victor

2012-03-01

160

Introducing Slide Sets for the Introductory Astronomy Instructor  

NASA Astrophysics Data System (ADS)

The NASA Science Mission Directorate (SMD) Science Education and Public Outreach (E/PO) community and Forums work together to bring the cutting-edge discoveries of NASA Astrophysics and Planetary Science missions to the introductory astronomy college classroom. These mission- and grant-based E/PO programs are uniquely poised to foster collaboration between scientists with content expertise and educators with pedagogy expertise. We present two new opportunities for college instructors to bring the latest NASA discoveries in Space Science into their classrooms.In an effort to keep the astronomy classroom apprised of the fast moving field of planetary science, the Division of Planetary Sciences (DPS) has developed “DPS Discoveries”, which are short, topical presentations that can be incorporated into college lectures. The slide sets are targeted at the Introductory Astronomy undergraduate level. Each slide set consists of three slides that cover a description of the discovery, a discussion of the underlying science, and a presentation of the big picture implications of the discovery, with a fourth slide that includes links to associated press releases, images, and primary sources. Topics span all subdisciplines of planetary science, and sets are available in Farsi and Spanish. The NASA SMD Planetary Science Forum has recently partnered with the DPS to continue producing the Discovery slides and connect them to NASA mission science. http://dps.aas.org/education/dpsdisc Similarly, the NASA SMD Astrophysics Forum is coordinating the development of a series of slide sets to help Astronomy 101 instructors incorporate new discoveries in their classrooms. The “Astro 101 slide sets” are presentations 5-7 slides in length on a new development or discovery from a NASA Astrophysics mission relevant to topics in introductory astronomy courses. We intend for these slide sets to help Astronomy 101 instructors include new developments (not yet in their textbooks) into the broader context of the course. http://www.astrosociety.org/education/astronomy-resource-guides/

Meinke, Bonnie K.; Schneider, Nicholas; Brain, David; Schultz, Gregory; Buxner, Sanlyn; Smith, Denise

2014-11-01

161

Constitutive modelling approach for evaluating the triggering of flow slides  

E-print Network

The paper presents a methodology to evaluate flow slide susceptibility in potentially liquefiable sandy slopes. The proposed approach accounts for both contractive and dilative volumetric behaviour during shearing using ...

Buscarnera, Giuseppe

162

Tracheal growth after slide tracheoplasty  

Microsoft Academic Search

Objective: Our goal was to investigate the effects of slide tracheoplasty on tracheal growth in newborn piglets. Methods: Slide tracheoplasty was performed on normal trachea (n = 6) and a model of tracheal stenosis resembling that seen in infants (n = 6). After division of the trachea at its midportion between the second cartilaginous ring above and the right upper

Paolo Macchiarini; Elisabeth Dulmet; Vincent de Montpreville; Guy-Michel Mazmanian; Alain Chapelier; Philippe Dartevelle

1997-01-01

163

Nucleosome sliding: facts and fiction.  

PubMed

Nucleosome sliding is a frequent result of energy-dependent nucleosome remodelling in vitro. This review discusses the possible roles for nucleosome sliding in the assembly and maintenance of dynamic chromatin and for the regulation of diverse functions in eukaryotic nuclei. PMID:12234915

Becker, Peter B

2002-09-16

164

Slides: How to Produce a Webinar  

NSDL National Science Digital Library

These are the slides for the webinar that was recorded on 04/10/09. This document illustrates how to effectively produce webinars. A webinar is a collaborative presentation that can include polling and question & answer sessions to allow full participation between the audience and the presenter. Webinars can be recorded so that those who missed your event can view it on their own time.

2010-05-14

165

Preemption of the "fraud on the FDA" exception to Michigan's tort immunity statute for drug manufacturers: reconsidering Garcia and Desiano after Levine.  

PubMed

In Buckman v. Plaintiff's Legal Committee, the Supreme Court of the United States held that "fraud on FDA" claims in medical device products liability actions were impliedly preempted by the Medical Device Amendments to the Food, Drug, and Cosmetic Act (FDCA). A Michigan statute that provides a complete regulatory compliance defense for drug manufacturers, absent a finding that the manufacturer defrauded or bribed the FDA. The Sixth Circuit found that the statute's fraud exception was preempted under Buckman, extending Buckman's holding to traditional products liability claims with circumstances involving fraud on the FDA. The Second Circuit reached the opposite conclusion in interpreting the same statute, confining Buckman to its narrow holding, preempting stand-alone fraud on the FDA claims while carving out a space for traditional state tort claims. The Supreme Court left the issue unresolved in its review of the Second Circuit, splitting 4-4. Since then, the great majority of courts have followed the Sixth Circuit's holding. This situation has created serious questions about the ability of Michigan citizens to obtain any relief in an action against a drug manufacturer. The Supreme Court recently refused to find blanket implied preemption for failure-to-warn claims involving prescription drugs in Wyeth v. Levine, holding that "common-law claims do not stand as an obstacle to the accomplishment of Congress's purposes in the FDCA." This holding casts serious doubt on the continued vitality of implied preemption in drug and device litigation, and could, and should, lead to a reexamination of the application of Buckman to traditional products liability claims against drug manufacturers from Michigan plaintiffs in circumstances that involve, inter alia, fraud on the FDA. The next time this application is considered, the court should allow plaintiffs to present evidence tending to show fraud on the FDA in rebutting the manufacturer's presumptive immunity under the Michigan immunity statute. PMID:24505848

Murdey, Jason

2011-01-01

166

Multiplying Slide Rule  

NSDL National Science Digital Library

In this activity students construct multiplying slide rules scaled in Base-10 exponents and use them to calculate products and quotients. They will come to appreciate that super numbers (exponents, orders of magnitude and logarithms) play by different rules of arithmetic than ordinary numbers (numbers, powers of ten and antilogs).  This is activity A2 in the "Far Out Math" educator's guide. Lessons in the guide include activities in which students measure,compare quantities as orders of magnitude, become familiar with scientific notation, and develop an understanding of exponents and logarithms using examples from NASA's GLAST mission. These are skills needed to understand the very large and very small quantities characteristic of astronomical observations. Note: In 2008, GLAST was renamed Fermi, for the physicist Enrico Fermi.

167

Slide 1 Fig 7-1, p.154 Planet Earth  

E-print Network

Aug 2008) #12;Slide 13 #12;Slide 14 #12;Slide 15 #12;Slide 16 Hubble Space Telescope #12;Slide 17 of Sydney, Australia (PIA01828) #12;Space Radar Image of Possible String of Impact Craters, Sahara Desert

Wardle, Mark

168

What's next after 50 years of psychiatric drug development: an FDA perspective.  

PubMed

This article discusses changes in psychiatric drug development from a US Food and Drug Administration (FDA) standpoint. It first looks back at changes that have been influenced by regulatory process and then looks forward at FDA initiatives that are likely to affect psychiatric drug development in the future. FDA protects the public health by ensuring the safety and efficacy of drug products introduced into the US market. FDA works with drug sponsors during development, and, when applications are submitted, reviews the safety and efficacy data and the proposed labeling. Drug advertising and promotion and postmarketing surveillance also fall within FDA's responsibility. Among the many changes in psychiatric drug development over the past 50 years, several have been particularly influenced by FDA. Populations studied have expanded diagnostically and demographically, and approved psychiatric indications have become more focused on the clinical entities actually studied, including in some cases specific symptom domains of recognized syndromes. Trial designs have become increasingly complex and informative, and approaches to data analysis have evolved to better model the reality of clinical trials. This article addresses 2 general areas of innovation at FDA that will affect psychiatric drug development in years to come. Several programs falling under the general heading of the Critical Path Initiative, ie, biomarkers, adaptive design, end-of-phase 2A meetings, and data standards, are described. In addition, a number of important safety initiatives, including Safety First, the Sentinel Initiative, the Safe Use Initiative, and meta-analysis for safety, are discussed. PMID:20923624

Laughren, Thomas P

2010-09-01

169

Sliding Mode Thermal Control System for Space Station Furnace Facility  

NASA Technical Reports Server (NTRS)

The decoupled control of the nonlinear, multiinput-multioutput, and highly coupled space station furnace facility (SSFF) thermal control system is addressed. Sliding mode control theory, a subset of variable-structure control theory, is employed to increase the performance, robustness, and reliability of the SSFF's currently designed control system. This paper presents the nonlinear thermal control system description and develops the sliding mode controllers that cause the interconnected subsystems to operate in their local sliding modes, resulting in control system invariance to plant uncertainties and external and interaction disturbances. The desired decoupled flow-rate tracking is achieved by optimization of the local linear sliding mode equations. The controllers are implemented digitally and extensive simulation results are presented to show the flow-rate tracking robustness and invariance to plant uncertainties, nonlinearities, external disturbances, and variations of the system pressure supplied to the controlled subsystems.

Jackson Mark E.; Shtessel, Yuri B.

1998-01-01

170

Buckman extended: federal preemption of state fraud-on-the-FDA statutes.  

PubMed

A number of states have enacted statutes that provide protection to drug manufacturers in product liability actions. Additionally, several of these states have enacted "fraud-on-the-FDA" statutory provisions, which remove statutory protection afforded to drug manufacturers in product liability actions if plaintiffs can provide evidence that the drug manufacturer made misrepresentations to the FDA during the process of obtaining marketing approval for the drug. Currently, the federal circuits are in disagreement over whether these state "fraud-on-the-FDA" statutes should be federally preempted. This issue warrants resolution for drug manufacturers, private citizens, and state legislatures. This Comment will discuss the history and role of the FDA's authority in drug and medical device regulation; federal preemption generally and the Supreme Court's decisions that considered whether state law failure to warn claims are federally preempted in the context of drugs and medical devices; the Supreme Court's decision in Buckman v. Plaintiffs' Legal Committee, where the Court held that claims that a medical device manufacturer made fraudulent representations to the FDA were federally preempted because such claims interfered with the relationship between the FDA and the entities it regulated, state fraud-on-the-FDA statutory provisions, and the existing circuit split regarding whether those statutes should be federally preempted; the potential resolutions to the circuit split; and will conclude and advocate that the Supreme Court's Buckman holding be applied to federally preempt state fraud-on-the-FDA statutes because such statutes involve the relationship between a federal agency and the entity it regulates and thus undermine the FDA's authority. PMID:24772688

Gaddis, Christine A

2014-01-01

171

Studies of sliding friction in compressed copper  

SciTech Connect

We present the results of simulations for sliding copper interfaces for pressures in the kilobar range. The velocity dependence and density dependence are discussed and the evolution of plastic damage is described. Density dependence embedded atom model (EAM) potentials are used to describe the atomic interactions. Simulations were typically for N=65,000 atoms and were carried out using molecular dynamics on massively parallel CM200 and CM5 platforms. A transition to a low friction state at high velocities is discussed.

Hammerberg, J.E.; Holian, B.L.; Zhou, S.J.

1995-09-01

172

Abrasive wear model for lubricated sliding contacts  

Microsoft Academic Search

A lubricated wear model for stochastic rough surface in sliding contacts is presented. In this model, the visco-elastic characteristic of the solid, the effects of surface roughness profiles, hardness of materials and operating conditions are included. The reasonableness of the model is proved by comparing calculated values with the test results on a ring-on-block test machine. They coincide well. From

Qian Zou; Ping Huang; ShiZhu When

1996-01-01

173

A Microprocessor-Based Robot Manipulator Control with Sliding Mode  

Microsoft Academic Search

The application of a sliding-mode control based on a Variable Structure System (VSS) for a multijoint manipulator is presented. The high-gain effect of a sliding-mode control suppresses the complicated interactions between each joint of a robot arm. The resulting system is completely robust whereas the obtained control law is simple and easy to apply to on-line computer control. In this-paper,

Hideki Hashimoto; Koji Maruyama; Fumio Harashima

1987-01-01

174

Atomistic wear in a single asperity sliding contact.  

PubMed

Abrasive wear of sharp silicon tips sliding distances of up to 750 m on a polymeric surface is studied using atomic force microscopy. The data cannot be explained by conventional macroscopic wear models. We present a new model in which the barrier for breaking an atomic bond is lowered by the frictional stress acting on the contact. Quantitative agreement is obtained between the model and wear data for all load forces and sliding distances studied. PMID:18851384

Gotsmann, Bernd; Lantz, Mark A

2008-09-19

175

Atomistic Wear in a Single Asperity Sliding Contact  

NASA Astrophysics Data System (ADS)

Abrasive wear of sharp silicon tips sliding distances of up to 750 m on a polymeric surface is studied using atomic force microscopy. The data cannot be explained by conventional macroscopic wear models. We present a new model in which the barrier for breaking an atomic bond is lowered by the frictional stress acting on the contact. Quantitative agreement is obtained between the model and wear data for all load forces and sliding distances studied.

Gotsmann, Bernd; Lantz, Mark A.

2008-09-01

176

Adaptive sliding mode control for bank-to-turn missiles  

Microsoft Academic Search

This paper presents an adaptive sliding mode controller for bank-to-turn (BTT) missiles, which have the characteristics of strong coupling nonlinearity and non-minimum phase phenomenon. From a nonlinear multivariate model of air-to-air missile, a two-loop mathematical model is educed based on singular perturbation theory and time scales. We achieve fin commands for actuators via two-loop adaptive sliding mode control scheme under

Duan Chaoyang; Zhang Yingxin; Dong Chaoyang; Sun Rui

2009-01-01

177

Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG Warehouse.  

PubMed

The FDA mandates that digital electrocardiograms (ECGs) from 'thorough' QTc trials be submitted into the ECG Warehouse in Health Level 7 extended markup language format with annotated onset and offset points of waveforms. The FDA did not disclose the exact Warehouse metrics and minimal acceptable quality standards. The author describes the Warehouse scoring algorithms and metrics used by FDA, points out ways to improve FDA review and suggests Warehouse benefits for pharmaceutical sponsors. The Warehouse ranks individual ECGs according to their score for each quality metric and produces histogram distributions with Warehouse-specific thresholds that identify ECGs of questionable quality. Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory. PMID:17877446

Sarapa, Nenad

2007-09-01

178

21 CFR 516.34 - FDA recognition of exclusive marketing rights.  

Code of Federal Regulations, 2012 CFR

...of exclusive marketing rights. 516.34 Section...SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND...or Minor Species New Animal Drug § 516.34 ...of exclusive marketing rights. (a) FDA...

2012-04-01

179

21 CFR 516.34 - FDA recognition of exclusive marketing rights.  

Code of Federal Regulations, 2011 CFR

...of exclusive marketing rights. 516.34 Section...SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND...or Minor Species New Animal Drug § 516.34 ...of exclusive marketing rights. (a) FDA...

2011-04-01

180

21 CFR 516.34 - FDA recognition of exclusive marketing rights.  

Code of Federal Regulations, 2013 CFR

...of exclusive marketing rights. 516.34 Section...SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND...or Minor Species New Animal Drug § 516.34 ...of exclusive marketing rights. (a) FDA...

2013-04-01

181

21 CFR 516.34 - FDA recognition of exclusive marketing rights.  

Code of Federal Regulations, 2010 CFR

...of exclusive marketing rights. 516.34 Section...SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND...or Minor Species New Animal Drug § 516.34 ...of exclusive marketing rights. (a) FDA...

2010-04-01

182

21 CFR 516.34 - FDA recognition of exclusive marketing rights.  

...of exclusive marketing rights. 516.34 Section...SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND...or Minor Species New Animal Drug § 516.34 ...of exclusive marketing rights. (a) FDA...

2014-04-01

183

NCI Director Asked by President to Also Assume Role of Interim Commissioner of FDA  

Cancer.gov

Andrew von Eschenbach, M.D., director of the NCI, was asked by President Bush on Friday, September 23, 2005, to assume the additional role of interim Commissioner of the U.S. Food and Drug Administration (FDA).

184

FDA Parental Advisory on Flavored Tobacco Products -- What You Need To Know  

MedlinePLUS

... Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Tobacco Products en Español Home Tobacco Products Youth & Tobacco Flavored ... Edition 2) FDA Parental Advisory on Flavored Tobacco Products - What You Need To Know View PDF (520KB) ...

185

Indoor Tanning Raises Risk of Melanoma: FDA Strengthens Warnings for Sunlamp Products  

MedlinePLUS

... Risk of Melanoma: FDA Strengthens Warnings for Sunlamp Products Search the Consumer Updates Section Get Consumer Updates ... Better-Informed Consumers Practices to Avoid Using sunlamp products such as tanning beds or tanning booths increases ...

186

Blood donation, deferral, and discrimination: FDA donor deferral policy for men who have sex with men.  

PubMed

U.S. Food and Drug Administration (FDA) policy prohibits blood donation from men who have had sex with men (MSM) even one time since 1977. Growing moral criticism claims that this policy is discriminatory, a claim rejected by the FDA. An overview of U.S. blood donation, recent donor deferral policy, and the conventional ethical debate introduce the need for a different approach to analyzing discrimination claims. I draw on an institutional understanding of injustice to discern and describe five features of the MSM policy and its FDA context that contribute to its discriminatory effect. I note significant similarities in the 1980s policy of deferring Haitians, suggesting an historical pattern of discrimination in FDA deferral policy. Finally, I point to changes needed to move toward a nondiscriminatory deferral policy. PMID:20131170

Galarneau, Charlene

2010-02-01

187

76 FR 31615 - Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products...  

Federal Register 2010, 2011, 2012, 2013

...FDA Staff: Commercially Distributed In Vitro Diagnostic Products Labeled for Research...entitled ``Commercially Distributed In Vitro Diagnostic Products Labeled for Research...and investigational use only (IUO) in vitro diagnostic (IVD) products and any...

2011-06-01

188

New Low-Nicotine Cigarettes Are Still as Harmful: Implications for FDA Regulation of Tobacco  

E-print Network

stains as indices of exposure PREP advertisement features and smokers' beliefs c) Marketing and labeling FDA bill ss907: Product design) 1. Reliability of carbon monoxide (CO) boost: The effect of filter

Illinois at Chicago, University of

189

Rough viscoelastic sliding contact: Theory and experiments  

NASA Astrophysics Data System (ADS)

In this paper, we show how the numerical theory introduced by the authors [Carbone and Putignano, J. Mech. Phys. Solids 61, 1822 (2013), 10.1016/j.jmps.2013.03.005] can be effectively employed to study the contact between viscoelastic rough solids. The huge numerical complexity is successfully faced up by employing the adaptive nonuniform mesh developed by the authors in Putignano et al. [J. Mech. Phys. Solids 60, 973 (2012), 10.1016/j.jmps.2012.01.006]. Results mark the importance of accounting for viscoelastic effects to correctly simulate the sliding rough contact. In detail, attention is, first, paid to evaluate the viscoelastic dissipation, i.e., the viscoelastic friction. Fixed the sliding speed and the normal load, friction is completely determined. Furthermore, since the methodology employed in the work allows to study contact between real materials, a comparison between experimental outcomes and numerical prediction in terms of viscoelastic friction is shown. The good agreement seems to validate—at least partially—the presented methodology. Finally, it is shown that viscoelasticity entails not only the dissipative effects previously outlined, but is also strictly related to the anisotropy of the contact solution. Indeed, a marked anisotropy is present in the contact region, which results stretched in the direction perpendicular to the sliding speed. In the paper, the anisotropy of the deformed surface and of the contact area is investigated and quantified.

Carbone, G.; Putignano, C.

2014-03-01

190

NCI, NHLBI, FDA, AACC, and CMS Collaborate in Advancing Proteomics Regulatory Science  

Cancer.gov

Despite great strides in proteomics and the growing number of articles citing the discovery of potential biomarkers, the actual rate of introduction of Food and Drug Administration (FDA) approved protein analytes has been relatively unchanged over the past 10 years. One of reasons for the lack of new protein-based biomarkers approved has been a lack of information and understanding by the proteomics research community to the regulatory process used by the FDA.

191

Exploring the FDA Adverse Event Reporting System (FAERS) to Generate Hypotheses for Disease Monitoring  

PubMed Central

The FDA Adverse Event Reporting System (FAERS) is a database for post-marketing drug safety monitoring and influences FDA safety guidance documents, such as changes in drug labels. The number of cases in the FAERS has rapidly increased with the improvement of submission methods and data standard and thus has become an important resource for regulatory science. While the FAERS has been predominantly used for safety signal detection, this study explored its utility for disease monitoring. PMID:24448476

Fang, Hong; Su, Zhenqiang; Wang, Yuping; Miller, Aaron; Liu, Zhichao; Howard, Paul; Tong, Weida; Lin, Simon M

2014-01-01

192

Exploring the FDA adverse event reporting system to generate hypotheses for monitoring of disease characteristics.  

PubMed

The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) is a database for postmarketing drug safety monitoring and influences changes in FDA safety guidance documents such as drug labels. The number of cases in the FAERS has rapidly increased with the improvement of submission methods and data standards and thus has become an important resource for regulatory science. Although the FAERS has been predominantly used for safety signal detection, this study explored its utility for disease characteristics. PMID:24448476

Fang, H; Su, Z; Wang, Y; Miller, A; Liu, Z; Howard, P C; Tong, W; Lin, S M

2014-05-01

193

Assessment of foetal risk associated with 93 non-US-FDA approved medications during pregnancy  

PubMed Central

Health care practitioners utilize the United States-Food and Drug Administration (US-FDA) pregnancy categorization (A, B, C, D, X) for making decision on the appropriateness of certain medications during pregnancy. Many non US-FDA approved medications are registered and marketed in Saudi Arabia. However, these medications do not have an assigned pregnancy risk categorization like those approved in the US. The objective of this review is to evaluate, report, and categorize the foetal risk associated with non-US-FDA approved medications registered by the Saudi Food and Drug Authority (S-FDA) according to the US-FDA pregnancy risk categorization system. We identified 109 non-US-FDA approved medications in the Saudi National Formulary (SNF) as of October 2007. We searched for data on functional or anatomical birth defects or embryocidal-associated risk using different databases and references. An algorithm for risk assessment was used to determine a pregnancy risk category for each medication. Out of 93 eligible medications, 73% were assigned category risk C, 10 medications (11%) were assigned category risk D, and 12 medications (13%) were assigned category risk B. Only three medications were judged to be safe during pregnancy based on the available evidence and were assigned category risk A. Inconsistencies in defining and reporting the foetal risk category among different drug regulatory authorities could create confusion and affect prescribing. We believe that standardization and inclusion of this information in the medication package insert is extremely important to all health care practitioners. PMID:23960803

Al-jedai, Ahmed H.; Balhareth, Sakra S.; Algain, Roaa A.

2012-01-01

194

A school nurse's guide to PowerPoint presentations.  

PubMed

In today's educational environment, school nurses are often called upon to provide presentations utilizing electronic slides. A tool frequently utilized for presentations is PowerPoint. However, as with any instructional method, it is only as effective as the presenter who has designed the slides. A study conducted to evaluate professional PowerPoint slides is the focus of this article. After reviewing 1,732 slides and comparing them to best practices criteria, the researchers call attention to common errors in slide presentations. Additionally, the article provides guidance to school nurses in reinventing the art of providing powerful, interactive, and interesting presentations. PMID:25141452

Nowak, Marian; Sayers, Pat; Ashton, Kathleen

2014-07-01

195

OpenSlide: A vendor-neutral software foundation for digital pathology  

PubMed Central

Although widely touted as a replacement for glass slides and microscopes in pathology, digital slides present major challenges in data storage, transmission, processing and interoperability. Since no universal data format is in widespread use for these images today, each vendor defines its own proprietary data formats, analysis tools, viewers and software libraries. This creates issues not only for pathologists, but also for interoperability. In this paper, we present the design and implementation of OpenSlide, a vendor-neutral C library for reading and manipulating digital slides of diverse vendor formats. The library is extensible and easily interfaced to various programming languages. An application written to the OpenSlide interface can transparently handle multiple vendor formats. OpenSlide is in use today by many academic and industrial organizations world-wide, including many research sites in the United States that are funded by the National Institutes of Health. PMID:24244884

Goode, Adam; Gilbert, Benjamin; Harkes, Jan; Jukic, Drazen; Satyanarayanan, Mahadev

2013-01-01

196

Registration of organs with sliding interfaces and changing topologies  

NASA Astrophysics Data System (ADS)

Smoothness and continuity assumptions on the deformation field in deformable image registration do not hold for applications where the imaged objects have sliding interfaces. Recent extensions to deformable image registration that accommodate for sliding motion of organs are limited to sliding motion along approximately planar surfaces or cannot model sliding that changes the topological configuration in case of multiple organs. We propose a new extension to free-form image registration that is not limited in this way. Our method uses a transformation model that consists of uniform B-spline transformations for each organ region separately, which is based on segmentation of one image. Since this model can create overlapping regions or gaps between regions, we introduce a penalty term that minimizes this undesired effect. The penalty term acts on the surfaces of the organ regions and is optimized simultaneously with the image similarity. To evaluate our method registrations were performed on publicly available inhale-exhale CT scans for which performances of other methods are known. Target registration errors are computed on dense landmark sets that are available with these datasets. On these data our method outperforms the other methods in terms of target registration error and, where applicable, also in terms of overlap and gap volumes. The approximation of the other methods of sliding motion along planar surfaces is reasonably well suited for the motion present in the lung data. The ability of our method to handle sliding along curved boundaries and for changing region topology configurations was demonstrated on synthetic images.

Berendsen, Floris F.; Kotte, Alexis N. T. J.; Viergever, Max A.; Pluim, Josien P. W.

2014-03-01

197

Effect of surface etching on the lubricated sliding wear of an eutectic aluminium–silicon alloy  

Microsoft Academic Search

The paper presents a study of the formation of wear grooves on near-eutectic aluminium–silicon alloy flats, by sliding a steel ball. The formation of the grooves are tracked on etched and unetched flats as functions of normal load and sliding distance. The groove is initially formed by plastic flow, and then expanded by micro-abrasion as the ball continues to slide

S. Das; T. Perry; S. K. Biswas

2006-01-01

198

Using a Slide in Beef Cattle Marketing  

E-print Network

this agreement is $488.36 per head. 6.17 cwt (617 lbs.) x $79.15/cwt = $488.36 L-5063 8-98 Using a Slide in Beef Cattle Marketing Rick Machen and Ronald Gill* *Extension Livestock Specialists, The Texas A&M University System. Down Slide A down slide is exercised... this agreement is $488.36 per head. 6.17 cwt (617 lbs.) x $79.15/cwt = $488.36 L-5063 8-98 Using a Slide in Beef Cattle Marketing Rick Machen and Ronald Gill* *Extension Livestock Specialists, The Texas A&M University System. Down Slide A down slide is exercised...

Machen, Richard V.; Gill, Ronald J.

1998-08-21

199

Complementary and integrative medical therapies, the FDA, and the NIH: definitions and regulation.  

PubMed

The National Center for Complementary and Alternative Medicine (NCCAM) presently defines complementary and alternative medicine (CAM) as covering "a broad range of healing philosophies (schools of thought), approaches, and therapies that mainstream Western (conventional) medicine does not commonly use, accept, study, understand, or make available. The research landscape, including NCCAM-funded research, is continually changing and subject to vigorous methodologic and interpretive debates. Part of the impetus for greater research dollars in this arena has been increasing consumer reliance on CAM to dramatically expand. State (not federal) law controls much of CAM practice. However, a significant federal role exists in the regulation of dietary supplements. The U.S. Food and Drug Administration (FDA) regulates foods, drugs, and cosmetics in interstate commerce. No new "drug" may be introduced into interstate commerce unless proven "safe" and "effective" for its intended use, as determined by FDA regulations. "Foods", however, are subject to different regulatory requirements, and need not go through trials proving safety and efficacy. The growing phenomenon of consumer use of vitamins, minerals, herbs, and other "dietary supplements" challenged the historical divide between drugs and foods. The federal Dietary Supplements Health Education Act (DSHEA) allows manufacturers to distribute dietary supplements without having to prove safety and efficacy, so long as the manufacturers make no claims linking the supplements to a specific disease. State law regulates the use of CAM therapies through a variety of legal rules. Of these, several major areas of concern for clinicians are professional licensure, scope of practice, and malpractice. Regarding licensure, each state has enacted medical licensing that prohibits the unlicensed practice of medicine and thereby criminalizes activity by unlicensed CAM providers who offer health care services to patients. Malpractice is defined as unskillful practice which fails to conform to a standard of care in the profession and results in injury. The definition is no different in CAM than in general medicine; its application to CAM, however, raises novel questions. Courts rely on medical consensus regarding the appropriateness of a given therapy. A framework for assessing potential liability risk involves assessing the medical evidence concerning safety and efficacy, and then aligning clinical decisions with liability concerns. Ultimately research will or will not establish a specific CAM therapy as an important part of the standard of care for the condition in question. Legal rules governing CAM providers and practices are, in many cases, new and evolving. Further, laws vary by state and their application depends on the specific clinical scenario in question. New research is constantly emerging, as are federal and state legislative developments and judicial opinions resulting from litigation. PMID:12919107

Cohen, Michael H

2003-01-01

200

Genetic-Fuzzy Sliding Mode Controller for a DC Servomotor system  

Microsoft Academic Search

A Genetic-Fuzzy Sliding Mode Controller is presented for DC Servomotor system control. The fuzzy logic controller was optimized by Genetic Algorithm method to reduce and eliminate the chattering phenomenon. To demonstrate the effectiveness of the presented approach, a comparison between the proposed system, and standard Sliding Mode controller were conducted. Simulation results have shown the advantages of choosing the proposed

Mohammad A. Jaradat; Mohammad I. Awad; Bashar Sami El-Khasawneh

2012-01-01

201

Smith predictor based-sliding mode controller for integrating processes with elevated deadtime  

Microsoft Academic Search

An approach to control integrating processes with elevated deadtime using a Smith predictor sliding mode controller is presented. A PID sliding surface and an integrating first-order plus deadtime model have been used to synthesize the controller. Since the performance of existing controllers with a Smith predictor decrease in the presence of modeling errors, this paper presents a simple approach to

Oscar Camacho; Francisco De la Cruz

2004-01-01

202

Grain boundary sliding behaviour of copper and alpha brass at intermediate temperatures  

NASA Technical Reports Server (NTRS)

The role of grain boundary sliding in copper and Cu-30 pct Zn in the temperature range 0.50-0.72 Tm, where Tm is the absolute melting point of the material, is examined. First, sliding data obtained on these materials are presented. The results indicate that the stress exponent for sliding is similar to that for lattice deformation, while the activation energy for sliding varies between 0.5 and 1.6 of the activation energy for creep. Several models proposed for grain boundary sliding are discussed, and it is shown that they do not account for the observed results on copper and alpha brass. A phenomenological model is proposed, where it is assumed that grain boundary sliding results from the glide of dislocations on secondary slip planes.

Raj, S. V.

1991-01-01

203

Credible deterrence: FDA and the Park Doctrine in the 21st century.  

PubMed

One of FDA's most powerful enforcement tools is strict liability criminal prosecution of corporate officers under the Park Doctrine. Recent comments by high-ranking FDA officials about using this power more aggressively and recent cases apparently making good on this promise have spurred commentators to call for the doctrine's demise. Critics argue that strict liability for corporate officers violates fundamental notions of fairness and the appropriate relationship between guilt and liability in criminal law. As a response to these critics, this article argues that the Park Doctrine continues to serve a valuable purpose in deterring conduct that endangers the public health and that structural, political, and practical limitations on FDA's use of Park prosecutions have been, and will continue to be, effective protections against the abuses critics fear. This article proposes a model for understanding why and how FDA uses its prosecutorial powers and assesses a sample of recent high-profile prosecutions under this model to argue that the modern "escalation" of Park prosecutions is in fact a continuation of FDA's historical policy. PMID:24640466

O'Leary, Patrick

2013-01-01

204

Making Powerpoint-like Presentations with LATEX  

E-print Network

Making Powerpoint-like Presentations with LATEX Elizabeth Brown ebrown@hsph.harvard.edu Making;Overview Goal: easily make presentation-quality slides Options: PowerPoint - what to do about equations-quality slides Options: PowerPoint - what to do about equations? LATEX pdf -several packages will do this Making

Davidian, Marie

205

Time-resolved particle image velocimetry measurements with wall shear stress and uncertainty quantification for the FDA benchmark nozzle model  

E-print Network

We present validation of benchmark experimental data for computational fluid dynamics (CFD) analyses of medical devices using advanced Particle Image Velocimetry (PIV) processing and post-processing techniques. This work is an extension of a previous FDA-sponsored multi-laboratory study, which used a medical device mimicking geometry referred to as the FDA benchmark nozzle model. Time-resolved PIV analysis was performed in five overlapping regions of the model for Reynolds numbers in the nozzle throat of 500, 2,000, 5,000, and 8,000. Images included a two-fold increase in spatial resolution in comparison to the previous study. Data was processed using ensemble correlation, dynamic range enhancement, and phase correlations to increase signal-to-noise ratios and measurement accuracy, and to resolve flow regions with large velocity ranges and gradients, which is typical of many blood-contacting medical devices. Parameters relevant to device safety, including shear stress at the wall and in bulk flow, were comput...

Raben, Jaime S; Robinson, Ronald; Malinauskas, Richard; Vlachos, Pavlos P

2014-01-01

206

Drug disposition and drug-drug interaction data in 2013 FDA new drug applications: a systematic review.  

PubMed

The aim of the present work was to perform a systematic review of drug metabolism, transport, pharmacokinetics, and DDI data available in the NDAs approved by the FDA in 2013, using the University of Washington Drug Interaction Database, and to highlight significant findings. Among 27 NMEs approved, 22 (81%) were well characterized with regard to drug metabolism, transport, or organ impairment, in accordance with the FDA drug interaction guidance (2012) and were fully analyzed in this review. In vitro, a majority of the NMEs were found to be substrates or inhibitors/inducers of at least one drug metabolizing enzyme or transporter. However, in vivo, only half (n = 11) showed clinically relevant drug interactions, with most related to the NMEs as victim drugs and CYP3A being the most affected enzyme. As perpetrators, the overall effects for NMEs were much less pronounced, compared with when they served as victims. In addition, the pharmacokinetic evaluation in patients with hepatic or renal impairment provided useful information for further understanding of the drugs' disposition. PMID:25271211

Yu, Jingjing; Ritchie, Tasha K; Mulgaonkar, Aditi; Ragueneau-Majlessi, Isabelle

2014-12-01

207

Under the law, FDA must grant different standards for new dietary ingredients and food additives.  

PubMed

The FDA's draft Guidance on notifications for new dietary ingredients attempts to narrow the scope of "old" dietary ingredients that do not require notification to FDA and repeats some mistakes from the past by going beyond what is required or permitted by the Food, Drug & Cosmetic Act, as amended by the Dietary Supplements Health and Education Act of 1994. The draft Guidance attempts to apply the notification requirement to new supplements, not just new ingredients, and it expands the working definition of "chemically altered" to include many changes that were not foreseen in the Congressional Record in 1994. Through these misinterpretations, FDA attempts to impose a food additives-like safety standard, and gain de facto premarket approval against the overt wishes of Congress. PMID:22310217

Mister, Steven; Hathcock, John

2012-04-01

208

Ancestry-based pharmacogenomics, adverse reactions and carbamazepine: is the FDA warning correct?  

PubMed

In an effort to prevent potentially fatal adverse reactions to carbamazepine, the US Food and Drug Administration (FDA) issued an alert in 2007 containing pharmacogenomic information, which is still in effect today. The alert states that carbamazepine-induced skin reactions are significantly more common in patients with the human leukocyte antigen (HLA)-B*1502 allele and that these people are almost exclusively from 'broad areas of Asia, including South Asian Indians.' This study reviews the medical evidence relied upon by the FDA and finds that the alert does not accurately reflect the medical evidence relied upon in 2007 or evidence that has been generated over the last 5 years since the label was created. The FDA drug labeling should be modified to reflect current medical evidence. PMID:24752310

Payne, P W

2014-10-01

209

Mannheim Type Slide Rule with Leather Sleeve  

USGS Multimedia Gallery

Original Box & Booklets. Marketed as being made of Ivorite, this slide rule was manufactured by Keuffel & Esser Company, New York & New Jersey in the 1960s. All slide rules consist of three parts (the stock, the slide and the cursor or indicator) and have logarithmic scales that can be moved in rela...

2009-07-22

210

Diseases of Landscape Ornamentals. Slide Script.  

ERIC Educational Resources Information Center

This slide script, part of a series of slide scripts designed for use in vocational agriculture classes, deals with recognizing and controlling diseases found on ornamental landscape plants. Included in the script are narrations for use with a total of 80 slides illustrating various foliar diseases (anthracnose, black spot, hawthorn leaf blight,…

Powell, Charles C.; Sydnor, T. Davis

211

Multiprocessor Architecture Companion slides for  

E-print Network

now ­ A bookcase · in the hall · To keep the books she will need soon #12;Art of MultiprocessorMultiprocessor Architecture Basics Companion slides for The Art of Multiprocessor Programming by Maurice Herlihy & Nir Shavit #12;Art of Multiprocessor Programming 2 Multiprocessor Architecture

Narasayya, Vivek

212

Heavy duty complete extension slides  

NASA Astrophysics Data System (ADS)

The selection from available commercial market of a set of slides to be used in an habitable pressurised module in space, to draw a 660 mm box out of a rack, up to a completely extracted position in a safely supported configuration, seems in principle not to be a complicated task. That was the first approach taken in the design process of the telescopic guides of the Crew Work Bench (CWB) included in the Fluid Science Laboratory (FSL), part of "ESA Microgravity Facilities for Columbus" within the Columbus Orbital Facility (COF) of the International Space Station (ISS). Nevertheless, common space compatible requirements such as materials, specific environmental loads, available envelope, total weight, etc., can make the selection of telescopic slides from commercial market unfeasible. A specific development to design space compatible telescopic slides for the CWB was undertaken. A set of heavy duty space compatible telescopic slides were designed, manufactured and tested. They should be operative in both, 1-g environment and in orbit, and additionally should withstand an inadvertent astronaut kick or bump of 556 N in any direction.

Bueno, José Ignacio; Vázquez, Javier

2001-09-01

213

slides compiled from Alex Aiken's,  

E-print Network

Testing slides compiled from Alex Aiken's, Neelam Gupta's, Tao Xie's. #12;CS590F Software Reliability Why Testing Researchers investigate many approaches to improving software quality But the world tests > 50% of the cost of software development is testing Testing is consistently a hot research topic

Zhang, Xiangyu

214

FDA: polyurethane condom carries "extremely misleading" label. Federal agency allows distribution for public health's sake.  

PubMed

The labeling of the Avanti polyurethane condom selling in 10 Western states makes misleading claims about protection from pregnancy and sexually transmitted diseases (STDs) according to officials at the US Food and Drug Administration (FDA). Avanti is sold in a foil package printed with the claim that it is effective against pregnancy, HIV, and STDs. However, polyurethane condoms have not undergone clinical efficacy testing for contraception or STDs, according to officials. The manufacturer of the condom refuted this allegation, stating that latex condoms have the same claims on them. In early 1995 the FDA met with the manufacturer and other companies developing plastic condoms, and concluded that these condoms could not make such claims, nor any claims about slippage and breakage rates. Despite warnings in 1993 to the manufacturer of Avanti about labeling restrictions, the company printed pregnancy and STD efficacy claims on the boxes and individual packages. The FDA later worked out a compromise with the firm in which only the boxes had to be reprinted with the generic label. The FDA had to weigh the risk of the public health cost of delaying sale of the condom, which is the first impermeable condom proven safe for people with latex allergies. In 1991 the FDA was defining standards for clinical testing and labeling of polyurethane condoms under congressional mandate, but the manufacturer of Avanti began mass production based on a preliminary approval determining that the condom was equivalent to latex condoms already on the market. 7000 Avanti condoms were subsequently tested in five countries, but these user tests did not compare Avanti to latex condoms and did not test for pregnancy and STD protection. Test results submitted to the FDA by the company indicated that, although Avanti is more than 1/3 less elastic than latex condoms, it did not break more frequently in an in-use study involving 187 couples. PMID:12290714

1995-02-01

215

The physics of sliding cylinders and curling rocks  

NASA Astrophysics Data System (ADS)

The lateral deflection of a rotating cylindrical shell sliding on one of its ends is considered and both theoretical and experimental results are presented. The coefficient of kinetic friction between a curling rock and an ice surface is then derived and compared with experiment. Current models of the motion of a curling rock are discussed and an alternate hypothesis is presented.

Penner, A. Raymond

2001-03-01

216

IRB/FDA requirements relevant to HIV/AIDS clinical trials in correctional settings.  

PubMed

Federally funded research involving inmates in US correctional facilities requires the approval of the Office for Protection from Research Risks (now called the Office for Human Research Protections [OHRP] and located in the Office of the Secretary of the Department of Health and Human Services). Trials that are carried out by pharmaceutical companies (not federally funded) fall under the jurisdiction of the FDA. This article reviews OHRP and FDA guidelines relevant to the conduct of HIV/AIDS clinical trials in correctional settings. PMID:11215087

Cohen, J

2001-01-01

217

Pressure vessel sliding support unit and system using the sliding support unit  

DOEpatents

Provided is a sliding support and a system using the sliding support unit. The sliding support unit may include a fulcrum capture configured to attach to a support flange, a fulcrum support configured to attach to the fulcrum capture, and a baseplate block configured to support the fulcrum support. The system using the sliding support unit may include a pressure vessel, a pedestal bracket, and a plurality of sliding support units.

Breach, Michael R.; Keck, David J.; Deaver, Gerald A.

2013-01-15

218

OP-TEC Presentations  

NSDL National Science Digital Library

This page from OP-TEC, the National Center for Optics and Photonics Education, contains a list of presentations given by OP-TEC at various conferences. Presentation topics include Improving Technician Education through E-materials and Innovative Online Teaching Strategies, Improving Technician Education through E-Books and E-Learning, and Enhancing High School Academic Programs by Infusing Photonics. A pdf of the presenter's slides are provided.

2011-10-11

219

AMERICANARUM DIATOMARUM EXISCCATA: CANA, VOUCHER SLIDES FROM EIGHT ACIDIC LAKES IN NORTHEASTERN NORTH AMERICA  

EPA Science Inventory

Ninety-eight slides from eight lakes in the Adirondack Mountains of the northeastern United States have been distributed as an exsiccata to 16 museums and collections around the world. his exsiccata presents slides of material from sediments of Adirondack Mountain lakes that were...

220

4/13/2006 http://www.chpc.utah.edu Slide 1 MPI profiling  

E-print Network

4/13/2006 http://www.chpc.utah.edu Slide 1 MPI profiling with TAU and Vampir Presentation Martin · What is TAU and Vampir. · How to use TAU to produce traces. · How to view traces in Vampir. #12 programs (Vampir) #12;4/13/2006 http://www.chpc.utah.edu Slide 8 TAU usage · Currently only support MPI

Alvarado, Alejandro Sánchez

221

Robust Low Altitude Behavior Control of a Quadrotor Rotorcraft Through Sliding Modes  

Microsoft Academic Search

This paper gives the full dynamical model of a commercially available quadrotor rotorcraft and presents its behavior control at low altitudes through sliding mode control. The control law is very well known for its robustness against disturbances and invariance during the sliding regime. The plant, on the other hand, is a nonlinear one with state variables are tightly coupled. The

Onder Efe

222

Robust low altitude behavior control of a quadrotor rotorcraft through sliding modes  

Microsoft Academic Search

This paper gives the full dynamical model of a commercially available quadrotor rotorcraft and presents its behavior control at low altitudes through sliding mode control. The control law is very well known for its robustness against disturbances and invariance during the sliding regime. The plant, on the other hand, is a nonlinear one with state variables are tightly coupled. The

M. O. Efe

2007-01-01

223

Feedback linearization and continuous sliding mode control for a quadrotor UAV  

Microsoft Academic Search

This paper presents a continuous sliding mode control method based on feedback linearization, an output tracking control is designed for the system. A discontinuous sliding mode control can be changed into a continuous one by dynamical extending the nonlinear system. The problem of zero dynamics from the state feedback exact linearization process can be solved by placing two integrators in

Zhou Fang; Zhang Zhi; Liang Jun; Wang Jian

2008-01-01

224

Delay-Independent Sliding Mode Control of Nonlinear Time-Delay Systems  

E-print Network

Delay-Independent Sliding Mode Control of Nonlinear Time-Delay Systems F. Hong, S. S. Ge, and T. H results are reported. In [5] and [6], the authors have studied a class of nonlinear time-delay systems. In this paper, we present a practical adaptive sliding mode control for a class of nonlinear time-delay systems

Ge, Shuzhi Sam

225

Automated single-slide staining device  

NASA Technical Reports Server (NTRS)

A simple apparatus and method is disclosed for making individual single Gram stains on bacteria inoculated slides to assist in classifying bacteria in the laboratory as Gram-positive or Gram-negative. The apparatus involves positioning a single inoculated slide in a stationary position and thereafter automatically and sequentially flooding the slide with increments of a primary stain, a mordant, a decolorizer, a counterstain and a wash solution in a sequential manner without the individual lab technician touching the slide and with minimum danger of contamination thereof from other slides.

Wilkins, J. R.; Mills, S. M. (inventors)

1977-01-01

226

Archive: Introduction to FDA Food Recalls December 9, 2009  

NSDL National Science Digital Library

This Web Seminar took place on December 9, 2009 from 6:30 p.m. to 8:00 p.m. Eastern Time. Presenting was Cecilia Wolyniak of the U.S. Food and Drug Administration's Center for Food Safety and Applied Nutrition. In this Seminar, Ms. Wolyniak presented info

1900-01-01

227

Network Traffic Modeling Selected Slides from Presentation Spring 2004, Aalborg  

E-print Network

: ­ Performance Analysis · Concerned with questions such as delay, throughput, packet loss. ­ Network Engineering day 1 week1 usec 1 sec Network Engineering effects happen on long timescales from an hour to months-timescale behavior ­ Part 2: Traffic patterns seen in practice · Afternoon: Network Engineering ­ Models of long

Schwefel, Hans-Peter

228

How to give a Good Presentation  

E-print Network

the audience · Do not assume too much knowledge · but do not patronise either · Better to be too basic than tooHow to give a Good Presentation Karen Petrie #12;This is a Seminar not a lecture · How start creating slides · How to prepare the talk · Hints and tips for better slides · Practice makes

Oxford, University of

229

New FDA informed consent regulation: ClinicalTrials.gov requirement To comply with a new FDA informed consent regulation, the MCW/FH IRB has updated the A Template  

E-print Network

New FDA informed consent regulation: ClinicalTrials.gov requirement To comply with a new FDA informed consent regulation, the MCW/FH IRB has updated the A Template consent. Section F1 has been re will need to include specific language regarding ClinicalTrials.gov in the consent form. The regulation

230

A semi-probabilistic assessment method for flow slides  

NASA Astrophysics Data System (ADS)

Flow slides in submerged slopes in non-lithified sandy and silty sediments form a major threat for flood defences along (estuary) coastlines and riverbanks in the Netherlands. Such flow slides may result in failure of levees and structures, eventually leading to flooding of the hinterland. Flow slide is a complex failure mechanism that includes both soil mechanical and hydraulic features. Two important sub-mechanisms are static liquefaction and breach flow. Static liquefaction entails the sudden loss of strength of loosely packed saturated sand or silt resulting in a collapse of the sand body. Breach flow is a more superficial process, involving the upslope retrogression of a local steep part of the slope which generates a turbulent sand-water mixture flow along the sand surface of the under water slope. Both mechanisms need a trigger, e.g. local steepening of the slope by erosion or slip failure. Although a breach flow slide generally takes more time than a liquefaction flow slide, both mechanisms result in a flowing sand-water mixture, that eventually resedimentates under a very gentle slope. Therefore in the analysis of historical flow slides it is often not clear to what extent static soil liquefaction and/or breach flow has played a role. In the current Dutch practice the prediction of levee failure due to flow sliding is based on either simple but conservative empirical rules based on documented historical flow slides in which distinction between mentioned sub-mechanisms is disregarded, or rather complex physical-based models describing mechanisms such as static liquefaction or breach flow. It will be presented how both approaches can be combined into a practical, probabilistic method for assessing dike failure due to flow sliding, accounting for uncertainties of the main influence factors. The method has recently been implemented in the so-called Dike Analysis Module (DAM). DAM is a platform for performing semi-automatic stability analyses on a large number of cross sections of levees, see companion paper of Koelewijn & Vastenburg (2013). Data acquired in the field, such as topographic and bathymetric data, is processed automatically so that it can be used in the stability analyses. Geological information, such as the presence of loosely packed sand layers, is incorporated in a stochastic fashion. The platform has already been applied in various parts of The Netherlands. Koelewijn, A.R., Vastenburg, E.W. (2013). Dike Strength Analysis on a Regional Scale. Submitted abstract for the AGU Fall meeting 2013.

van den Ham, G.; Mastbergen, D.; de Groot, M.

2013-12-01

231

Science documentary video slides to enhance education and communication  

NASA Astrophysics Data System (ADS)

Documentary production can convey powerful messages using a combination of authentic science and reinforcing video imagery. Conventional documentary production contains too much information for many viewers to follow; hence many powerful points may be lost. But documentary productions that are re-edited into short video sequences and made available through web based video servers allow the teacher/viewer to access the material as video slides. Each video slide contains one critical discussion segment of the larger documentary. A teacher/viewer can review the documentary one segment at a time in a class room, public forum, or in the comfort of home. The sequential presentation of the video slides allows the viewer to best absorb the documentary message. The website environment provides space for additional questions and discussion to enhance the video message.

Byrne, J. M.; Little, L. J.; Dodgson, K.

2010-12-01

232

Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium  

Microsoft Academic Search

The first formal qualification of safety biomarkers for regulatory decision making marks a milestone in the application of biomarkers to drug development. Following submission of drug toxicity studies and analyses of biomarker performance to the Food and Drug Administration (FDA) and European Medicines Agency (EMEA) by the Predictive Safety Testing Consortium's (PSTC) Nephrotoxicity Working Group, seven renal safety biomarkers have

Frank Sistare; Federico Goodsaid; Marisa Papaluca; Josef S Ozer; Craig P Webb; William Baer; Anthony Senagore; Matthew J Schipper; Jacky Vonderscher; Stefan Sultana; David L Gerhold; Jonathan A Phillips; Gérard Maurer; Kevin Carl; David Laurie; Ernie Harpur; Manisha Sonee; Daniela Ennulat; Dan Holder; Dina Andrews-Cleavenger; Yi-Zhong Gu; Karol L Thompson; Peter L Goering; Jean-Marc Vidal; Eric Abadie; Romaldas Maciulaitis; David Jacobson-Kram; Albert F Defelice; Elizabeth A Hausner; Melanie Blank; Aliza Thompson; Patricia Harlow; Douglas Throckmorton; Shen Xiao; Nancy Xu; William Taylor; Spiros Vamvakas; Bruno Flamion; Beatriz Silva Lima; Peter Kasper; Markku Pasanen; Krishna Prasad; Sean Troth; Denise Bounous; Denise Robinson-Gravatt; Graham Betton; Myrtle A Davis; Jackie Akunda; James Eric McDuffie; Laura Suter; Leslie Obert; Magalie Guffroy; Mark Pinches; Supriya Jayadev; Eric A Blomme; Sven A Beushausen; Valérie G Barlow; Nathaniel Collins; Jeff Waring; David Honor; Sandra Snook; Jinhe Lee; Phil Rossi; Elizabeth Walker; William Mattes; Frank Dieterle

2010-01-01

233

Penn study finds FDA-approved drug makes established cancer vaccine work better  

Cancer.gov

A team from the Perelman School of Medicine and the Abramson Family Cancer Research Institute at the University of Pennsylvania found that the FDA-approved drug daclizumab improved the survival of breast cancer patients taking a cancer vaccine by 30 percent, compared to those patients not taking daclizumab. This proof-of-concept study is published this week in Science Translational Medicine.

234

Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs.  

PubMed

Specialty drugs are notable among prescription drugs in that they offer the possibility of substantial clinical improvement, come with important risks of adverse events and mortality, can be complex to manufacture or administer, and are usually extremely costly. The Food and Drug Administration (FDA) plays a critical role in ensuring that patients who could benefit from specialty drugs have access to them in a timely fashion. In this article we review the different strategies that the FDA can use to approve and influence the post-approval prescribing of specialty drugs. When specialty drugs show promise in early clinical trials, the FDA can expedite the drugs' availability to patients through expanded access programs and expedited approval pathways that speed regulatory authorization. After approval, to ensure that specialty drugs are directed to the patients who are most likely to benefit from them, the FDA can limit the scope of the drugs' indications, encourage the development of companion diagnostic tests to indicate which patients should receive the drugs, or require that manufacturers subject them to Risk Evaluation and Mitigation Strategies to ensure that their use is appropriately limited to a restricted population that is aware of the drugs' risks and benefits. Implementing these existing regulatory approaches can promote timely patient access to specialty drugs while preventing expensive and potentially inappropriate overuse. PMID:25288421

Kesselheim, Aaron S; Tan, Yongtian Tina; Darrow, Jonathan J; Avorn, Jerry

2014-10-01

235

Investigator-initiated, FDA-regulated Clinical Investigations Guidelines for Sponsor-investigators  

E-print Network

food additives, color additives, electronic products, or · a "Device" defined as including: o medical but does not handle regulatory requirements.). The U. S. Food & Drug Administration (FDA) regulates intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part

Spence, Harlan Ernest

236

75 FR 28622 - FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of...  

Federal Register 2010, 2011, 2012, 2013

...AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0247...Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability AGENCY: Food and...Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration.'' The report......

2010-05-21

237

FDA 101: How to Use the Consumer Complaint System and MedWatch  

MedlinePLUS

... FDA safety evaluator, often a pharmacist, doctor, or nurse, reviews the report and examines the database for ... new warnings requiring a product to have a Medication Guide—a consumer-friendly instruction sheet ... Problem with different manufacturer of same medicine ...

238

HRC Exec. Recomm./FDA/Blood Ban End Discrimination against Gay and Bisexual Blood Donors  

E-print Network

the risk of blood infected with undetected HIV entering the blood supply. 3 New HIV tests, however, have Nucleic Acid Test (NAT) System to Screen Whole Blood Donors for Infections with Human ImmunodeficiencyHRC Exec. Recomm./FDA/Blood Ban End Discrimination against Gay and Bisexual Blood Donors Issue

Khan, Javed I.

239

NCI and FDA Announce Joint Program to Streamline Cancer Drug Development  

Cancer.gov

Under an agreement between the Food and Drug Administration (FDA) and the National Cancer Institute (NCI), which is part of the National Institutes of Health (NIH), the two agencies will share knowledge and resources to facilitate the development of new cancer drugs and speed their delivery to patients.

240

Understanding the FDA Guidance on Adaptive Designs: Historical, Legal, and Statistical Perspectives  

Microsoft Academic Search

The recent Food and Drug Administration (FDA) guidance for industry on adaptive designs is perhaps one of the important undertakings by CDER\\/CBER Office of Biostatistics. Undoubtedly, adaptive designs may affect almost all phases of clinical development and impact nearly all aspects of clinical trial planning, execution and statistical inference. Thus, it is a significant accomplishment for the Office of Biostatistics

Qing Liu; George Y. H. Chi

2010-01-01

241

A Method for Analysis of Expert Committee Decision-Making Applied to FDA Medical Device Panels  

E-print Network

A Method for Analysis of Expert Committee Decision-Making Applied to FDA Medical Device Panels Systems Division Education Committee #12;2 A Method for Analysis of Expert Committee Decision-Making in Technology, Management, and Policy ABSTRACT Committees of experts are critical for decision-making

de Weck, Olivier L.

242

FDA Proposed Guidelines on Antibiotic Use in Food Animals Max Irsik DVM, MAB  

E-print Network

FDA Proposed Guidelines on Antibiotic Use in Food Animals Max Irsik DVM, MAB Beef Cattle Extension is the availability of efficacious antibiotics to treat diseases or to prevent disease from occurring in a herd with tremendous benefits for both human and animal health. One of the concerns regarding the use of antibiotics

Watson, Craig A.

243

Evaluation of hepatic impairment dosing recommendations in FDA-approved product labels.  

PubMed

Pharmacokinetic (PK) studies in patients with liver disease are an important clinical pharmacology component of drug development. In 2003, FDA released the guidance for industry on "Pharmacokinetics in Patients with Impaired Hepatic Function," which provides recommendations to sponsors on study design, data analysis, and impact on dosing and labeling. We evaluated the quality and consistency of hepatic dosing recommendations, and compared contemporary clinical practice of dosing in patients with impaired hepatic function with product labels. All new molecular entities (NME) and labels approved by the FDA during the period of January 2004 to December 2011 were reviewed. The fraction of the dose hepatically eliminated, quality of hepatic impairment PK studies reported, and any dose recommendations provided in the label and in a tertiary clinical reference (Micromedex) were reviewed. Out of 157 NMEs, 67 met the criteria for evaluation of dosing in hepatic disease. Problem areas were identified related to the lack of specific hepatic metabolism information in 90% of FDA-approved labels, inconsistent terminology, and "use with caution in liver disease" in 27% of NME. Updating the FDA guidance on PK studies in patients with impaired hepatic function could provide a standardized approach to improve the clinical usefulness of this dosing information for practitioners. PMID:23832278

Chang, Yang; Burckart, Gilbert J; Lesko, Lawrence J; Dowling, Thomas C

2013-09-01

244

ADVERSE PRE- AND POSTNATAL EVENTS REPORTED TO FDA IN ASSOCIATION WITH MATERNAL ATENOLOL TREATMENT IN PREGNANCY  

EPA Science Inventory

Atenolol is a beta-adrenoreceptor blocker used for treatment of hypertension in pregnancy. This study evaluates the reporting frequency of adverse pre- and postnatal outcomes in a series of 70 cases of maternal exposure during gestation, derived from 140 reports to FDA with Ateno...

245

PRESENTATION RUBRIC POOR GOOD EXCELLENT  

E-print Network

PRESENTATION RUBRIC POOR GOOD EXCELLENT Format/Style 0-9 points 11-14 points 15-16 points Visual presentation of the material; clarity of voice; Time requirement. Goes significantly under or over the time of the presentation is good. The slides are well designed throughout the presentation finish, without errors. The talk

Dever, Jennifer A.

246

Base-Two Slide Rule  

NSDL National Science Digital Library

In this activity, students construct base-two slide rules that add and subtract base-2 exponents (log distances), in order to multiply and divide corresponding powers of two. Students use these slide rules to generate both log and antilog equations, learning to translate one in terms of the other. This is activity C1 in the "Far Out Math" educator's guide. Lessons in the guide include activities in which students measure,compare quantities as orders of magnitude, become familiar with scientific notation, and develop an understanding of exponents and logarithms using examples from NASA's GLAST mission. These are skills needed to understand the very large and very small quantities characteristic of astronomical observations. Note: In 2008, GLAST was renamed Fermi, for the physicist Enrico Fermi.

247

Paleo Slide Set: Heinrich Events  

NSDL National Science Digital Library

This slide show explains that by understanding past climate variability, scientists hope to understand the course of future changes in the earth's climate system. This slide set outlines past climate variability by reconstructing abrupt climate changes in the Late Pleistocene, specifically sudden cold events known as Heinrich Events, which have occurred six times in the past 75,000 years involving the large scale discharge of icebergs into the North Atlantic Ocean. The set contains a comprehensive text and accompanying color photographs of icebergs, iceberg-rafted debris in marine sediment cores, and laboratory techniques with sediment cores. Detailed graphics and discussion of Heinrich events, their causes, and their climatic significance are also included. This set can be used as a comprehensive educational tool for studying current issues in oceanography and the implications of natural climate variability from the past to the future.

248

Archive: FDA/CFSAN International Affairs November 18, 2009  

NSDL National Science Digital Library

This Web Seminar took place on November 18, 2009 from 6:30 p.m. to 8:00 p.m. Eastern Time. Presenting was Dr. Julie Moss of the U.S. Food and Drug Administration's Center for Food Safety and Applied Nutrition. In this Seminar, Dr. Moss focused the discus

Moss, Julie

1900-01-01

249

2 | P a g e The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety  

E-print Network

2 | P a g e Background The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law by the President of the United States), of which FDA is a member, has been working to develop an integrated food safety system with strengthened

Florida, University of

250

76 FR 53912 - FDA's Public Database of Products With Orphan-Drug Designation: Replacing Non-Informative Code...  

Federal Register 2010, 2011, 2012, 2013

...FDA-2011-N-0607] FDA's Public Database of Products With Orphan-Drug Designation...descriptive identifiers on its public database of products that have received orphan-drug...designation were published on our public database with non-informative code names....

2011-08-30

251

Identification of novel activity against Borrelia burgdorferi persisters using an FDA approved drug library  

PubMed Central

Although antibiotic treatment for Lyme disease is effective in the majority of cases, especially during the early phase of the disease, a minority of patients suffer from post-treatment Lyme disease syndrome (PTLDS). It is unclear what mechanisms drive this problem, and although slow or ineffective killing of Borrelia burgdorferi has been suggested as an explanation, there is a lack of evidence that viable organisms are present in PTLDS. Although not a clinical surrogate, insight may be gained by examining stationary-phase in vitro Borrelia burgdorferi persisters that survive treatment with the antibiotics doxycycline and amoxicillin. To identify drug candidates that can eliminate B. burgdorferi persisters more effectively, we screened an Food and Drug Administration (FDA)-approved drug library consisting of 1524 compounds against stationary-phase B. burgdorferi by using a newly developed high throughput SYBR Green I/propidium iodide (PI) assay. We identified 165 agents approved for use in other disease conditions that had more activity than doxycycline and amoxicillin against B. burgdorferi persisters. The top 27 drug candidates from the 165 hits were confirmed to have higher anti-persister activity than the current frontline antibiotics. Among the top 27 confirmed drug candidates from the 165 hits, daptomycin, clofazimine, carbomycin, sulfa drugs (e.g., sulfamethoxazole), and certain cephalosporins (e.g. cefoperazone) had the highest anti-persister activity. In addition, some drug candidates, such as daptomycin and clofazimine (which had the highest activity against non-growing persisters), had relatively poor activity or a high minimal inhibitory concentration (MIC) against growing B. burgdorferi. Our findings may have implications for the development of a more effective treatment for Lyme disease and for the relief of long-term symptoms that afflict some Lyme disease patients.

Feng, Jie; Wang, Ting; Shi, Wanliang; Zhang, Shuo; Sullivan, David; Auwaerter, Paul G; Zhang, Ying

2014-01-01

252

Effect of Microstructural Variation on Dry Sliding Wear Behavior of Ti-6Al-4V Alloy  

NASA Astrophysics Data System (ADS)

The present article evaluates the influence of independent control factors such as microstructural variation, normal load, sliding velocity, and test duration on dry sliding wear behavior of Ti-6Al-4V alloy at room temperature using a statistical approach. Ti-6Al-4V alloy has been heat treated in a controlled manner in order to produce different microstructural features (i.e., lamellar, bimodal, and equiaxed). Lamellar microstructure is found to be harder than bimodal microstructure followed by equiaxed microstructure in Ti-6Al-4V alloy. Dry sliding wear tests have been carried out using a multiple Tribo tester following a well planned experimental schedule based on Taguchi's L9 orthogonal array design. Dry sliding wear behavior of Ti-6Al-4V alloy consisting of various microstructural features is related to their hardness values. Results indicated that lamellar microstructure has the lowest sliding wear resistance followed by bimodal and equiaxed microstructure. With the help of signal-to-noise ratios, optimal combination of control factors to minimize the dry sliding wear in Ti-6Al-4V alloy has been determined. Normal load is the most significant control factor influencing the dry sliding wear behavior of investigated Ti-6Al-4V alloy followed by sliding velocity, test duration, and microstructural variation. Normal load has greater static influence of 27.02%, sliding velocity has an influence of 18.07%, test duration has an influence of 12.71%, and microstructural variation has an influence of 10.55% on weight loss of Ti-6Al-4V alloy due to wear having R 2 = 0.89. Two wear mechanisms have been identified: oxidative wear occurs at the lowest sliding velocity and delamination wear occurs at the highest sliding velocity. Optical microscopy, scanning electron microscopy, energy dispersive x-ray spectroscopy, and Rockwell hardness measurements have been used to characterize the microstructures in order to correlate the results obtained.

Sahoo, R.; Jha, B. B.; Sahoo, T. K.; Sahoo, D.

2014-06-01

253

Analog Sliding Mode Controller for Position Tracking of Piezoelectric Actuators  

E-print Network

Analog Sliding Mode Controller for Position Tracking of Piezoelectric Actuators S. Yannier and A) of piezoelectric actuators is presented. DSP application of the algorithm suffers from ADC and DAC conversions and faces speed limitations. Moreover, piezoelectric actuators are known to have very large bandwidth close

Yanikoglu, Berrin

254

Mitosis Extraction in Breast-Cancer Histopathological Whole Slide Images  

E-print Network

Mitosis Extraction in Breast-Cancer Histopathological Whole Slide Images Vincent Roullier1. In this paper, we present a graph-based multi-resolution ap- proach for mitosis extraction in breast cancer staining of mitosis is able to facilitate their detection. Nevertheless, the visual counting method remains

Lezoray, Olivier

255

Static & dynamic sliding mode control of ball and beam system  

Microsoft Academic Search

This paper presents an application of static and dynamic sliding mode control of ball and beam system. Conventional PID controllers use incomplete simplified models and are mostly designed for linear systems. Although, some PID controllers are designed for nonlinear system but they are using simplified incomplete model which do not cater for matched disturbances. Our proposed control laws using static

Abdul Manan Khan; Amir Iqbal Bhatti; Sami-ud-Din; Qudrat Khan

2012-01-01

256

Rolling-Sliding Analysis in Ball Bearing Considering Thermal Effect  

Microsoft Academic Search

An analytical method is applied in the calculations of ball contact angles varying with the position angle of a ball bearing with a centrifugal force. This is further extended to investigate the thermal slipping behavior occurring at the contact surface of the inner raceway. The sliding velocities at the contact area are analyzed in the present study by the ball

NENG-TUNG LIAO; JEN FIN LIN

2006-01-01

257

Sliding mode control of crowd dynamics with matched disturbance  

Microsoft Academic Search

In this paper the design of nonlinear sliding mode feedback controller for a model representing crowd dynamics is presented. The model is a system of partial differential equations based on the laws of conservation of mass and momentum. The equations of motion are described by a set of nonlinear hyperbolic partial differential equations. The feedback control is designed in presence

Sabiha A Wadoo

2011-01-01

258

A novel approach to interactive playgrounds: the interactive slide project  

Microsoft Academic Search

The incipient research on interactive playgrounds is a promising field that can enhance in many ways growth, health and education of children and youngsters. In this paper, we present a novel approach to interactive playgrounds by describing the physical and interaction design of a new platform: the Interactive Slide. We concentrate on the main design issues and relate the acceptance

Joan Soler-Adillon; Jaume Ferrer; Narcís Parés

2009-01-01

259

A history of slide rules for blackbody radiation computations  

NASA Astrophysics Data System (ADS)

During the Second World War the importance of utilizing detection devices capable of operating in the infrared portion of the electromagnetic spectrum was firmly established. Up until that time, laboriously constructed tables for blackbody radiation needed to be used in calculations involving the amount of radiation radiated within a given spectral region or for other related radiometric quantities. To rapidly achieve reasonably accurate calculations of such radiometric quantities, a blackbody radiation calculator was devised in slide rule form first in Germany in 1944 and soon after in England and the United States. In the immediate decades after its introduction, the radiation slide rule was widely adopted and recognized as a useful and important tool for engineers and scientists working in the infrared field. It reached its pinnacle in the United States in 1970 in a rule introduced by Electro Optical Industries, Inc. With the onset in the latter half of the 1970s of affordable, hand-held electronic calculators, the impending demise of the radiation slide rule was evident. No longer the calculational device of choice, the radiation slide rule all but disappeared within a few short years. Although today blackbody radiation calculations can be readily accomplished using anything from a programmable pocket calculator upwards, with each device making use of a wide variety of numerical approximations to the integral of Planck's function, radiation slide rules were in the early decades of infrared technology the definitive "workhorse" for those involved in infrared systems design and engineering. This paper presents a historical development of radiation slide rules with many versions being discussed.

Johnson, R. Barry; Stewart, Sean M.

2012-10-01

260

Triggering mechanism and tsunamogenic potential of the Cape Fear Slide complex, U.S. Atlantic margin  

NASA Astrophysics Data System (ADS)

Analysis of new multibeam bathymetry data and seismic Chirp data acquired over the Cape Fear Slide complex on the U.S. Atlantic margin suggests that at least 5 major submarine slides have likely occurred there within the past 30,000 years, indicating that repetitive, large-scale mass wasting and associated tsunamis may be more common in this area than previously believed. Gas hydrate deposits and associated free gas as well as salt tectonics have been implicated in previous studies as triggers for the major Cape Fear slide events. Analysis of the interaction of the gas hydrate phase boundary and the various generations of slides indicates that only the most landward slide likely intersected the phase boundary and inferred high gas pressures below it. For much of the region, we believe that displacement along a newly recognized normal fault led to upward migration of salt, oversteepening of slopes, and repeated slope failures. Using new constraints on slide morphology, we develop the first tsunami model for the Cape Fear Slide complex. Our results indicate that if the most seaward Cape Fear slide event occurred today, it could produce waves in excess of 2 m at the present-day 100 m bathymetric contour.

Hornbach, Matthew J.; Lavier, Luc L.; Ruppel, Carolyn D.

2007-12-01

261

Pleistocene Suvero slide, Paola basin, southern Italy  

USGS Publications Warehouse

The Suvero slide covers an area of about 225 km2 in the Paola slope basin on the Eastern Tyrrhenian margin. The shape and lateral extent of the deposit reflect topographic confinement of the slide between the continental slope and a morphologic barrier formed by a margin-parallel slope ridge. No headwall or slide plane comparable in scale with the slide deposit were found, suggesting that quasi in situ deformation of semi-consolidated sediments took place when the failed materials reached the floor of the slope basin. The failure occurred downslope from a basement high originating from local uplift. Continued uplift, after the Suvero slide occurred, is documented by the presence of steep upper-slope gradients within the study area and by the presence of small-scale creep and failure events that postdate the Suvero slide. ?? 1989.

Trincardi, F.; Normark, W.R.

1989-01-01

262

Sliding mode of cyclodextrin in polyrotaxane and slide-ring gel  

Microsoft Academic Search

The sliding modes of cyclic molecules in polyrotaxane and of cross-linking junctions in topological gel or slide-ring gel were investigated by quasi-elastic light scattering. We found that a polyrotaxane sparsely including alpha-cyclodextrin showed the sliding mode in solution other than the self- and cooperative-diffusion modes whereas the sliding mode was not observed in a polyrotaxane densely including alpha-cyclodextrin. After gelation

Changmei Zhao; Yusuke Domon; Yasushi Okumura; Satoshi Okabe; Mitsuhiro Shibayama; Kohzo Ito

2005-01-01

263

Tape-recorded Lectures With Slide Synchronization  

ERIC Educational Resources Information Center

Describes "Taped Explanation Slide Synchronization" programs used for individual study or group showing in college zoology. Discusses preparation of programs, class organization, equipment, and costs. (EB)

Goodhue, D.

1969-01-01

264

Participation of Women and Sex Analyses in Late-Phase Clinical Trials of New Molecular Entity Drugs and Biologics Approved by the FDA in 2007-2009  

PubMed Central

Abstract Background Biological sex differences may contribute to differential treatment outcomes for therapeutic products. This study tracks women's participation in late-phase clinical trials (LPCTs), where efficacy and safety of drugs and biologics are evaluated, of new molecular entity (NME) drugs and biologics approved by the U.S. Food and Drug Administration (FDA) in 2007–2009. Furthermore, presentations of sex-based analyses were assessed from the FDA reviews. Methods New drug applications (NDAs) and biologics license applications (BLAs) were accessed from the U.S. FDA database and evaluated for women's participation in LPCTs. Sex-based analyses for efficacy and safety contained in FDA reviews were surveyed. Ratios for women's LPCT participation (PROPORTION OF STUDY SUBJECTS) to their proportion in the disease population were calculated for each approved therapeutic product and grouped into therapeutic categories. Results Sex-specific (n=5) and pediatric (n=3) drug applications were excluded. Women's participation in LPCTs was 39%, 48%, and 42% in NDAs (n=50) and 49%, 62%, and 58% in BLAs (n=11) for 2007, 2008, and 2009, respectively. Sixty-four percent of NDAs and 91% of BLAs had participation to proportion ratios of ?0.80. Seventy-four percent of NDA reviews and 64% of BLA reviews included safety and efficacy sex analysis. Ninety-six percent of NDA reviews and 100% of BLA reviews included efficacy sex analysis. Conclusion Women's participation in LPCTs averaged 43% for NDAs and 57% for BLAs in 2007–2009 and varied widely by indication. As a comparison, the 2001 U.S. Government Accountability Office (GAO) reported 52% of women's participation for drug clinical trials in1998–2000 and an FDA study reported 45% for BLAs approved from 1995 to 1999. This study showed that sex-analysis of both safety and efficacy in NDA has increased to 74% since the GAO report of 72%, while those for BLAs increased to 64% from 37% reported for therapeutic biologics approved in 1995–1999. Knowledge of disease prevalence and participation in clinical trials provides an understanding of recruitment and retention patterns of patients in these trials. PMID:23768021

Poon, Rita; Khanijow, Keshav; Umarjee, Sphoorti; Yu, Monica; Zhang, Lei; Parekh, Ameeta

2013-01-01

265

Wear Behavior of Composites Based on ZA27 Alloy Reinforced by Al 2 O 3 Particles Under Dry Sliding Condition  

Microsoft Academic Search

In present study, the effect of Al2O3 particle reinforcement on the sliding behavior of ZA-27 alloy composites was investigated. The composites with 3, 5, and\\u000a 10 wt% of Al2O3 particles were produced by the compocasting procedure. Tribological properties of unreinforced alloy and composite were studied,\\u000a using block-on-disk tribometer under unlubricated sliding conditions at different specific loads and sliding speeds. The worn

Babic MiroslavSlobodan Mitrovic ´; Slobodan Mitrovi?; Fatima Zivic; Ilija Bobi?

2010-01-01

266

Robust control for a class of time-delay uncertain nonlinear systems based on sliding mode observer  

Microsoft Academic Search

In this paper, a robust control scheme is proposed for a class of time-delay uncertain nonlinear systems with unknown input\\u000a using the sliding mode observer. The sliding mode state observer is given with radial basis function neural networks, and\\u000a then the robust control scheme is presented based on the designed sliding mode observer. The developed observer-based control\\u000a scheme consists of

Mou ChenBin; Bin Jiang; Chang-Sheng Jiang; Qing-Xian Wu

2010-01-01

267

Rocks and Minerals Slide Show  

NSDL National Science Digital Library

This interactive slide show of common rocks and minerals allows students to choose from two sets of minerals and click on a thumbnail to see a larger photograph with a full description of the mineral including color, streak, hardness, cleavage/fracture, and chemical composition. Also included are its use and where it is found. The rocks are divided into igneous, sedimentary, and metamorphic and can be accessed in the same manner. They are described on the basis of crystal size and mineral composition as well as use.

268

Preferential sliding directions on graphite  

NASA Astrophysics Data System (ADS)

The anisotropy of friction on graphitic surfaces is investigated by a combined friction force microscopy and modeling study. Friction vectors deviate up to 15° from pulling directions. The strongest deviations are found for pulling directions which lie almost along one zigzag direction of the honeycomb structure, the preferred sliding direction on graphite surfaces and epitaxial graphene grown on SiC(0001). Atomic stick-slip events along and across molecular rows determine direction and magnitude of friction. Simulation and modeling reveal the role of temperature and of the two-dimensional character of the surface potential for the friction anisotropy.

Balakrishna, S. G.; de Wijn, Astrid S.; Bennewitz, Roland

2014-06-01

269

Violations of exhibiting and FDA rules at an American Psychiatric Association annual meeting.  

PubMed

We conducted a cross-sectional study of all exhibit booths for the 24 pharmaceutical companies at the 2002 American Psychiatric Association (APA) convention. We collected and categorized one of each item distributed by the companies at each booth. A total of 268 items were collected from 24 companies (median=8). The most common categories of items were "reprints or pamphlets" (37%) and "noneducational gifts" (27%), including music CDs and invitations to dinners and museums. There were a total of 16 violations of the APA's own exhibit rules: eight companies had one violation and two companies had four violations. Four companies engaged in FDA-prohibited off-label promotion; one also violated the APA code. Over half of all companies (54%) were in violation of either APA rules or FDA regulations. The APA's voluntary code has failed to adequately reduce inappropriate promotional activity at the annual APA meeting. PMID:16392738

Lurie, Peter; Tran, Tung; Wolfe, Sidney Manuel; Goodman, Robert

2005-12-01

270

FDA direct-to-consumer advertising for prescription drugs: what are consumer preferences and response tendencies?  

PubMed

The effect of direct-to-consumer (DTC) television advertising of prescription medications is a growing concern of the United States (U.S.) Congress, state legislatures, and the Food and Drug Administration (FDA). This research study was conducted in order to examine consumers' perceived preferences of DTC television advertisement in relation to "reminder" "help-seeking," and "product-claim" FDA-approved advertisement categories. An additional objective was to examine the influence of DTC television advertising of prescription drugs on consumers' tendency to seek more information about the medication and/or the medical condition. The research indicates that DTC television drug ads appear to be insufficient for consumers to make informed decisions. Their mixed perception and acceptance of the advertisements seem to influence them to seek more information from a variety of medical sources. PMID:19042521

Khanfar, Nile; Loudon, David; Sircar-Ramsewak, Feroza

2007-01-01

271

NCI/CPFP - 2010 Application Catalog - Program Description - NCI-FDA Joint Training in Cancer Prevention  

Cancer.gov

Cancer Prevention Fellows are eligible to participate in the NCI—FDA joint training in cancer prevention initiative. This component of the CPFP provides training in cancer prevention and in the development and approval processes of drugs, biologic agents, devices, or nutritional products. The program's interdisciplinary training will enable scientists to more rapidly move novel chemopreventive agents and early detection methods from the laboratory to the community.

272

The Use of Slides in Psychology Classes: Do They Help or Are They an Invitation to Sleep?  

ERIC Educational Resources Information Center

The effectiveness of a Sensation and Perception course was improved when the teacher used slides in his presentations. Using slides allows smoother presentation of the material, speeds the pace of the class without confusing students, and provides them with a more positive experience in dealing with a difficult psychology course. (RM)

Beins, Barney

1984-01-01

273

Slides  

E-print Network

Mar 25, 2014 ... ... with transverse symmetries. Let M be a smooth, connected manifold with dimension d + h. ... fundamental differences with the Riemannian geometries. ... sub-Riemannian structure on S2n+1 which has transverse symmetries. ... symmetries. ? The quaternionic Hopf fibration SU(2) ? S4n+3 ? HPn.

Fabrice Baudoin

2014-03-22

274

slides  

E-print Network

Difference in conductivity : The conductivity differences in human and biological tissue .... Hybrid Inverse Problems Classification. Carlos Montalto ..... Figure 12: Postmortem animal imaging of a swine leg using a 3 T MRI scanner. (Minhas et al.

2013-11-15

275

Slides  

E-print Network

Jun 22, 2012 ... settings and finish with some related questions. Basic structure of an adiabatic problem. Inversion of ... fibres) on M and h is a metric on the base, B. ... In general of course this does not make sense, since the ?j(Zb) will be ...

Richard Melrose

2012-06-22

276

When is a cost-effectiveness claim valid? How much should the FDA care?  

PubMed

Federal law requires the Food and Drug Administration (FDA) to regulate the promotional claims of prescription drugs and certain devices. Standards of evidence for claims of safety and therapeutic efficacy are rigorous because inappropriate product use may place human life at risk. However, equally demanding criteria for claims of cost-effectiveness of marketed technologies seem to be unnecessary because the consequence of error is principally a bad buy rather than patient harm. Concern exists about the validity of cost-effectiveness studies, the potential for bias, standards for the conduct of cost-effectiveness research, and the needs of managed care. The FDA should moderate its role in regulating cost-effectiveness claims of drugs and devices. This would foster information flow to healthcare providers and insurers and protect the FDA concern regarding false or misleading claims of effectiveness. Although the issues are applicable to both devices and drugs, we draw mainly from the field of pharmacoeconomics because this is where most of the policy has developed. PMID:10178464

Luce, B R; Hillman, A L

1997-11-01

277

Heparin crisis 2008: a tipping point for increased FDA enforcement in the pharma sector?  

PubMed

Against a backdrop of steady deregulation, the pharmaceutical industry is increasingly outsourcing manufacturing, resulting in decentralized control of the global supply chain. Established products such as heparin have been held to outdated analytical standards. Ten million Americans receive heparin every year; Baxter International accounts for half of this market. In 2008, contamination of Baxter's heparin--sourced in China--resulted in about 350 adverse events and 150 deaths in the United States. In future, increasingly stringent FDA inspections and enforcement are expected for imported drugs and ingredients. More regional FDA offices will be set up overseas. FDA funding will likely be supplemented in future by user fees charged to importers. For newer products, companies will face pressure to adopt Quality by Design, with solid control of the global supply chain and a proactive focus on GMP. Older products will be held to modern standards. Long-term, imports of drugs and ingredients from developing markets will continue. This makes sense to companies from an economic standpoint, but protections will be essential to ensure that it is also justifiable from a public health perspective. PMID:24479237

Rosania, Larry

2010-01-01

278

Study says FDA was lax in reacting to threat to blood supply. Food and Drug Administration.  

PubMed

An investigation by the Institute of Medicine has found that Federal public health experts failed to protect Americans from HIV-tainted blood products during the 1980's. The Food and Drug Administration (FDA) was especially faulted for relying extensively on the advice of self-interested blood bankers and manufacturers of blood-clotting products, making the industry self-regulating. The year-long study examined the period from 1982 to 1986, when more than half of the nation's 16,000 hemophiliacs acquired HIV from blood-clotting products. Health and Human Services Secretary, Donna E. Shalala, who commissioned the report, said she accepted in principle the findings and has begun to implement the recommendations. The Institute recommends the following changes: a no-fault compensation for individuals harmed by tainted blood or blood-products; the appointment of a blood safety director at the level of a deputy assistant secretary or higher; and a requirement that the blood industry implement partial solutions having little risk in cases of uncertainty about possible threats to the blood supply. A key point in the study is that the FDA take a more aggressive stance in protecting the blood supply, which is at odds with the efforts of House Republicans to minimize the FDA's regulatory role. PMID:11362715

1995-08-11

279

FDA regulations require acidified foods and low acid canned foods to be produced under the watchful eye of trained supervisors. USDA/FSIS regulations also require  

E-print Network

Better Process Control School FDA regulations require acidified foods and low acid canned foods Control School is designed to train you in processing Acidified Foods under FDA regulations to ensure safe products and reduce liability. Topics we will cover: FDA regulations Aseptic Processing Principals

Hayes, Jane E.

280

Sliding Trellis-Based Frame Synchronization  

E-print Network

Frame Synchronization (FS) is required in several communication standards in order to recover the individual frames that have been aggregated in a burst. This paper proposes a low-delay and reducedcomplexity Sliding Trellis (ST)-based FS technique, compared to our previously proposed trellis-based FS method. Each burst is divided into overlapping windows in which FS is performed. Useful information is propagated from one window to the next. The proposed method makes use of soft information provided by the channel, but also of all sources of redundancy present in the protocol stack. An illustration of our STbased approach for the WiMAX Media Access Control (MAC) layer is provided. When FS is performed on bursts transmitted over Rayleigh fading channel, the ST-based approach reduces the FS latency and complexity at the cost of a very small performance degradation compared to our full complexity trellis-based FS and outperforms state-of-the-art FS techniques.

Ali, Usman; Kieffer, Michel

2011-01-01

281

Education Techniques for Lifelong Learning Making a PowerPoint Presentation1  

Microsoft Academic Search

Most radiologists are now creating their own image and text slides for oral presentations. PowerPoint software offers a tremendous number of options for personalizing slides. Having choices of font, color scheme, display options, sound, and graphics provide an opportunity to enhance a presentation in ways that were not possible with 35-mm slides and slide projectors. However, inappropriate use of PowerPoint

Jannette Collins

282

3D finite element modeling of sliding wear  

NASA Astrophysics Data System (ADS)

Wear is defined as "the removal of material volume through some mechanical process between two surfaces". There are many mechanical situations that can induce wear and each can involve many wear mechanisms. This research focuses on the mechanical wear due to dry sliding between two surfaces. Currently there is a need to identify and compare materials that would endure sliding wear under severe conditions such as high velocities. The high costs associated with the field experimentation of systems subject to high-speed sliding, has prevented the collection of the necessary data required to fully characterize this phenomena. Simulating wear through Finite Elements (FE) would enable its prediction under different scenarios and would reduce experimentation costs. In the aerospace, automotive and weapon industries such a model can aid in material selection, design and/or testing of systems subjected to wear in bearings, gears, brakes, gun barrels, slippers, locomotive wheels, or even rocket test tracks. The 3D wear model presented in this dissertation allows one to reasonably predict high-speed sliding mechanical wear between two materials. The model predictions are reasonable, when compared against those measured on a sled slipper traveling over the Holloman High Speed Tests Track. This slipper traveled a distance of 5,816 meters in 8.14 seconds and reached a maximum velocity of 1,530 m/s.

Buentello Hernandez, Rodolfo G.

283

Presenting Mitosis  

ERIC Educational Resources Information Center

When the topic of cell division is introduced in the classroom, students can showcase their interpretations of the stages of mitosis by creating a slide show illustrating prophase, metaphase, anaphase, and telophase (see samples in Figure 1). With the help of a computer, they can create a model of mitosis that will help them distinguish the…

Roche, Stephanie; Sterling, Donna R.

2005-01-01

284

ABB Group April 16, 2009 | Slide 1  

E-print Network

an electrical circuit from damage caused by overload or short-circuit A circuit breaker is a device used to open© ABB Group April 16, 2009 | Slide 1 Physics of arc interruption in circuit breakers Nils P. Basse 2 Outline 1. Circuit breakers 2. Mixing experiment #12;© ABB Group April 16, 2009 | Slide 3 Outline

Basse, Nils Plesner

285

Visual Perception Slide 2 Aditi Majumder, UCI  

E-print Network

1 PERCEIVING MOVEMENT Visual Perception Slide 2 Aditi Majumder, UCI Ways to create movement Perception More than one ways to create the sense of movement Real movement is only one of them #12;2 Slide 3 They will be detected if they move Many animals have poor depth perception (pigeon) and color vision (cats and dogs

Majumder, Aditi

286

Getting Clever with the Sliding Ladder  

ERIC Educational Resources Information Center

The familiar system involving a uniform ladder sliding against a vertical wall and a horizontal floor is considered again. The floor is taken to be smooth and the wall to be possibly rough--a situation where no matter how large the static friction coefficient between the ladder and the wall, the ladder cannot lean at rest and must slide down.…

De, Subhranil

2014-01-01

287

NCI: SBIR & STTR - Resource Center - SBIR Presentations  

Cancer.gov

This presentation contains slides from the SBIR-IMAT solicitation pre-application webinar led by NCI SBIR Program Director Amir Rahbar and featuring Tony Dickherber, Director of the NCI Innovative Molecular Analysis Technologies program.

288

Sliding induced crystallization of metallic glass  

NASA Technical Reports Server (NTRS)

Sliding friction and wear experiments, electron microscopy, and diffraction studies were conducted with an Fe67Co18B14Si1 ferrous-base metallic glass in sliding contact with aluminum oxide at room temperature in air. The results indicate that the amorphous alloy can be crystallized during the sliding process. Crystallization of the wear surface causes high friction. Plastic flow occurred on the amorphous alloy with sliding, and the flow film of the alloy transferred to the aluminum oxide surface. Two distinct types of wear debris were observed as a result of sliding: an alloy wear debris, and powdery and whiskery oxide debris. Generation of oxide wear debris particles on an alloy can cause transitions in friction behavior.

Miyoshi, K.; Buckley, D. H.

1983-01-01

289

66 FR 4688 - Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data...  

Federal Register 2010, 2011, 2012, 2013

...No. 00N-0989] Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related...provisions that would make available for public disclosure, and require submission for public...

2001-01-18

290

Human Capital: Continued Opportunities Exist for FDA and OPM to Improve Oversight of Recruitment, Relocation, and Retention Incentives.  

National Technical Information Service (NTIS)

The Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) has faced challenges in obtaining the workforce needed to support its responsibilities and similar to other agencies, has paid selected employees recruitment, ...

2010-01-01

291

The “High Solubility” Definition of the Current FDA Guidance on Biopharmaceutical Classification System May Be Too Strict for Acidic Drugs  

Microsoft Academic Search

Purpose. The purpose of this study was to assess if the definition of high solubility as proposed in the FDA Guidance on Biopharmaceutical Classification System (BCS) is too strict for highly permeable acidic drugs.

Mehran Yazdanian; Katherine Briggs; Corinne Jankovsky; Amale Hawi

2004-01-01

292

Sliding mode control experiments of uncertain dynamical systems with time delay  

NASA Astrophysics Data System (ADS)

This article presents the simulation and experimental studies for the nonlinear time-delayed dynamical systems with uncertainties. A rotary flexible joint made by Quanser is chosen as the model system to investigate the method for sliding mode control design. We considered the geometric nonlinearity of the flexible joint consisting of two linear springs. The system is assumed to have constant delay time and uncertain parameters with known upper and lower bounds. We also design an optimal sliding surface for the sliding mode control. Simulations and experiments are carried out to demonstrate the utility of the control method. Finally, the results from the simulations and experiments are in excellent agreement.

Qin, Zhi-Chang; Zhong, Shun; Sun, Jian-Qiao

2013-12-01

293

Overlap of US FDA residue tests and pesticides used on imported vegetables: Empirical findings and policy recommendations  

Microsoft Academic Search

In the United States, the Environmental Protection Agency (EPA) registers pesticides and sets crop-specific tolerances while the Food and Drug Administration (FDA) enforces EPA regulations by testing plant-based foods for pesticide residues. Pesticide treatment histories are almost always unknown, especially on imported produce, posing an empirical question: to what extent do FDA’s residue testing methods used on imported produce correspond

Ryan E. Galt

2009-01-01

294

Minimum sliding mode error feedback control for fault tolerant small satellite attitude control  

NASA Astrophysics Data System (ADS)

This paper proposes a new control strategy (which we call "minimum sliding mode error feedback control, MSMEFC") for small satellite attitude control. As we know, the attitude control algorithm plays a significant role in the whole performance of the satellite, especially under the existence of uncertain disturbances from the space. Without loss of generality, the MSMEFC is presented based on the sliding mode theory. It is assumed that the equivalent control error is defined to offset the uncertain disturbances to improve the control performance. Hence, in order to estimate the optimal equivalent control error, a cost function is derived on the basis of the principle of minimum sliding mode error. Then, the equivalent control error wills feedback to the conventional sliding mode control to obtain the final MSMEFC. According to the theoretical analyzes, the sliding mode after the MSMEFC will approximate to the ideal sliding mode, resulting in enhancing the control performance. Moreover, an adaptive non-singular terminal sliding mode is employed to compare with the performance of MSMEFC. Several simulations are performed to verify the effectiveness of proposed MSMEFC in the presence of serious perturbations, even in some fault-tolerant scenarios.

Cao, Lu; Li, Xiaolong; Chen, Xiaoqian; Zhao, Yong

2014-01-01

295

SlideToolkit: An Assistive Toolset for the Histological Quantification of Whole Slide Images  

PubMed Central

The demand for accurate and reproducible phenotyping of a disease trait increases with the rising number of biobanks and genome wide association studies. Detailed analysis of histology is a powerful way of phenotyping human tissues. Nonetheless, purely visual assessment of histological slides is time-consuming and liable to sampling variation and optical illusions and thereby observer variation, and external validation may be cumbersome. Therefore, within our own biobank, computerized quantification of digitized histological slides is often preferred as a more precise and reproducible, and sometimes more sensitive approach. Relatively few free toolkits are, however, available for fully digitized microscopic slides, usually known as whole slides images. In order to comply with this need, we developed the slideToolkit as a fast method to handle large quantities of low contrast whole slides images using advanced cell detecting algorithms. The slideToolkit has been developed for modern personal computers and high-performance clusters (HPCs) and is available as an open-source project on github.com. We here illustrate the power of slideToolkit by a repeated measurement of 303 digital slides containing CD3 stained (DAB) abdominal aortic aneurysm tissue from a tissue biobank. Our workflow consists of four consecutive steps. In the first step (acquisition), whole slide images are collected and converted to TIFF files. In the second step (preparation), files are organized. The third step (tiles), creates multiple manageable tiles to count. In the fourth step (analysis), tissue is analyzed and results are stored in a data set. Using this method, two consecutive measurements of 303 slides showed an intraclass correlation of 0.99. In conclusion, slideToolkit provides a free, powerful and versatile collection of tools for automated feature analysis of whole slide images to create reproducible and meaningful phenotypic data sets. PMID:25372389

Nelissen, Bastiaan G. L.; van Herwaarden, Joost A.; Moll, Frans L.; van Diest, Paul J.; Pasterkamp, Gerard

2014-01-01

296

A Combined High Gain Observer and High-Order Sliding Mode Controller for a DFIG-Based Wind  

E-print Network

A Combined High Gain Observer and High-Order Sliding Mode Controller for a DFIG-Based Wind Turbine optimization of a DFIG- based wind turbine. The proposed control strategy combines an MPPT using a high gain observer and second-order sliding mode for the DFIG control. This strategy presents attractive features

Paris-Sud XI, Université de

297

Speed control of permanent magnet motors using sliding mode observers for induced EMF position and speed estimation  

Microsoft Academic Search

This paper presents a speed control system for a permanent magnet synchronous motor (PMSM) in which the sliding mode technique is used to estimate the induced EMF, rotor position and speed. The electrical dynamic equations of PMSM are modified to obtain the sliding mode observer model and then the variables are estimated by using only measured stator currents and voltages.

Zelia M. A. Peixoto; Flavia M. F. Sa; P. F. Seixas; Benjamin R. Menezes; Porfirio C. Cortizo

1995-01-01

298

An updated nuclear criticality slide rule  

SciTech Connect

This Volume 2 contains the functional version of the updated nuclear criticality slide rule (more accurately, sliding graphs) that is referenced in An Updated Nuclear Criticality Slide Rule: Technical Basis, NUREG/CR-6504, Vol. 1 (ORNL/TM-13322/V1). This functional slide rule provides a readily usable {open_quotes}in-hand{close_quotes} method for estimating pertinent nuclear criticality accident information from sliding graphs, thereby permitting (1) the rapid estimation of pertinent criticality accident information without laborious or sophisticated calculations in a nuclear criticality emergency situation, (2) the appraisal of potential fission yields and external personnel radiation exposures for facility safety analyses, and (3) a technical basis for emergency preparedness and training programs at nonreactor nuclear facilities. The slide rule permits the estimation of neutron and gamma dose rates and integrated doses based upon estimated fission yields, distance from the fission source, and time-after criticality accidents for five different critical systems. Another sliding graph permits the estimation of critical solution fission yields based upon fissile material concentration, critical vessel geometry, and solution addition rate. Another graph provides neutron and gamma dose-reduction factors for water, steel, and concrete. Graphs from historic documents are provided as references for estimating critical parameters of various fissile material systems. Conversion factors for various English and metric units are provided for quick reference.

Hopper, C.M.; Broadhead, B.L.

1998-04-01

299

Has the tobacco industry evaded the FDA's ban on 'Light' cigarette descriptors?  

PubMed Central

Background Under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), the Food and Drug Administration (FDA) banned the use of “Lights” descriptors or similar terms on tobacco products that convey messages of reduced risk. Manufacturers eliminated terms explicitly stated and substituted colour name descriptors corresponding to the banned terms. This paper examines whether the tobacco industry complied with or circumvented the law and potential FDA regulatory actions. Methods Philip Morris retailer manuals, manufacturers' annual reports filed with the Massachusetts Department of Public Health, a national public opinion survey, and market-wide cigarette sales data were examined. Results Manufacturers substituted “Gold” for “Light” and “Silver” for “Ultra-light” in the names of Marlboro sub-brands, and “Blue”, “Gold”, and “Silver” for banned descriptors in sub-brand names. Percent filter ventilation levels, used to generate the smoke yield ranges associated with “Lights” categories, appear to have been reassigned to the new colour brand name descriptors. Following the ban, 92% of smokers reported they could easily identify their usual brands, and 68% correctly named the package colour associated with their usual brand, while sales for “Lights” cigarettes remained unchanged. Conclusions Tobacco manufacturers appear to have evaded a critical element of the FSPTCA, the ban on misleading descriptors that convey reduced health risk messages. The FPSTCA provides regulatory mechanisms, including banning these products as adulterated (Section 902). Manufacturers could then apply for pre-market approval as new products and produce evidence for FDA evaluation and determination whether or not sales of these products are in the public health interest. PMID:23485704

Connolly, Gregory N; Alpert, Hillel R

2014-01-01

300

Why (not) go east? Comparison of findings from FDA Investigational New Drug study site inspections performed in Central and Eastern Europe with results from the USA, Western Europe, and other parts of the world  

PubMed Central

Since the mid-1990s, investigational sites in the countries of Central and Eastern Europe (CEE) have been increasingly utilized by pharmaceutical companies because of their high productivity in terms of patient enrolment into clinical trials. Based on the FDA’s publicly accessible Clinical Investigator Inspection List, we present an analysis of findings and outcome classifications from FDA inspections during Investigational New Drug (IND) studies and compare the results for the CEE region to those from Western European countries and the USA. Data from all 5531 FDA clinical trials inspections that occurred between 1994 (when the FDA first performed inspections in CEE) and the end of 2010 were entered into the database for comparative analysis. Of these, 4865 routine data audit (DA) inspections were analyzed: 401 from clinical trials performed in Western Europe, 230 in CEE, 3858 in the USA, and 376 in other countries. The average number of deficiencies per inspection ranged between 0.99 for CEE and 1.97 in Western Europe. No deficiencies were noted during 16.6%, 39.0%, and 21.5% of the inspections in Western Europe, CEE and USA, respectively. The percentages of inspections after which no follow-up action was indicated were 36.9% for Western Europe, 55.7% for CEE, and 44.3% for US sites. CEE was also the region with the lowest percentage of inspections that required official or voluntary action. On the basis of FDA inspection data, the high productivity of CEE sites appears to be accompanied by regulatory compliance as well as by data quality standards that are not inferior to those in Western regions. PMID:22563236

Caldron, Paul H; Gavrilova, Svetlana I; Kropf, Siegfried

2012-01-01

301

Slides from NACK Webinar: Nanotechnology Applications in Today's World  

NSDL National Science Digital Library

These are the slides for the Nano Application in Today's World webinar that was presented on September 24, 2010. Nanotechnology has often been thought of as playing a key role in the next industrial revolution. Nanotechnology is not an industry; it is an enabling technology that is impacting a growing number of industry sectors, which now include electronics, biotechnology, biomedicine, pharmaceuticals, and many others. 

2014-09-01

302

An enhanced sliding-mode control for a pneumatic-actuated teleoperation system  

Microsoft Academic Search

e Abstract— This paper presents an enhanced sliding mode control for pneumatic master-slave teleoperation systems that are actuated by low-cost solenoid valves. A five-mode sliding control is incorporated into position-position, force-force, and force-position teleoperation architectures. While on\\/off valve pneumatic actuators have previously been modeled as having three discrete operating modes, an extension to five discrete control levels as proposed here

M. Q. Le; M. T. Pham; M. Tavakoli; R. Moreau

2011-01-01

303

Short-time spectral analysis with the conventional and sliding CZT  

Microsoft Academic Search

Two sequential short-time spectral analysis techniques, amenable to nonrecursive filter implementation, are the conventional chirp-z-transform (CZT) realization of the discrete Fourier transform and the sliding CZT realization of the discrete sliding Fourier transform. This paper presents a comparative study of frame rate limitations, windowing, time and frequency resolution, spectral correlation, complexity, and inverse structures for these methods, with particular emphasis

1978-01-01

304

Micro-Sliding in High-Speed Aircraft Engine Ball Bearings  

Microsoft Academic Search

Micro-sliding within the contact ellipse of high-speed ball bearings is a tribological phenomenon that occurs in large, high-speed aircraft turbine engine ball bearings that should be taken into consideration in the design of high-speed ball bearings. This article presents the phenomenon of micro-sliding within the ball bearing contact zone, the parameters that impact its generation, and the extent and the

Peter Gloeckner; Franz-Josef Ebert

2010-01-01

305

Sliding mode autopilot and observer design for a supersonic flight vehicle  

Microsoft Academic Search

Design and synthesis of a nonlinear supersonic missile longitudinal dynamics control for angle-of-attack output tracking are presented. In addition a sliding mode observer is designed to estimate the angle-of-attack which is difficult to measure in practice. The employed method is simple to implement in practical applications and enables the sliding mode control design to exhibit the desired dynamic properties during

M. Bahrami; B. Ebrahimi; G. R. Ansarifar; J. Roshanian

2008-01-01

306

The steady state wear behaviour of pearlitic rail steel under dry rolling-sliding contact conditions  

Microsoft Academic Search

The present study is aimed at studying the onset of steady state wear behaviour of pearlitic rail steel. Wheel-rail contact is simulated by a rolling-sliding line contact. The results show that steady state wear rate prevails after a certain number of rolling-sliding cycles. The effect of strain hardening and uni-directional plastic strain accumulation on the wear behaviour has also been

W. R. Tyfour; J. H. Beynon; A. Kapoor

1995-01-01

307

Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors  

NSDL National Science Digital Library

Released online by the Food and Drug Administration (FDA) on September 7, this 59-page report "establishes a baseline to measure how effective industry and regulatory efforts are in changing behaviors and practices that directly relate to food-borne illness in the retail food industry." Based on data collected from close to 900 institutional food service establishments, restaurants, and retail food stores, the report finds that three areas deserve special attention: improper holding times and temperatures, contaminated equipment, and poor personal hygiene. The full text of the report is available in HTML and .pdf formats.

308

Presentations: Giving Effective Presentations  

E-print Network

; o Capture attention of visual learners; o Increase the audience's retention of your presentation? Anecdotes? Visual aids? Statistics? Examples? THE OPENING Prepare this only after forming and organizing

309

Sliding mode of cyclodextrin in polyrotaxane and slide-ring gel  

NASA Astrophysics Data System (ADS)

The sliding modes of cyclic molecules in polyrotaxane and of cross-linking junctions in topological gel or slide-ring gel were investigated by quasi-elastic light scattering. We found that a polyrotaxane sparsely including ?-cyclodextrin showed the sliding mode in solution other than the self- and cooperative-diffusion modes whereas the sliding mode was not observed in a polyrotaxane densely including ?-cyclodextrin. After gelation of the sparse polyrotaxane, the self-diffusion mode of the polyrotaxane disappeared but the sliding mode was still observed. This indicated that the figure-of-eight cross-links in the slide-ring gel slid in the polymer network, passing through the polymer chains.

Zhao, Changmei; Domon, Yusuke; Okumura, Yasushi; Okabe, Satoshi; Shibayama, Mitsuhiro; Ito, Kohzo

2005-08-01

310

Color standardization in whole slide imaging using a color calibration slide  

PubMed Central

Background: Color consistency in histology images is still an issue in digital pathology. Different imaging systems reproduced the colors of a histological slide differently. Materials and Methods: Color correction was implemented using the color information of the nine color patches of a color calibration slide. The inherent spectral colors of these patches along with their scanned colors were used to derive a color correction matrix whose coefficients were used to convert the pixels’ colors to their target colors. Results: There was a significant reduction in the CIELAB color difference, between images of the same H & E histological slide produced by two different whole slide scanners by 3.42 units, P < 0.001 at 95% confidence level. Conclusion: Color variations in histological images brought about by whole slide scanning can be effectively normalized with the use of the color calibration slide. PMID:24672739

Bautista, Pinky A.; Hashimoto, Noriaki; Yagi, Yukako

2014-01-01

311

Four Key Keys to Powerful Presentations in PowerPoint: Take Your Presentations to the Next Level  

ERIC Educational Resources Information Center

If a person is on a presentation and he/she does not know how to go back to a previous PowerPoint slide, his/her credibility will be clouded and the audience will become frustrated. More sophisticated presenters use handheld remotes to control the basic navigation of slides. Even in this case, keyboard shortcuts can be an added benefit. For those…

Howell, Dusti D.

2008-01-01

312

Ornamental Annual Plants and Their Uses. Slide Script.  

ERIC Educational Resources Information Center

This slide script, part of a series of slide scripts designed for use in vocational agriculture classes, deals with ornamental annual plants and their uses. Included in the script are narrations for use with a total of 254 slides illustrating 97 different plants. At least two slides are provided for each plant: one shows the growth habits of the…

Still, Steven

313

Sliding scale insulin use: myth or insanity?  

PubMed

Inpatient hyperglycemia in people with or without diabetes is associated with an increased risk of complications and mortality, a longer hospital stay, a higher admission rate to the intensive care unit, and higher hospitalization costs. Despite increasing evidence that supports intensive glycemic control in hospitalized patients, blood glucose control continues to be challenging, and sliding scale insulin coverage, a practice associated with limited therapeutic success, continues to be the most frequent insulin regimen in hospitalized patients. Sliding scale insulin has been in use for more than 80 years without much evidence to support its use as the standard of care. Several studies have revealed evidence of poor glycemic control and deleterious effects in sliding scale insulin use. To understand its wide use and acceptance, we reviewed the origin, advantages, and disadvantages of sliding scale insulin in the inpatient setting. PMID:17602924

Umpierrez, Guillermo E; Palacio, Andres; Smiley, Dawn

2007-07-01

314

Sliding Down an Incline Plane Model  

NSDL National Science Digital Library

The Sliding Down an Incline Plane model shows a stone block is lying on an inclined plane. Initially, the component of gravity along the plane surface, Ft, is compensated by the force of static friction Fsf, which is proportional to the normal to the plane, N. Because the modulus of this force cannot exceed a limit value of ?|N| (? is the static friction coefficient between the block and the plane). When the user increases the slope of the plane by dragging the double arrow at the plane top, Ft ends up being larger than this limit and the block slides down the plane The Sliding Down an Incline Plane model was created using the Easy Java Simulations (Ejs) modeling tool. It is distributed as a ready-to-run (compiled) Java archive. Double clicking the ejs_murcia_mech_SlidingDownAnInclinePlane.jar file will run the program if Java is installed.

Franciscouembre

2010-04-16

315

Automated single-slide staining system  

NASA Technical Reports Server (NTRS)

Apparatus developed to Gram-stain single slides automatically is flexible enough to accommodate other types of staining procedures. Method frees operator and eliminates necessity for subjective evaluations as to length of staining or decolorizing time.

Mills, S. M.; Wilkins, J. R.

1974-01-01

316

Magic Lantern Slides Collection from Japan  

NSDL National Science Digital Library

The University of Hawaii at Manoa (UHM) has a collection of approximately 1,500 magic lantern slides in its Japan Collection, which it has digitized with the permission of the Japan Foundation. The magic lantern was the precursor to the modern slide projector, and was extremely popular in Europe and Asia in the 1800s, with people going from towns to villages doing public shows. The slides featured on the UHM website are those that were produced and distributed by KBS, a group that was the predecessor of the Japan Foundation. To view the collection, you can browse alphabetically by title, category (from alcohol to fan making to Western clothes), and by slides with recent comments made about them. Visitors to the website shouldn't leave the site without browsing under the "University" category. With few exceptions, all the buildings are Western in style, and reminiscent of many U.S. colleges with their columns, stone, and tendency to sprawl.

317

Copyright 2003 LeslieCopyright 2003 Leslie Atlanta Seminar April 2003Atlanta Seminar April 2003 SlideSlide 11  

E-print Network

Copyright 2003 © LeslieCopyright 2003 © Leslie SmithSmith Atlanta Seminar April 2003Atlanta Seminar © Leslie SmithSmith Atlanta Seminar April 2003Atlanta Seminar April 2003 SlideSlide 22 NeuralSmith Atlanta Seminar April 2003Atlanta Seminar April 2003 SlideSlide 33 Silicon electronics and neural systems

Smith, Leslie S.

318

Antiwear Additive Mechanisms in Sliding Contacts  

NASA Technical Reports Server (NTRS)

The possible mechanisms associated with wear in a sliding contact and how an oil and antiwear additive can mitigate wear or prevent catastropic seizure of the contacting parts was examined. The various load and temperature regimes are examined and the mechanisms which are predominant under these conditions are determined. The critical mechanism(s) depend on the test parameters, particularly load and temperature, although sliding speed is also a factor. Different ways to improve the efficiency of antiwear additives are suggested.

Baldwin, B. A.

1984-01-01

319

Proton-pump inhibitors in patients requiring antiplatelet therapy: new FDA labeling.  

PubMed

Proton-pump inhibitors (PPIs) are recommended for patients who require antiplatelet therapy and have a history of upper gastrointestinal bleeding. Proton-pump inhibitors should also be considered for patients receiving antiplatelet therapy who have other risk factors for gastrointestinal bleeding, including use of aspirin. Thus, evidence of pharmacokinetic and pharmacodynamic interactions between PPIs and consequent impaired effectiveness of the antiplatelet agent clopidogrel has caused concern. Here, we discuss comparative studies suggesting that the extent to which a PPI reduces exposure to the active metabolite of clopidogrel and attenuates its antithrombotic effect differs among PPIs. Although a clinically meaningful effect of the interaction between PPIs and clopidogrel on cardiovascular outcomes has not been established, these studies provided the basis for recent changes in US Food and Drug Administration (FDA) labeling for several PPIs and clopidogrel. New labeling suggests that PPI use among patients taking clopidogrel be limited to pantoprazole, rabeprazole, lansoprazole, or dexlansoprazole. Because comparative studies indicate that omeprazole and esomeprazole have a greater effect on the CYP2C19-mediated conversion of clopidogrel to its active metabolite and, consequently, clopidogrel's effect on platelet reactivity, FDA labeling recommends avoiding omeprazole and esomeprazole in patients taking clopidogrel. Even a 12-hour separation of dosing does not appear to prevent drug interactions between omeprazole and clopidogrel. PMID:24918808

Johnson, David A; Chilton, Robert; Liker, Harley R

2014-05-01

320

A comparison of homopolymer and block copolymer structure in 6FDA-based polyimides.  

PubMed

Two homopolyimides and the corresponding block copolyimide, all based on the 4,4'-(hexafluoroisopropylidene)diphthalic dianhydride (6FDA), have been synthesized and fully atomistic models have been studied using molecular dynamics (MD) simulation. The respective diamines were 1,3-phenylenediamine (mPDA) and 2,3,5,6-tetramethyl-1,4-phenylenediamine (durene). These polyimides are potential candidates for gas separation applications. The synthesized polymers were processed as dense flat membranes. The effects of diamine structure were investigated at the molecular level and an attempt to compare the structural features of homo- and block copolyimides was made. Amorphous models were generated using a hybrid pivot Monte Carlo-MD sampling preparation technique. Average model densities were validated against experimental measurements on the dense films. Cohesive energies, Hildebrand solubility parameters, conformational characteristics, intermolecular interactions and available void spaces were analysed for each system. The durene diamine was found to hinder stacking and increase the available space. This is associated with the steric effect of the methyl substituents. In general, 6FDA-mPDA/durene exhibits an intermediate behaviour with respect to its base polyimides. For most of the examined properties, the differences between different size simulated systems were minor with the exception of the free volume distribution. PMID:25247609

Tanis, I; Brown, D; Neyertz, S J; Heck, R; Mercier, R

2014-10-01

321

Larval Zebrafish Model for FDA-Approved Drug Repositioning for Tobacco Dependence Treatment  

PubMed Central

Cigarette smoking remains the most preventable cause of death and excess health care costs in the United States, and is a leading cause of death among alcoholics. Long-term tobacco abstinence rates are low, and pharmacotherapeutic options are limited. Repositioning medications approved by the U.S. Food and Drug Administration (FDA) may efficiently provide clinicians with new treatment options. We developed a drug-repositioning paradigm using larval zebrafish locomotion and established predictive clinical validity using FDA-approved smoking cessation therapeutics. We evaluated 39 physician-vetted medications for nicotine-induced locomotor activation blockade. We further evaluated candidate medications for altered ethanol response, as well as in combination with varenicline for nicotine-response attenuation. Six medications specifically inhibited the nicotine response. Among this set, apomorphine and topiramate blocked both nicotine and ethanol responses. Both positively interact with varenicline in the Bliss Independence test, indicating potential synergistic interactions suggesting these are candidates for translation into Phase II clinical trials for smoking cessation. PMID:24658307

Cousin, Margot A.; Ebbert, Jon O.; Wiinamaki, Amanda R.; Urban, Mark D.; Argue, David P.; Ekker, Stephen C.; Klee, Eric W.

2014-01-01

322

Evidence of Self-Organized Criticality in Dry Sliding Friction  

NASA Technical Reports Server (NTRS)

This letter presents experimental results on unlubricated friction, which suggests that stick-slip is described by self-organized criticality (SOC). The data, obtained with a pin-on-disc tribometer examines the variation of the friction force as a function of time-or sliding distance. This is the first time that standard tribological equipment has been used to examine the possibility of SOC. The materials were matching pins and discs of aluminium loaded with 250, 500 and 1000 g masses, and matching M50 steel couples loaded with a 1000 g mass. An analysis of the data shows that the probability distribution of slip sizes follows a power law. We perform a careful analysis of all the properties, beyond the two just mentioned, which are required to imply the presence of SOC. Our data strongly support the existence of SOC for stick-slip in dry sliding friction.

Zypman, Fredy R.; Ferrante, John; Jansen, Mark; Scanlon, Kathleen; Abel, Phillip

2003-01-01

323

Finite-time sliding mode synchronization of chaotic systems  

NASA Astrophysics Data System (ADS)

A new finite-time sliding mode control approach is presented for synchronizing two different topological structure chaotic systems. With the help of the Lyapunov method, the convergence property of the proposed control strategy is discussed in a rigorous manner. Furthermore, it is mathematically proved that our control strategy has a faster convergence speed than the conventional finite-time sliding mode control scheme. In addition, the proposed control strategy can ensure the finite-time synchronization between the master and the slave chaotic systems under internal uncertainties and external disturbances. Simulation results are provided to show the speediness and robustness of the proposed scheme. It is worth noticing that the proposed control scheme is applicable for secure communications.

Ni, Jun-Kang; Liu, Chong-Xin; Liu, Kai; Liu, Ling

2014-10-01

324

A giant three-stage submarine slide off Norway  

Microsoft Academic Search

One of the largest submarine slides known, The Storegga Slide, is located on the Norwegian continental margin. The slide is up to 450 m thick and has a total volume of about 5,600 km3. The headwall of the slide scar is 290 km long and the total run-out distance is about 800 km. The slide involved sediments of Quaternary to

Tom Bugge; Stein Befring; Robert H. Belderson; Tor Eidvin; Eystein Jansen; Neil H. Kenyon; Hans Holtedahl; Hans Petter Sejrup

1987-01-01

325

Compact, Automated Centrifugal Slide-Staining System  

NASA Technical Reports Server (NTRS)

The Directional Acceleration Vector-Driven Displacement of Fluids (DAVD-DOF) system, under development at the time of reporting the information for this article, would be a relatively compact, automated, centrifugally actuated system for staining blood smears and other microbiological samples on glass microscope slides in either a microgravitational or a normal Earth gravitational environment. The DAVD-DOF concept is a successor to the centrifuge-operated slide stainer (COSS) concept, which was reported in Slide-Staining System for Microgravity or Gravity (MSC-22949), NASA Tech Briefs, Vol. 25, No. 1 (January, 2001), page 64. The COSS includes reservoirs and a staining chamber that contains a microscope slide to which a biological sample is affixed. The staining chamber is sequentially filled with and drained of staining and related liquids from the reservoirs by use of a weighted plunger to force liquid from one reservoir to another at a constant level of hypergravity maintained in a standard swing-bucket centrifuge. In the DAVD-DOF system, a staining chamber containing a sample would also be sequentially filled and emptied, but with important differences. Instead of a simple microscope slide, one would use a special microscope slide on which would be fabricated a network of very small reservoirs and narrow channels connected to a staining chamber (see figure). Unlike in the COSS, displacement of liquid would be effected by use of the weight of the liquid itself, rather than the weight of a plunger.

Feeback, Daniel L.; Clarke, Mark S. F.

2004-01-01

326

Registration of sliding objects using direction dependent B-splines decomposition  

NASA Astrophysics Data System (ADS)

Sliding motion is a challenge for deformable image registration because it leads to discontinuities in the sought deformation. In this paper, we present a method to handle sliding motion using multiple B-spline transforms. The proposed method decomposes the sought deformation into sliding regions to allow discontinuities at their interfaces, but prevents unrealistic solutions by forcing those interfaces to match. The method was evaluated on 16 lung cancer patients against a single B-spline transform approach and a multi B-spline transforms approach without the sliding constraint at the interface. The target registration error (TRE) was significantly lower with the proposed method (TRE = 1.5 mm) than with the single B-spline approach (TRE = 3.7 mm) and was comparable to the multi B-spline approach without the sliding constraint (TRE = 1.4 mm). The proposed method was also more accurate along region interfaces, with 37% less gaps and overlaps when compared to the multi B-spline transforms without the sliding constraint. This work was presented in part at the 4th International Workshop on Pulmonary Image Analysis during the Medical Image Computing and Computer Assisted Intervention (MICCAI) in Toronto, Canada (2011).

Delmon, V.; Rit, S.; Pinho, R.; Sarrut, D.

2013-03-01

327

Clay slides in the Målselv valley, northern Norway: Characteristics, occurrence, and triggering mechanisms  

NASA Astrophysics Data System (ADS)

The distribution of a large number of clay slides in the Målselv valley, northern Norway, is analysed and put into context with the stratigraphic organization of the valley-fill sediments. About 32% of the landslides larger than 10 4 m 3 occur close to the valley margins, where mud is either exposed or at shallow depth. About 57% of the landslides occur mid-valley, where relatively thin (< 15 m) coarse-grained deltaic sediments overlay fine-grained marine and glaciomarine sediments, and about 11% of the landslides occur in front of ice-contact deposits. The slide-prone areas are all characterized by the occurrence of heterogeneous sediments (interbedded clay, silt and sand), in addition to the presence of steep slopes eroded by rivers. The heterogeneous nature of the sediments probably enhanced groundwater drainage and leaching of salts from the clay, increasing sensitivity. Thus, the distribution and organization of the valley-fill sediments and groundwater drainage probably controlled the position of the slide scars and sliding planes. Since deglaciation of the valley (11,500 BP-present), isostatic rebound has enhanced fluvial incision and the creation of steep slopes due to a fall in relative sea level of up to 80 m. Arcuate-shaped, 'bottleneck' landslide scars ranging from c. 10 4 to 10 7 m 3 in size is the dominant morphological signature of the slides, typical for quick clay slides or earth flows involving fluid mud. Their most common triggering mechanism is probably erosion at the toe slopes by the river Målselv or its tributaries. River erosion close to the valley margin, where glaciomarine and marine sediments are present, seems to give the most severe slides. The overall valley-fill organization controls the distribution of clay slides, which may apply to other fjord valleys having similar sediment distribution.

Eilertsen, Raymond S.; Hansen, Louise; Bargel, Terje H.; Solberg, Inger-Lise

2008-01-01

328

The challenges of new drugs benefits and risks analysis: lessons from the ximelagatran FDA Cardiovascular Advisory Committee.  

PubMed

Ximelagatran is a new oral anticoagulant that acts by direct and reversible inhibition of thrombin and has the potential to replace warfarin. In 2004, the FDA Cardiovascular and Renal drug Advisory Committee (CRAC) reviewed the ximelagatran clinical program. Three indications were proposed: the prevention of venous thromboembolism (VTE) in patients undergoing total knee replacement surgery (TKR), the prevention of stroke and other thromboembolic complications associated with atrial fibrillation (AF), and the long-term secondary prevention of VTE after standard treatment of an episode of acute VTE. The database consisted of a total of 30,698 subjects and included five phase III pivotal studies. During the advisory panel debate, widely divergent analyses of the benefits and risks of ximelagatran were presented. Ximelagatran hepatic toxicity was a key feature leading the CRAC to conclude that the benefit risk ratio of ximelagtran was unfavorable for the three proposed indications. Some design issues also undermined the strength of efficacy data. This paper reviews the benefits and risks of ximelagatran and analyzes the reasons leading to conflicting conclusions among various experts. The aim of this review is to facilitate the interpretation of benefits and risks associated with a new drug product and to improve future clinical drug developments. PMID:16769255

Boudes, Pol F

2006-10-01

329

Exit Presentation -- Maintaining Balance  

NASA Technical Reports Server (NTRS)

This slide presentation reviews the projects which the author engaged in during an internship at Johnson Space Center. Project 1 was involved with Stochastic Resonance (SR). Stochastic resonance is a phenomenon in which the response of a non-linear system to a weak input signal is optimized by the presence of a particular non-zero level of noise. The goal of this project was to develop a countermeasure for sensorimotor disturbances that are experienced after long duration space flight. The second project was a pilot study that was to examine how adaptation to a novel functional task was affected by postural disturbance.

Heap, Erin

2010-01-01

330

"Discoveries in Planetary Sciences": Slide Sets Highlighting New Advances for Astronomy Educators  

NASA Astrophysics Data System (ADS)

Planetary science is a field that evolves rapidly, motivated by spacecraft mission results. Exciting new mission results are generally communicated rather quickly to the public in the form of press releases and news stories, but it can take several years for new advances to work their way into college textbooks. Yet it is important for students to have exposure to these new advances for a number of reasons. In some cases, new work renders older textbook knowledge incorrect or incomplete. In some cases, new discoveries make it possible to emphasize older textbook knowledge in a new way. In all cases, new advances provide exciting and accessible examples of the scientific process in action. To bridge the gap between textbooks and new advances in planetary sciences we have developed content on new discoveries for use by undergraduate instructors. Called 'Discoveries in Planetary Sciences', each new discovery is summarized in a 3-slide PowerPoint presentation. The first slide describes the discovery, the second slide discusses the underlying planetary science concepts, and the third presents the big picture implications of the discovery. A fourth slide includes links to associated press releases, images, and primary sources. This effort is generously sponsored by the Division for Planetary Sciences of the American Astronomical Society, and the slide sets are available at http://dps.aas.org/education/dpsdisc/. Sixteen slide sets have been released so far covering topics spanning all sub-disciplines of planetary science. Results from the following spacecraft missions have been highlighted: MESSENGER, the Spirit and Opportunity rovers, Cassini, LCROSS, EPOXI, Chandrayan, Mars Reconnaissance Orbiter, Mars Express, and Venus Express. Additionally, new results from Earth-orbiting and ground-based observing platforms and programs such as Hubble, Keck, IRTF, the Catalina Sky Survey, HARPS, MEarth, Spitzer, and amateur astronomers have been highlighted. 4-5 new slide sets are scheduled for release before December 2010. In this presentation we will discuss our motivation for this project, our implementation approach (from choosing topics to creating the slide sets, to getting them reviewed and released), and give examples of slide sets. We will present information in the form of web statistics on how many educators are using the slide sets, and which topics are most popular. We will also present feedback from educators who have used them in the classroom, and possible new directions for our activity.

Brain, D. A.; Schneider, N. M.; Beyer, R. A.

2010-12-01

331

A Kinematic Model of the Translational Slide at the Cidu Section 3.1k of Formosan Freeway  

NASA Astrophysics Data System (ADS)

This paper presents the results of a case study on the translational slide at the Cidu section 3.1k of Formosan freeway, including its kinematic process and the deposition geometry. Before translational slide, there are morphological indications that the potential translation rockslide can be track and find. Numerical modeling of the slides interaction was carried out using a 3D distinct element program. When the friction coefficient of each particle was about 0.03, the predicted maximum velocity was about 23.6m/sec (about 85km/hr) and the debris reached the other side of Formosan freeway. Simulations showed the three cars and Formosan freeway were buried at 2-4sec (the predicted average velocity was about 10.2m/sec) and the translational slide stopped all motions to form the low fragmentation deposit at 7.5sec. Key Words: translational slide, kinematic process, numerical modeling.

Lo, Chia-Ming

2014-05-01

332

Synthetic Biology Slides by Daisuke KigaSlides by Daisuke Kiga  

E-print Network

#12; DNA RNA #12;Synthetic Biology Slides by Daisuke KigaSlides by Daisuke Kiga #12;Two translation DNAamino acid translation signal transduction rhythm RNA protein nucleotide Synthetic Biology #12;Synthetic Biology in the World The Department of Synthetic Biology: UC Berkely, 2003, June Jay D Keasling

Hagiya, Masami

333

Constraining the characteristics of tsunami waves from deformable submarine slides  

NASA Astrophysics Data System (ADS)

The last decade has produced unprecedented increase in national and international relevance of coastal cities. Coastal cities are important links in the quickly globalizing economy. As a marine hazard, submarine slope failures have the potential to directly destroy offshore infrastructure, and, if a tsunami in generated, it also endangers the life of those who life and/or work at the coastline. Tsunami generated by earthquakes can be constrained by independent measurements of the parent earthquake by seismographs. Such measurements are impossible in case of landslides. Hence, the use of simulation tools in less effective and reliable due to the introduced unpredictable uncertainty. This uncertainty has to decrease. To lower the uncertainty, we present a method that determines material parameters for the slide body that result in a more realistic rheological behavior and a constraint of the generated tsunami waves. Our method employs the distribution of landslide run-out masses and their comparison with simulations. If the characteristic of observed run-out masses is reproduced with a certain amount of confidence, then it is assumed that the dynamical behavior of the slide is known, and the tsunami waves are constraint. To demonstrate our method, we make use of Valdes run-out masses off the Chilean coast. Even though our method suffers from the basic assumption that the parameters describing the rheological behavior of the slide do not change during the slide motion, our method represents a first step toward a better and more constraint understanding of risk and hazard from tsunami waves generated by submarine landslides.

Weiss, R.; Krastel, S.; Anasetti, A.

2012-04-01

334

Mining FDA drug labels using an unsupervised learning technique - topic modeling  

PubMed Central

Background The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. Method In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering “topics” that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. Results The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that might arise from specific medications via topics. Conclusions The successful application of topic modeling on the FDA drug labeling demonstrates its potential utility as a hypothesis generation means to infer hidden relationships of concepts such as, in this study, drug safety and therapeutic use in the study of biomedical documents. PMID:22166012

2011-01-01

335

A Locally Adaptive Regularization Based on Anisotropic Diffusion for Deformable Image Registration of Sliding Organs  

PubMed Central

We propose a deformable image registration algorithm that uses anisotropic smoothing for regularization to find correspondences between images of sliding organs. In particular, we apply the method for respiratory motion estimation in longitudinal thoracic and abdominal computed tomography scans. The algorithm uses locally adaptive diffusion tensors to determine the direction and magnitude with which to smooth the components of the displacement field that are normal and tangential to an expected sliding boundary. Validation was performed using synthetic, phantom, and 14 clinical datasets, including the publicly available DIR-Lab dataset. We show that motion discontinuities caused by sliding can be effectively recovered, unlike conventional regularizations that enforce globally smooth motion. In the clinical datasets, target registration error showed improved accuracy for lung landmarks compared to the diffusive regularization. We also present a generalization of our algorithm to other sliding geometries, including sliding tubes (e.g., needles sliding through tissue, or contrast agent flowing through a vessel). Potential clinical applications of this method include longitudinal change detection and radiotherapy for lung or abdominal tumours, especially those near the chest or abdominal wall. PMID:23899632

Pace, Danielle F.; Aylward, Stephen R.; Niethammer, Marc

2014-01-01

336

Analysis of slide exploration strategy of cytologists when reading digital slides  

NASA Astrophysics Data System (ADS)

Cytology is the sub-domain of Pathology that deals mainly with the diagnosis of cellular changes caused by disease. Current clinical practice involves a cytotechnologist that manually screens glass slides containing fixed cytology material using a light microscope. Screened slides are then forwarded to a specialized pathologist, a cytopathologist, for microscopic review and final diagnostic interpretation. If no abnormalities are detected, the specimen is interpreted as "normal", otherwise the abnormalities are marked with a pen on the glass slide by the cytotechnologist and then are used to render a diagnosis. As Pathology is migrating towards a digital environment it is important to determine whether these crucial screening and diagnostic tasks can be performed as well using digital slides as the current practice with glass slides. The purpose of this work is to make this assessment, by using a set of digital slides depicting cytological materials of different disease processes in several organs, and then to analyze how different cytologists including cytotechnologists, cytopathologists and cytotechnology-trainees explored the digital slides. We will (1) collect visual search data from the cytologists as they navigate the digital slides, as well as record any electronic marks (annotations) made by the cytologists; (2) convert the dynamic visual search data into a static representation of the observers' exploration strategy using 'search maps'; and (3) determine slide coverage, per viewing magnification range, for each group. We have developed a virtual microscope to collect this data, and this interface allows for interactive navigation of the virtual slide (including panning and zooming), as well as annotation of reportable findings. Furthermore, all interactions with the interface are time stamped, which allows us to recreate the cytologists' search strategy.

Pantanowitz, Liron; Parwani, Anil; Tseytlin, Eugene; Mello-Thoms, Claudia

2012-02-01

337

FDA's Nozzle Numerical Simulation Challenge: Non-Newtonian Fluid Effects and Blood Damage  

PubMed Central

Data from FDA’s nozzle challenge–a study to assess the suitability of simulating fluid flow in an idealized medical device–is used to validate the simulations obtained from a numerical, finite-differences code. Various physiological indicators are computed and compared with experimental data from three different laboratories, getting a very good agreement. Special care is taken with the derivation of blood damage (hemolysis). The paper is focused on the laminar regime, in order to investigate non-Newtonian effects (non-constant fluid viscosity). The code can deal with these effects with just a small extra computational cost, improving Newtonian estimations up to a ten percent. The relevance of non-Newtonian effects for hemolysis parameters is discussed. PMID:24667931

Trias, Miquel; Arbona, Antonio; Masso, Joan; Minano, Borja; Bona, Carles

2014-01-01

338

FDA-approved drug labeling for the study of drug-induced liver injury.  

PubMed

Drug-induced liver injury (DILI) is a leading cause of drugs failing during clinical trials and being withdrawn from the market. Comparative analysis of drugs based on their DILI potential is an effective approach to discover key DILI mechanisms and risk factors. However, assessing the DILI potential of a drug is a challenge with no existing consensus methods. We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts. The method is transparent and reproducible with a potential to serve as a common practice to study the DILI of marketed drugs for supporting drug discovery and biomarker development. PMID:21624500

Chen, Minjun; Vijay, Vikrant; Shi, Qiang; Liu, Zhichao; Fang, Hong; Tong, Weida

2011-08-01

339

An analysis of FDA-approved drugs for infectious disease: antibacterial agents.  

PubMed

Drugs targeting infectious diseases have greatly improved public health. A study to evaluate all US Food and Drug Administration (FDA)-approved new molecular entities (NMEs) reveals that the number of new agents targeting infectious disease peaked during the 1990s and declined rapidly thereafter. Molecules targeting bacterial pathogens represent the most common component of anti-infectives followed by antivirals and antifungals. Focusing on antibacterial agents, an increase in new NMEs predominated from the 1960s through to the 1990s, dropping sharply thereafter. Obsolescence and resistance has eliminated one-third of these drugs. Consequently, the arsenal of antibiotics peaked in 2000 and is declining. Likewise, the number of organizations awarded at least one NME for a bacterial indication has declined to a level not seen in more than a half century. PMID:25043770

Kinch, Michael S; Patridge, Eric; Plummer, Mark; Hoyer, Denton

2014-09-01

340

Potential reduction exposure products and FDA tobacco and regulation: a CNS call to action.  

PubMed

A new generation of tobacco harm reduction products is stirring controversy and confusion among healthcare providers. These products, known as "potential reduction exposure products" (PREPs), can be described in terms of reported scientific evidence, as "the good, the bad, and the ugly." On the good side, there is sufficient scientific evidence to support the use of Commit, a new over-the-counter nicotine lozenge PREP, approved for smoking cessation. On the bad side, there is no scientific evidence to support the use of Ariva, another over-the-counter nicotine lozenge PREP, marketed as an alternative to cigarettes when smoking is restricted. On the ugly side, both of these PREPs are nicotine delivery systems with "candy-like" appearances; however, one (Commit) has the Food and Drug Administration (FDA) approval and the other (Ariva) does not. This article provides an overview of PREPs and strategies to help clinical nurse specialists (CNSs) address tobacco harm reduction issues. PMID:15061445

Heath, Janie; Andrews, Jeannette; Balkstra, Cindy R

2004-01-01

341

Real-time imaging of electrical signals with an infrared FDA-approved dye.  

PubMed

Clinical methods used to assess the electrical activity of excitable cells are often limited by their poor spatial resolution or their invasiveness. One promising solution to this problem is to optically measure membrane potential using a voltage-sensitive dye, but thus far, none of these dyes have been available for human use. Here we report that indocyanine green (ICG), an infrared fluorescent dye with FDA approval as an intravenously administered contrast agent, is voltage-sensitive. The fluorescence of ICG can follow action potentials in artificial neurons and cultured rat neurons and cardiomyocytes. ICG also visualized electrical activity induced in living explants of rat brain. In humans, ICG labels excitable cells and is routinely visualized transdermally with high spatial resolution. As an infrared voltage-sensitive dye with a low toxicity profile that can be readily imaged in deep tissues, ICG may have significant utility for clinical and basic research applications previously intractable for potentiometric dyes. PMID:25229155

Treger, Jeremy S; Priest, Michael F; Iezzi, Raymond; Bezanilla, Francisco

2014-09-16

342

FDA's nozzle numerical simulation challenge: non-Newtonian fluid effects and blood damage.  

PubMed

Data from FDA's nozzle challenge-a study to assess the suitability of simulating fluid flow in an idealized medical device-is used to validate the simulations obtained from a numerical, finite-differences code. Various physiological indicators are computed and compared with experimental data from three different laboratories, getting a very good agreement. Special care is taken with the derivation of blood damage (hemolysis). The paper is focused on the laminar regime, in order to investigate non-Newtonian effects (non-constant fluid viscosity). The code can deal with these effects with just a small extra computational cost, improving Newtonian estimations up to a ten percent. The relevance of non-Newtonian effects for hemolysis parameters is discussed. PMID:24667931

Trias, Miquel; Arbona, Antonio; Massó, Joan; Miñano, Borja; Bona, Carles

2014-01-01

343

FDA approves two new approaches to HIV testing. Food and Drug Administration.  

PubMed

The Food and Drug Administration (FDA) approved two HIV home testing kits. Johnson & Johnson's Confide kit, currently only available in Texas and Florida, costs about $40. It includes a lancet to draw blood, a self-addressed postage-paid envelope to mail the sample, and a 14-digit anonymous identification code. Epitope has developed a kit called OraSure, which uses saliva samples to measure HIV antibodies. Persons testing positive will be connected directly with a trained counselor, selected from the National AIDS Hotline database. The Centers for Disease Control and Prevention (CDC) estimate that as many as two-thirds of the people at risk have not been tested for HIV, and 42 percent of those would be likely to use a home collection kit which provides anonymity. PMID:11363616

Vazquez, E

1996-01-01

344

An overview of FDA-approved new molecular entities: 1827-2013.  

PubMed

The pharmaceutical industry is undergoing fundamental change and its future is unclear. We performed a meta-analysis by cataloging FDA-approved legacy drugs and new molecular entities (NMEs). Objective information regarding scientific, medical and commercial activities was captured and provides insight into processes governing drug development. In this report, we review the rates of NME introduction through to the end of 2013. Recent trends show the emergence of a handful of companies that controls two-thirds of NMEs. We also report growth in the number of NMEs controlled by marketing organizations that have little or no internal drug discovery or development activities. This trend has increased dramatically since 2000 and could raise important questions about the future landscape and viability of drug discovery and development. PMID:24680947

Kinch, Michael S; Haynesworth, Austin; Kinch, Sarah L; Hoyer, Denton

2014-08-01

345

Electrosurgical injuries during robot assisted surgery: insights from the FDA MAUDE database  

NASA Astrophysics Data System (ADS)

Introduction: The da Vinci surgical system requires the use of electrosurgical instruments. The re-use of such instruments creates the potential for stray electrical currents from capacitive coupling and/or insulation failure with subsequent injury. The morbidity of such injuries may negate many of the benefits of minimally invasive surgery. We sought to evaluate the rate and nature of electrosurgical injury (ESI) associated with this device. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database is administered by the US Food and Drug Administration (FDA) and reports adverse events related to medical devices in the United States. We analyzed all incidents in the context of robotic surgery between January 2001 and June 2011 to identify those related to the use of electrosurgery. Results: In the past decade, a total of 605 reports have been submitted to the FDA with regard to adverse events related to the da Vinci robotic surgical platform. Of these, 24 (3.9%) were related to potential or actual ESI. Nine out of the 24 cases (37.5%) resulted in additional surgical intervention for repair. There were 6 bowel injuries of which only one was recognized and managed intra-operatively. The remainder required laparotomy between 5 and 8 days after the initial robotic procedure. Additionally, there were 3 skin burns. The remaining cases required conservative management or resulted in no harm. Conclusion: ESI in the context of robotic surgery is uncommon but remains under-recognized and under-reported. Surgeons performing robot assisted surgery should be aware that ESI can occur with robotic instruments and vigilance for intra- and post-operative complications is paramount.

Fuller, Andrew; Vilos, George A.; Pautler, Stephen E.

2012-02-01

346

Synergy testing of FDA-approved drugs identifies potent drug combinations against Trypanosoma cruzi.  

PubMed

An estimated 8 million persons, mainly in Latin America, are infected with Trypanosoma cruzi, the etiologic agent of Chagas disease. Existing antiparasitic drugs for Chagas disease have significant toxicities and suboptimal effectiveness, hence new therapeutic strategies need to be devised to address this neglected tropical disease. Due to the high research and development costs of bringing new chemical entities to the clinic, we and others have investigated the strategy of repurposing existing drugs for Chagas disease. Screens of FDA-approved drugs (described in this paper) have revealed a variety of chemical classes that have growth inhibitory activity against mammalian stage Trypanosoma cruzi parasites. Aside from azole antifungal drugs that have low or sub-nanomolar activity, most of the active compounds revealed in these screens have effective concentrations causing 50% inhibition (EC50's) in the low micromolar or high nanomolar range. For example, we have identified an antihistamine (clemastine, EC50 of 0.4 µM), a selective serotonin reuptake inhibitor (fluoxetine, EC50 of 4.4 µM), and an antifolate drug (pyrimethamine, EC50 of 3.8 µM) and others. When tested alone in the murine model of Trypanosoma cruzi infection, most compounds had insufficient efficacy to lower parasitemia thus we investigated using combinations of compounds for additive or synergistic activity. Twenty-four active compounds were screened in vitro in all possible combinations. Follow up isobologram studies showed at least 8 drug pairs to have synergistic activity on T. cruzi growth. The combination of the calcium channel blocker, amlodipine, plus the antifungal drug, posaconazole, was found to be more effective at lowering parasitemia in mice than either drug alone, as was the combination of clemastine and posaconazole. Using combinations of FDA-approved drugs is a promising strategy for developing new treatments for Chagas disease. PMID:25033456

Planer, Joseph D; Hulverson, Matthew A; Arif, Jennifer A; Ranade, Ranae M; Don, Robert; Buckner, Frederick S

2014-07-01

347

Newly recognized submarine slide complexes in the southern California Bight  

NASA Astrophysics Data System (ADS)

New high-resolution bathymetric and seismic-reflection surveys have imaged large (<0.5 km3) submarine landslides offshore southern California that have not been previously recognized in the Borderland. The new data show several large slides or slide complexes that include: 1) a slide complex consisting of numerous (>7) individual overlapping slides along the western margin of Santa Cruz Basin (SCB slide); 2) a series of slumps and slide scars on the slope south of San Pedro shelf (SPS slide); and 3) a slope failure along the shelf edge in northern San Diego County, termed the Del Mar slide. The SCB slide complex extends for 30 km along the western slope of Santa Cruz Basin, with debris lobes extending 5-8 km into the basin. Head scarps of some of these slides are 50-75 m high. The SPS slide complex also appears to consist of multiple slides, which roughly parallel the Palos Verdes Fault and the San Gabriel Canyon submarine channel on the shelf edge and slope south of San Pedro shelf. Slide deposits associated with this complex are only partially mapped due to limited high-resolution bathymetric coverage, but extend to the south in the area SW of Lasuen Knoll. Seismic-reflection profiles show that some of these deposits are up to 20 m thick. The Del Mar slide is located about 10 km north of La Jolla Canyon and extends about 6 km along the shelf edge. The head scarp lies along the trend of a branch of the Rose Canyon Fault Zone. Radiocarbon ages of sediment overlying this slide indicate the Del Mar slide is approximately 12-16 ka. These large slide complexes have several characteristics in common. Nearly all occur in areas of tectonic uplift. All of the complexes show evidence of recurrent slide activity, exhibiting multiple headwall scarps and debris lobes, and where available, high-resolution seismic-reflection profiles of these slide areas provide evidence of older, buried mass transport deposits. Assuming typical sedimentation rates, the recurrence interval of major slide events appears to be on the order of tens of thousands of years. Most of the slide complexes do not appear to be located in areas of high sediment input. The SCB and Del Mar slides are in areas receiving relatively small terrestrial sediment input from fluvial sources, as are most other previously recognized submarine slides in the Borderland. Only the SPS slide, which lies adjacent to the San Gabriel Canyon submarine channel, is associated with a significant fluvial sediment source.

Conrad, J. E.; Lee, H. J.; Edwards, B. D.; McGann, M.; Sliter, R. W.

2012-12-01

348

NEMD simulations for ductile metal sliding  

SciTech Connect

We have studied the sliding behavior for a 19 M Al(110)/Al(110) defective crystal at 15 GPa as a function of relative sliding velocity. The general features are qualitatively similar to smaller scale (1.4 M) atom simulations for Al(111)/Al(110) nondefective single crystal sliding. The critical velocity, v{sub c}, is approximately the same for the defective crystal as the size scaled v{sub c}. The lower velocity tangential force is depressed relative to the perfect crystal. The critical temperature, T*, is depressed relative to the perfect crystal. These conclusions are consistent with a lower value for f{sub c} for the defective crystal. The detailed features of structural transformation and the high velocity regime remain to be mapped.

Hammerberg, James E [Los Alamos National Laboratory; Germann, Timothy C [Los Alamos National Laboratory; Ravelo, Ramon J [Los Alamos National Laboratory; Holian, Brad L [Los Alamos National Laboratory

2011-01-31

349

Experimental Testing of Glacier Sliding Laws  

NASA Astrophysics Data System (ADS)

Glacier sliding laws exist in various forms and are applied in modeling of glacier dynamics. Sliding laws have been, in most cases, theoretically derived but not experimentally tested. Under certain conditions ice sliding over a rigid bed will generate cavities in the lees of bedrock bumps. These cavities will redistribute shear stress to regions of the bed that are in contact with ice. Sliding laws that incorporate cavity formation relate drag to the maximum adverse slope of the region of ice-bed contact. Sinusoidal and stepped-bed geometries are, therefore, predicted to affect basal drag differently. A sinusoidal bed is predicted to have a double-valued drag response as a function of sliding velocity, whereas the steady-state drag on a stepped bed with linear adverse slopes is expected to be independent of sliding velocity. We have conducted an experimental study of sliding laws using a ring shear apparatus that slides ice over a rigid bed. The device rotates a ring of ice that is 20 cm wide, 20 cm tall, with outer diameter of 90 cm. The sliding speed at the ice ring's centerline was incrementally stepped between 7.25--324 m/yr, and a vertical stress of 500 kPa was applied to the ice ring. The ice consisted initially of randomly oriented crystals that with sliding quickly developed a fabric like those observed in ice near glacier beds. The temperature of the ice is held at the pressure melting point and is regulated to ~0.01oC by a bath of circulating fluid that surrounds the sample chamber. Experiments have been conducted on a stepped bed with a constant slope of 8.3 and a sinusoidal bed with a wavelength of 183.3 mm and an amplitude of 15.3 mm. Water was allowed to drain from cavities, so effective stress at the bed was equal to the total vertical stress. Our experimental results differ from theoretical predictions. For the stepped bed, a decrease in shear stress of ~50% over a 12-fold increase in velocity is observed, in contrast to theoretical predictions of a constant shear stress. This rate weakening could be attributed to spatial variability in the rheological properties of the ice, or an unresolved three-dimensional effect. Rheological variability could result from steep gradients in deviatoric stress in ice as it moves from above the cavity to the bed. The results from the sinusoidal bed demonstrate a decrease in shear stress with increasing sliding velocity that is larger than with the stepped bed. Thus, the well-described theoretical effect of a sinusoidal bed on rate weakening is augmented by whatever effect is responsible for rate weakening with the stepped bed. These results provide the first experimental targets for models of sliding that attempt to assess effects of ice-bed separation.

Zoet, L.; Iverson, N. R.

2013-12-01

350

Reversible sliding in networks of nanowires.  

PubMed

This work demonstrates that metal nanowires in a percolating network can reversibly slide across one another. Reversible sliding allows networks of metal nanowires to maintain electrical contact while being stretched to strains greater than the fracture strain for individual nanowires. This phenomenon was demonstrated by using networks of nanowires as compliant electrodes for a dielectric elastomer actuator. Reversible nanowire sliding enabled actuation to a maximum area strain of 200% and repetitive cycling of the actuator to an area strain of 25% over 150 times. During actuation, the transmittance of the network increased 4.5 times, from 13% to 58%. Compared to carbon-based compliant electrodes, networks of metal nanowires can actuate across a broader range of optical transmittance. The widely tunable transmittance of nanowire-based actuators allows for their use as a light valve. PMID:23634844

Wu, Jianghong; Zang, Jianfeng; Rathmell, Aaron R; Zhao, Xuanhe; Wiley, Benjamin J

2013-06-12

351

Do grain boundaries in nanophase metals slide?  

SciTech Connect

Nanophase metallic materials show a maximum in strength as grain size decreases to the nano scale, indicating a break down of the Hall-Petch relation. Grain boundary sliding, as a possible accommodation mechanisms, is often the picture that explain computer simulations results and real experiments. In a recent paper, Bringa et al. Science 309, 1838 (2005), we report on the observation of an ultra-hard behavior in nanophase Cu under shock loading, explained in terms of a reduction of grain boundary sliding under the influence of the shock pressure. In this work we perform a detailed study of the effects of hydrostatic pressure on nanophase Cu plasticity and find that it can be understood in terms of pressure dependent grain boundary sliding controlled by a Mohr-Coulomb law.

Bringa, E M; Leveugle, E; Caro, A

2006-10-27

352

Paleo Slide Set: Polar Ice Cores  

NSDL National Science Digital Library

This slide show describes scientists' travels to the ends of the earth to study climate variability. Included in this set are color photos of the Greenland Ice Sheet and the Antarctic Ice Sheet, in addition to a comprehensive text for each slide. Examine ice cores, visit science camps, and understand the importance of these two enormous ice sheets. Maps and graphical representations of ice core data along with ice core methodology and long term glacial/interglacial climatic reconstructions are also included. This set can also be used as an educational tool for studying current issues in glaciology, global warming, the greenhouse effect, and global climate variability.

353

Physics 116 Design Practical Oral Presentation  

E-print Network

for contributing to the presentation; the group grade must reflect a group effort. Grading: · Presentation gradeRubric11613.pdf · You must submit your graded design practical along with a printout of your slides on the day of your presentation, or your grade will be severely penalized. · Each member of the group is responsible

Glashausser, Charles

354

Seafood Contamination after the BP Gulf Oil Spill and Risks to Vulnerable Populations: A Critique of the FDA Risk Assessment  

Microsoft Academic Search

Background: The BP oil spill of 2010 resulted in contamination of one of the most productive fisheries in the United States by polycydic aromatic hydrocarbons (PAHs). PAHs, which can accumulate in seafood, are known carcinogens and developmental toxicants. In response to the oil spill, the U.S. Food and Drug Administration (FDA) developed risk criteria and established thresholds for allowable levels

Miriam Rotkin-Ellman; Karen K. Wong; Gina M. Solomon

2012-01-01

355

FDA Draft Guidances Compound the Compounding Uncertainty: A New List of 503B Outsourcing Facilities Offers No Guarantee of Anything.  

PubMed

Compounders who prepare nonpatient-specific prescriptions have been slow to sign up for a new FDA program meant to serve as a de facto "Good Housekeeping" seal of approval. Meanwhile, inspectors are turning up problems wherever they go. PMID:25050055

Barlas, Stephen

2014-06-01

356

A Clinical Plan for MDMA (Ecstasy) in the Treatment of Posttraumatic Stress Disorder (PTSD): Partnering with the FDA  

Microsoft Academic Search

The FDA and the Spanish Ministry of Health have concluded that the risk\\/benefit ratio is favorable under certain circumstances for clinical studies investigating MDMA-assisted psychotherapy. Both agencies have approved pilot studies in chronic posttraumatic stress disorder (PTSD) patients who have failed to obtain relief from at least one course of conventional treatment. These studies, the only ones in the world

Rick Doblin

2002-01-01

357

76 FR 41506 - Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability  

Federal Register 2010, 2011, 2012, 2013

...Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability...availability of a draft guidance entitled ``In Vitro Companion Diagnostic Devices.'' This...product that depends on the use of an in vitro companion diagnostic device for its...

2011-07-14

358

Slide Set - Unit 3 - People and Animals: United for Health  

NSDL National Science Digital Library

The slide set (converted from 35mm to PDF) illustrates facts from the corresponding unit in the Reference Manual and Discussion Guide. Detailed captions for each slide are found in the Discussion Guide.

Dr. Leslie Nader (MSMR)

1992-07-01

359

Improved section bonding using silanated glass slides —application protocol  

Microsoft Academic Search

Summary Silanated slides provide excellent tissue adhesion for routine histology, immunhistochemistry and in situ hybridization of frozen, paraffin embedded material or cell smears. An easy and inexpensive method of treating glass microscope slides with triethoxysilylpropylamine is reported.

L. Pötsch; A. Jauche

1992-01-01

360

GRAIN BOUNDARY SLIDING AND HETEROGENEITIES OF STRAIN DURING  

E-print Network

GRAIN BOUNDARY SLIDING AND HETEROGENEITIES OF STRAIN DURING SUPERPLASTIC DEFORMATION NSF Grant DMR between grain boundary sliding and intragranular slip during superplasticity. 4. Deformation processes on the surface and in the bulk during superplasticity. 5. Peculiarities of strain localization during

Garmestani, Hamid

361

How to Prepare Clay-Lift and Sandwich Slides.  

ERIC Educational Resources Information Center

Describes two techniques for making 35 millimeter slides without using photographic film. One method uses clear adhesive contact paper and the other uses transparency film. Both techniques are inexpensive and require only a few minutes of preparation per slide. (JM)

Barman, Charles R.

1984-01-01

362

Slide Set - Unit 2 - People and Animals: United for Health  

NSDL National Science Digital Library

The slide set (converted from 35mm to PDF) illustrates facts from the corresponding unit in the Reference Manual and Discussion Guide. Detailed captions for each slide are found in the Discussion Guide.

Dr. Leslie Nader (MSMR)

1992-07-01

363

Slide Set - Unit 1 - People and Animals: United for Health  

NSDL National Science Digital Library

The slide set (converted from 35mm to PDF) illustrates facts from the corresponding unit in the Reference Manual and Discussion Guide. Detailed captions for each slide are found in the Discussion Guide.

Dr. Leslie Nader (MSMR)

1992-07-01

364

Slide Set - Unit 10 - People and Animals: United for Health  

NSDL National Science Digital Library

The slide set (converted from 35mm to PDF) illustrates facts from the corresponding unit in the Reference Manual and Discussion Guide. Detailed captions for each slide are found in the Discussion Guide.

Dr. Leslie Nader (MSMR)

1992-07-01

365

Numerical modelling of tsunami generation by deformable submarine slides using mesh adaptivity  

NASA Astrophysics Data System (ADS)

Tsunamis generated by submarine slides are often under considered in comparison to earthquake generated tsunami, despite several recent examples. Tsunamigenic slides have generated waves that have caused significant damage and loss of life, for example the 1998 Papua New Guinea submarine mass failure resulted in a tsunami that devastated coastal villages and killed over 2,100 people. Numerical simulations of submarine slide generated waves can help us understand the nature of the waves that are generated, and identify the important factors in determining wave characteristics. There have not been many studies of tsunami generation by deformable submarine slides, largely because of the complexities and computational expense involved in modelling these large scale events. At large, real world, scales modelling of tsunami waves by the generation of slides is computationally challenging. Fluidity is an open source finite element code that is ideally suited to tackle this type of problem as it uses unstructured, adaptive meshes, which help to reduce the computational expense without losing accuracy in the results. Adaptive meshes change topology and resolution based on the current simulation state and as such can focus or reduce resolution when and where it is required. The model also allows a number of different numerical approaches to be taken to simulate the same problem within the same numerical framework. In this example we use multi-material approach, with both two materials (slide and water) and three materials (slide, water and air), alongside a density-driven sediment model approach. We will present results of validating Fluidity against benchmarks from experimental and other numerical studies, at different scales, for deformable underwater slides, and consider the utility of mesh adaptivity. We show good agreement to both laboratory results and other numerical models, both with a fixed mesh and a dynamically adaptive mesh, tracking important features of the slide geometry as the simulation progresses. This is the first step in being able to simulate both the wave initiation, propagation, and inundation within the same numerical model at real-world scales for submarine slide generated tsunamis.

Smith, Rebecca; Parkinson, Samuel; Hill, Jon; Collins, Gareth; Piggott, Matthew

2014-05-01

366

Parallel Fault Systems with Evolving Self-similar Sliding Zones  

Microsoft Academic Search

Catastrophic fault sliding is preceded by the development of sliding zones which grow further driven by the excess of the\\u000a shear stress over friction at the loci of initiation. This growth is strongly affected by the interaction between the sliding\\u000a zones. We propose a model of development of such zones based on two major simplifications. Firstly, each sliding zone is

A. V. Dyskin

2008-01-01

367

Parallel Fault Systems with Evolving Self-similar Sliding Zones  

Microsoft Academic Search

Catastrophic fault sliding is preceded by the development of sliding zones which grow further driven by the excess of the\\u000a shear stress over friction at the loci of initiation. This growth is strongly affected by the interaction between the sliding\\u000a zones. We propose a model of development of such zones based on two major simplifications. Firstly, each sliding zone is

A. V. Dyskin

368

Fuzzy Incremental Hierarchical Sliding Mode Control for Underactuated Systems  

Microsoft Academic Search

This paper designs a fuzzy incremental hierarchical sliding mode controller for a class of under actuated systems. By capturing the physical structure of the class, the hierarchical sliding surfaces with incremental structure are designed as follows. The first-layer sliding surface is firstly defined. Then, the first-layer sliding surface and one of the left states are employed to construct the second-layer

Dianwei Qian; Jianqiang Yi; Yufen Ma

2010-01-01

369

Complete Genome Sequence of West Nile Virus Strains Used for the Formulation of CBER/FDA RNA Reference Reagents and Lot Release Panels for Nucleic Acid Testing  

PubMed Central

We report the complete sequences of two West Nile virus strains (FDA-Hu02 and NY99) used for the formulation of CBER/FDA RNA reference reagents and lot release panels for use with nucleic acid technology testing. PMID:25359905

Añez, Germán

2014-01-01

370

Complete Genome Sequence of West Nile Virus Strains Used for the Formulation of CBER/FDA RNA Reference Reagents and Lot Release Panels for Nucleic Acid Testing.  

PubMed

We report the complete sequences of two West Nile virus strains (FDA-Hu02 and NY99) used for the formulation of CBER/FDA RNA reference reagents and lot release panels for use with nucleic acid technology testing. PMID:25359905

Grinev, Andriyan; Añez, Germán; Rios, Maria

2014-01-01

371

1 / FDA Consumer Health Infor mat ion / U. S. Food and Dr ug Adminis t r at ion APR IL 2011 Consumer Health Information  

E-print Network

1 / FDA Consumer Health Infor mat ion / U. S. Food and Dr ug Adminis t r at ion APR IL 2011 Consumer Health Information www.fda.gov/consumer Most drugs can be thrown in the household trash, but consumers should take certain precautions before tossing them out, according to the Food and Drug Administra

Van Stryland, Eric

372

Stanford University Special Considerations for the Oversight of Research GUI-26m Research Compliance Office Protocols in FDA-regulated Drug or Device Studies  

E-print Network

Compliance Office Protocols in FDA-regulated Drug or Device Studies File:GUI01026 rev2 03/06 1 of 2 Considerations for the Oversight of Research GUI-26m Research Compliance Office Protocols in FDA-regulated Drug according to the signed statement, the investigational plan, and applicable regulations. protecting

Puglisi, Joseph

373

Optimization of FDA-PI method using flow cytometry to measure metabolic activity of the cyanobacteria, Microcystis aeruginosa  

NASA Astrophysics Data System (ADS)

A rapid toxicity test based on inhibition of esterase activity in the harmful freshwater microalgae - Microcystis aeruginosa was developed using flow cytometry. The hydrolysis rate of fluorescein diacetate (FDA) by intracellular esterase to fluorescein was used to indicate the metabolic activity of algae. Uptake of FDA was optimized at different concentrations and incubation times. Propidium iodide (PI) was utilized to assess cell membrane integrity. The optimized FDA/PI staining dosages were 10 mg/L and 10 ?M, respectively, lower than the reported concentrations. Correspondingly, the proper incubation time was 14-21 min at the optimal FDA dosage determined in this study. A new procedure based on optimized FDA/PI condition, called “whole algal culture flow cytometry with fluorescence triggering”, was developed for short-term bioassays. This new procedure, taking account of working conditions such as pH and impure cultures, is able to avoid algal cell damages in sample preparation and separate algal cells from non-algal particles by fluorescence triggering. This newly-developed procedure was then used to assess the toxicity of copper on M. aeruginosa in a short-term exposure (36 h). As copper concentrations increased, it was found that the esterase activity decreased in a concentration-dependent manner with increased membrane fragments. Moreover, esterase activity was a good indicator of copper toxicity in M. aeruginosa. The EC 50 value based on mean fluorescence intensity (MFI) was 123.3 ?g/L (95% confidence limits 101.5-146.2 ?g/L). Therefore, the new-developed procedure could be used for sublethal endpoints detection, and has the potential to be a rapid and cost-effective bioassay for selecting M. aeruginosa control methods or exploring the M. aeruginosa activity inhibition mechanism.

Xiao, Xi; Han, Zhi-ying; Chen, Ying-xu; Liang, Xin-qiang; Li, Hua; Qian, Yi-chao

374

In-situ physical properties of submarine slides along the Lesser Antilles Arc derived from rock physics models  

NASA Astrophysics Data System (ADS)

Submarine slides are ubiquitous along the flanks of volcanic islands and continental margins. They alter seafloor morphology, transport huge sediment volumes, and sometimes generate tsunamis. Constraining in-situ sediment physical properties, and in particular, pore fluid pressure in submarine slide debris offers insight into slope failure processes. Unfortunately, in-situ measurements of physical properties are difficult to acquire and often require specialized tools or long-term sub-seafloor hydrogeological observatories. Here, using data collected from the Lesser Antilles Volcanic Arc during IODP Expedition 340, we demonstrate that rock physics models (e.g. Dvorkin et al., 1999; Mavko et al., 2009) applied to shipboard physical properties measurements provide a valid approach for estimating in-situ P-wave, S-wave, and Poisson's ratio values for slide debris. The rock physics approach presented here is especially valuable at depths less than 80 m below the seafloor where shallow slides often exist but open-hole well logging is limited. Seismic velocities, and in particular, Poisson's ratio values obtained using the rock physics model provide insight into subsurface pore-pressure in submarine slide complexes along the Lesser Antilles Arc. Near the volcanic arc, submarine slide debris has anomalously high P-wave and S-wave velocities and low Poisson's ratios, atypical of shallowly buried marine sediments, implying over-compaction and perhaps rapid dewatering. In the slide apron away from the arc, however, slide debris generally has high porosity, low seismic velocity and anomalously high Poisson's ratio values. The inferences obtained using rock physics models are consistent with numerical models and analog laboratory experiments of debris flows that infer normal dewatering, compaction, and erosion in the run-out area of submarine slides but higher porosity and elevated fluid pressure in submarine debris flow aprons. Analysis of rock physics model results shows that Poisson's ratio typically drops sharply at the base of slides. We hypothesize that the basal boundaries of submarine slides consist of stronger, dewatered material overlain by weaker, less-compacted sediment. The analysis implies significant variability in sediment strength and permeability with depth in deep-water basins where slide debris accumulates. At IODP sites 1398 and 1399 in the Grenada Basin we observe high Poisson's ratios and anomalously high porosity in sediments older than 100ky. Our analysis suggests the permeability of some shallowly buried (<200 m below sea-level) slide debris exceeds 10^-17 m^2 at these sites; this in-part explains why elevated pressures exist in the basin. The analysis implies near-lithostatic pressure at some locations beneath the Grenada basin and perhaps in other similar settings where distal mass wasting acts as the dominant sediment source.

Hornbach, M. J.; Manga, M.; Adachi, T.; Breitkreuz, C. F.; Lafuerza, S.; Le Friant, A.; Morgan, S.; Ishizuka, O.; Jutzeler, M.; Slagle, A. L.; Talling, P. J.

2012-12-01

375

Sliding mode control for offshore steel jacket platforms  

Microsoft Academic Search

This paper is concerned with sliding mode control of offshore steel jacket platforms subject to nonlinear wave-induced forces. Two sliding mode control schemes are proposed to reduce the oscillation amplitudes of the platforms. One scheme is that a conventional sliding mode controller (SMC) is designed, under the SMC the oscillation amplitudes of the platform are effectively reduced; however, a very

Bao-Lin Zhang; Qing-Long Han; Xian-Ming Zhang; Xinghuo Yu

2010-01-01

376

Sliding mode observers for fault detection and isolation  

Microsoft Academic Search

This paper considers the application of a particular sliding mode observer to the problem of fault detection and isolation. The novelty lies in the application of the equivalent output injection concept to explicitly reconstruct fault signals. Previous work in the area of fault detection using sliding mode observers has used disruption of the sliding motion to detect faults. A design

Christopher Edwards; Sarah K. Spurgeon; Ronald J. Patton

2000-01-01

377

CSc 165 Lecture Note Slides Using Sound In  

E-print Network

CSc 165 Lecture Note Slides Using Sound In Games CSc 165 Lecture Note Slides Using Sound In Games 2 Overview · Sound Characteristics & File Formats (CSc 133) · Sound APIs · 3D Sound · OpenAL and JOAL · Game Engine API CSc 165 Lecture Note Slides Using Sound In Games 3 Sampled Audio (from CSc-133) Analog Sound

Gordon, Scott

378

Apparatus for correcting precision errors in slide straightness in machine tools  

DOEpatents

The present invention is directed to a mechanism by which small deviations in slideway straightness and roll of a precision machining apparatus may be compensated for. The mechanism of the present invention comprises a fixture support disposed between the slideway carriage and the tool or workpiece fixture and provided with a hinge-like coupling between the carriage and the fixture support so as to allow for the minute and precise displacement of the fixture support in a direction normal to the direction of the slide path so as to readily compensate for slight deviations in the straightness and roll of the slide path.

Robinson, Samuel C. (Clinton, TN); Gerth, Howard L. (Knoxville, TN)

1981-01-01

379

Planning for Dexterous Manipulation with Sliding Contacts  

Microsoft Academic Search

Dexterous manipulation refers to the skillful execution of object reorienting and repositioning maneuvers, especially when performed within the grasp of an articulated mechani cal hand. In this paper we study the problem of gaining a secure and enveloping grasp of a two-dimensional object by exploiting sliding at the contacts between the object and the hand. This is done in two

Jeffrey C. Trinkle; Richard P. Paul

1990-01-01

380

Output tracking via robust sliding mode controller  

SciTech Connect

In this paper, we propose a robust sliding mode controller for tracking nonlinear systems based on a switching surface with the same order as the system. This methodology enables the closed loop system to keep its initial order and reduces chattering. An example is given to illustrate the theoretical results.

Hajri, S.; Vanheeghe, P.; Borne, P. [CNRS, Villeneuve (France)

1994-12-31

381

Title Slide "Balancing static and dynamic testing  

E-print Network

. © L.Hatton, 2000- Overview v Static v. dynamic testing v Forensic work: patterns in failure v that the causal relationship between fault and failure differs in some standards:- · IEEE + other sources: errorTitle Slide 2000- "Balancing static and dynamic testing: Some observations from measurement" by Les

Hatton, Les

382

Color Microfiche as a Replacement for Slides.  

ERIC Educational Resources Information Center

This is the summary of a larger paper describing the evolution of a mediated elementary accounting course at the University of Wisconsin-Stout. The course was initially developed as a 25 slide-tape lesson course which included 950 visuals and approximately 25 hours of instruction. One hundred students per semester took the course in the following…

Schwarz, Philip

383

Sliding of outrunner blocks from submarine landslides  

Microsoft Academic Search

Outrunner blocks are nearly intact pieces of debris that detach from a slowing-down submarine landslide and flow ahead of the front. Data gathered from different sliding areas highlight some properties of outrunner blocks and in particular their inordinate mobility reflected in runouts of up to 25 kilometres, even on very gentle slopes. Blocks may produce an erosion glide track on

Fabio Vittorio De Blasio; Lars Enok Engvik; Anders Elverhøi

2006-01-01

384

Slide #1CENTER FOR INTEGRATED ACCESS NETWORKS  

E-print Network

· Fiber preform fabrication · Fiber pulling #12;Slide #14CENTER FOR INTEGRATED ACCESS NETWORKS Rod design · Raman amplifiers Module 11: Fiber Optic Networks and the Internet (M. Fallahi) · Network it to an electrical signal Optical fiber transmission line Bit of information Signal is too weak to be detected Need

Kieu, Khanh

385

Ceramic wear in indentation and sliding  

NASA Technical Reports Server (NTRS)

The various wear mechanisms involved with single-crystal ceramic materials in indentation and in sliding contacts. Experiments simulating interfacial events have been conducted with hemispherical, conical and pyramidal indenters (riders). With spherical riders, under either abrasive or adhesive conditions, two types of fracture pits have been observed. First, spherical-shaped fracture pits and wear particles are found as a result of either indenting or sliding. These are shown to be due to a spherical-shaped fracture along the circular or spherical stress trajectories. Second, polyhedral fracture pits and debris, produced by anisotropic fracture, and also found both during indenting and sliding. These are primarily controlled by surface and subsurface cracking along cleavage planes. Several quantitative results have also been obtained from this work. For example, using a pyramidal diamond, crack length of Mn-Zn ferrite in the indentation process grows linearly with increasing normal load. Moreover, the critical load to fracture both in indentation and sliding is essentially isotropic and is found to be directly proportional to the indenter radius.

Miyoshi, K.; Buckley, D. H.

1984-01-01

386

USER MODELLING FOR PRINCIPLED SLIDING AUTONOMY IN  

E-print Network

-benefit analysis. The autonomous system does not learn to improve its task performance, resulting in a model basedUSER MODELLING FOR PRINCIPLED SLIDING AUTONOMY IN HUMAN-ROBOT TEAMS Brennan Sellner, Reid Simmons the ability of autonomous control software to handle the myriad failure modes inherent in such sys- tems

Singh, Sanjiv

387

CSc 155 Lecture Note Slides Atmospheric Effects  

E-print Network

Fog A useful effect: blend pixel color with another color (e.g. gray) based on distance from eye. "Fog" is not just for simulating fog, but also for enhancing the sense of 3D depth for the viewer. There are simple Slides Atmospheric Effects 3 Pixel color based (mostly) on object Pixel color based (mostly) on fog color

Gordon, Scott

388

Stanford London 2005 Slide 1 Technology Entrepreneurship  

E-print Network

· Research funding and culture of creativity · Silicon Valley as nearby planting ground for ideas and early entrepreneurial skills to be successful at any level within an organization. STVP prepares students for leadership · International Partners http://edcorner.stanford.edu #12;Stanford London 2005 Slide 10 Ten Enduring Success

Prinz, Friedrich B.

389

Identification of FDA-approved Drugs Targeting Breast Cancer Stem Cells Along With Biomarkers of Sensitivity  

PubMed Central

Recently developed genomics-based tools are allowing repositioning of Food and Drug Administration (FDA)-approved drugs as cancer treatments, which were employed to identify drugs that target cancer stem cells (CSCs) of breast cancer. Gene expression datasets of CSCs from six studies were subjected to connectivity map to identify drugs that may ameliorate gene expression patterns unique to CSCs. All-trans retinoic acid (ATRA) was negatively connected with gene expression in CSCs. ATRA reduced mammosphere-forming ability of a subset of breast cancer cells, which correlated with induction of apoptosis, reduced expression of SOX2 but elevated expression of its antagonist CDX2. SOX2/CDX2 ratio had prognostic relevance in CSC-enriched breast cancers. K-ras mutant breast cancer cell line enriched for CSCs was resistant to ATRA, which was reversed by MAP kinase inhibitors. Thus, ATRA alone or in combination can be tested for efficacy using SOX2, CDX2, and K-ras mutation/MAPK activation status as biomarkers of response. PMID:23982413

Bhat-Nakshatri, Poornima; Goswami, Chirayu P.; Badve, Sunil; Sledge, George W.; Nakshatri, Harikrishna

2013-01-01

390

Ceftriaxone, an FDA-approved cephalosporin antibiotic, suppresses lung cancer growth by targeting Aurora B  

PubMed Central

Ceftriaxone, an FDA-approved third-generation cephalosporin antibiotic, has antimicrobial activity against both gram-positive and gram-negative organisms. Generally, ceftriaxone is used for a variety of infections such as community-acquired pneumonia, meningitis and gonorrhea. Its primary molecular targets are the penicillin-binding proteins. However, other activities of ceftriaxone remain unknown. Herein, we report for the first time that ceftriaxone has antitumor activity in vitro and in vivo. Kinase profiling results predicted that Aurora B might be a potential ‘off’ target of ceftriaxone. Pull-down assay data confirmed that ceftriaxone could bind with Aurora B in vitro and in A549 cells. Furthermore, ceftriaxone (500 µM) suppressed anchorage-independent cell growth by targeting Aurora B in A549, H520 and H1650 lung cancer cells. Importantly, in vivo xenograft animal model results showed that ceftriaxone effectively suppressed A549 and H520 lung tumor growth by inhibiting Aurora B. These data suggest the anticancer efficacy of ceftriaxone for the treatment of lung cancers through its inhibition of Aurora B. PMID:22962305

Li, Xiang; Li, Haitao; Li, Shengqing; Zhu, Feng; Dong, Zigang

2012-01-01

391

FDA-Approved Selective Estrogen Receptor Modulators Inhibit Ebola Virus Infection  

PubMed Central

Ebola viruses remain a substantial threat to both civilian and military populations as bioweapons, during sporadic outbreaks, and from the possibility of accidental importation from endemic regions by infected individuals. Currently, no approved therapeutics exist to treat or prevent infection by Ebola viruses. Therefore, we performed an in vitro screen of Food and Drug Administration (FDA)– and ex–US-approved drugs and selected molecular probes to identify drugs with antiviral activity against the type species Zaire ebolavirus (EBOV). From this screen, we identified a set of selective estrogen receptor modulators (SERMs), including clomiphene and toremifene, which act as potent inhibitors of EBOV infection. Anti-EBOV activity was confirmed for both of these SERMs in an in vivo mouse infection model. This anti-EBOV activity occurred even in the absence of detectable estrogen receptor expression, and both SERMs inhibited virus entry after internalization, suggesting that clomiphene and toremifene are not working through classical pathways associated with the estrogen receptor. Instead, the response appeared to be an off-target effect where the compounds interfere with a step late in viral entry and likely affect the triggering of fusion. These data support the screening of readily available approved drugs to identify therapeutics for the Ebola viruses and other infectious diseases. The SERM compounds described in this report are an immediately actionable class of approved drugs that can be repurposed for treatment of filovirus infections. PMID:23785035

Johansen, Lisa M.; Brannan, Jennifer M.; Delos, Sue E.; Shoemaker, Charles J.; Stossel, Andrea; Lear, Calli; Hoffstrom, Benjamin G.; DeWald, Lisa Evans; Schornberg, Kathryn L.; Scully, Corinne; Lehar, Joseph; Hensley, Lisa E.; White, Judith M.; Olinger, Gene G.

2014-01-01

392

A History of the Sonocare CST-100: The First FDA-approved HIFU Device  

NASA Astrophysics Data System (ADS)

The Sonocare CST-100 Therapeutic Ultrasound System, designed for the treatment of glaucoma, was developed in the 1980s and became the first high intensity focused ultrasound (HIFU) device to receive Food and Drug Administration approval. The system arose from studies done by F.L. Lizzi, Eng.Sc.D., of Riverside Research Institute and D.J. Coleman, M.D., of Cornell Medical Center/New York Hospital on the safety of ultrasound diagnosis of the eye. As safety limits were probed, therapeutic regimes were discovered. Optimization of operational parameters, clinical experience, and engineering design came together through a spin-off company, Sonocare, Inc., formed to produce and market the ophthalmic device. Various precedents were set during the approval process, including the acceptance by the FDA of radiation momentum imparted to an absorber as a measure of acoustic power. Many devices were sold, but the laser industry, grandfathered into the therapeutic field, eventually out-marketed Sonocare. The CST-100 remains as a model of elegant industrial design, and existing units are used daily in HIFU laboratory experiments.

Muratore, Robert

2006-05-01

393

FDA-approved selective estrogen receptor modulators inhibit Ebola virus infection.  

PubMed

Ebola viruses remain a substantial threat to both civilian and military populations as bioweapons, during sporadic outbreaks, and from the possibility of accidental importation from endemic regions by infected individuals. Currently, no approved therapeutics exist to treat or prevent infection by Ebola viruses. Therefore, we performed an in vitro screen of Food and Drug Administration (FDA)- and ex-US-approved drugs and selected molecular probes to identify drugs with antiviral activity against the type species Zaire ebolavirus (EBOV). From this screen, we identified a set of selective estrogen receptor modulators (SERMs), including clomiphene and toremifene, which act as potent inhibitors of EBOV infection. Anti-EBOV activity was confirmed for both of these SERMs in an in vivo mouse infection model. This anti-EBOV activity occurred even in the absence of detectable estrogen receptor expression, and both SERMs inhibited virus entry after internalization, suggesting that clomiphene and toremifene are not working through classical pathways associated with the estrogen receptor. Instead, the response appeared to be an off-target effect where the compounds interfere with a step late in viral entry and likely affect the triggering of fusion. These data support the screening of readily available approved drugs to identify therapeutics for the Ebola viruses and other infectious diseases. The SERM compounds described in this report are an immediately actionable class of approved drugs that can be repurposed for treatment of filovirus infections. PMID:23785035

Johansen, Lisa M; Brannan, Jennifer M; Delos, Sue E; Shoemaker, Charles J; Stossel, Andrea; Lear, Calli; Hoffstrom, Benjamin G; Dewald, Lisa Evans; Schornberg, Kathryn L; Scully, Corinne; Lehár, Joseph; Hensley, Lisa E; White, Judith M; Olinger, Gene G

2013-06-19

394

Improving the visualization and detection of tissue folds in whole slide images through color enhancement  

PubMed Central

Objective: The objective of this paper is to improve the visualization and detection of tissue folds, which are prominent among tissue slides, from the pre-scan image of a whole slide image by introducing a color enhancement method that enables the differentiation between fold and non-fold image pixels. Method: The weighted difference between the color saturation and luminance of the image pixels is used as shifting factor to the original RGB color of the image. Results: Application of the enhancement method to hematoxylin and eosin (H&E) stained images improves the visualization of tissue folds regardless of the colorimetric variations in the images. Detection of tissue folds after application of the enhancement also improves but the presence of nuclei, which are also stained dark like the folds, was found to sometimes affect the detection accuracy. Conclusion: The presence of tissue artifacts could affect the quality of whole slide images, especially that whole slide scanners select the focus points from the pre-scan image wherein the artifacts are indistinguishable from real tissue area. We have a presented in this paper an enhancement scheme that improves the visualization and detection of tissue folds from pre-scan images. Since the method works on the simulated pre-scan images its integration to the actual whole slide imaging process should also be possible. PMID:21221170

Bautista, Pinky A.; Yagi, Yukako

2010-01-01

395

Phosphoproteome analysis of formalin-fixed and paraffin-embedded tissue sections mounted on microscope slides.  

PubMed

Formalin-fixed and paraffin-embedded (FFPE) sections mounted on microscope slides are one of the largest available resources for retrospective research on various diseases, but quantitative phosphoproteome analysis of FFPE sections has never been achieved because of the extreme difficulty of procuring sufficient phosphopeptides from the limited amounts of proteins on the slides. Here, we present the first protocol for quantitative phosphoproteome analysis of FFPE sections by utilizing phase-transfer surfactant-aided extraction/tryptic digestion of FFPE proteins followed by high-recovery phosphopeptide enrichment via lactic acid-modified titania chromatography. We established that FFPE sections retain a similar phosphoproteome to fresh tissue specimens during storage for at least 9 months, confirming the utility of our method for evaluating phosphorylation profiles in various diseases. We also verified that chemical labeling based on reductive dimethylation of amino groups was feasible for quantitative phosphoproteome analysis of FFPE samples on slides. Furthermore, we improved the LC-MS sensitivity by miniaturizing nanoLC columns to 25 ?m inner diameter. With this system, we could identify 1090 phosphopeptides from a single FFPE section obtained from a microscope slide, containing 25.2 ± 5.4 ?g of proteins. This protocol should be useful for large-scale phosphoproteome analysis of archival FFPE slides, especially scarce samples from patients with rare diseases. PMID:24328109

Wakabayashi, Masaki; Yoshihara, Hiroki; Masuda, Takeshi; Tsukahara, Mai; Sugiyama, Naoyuki; Ishihama, Yasushi

2014-02-01

396

Comparison of coefficient of friction and contact resistance during sliding wear on clad gold-nickel surfaces  

Microsoft Academic Search

This paper presents analysis of experimental sliding wear data for four hard-gold flash over gold-diffused nickel material systems (GF-DGNi). The surface hardness of the DGNi material was altered by varying both the gold surface concentration and the amount of gold reduction after the diffusion anneal. These material systems were evaluated for unlubricated and lubricated sliding wear durability. The lubricant used

Nicole Gabel; Harry Hardee; Philip Lees

2001-01-01

397

The liberal state and the rogue agency: FDA's regulation of drugs for mood disorders, 1950s-1970s?  

PubMed Central

The theory of the liberal state does not generally contemplate the possibility that regulatory agencies will turn into “rogues,” regulating against the interests of their clients and, indeed, the public interest. In the years between circa 1955 and 1975 this seems to have happened to one of the prime regulatory agencies of the US federal government: the Food and Drug Administration (FDA). Intent upon transforming itself from a traditional “cop” agency to a regulatory giant, the FDA campaigned systematically to bring down some safe and effective drugs. This article concentrates on hearings in the area of psychopharmacology regarding several antianxiety drugs, namely meprobamate (Miltown), chlordiazepoxide (Librium) and diazepam (Valium). In addition, from 1967 to 1973 this regulatory vengefulness occurred on a broad scale in the Drug Efficacy Study Implementation (DESI), an administrative exercise that removed from the market almost half of the psychopharmacopoeia. The article explores possible bureaucratic motives for these actions. PMID:18343498

Shorter, Edward

2013-01-01

398

BIOCHEMISTRY: RT Slides Home⦠ 

NSDL National Science Digital Library

Access to the article is free, however registration and sign-in are required. To access its target sites, HIV reverse transcriptase (RT) slides and flips on nucleic acid substrates. Although 20 years of crystallographic and biochemical studies have illuminated the molecular details of the chemistry of DNA synthesis, there have been relatively few insights into how RT finds the end of the nucleic acid substrate where it begins DNA synthesis, how it displaces nucleic acid fragments, or where and how it executes masterful leaps when transferring DNA between templates. On page 1092 of this issue, Liu et al. (2) describe elegant single-molecule fluorescence resonance energy transfer (FRET) experiments that provide a view of RT at work. They show that RT has a remarkable ability to slide on nucleic acid duplexes, rapidly shuttling between the two ends and flipping into the polymerase-competent binding mode when needed.

Stefan G. Sarafianos (University of Missouri;Christopher S. Bond Life Sciences Center, Department of Molecular Microbiology and Immunology); Eddy Arnold (Rutgers University;Center for Advanced Biotechnology and Medicine, Department of Chemistry and Chemical Biology)

2008-11-14

399

Plastic deformation at surface during unlubricated sliding  

NASA Technical Reports Server (NTRS)

The plastic deformation and wear of 304 stainless-steel surface slid against an aluminum oxide rider were observed by using a scanning electron microscope and an optical microscope. Experiments were conducted in a vacuum of 0.000001 Pa and in an environment of 0.0005 Pa chlorine gas at 25 C. The load was 500 grams and the sliding velocity was 0.5 centimeter per second. The deformed surface layer which accumulates and develops successively is left behind the rider, and step-shaped protuberances are developed even after single pass sliding under both environmental conditions. A fully developed surface layer is gradually torn off leaving a characteristic pattern. These observations result from both adhesion and an adhesive wear mechanism.

Yamamoto, T.; Buckley, D. H.

1982-01-01

400

CARS: 2001 Presentation  

Cancer.gov

Slide 1 Title: Information Guided Therapy Resources Laurence P. Clarke Ph.D.Branch ChiefImaging Technology DevelopmentImage Guided TherapyNCI: Biomedical Imaging Program, USA Slide 2 Image of CIP Organizational Chart NCI Division of Cancer Treatment

401

Discovery of FDA-Approved Drugs as Inhibitors of Fatty Acid Binding Protein 4 Using Molecular Docking Screening.  

PubMed

We first identified fluorescein, ketazolam, antrafenine, darifenacin, fosaprepitant, paliperidone, risperidone, pimozide, trovafloxacin, and levofloxacin as inhibitors of fatty acid binding protein 4 using molecular docking screening from FDA-approved drugs. Subsequently, the biochemical characterizations showed that levofloxacin directly inhibited FABP4 activity in both the in vitro ligand displacement assay and cell-based function assay. Furthermore, levofloxacin did not induce adipogenesis in adipocytes, which is the major adverse effect of FABP4 inhibitors. PMID:25360897

Wang, Yan; Law, Wai-Kit; Hu, Jian-Shu; Lin, Huang-Quan; Ip, Tsz-Ming; Wan, David Chi-Cheong

2014-11-24

402

Original research: Intravenous ribavirin--review of the FDA's Emergency Investigational New Drug Database (1997-2008) and literature review.  

PubMed

Intravenous (IV) ribavirin does not have US Food and Drug Administration (FDA) approval, although oral and aerosol formulations have been approved. Intravenous ribavirin can, however, be authorized for use as a result of an Emergency Investigational New Drug (EIND) application as investigational treatment for patients with serious viral infections, including emerging or rare infections for which no alternative treatment is available. This retrospective study evaluated clinical experience with IV ribavirin based on a review of the FDA's EIND database and a literature review. The main outcome measures were disease condition, clinical outcomes, and adverse events (AEs). First, the FDA's EIND database was evaluated for these variables among patients authorized to receive investigational IV ribavirin. Second, published literature on IV ribavirin was reviewed for diseases treated, reported clinical outcomes, and AEs. Adverse events reported in the literature were compared with AEs listed in approved product labeling (aerosol and oral formulations). From February 1997 to December 2008, 608 IV ribavirin EIND requests were made for 19 disease conditions. Adenovirus, respiratory syncytial virus, and parainfluenza infections comprised 84.7% of IV ribavirin EINDs. Inadequate reporting of clinical outcomes and AEs in the EIND database prevented analysis of either outcome. Data interpretation in the literature was limited by multiple factors, including retrospective design, small sample sizes, differences in reporting outcomes and AEs, lack of generalizability, and potential confounders such as concomitant medications, selection bias, and reporting bias. Reported AEs were consistent with labels of approved aerosol and oral formulations, except for lip and gingival swelling. However, estimates of frequency, severity, and causality of AEs associated with IV ribavirin could not be determined because of study limitations. Our study findings suggest that the literature is inconclusive on the potential benefit for continued use of IV ribavirin. A review of the literature and the FDA's EIND database suggests that prospective, controlled trials of IV ribavirin in patients with adenovirus, parainfluenza, or serious respiratory syncytial virus infections could be feasible. PMID:19491552

Riner, Andrea; Chan-Tack, Kirk M; Murray, Jeffrey S

2009-05-01

403

Model-following adaptive second-order sliding model control of a class of nonlinear uncertain systems  

NASA Astrophysics Data System (ADS)

In this paper, a novel algorithm model-following adaptive second-order sliding model control is proposed for a class of nonlinear uncertain systems. Second-order sliding model control can effectively counteract chattering that conventional sliding model control hold. The difference between the output of pant and the output of the followed model is regarded as sliding variable; the algorithm presented here introduced a suitable commutation logic that prevents uncontrollable growth of the uncertainties in the control system. Thank to this algorithm, the nonlinear uncertain systems are properly controlled. The example of simulation shows that the method is very effective for a class of nonlinear uncertain systems, and can be used in real time online control.

Shang, Anli; Gu, Wenjin

2003-09-01

404

Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance  

PubMed Central

Background Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Results Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Conclusions Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware. PMID:22829874

Kramer, Daniel B.; Baker, Matthew; Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Reynolds, Matthew R.

2012-01-01

405

A Systematic Screen of FDA-Approved Drugs for Inhibitors of Biological Threat Agents  

PubMed Central

Background The rapid development of effective medical countermeasures against potential biological threat agents is vital. Repurposing existing drugs that may have unanticipated activities as potential countermeasures is one way to meet this important goal, since currently approved drugs already have well-established safety and pharmacokinetic profiles in patients, as well as manufacturing and distribution networks. Therefore, approved drugs could rapidly be made available for a new indication in an emergency. Methodology/Principal Findings A large systematic effort to determine whether existing drugs can be used against high containment bacterial and viral pathogens is described. We assembled and screened 1012 FDA-approved drugs for off-label broad-spectrum efficacy against Bacillus anthracis; Francisella tularensis; Coxiella burnetii; and Ebola, Marburg, and Lassa fever viruses using in vitro cell culture assays. We found a variety of hits against two or more of these biological threat pathogens, which were validated in secondary assays. As expected, antibiotic compounds were highly active against bacterial agents, but we did not identify any non-antibiotic compounds with broad-spectrum antibacterial activity. Lomefloxacin and erythromycin were found to be the most potent compounds in vivo protecting mice against Bacillus anthracis challenge. While multiple virus-specific inhibitors were identified, the most noteworthy antiviral compound identified was chloroquine, which disrupted entry and replication of two or more viruses in vitro and protected mice against Ebola virus challenge in vivo. Conclusions/Significance The feasibility of repurposing existing drugs to face novel threats is demonstrated and this represents the first effort to apply this approach to high containment bacteria and viruses. PMID:23577127

Madrid, Peter B.; Chopra, Sidharth; Manger, Ian D.; Gilfillan, Lynne; Keepers, Tiffany R.; Shurtleff, Amy C.; Green, Carol E.; Iyer, Lalitha V.; Dilks, Holli Hutcheson; Davey, Robert A.; Kolokoltsov, Andrey A.; Carrion, Ricardo; Patterson, Jean L.; Bavari, Sina; Panchal, Rekha G.; Warren, Travis K.; Wells, Jay B.; Moos, Walter H.; Burke, RaeLyn L.; Tanga, Mary J.

2013-01-01

406

Regulatory underpinnings of Global Health security: FDA's roles in preventing, detecting, and responding to global health threats.  

PubMed

In February 2014, health officials from around the world announced the Global Health Security Agenda, a critical effort to strengthen national and global systems to prevent, detect, and respond to infectious disease threats and to foster stronger collaboration across borders. With its increasing global roles and broad range of regulatory responsibilities in ensuring the availability, safety, and security of medical and food products, the US Food and Drug Administration (FDA) is engaged in a range of efforts in support of global health security. This article provides an overview of FDA's global health security roles, focusing on its responsibilities related to the development and use of medical countermeasures (MCMs) for preventing, detecting, and responding to global infectious disease and other public health emergency threats. The article also discusses several areas-antimicrobial resistance, food safety, and supply chain integrity-in which FDA's global health security roles continue to evolve and extend beyond MCMs and, in some cases, beyond traditional infectious disease threats. PMID:25254912

Courtney, Brooke; Bond, Katherine C; Maher, Carmen

2014-01-01

407

Medical devices; performance standards for dental and mammographic X-ray devices; amendment--FDA. Proposed rule.  

PubMed

The Food and Drug Administration (FDA) is proposing to exempt panoramic dental x-ray units from the requirement that they be manufactured with exposure timers which automatically reset to zero upon premature termination of an exposure. Removing the automatic timer reset requirement will not compromise the quality of the radiographic image and will protect patients from being subjected to unnecessary radiation due to repeat radiographs. FDA also proposes five changes to align the performance standard with the equipment requirements issued under the Mammography Quality Standards Act of 1992 (MQSA). First, the agency proposes to remove any reference to the use of equipment not specifically designed for mammography from the performance requirements for mammography equipment. Second, FDA proposes that the mammographic field alignment requirements restrict the irradiation beam to less than 2 percent of the source-image receptor distance (SID) beyond the image receptor edges. Third, it is proposed that the definition of an image receptor support device be amended to specify that it must provide a primary protective barrier for any orientation of the x-ray tube and image receptor support device assembly. Fourth, it is proposed that the useful beam must be confined to the dimensions of the primary barrier provided by the image receptor support device (except on the chest wall side). Fifth, it is proposed that exposures not be permitted without the primary barrier in place. PMID:10185846

1998-10-29

408

Sliding mode control of locomotion for a biomimetic robot inspired by pillbugs  

Microsoft Academic Search

Reconnaissance robots can reduce the danger of hazardous places by providing information before human personnel take action. In practice, the robot platform should be small and light. However, this fact leads to a scaling issue with terrain that poses a huge obstacle for the vehicle. The problem can be solved by the inspiration of nature. This paper presents a sliding

Kyung-soo Kim; Soo-hyun Kim

2010-01-01

409

FLEXIBLE SPACECRAFT VIBRATION SUPPRESSION USING PWPF MODULATED INPUT COMPONENT COMMAND AND SLIDING MODE CONTROL  

Microsoft Academic Search

This paper presents a dual-stage control system design method for the rotational maneuver and vibration stabilization of a spacecraft with flexible appendages. In this design approach, attitude control system and vibration suppression were designed separately using lower order model. The design of attitude controller was based on sliding mode control (SMC) theory leading to a discontinuous control law. This controller

Qing-Lei Hu; Guang-Fu Ma

2007-01-01

410

Bubble-wall interactions in a vertical gas–liquid flow: Bouncing, sliding and bubble deformations  

Microsoft Academic Search

The paper presents the results of a study on the motion of single (individual) bubbles rising in upward shear liquid flow in the vicinity of a vertical wall. Bubbles were found to slide along the wall when their diameter is small. Bubbles could also experience multiple collisions with the wall at certain experimental parameters (geometry of a channel, range of

Alexander Zaruba; Dirk Lucas; Horst-Michael Prasser; Thomas Höhne

2007-01-01

411

Compensation of significant parametric uncertainties using sliding mode online learning  

NASA Astrophysics Data System (ADS)

An augmented nonlinear inverse dynamics (NID) flight control strategy using sliding mode online learning for a small unmanned aircraft system (UAS) is presented. Because parameter identification for this class of aircraft often is not valid throughout the complete flight envelope, aerodynamic parameters used for model based control strategies may show significant deviations. For the concept of feedback linearization this leads to inversion errors that in combination with the distinctive susceptibility of small UAS towards atmospheric turbulence pose a demanding control task for these systems. In this work an adaptive flight control strategy using feedforward neural networks for counteracting such nonlinear effects is augmented with the concept of sliding mode control (SMC). SMC-learning is derived from variable structure theory. It considers a neural network and its training as a control problem. It is shown that by the dynamic calculation of the learning rates, stability can be guaranteed and thus increase the robustness against external disturbances and system failures. With the resulting higher speed of convergence a wide range of simultaneously occurring disturbances can be compensated. The SMC-based flight controller is tested and compared to the standard gradient descent (GD) backpropagation algorithm under the influence of significant model uncertainties and system failures.

Schnetter, Philipp; Kruger, Thomas

412

Sliding Seal Materials for Adiabatic Engines, Phase 2  

NASA Technical Reports Server (NTRS)

An essential task in the development of the heavy-duty adiabatic diesel engine is identification and improvements of reliable, low-friction piston seal materials. In the present study, the sliding friction coefficients and wear rates of promising carbide, oxide, and nitride materials were measured under temperature, environmental, velocity, and loading conditions that are representative of the adiabatic engine environment. In addition, silicon nitride and partially stabilized zirconia disks were ion implanted with TiNi, Ni, Co, and Cr, and subsequently run against carbide pins, with the objective of producing reduced friction via solid lubrication at elevated temperature. In order to provide guidance needed to improve materials for this application, the program stressed fundamental understanding of the mechanisms involved in friction and wear. Electron microscopy was used to elucidate the micromechanisms of wear following wear testing, and Auger electron spectroscopy was used to evaluate interface/environment interactions which seemed to be important in the friction and wear process. Unmodified ceramic sliding couples were characterized at all temperatures by friction coefficients of 0.24 and above. The coefficient at 800 C in an oxidizing environment was reduced to below 0.1, for certain material combinations, by the ion implanation of TiNi or Co. This beneficial effect was found to derive from lubricious Ti, Ni, and Co oxides.

Lankford, J.; Wei, W.

1986-01-01

413

Denuded Zones, Diffusional Creep, and Grain Boundary Sliding  

SciTech Connect

The appearance of denuded zones following low stress creep in particle-containing crystalline materials is both a microstructural prediction and observation often cited as irrefutable evidence for the Nabarro-Herring mechanism of diffusional creep. The denuded zones are predicted to be at grain boundaries that are orthogonal to the direction of the applied stress. Furthermore, their dimensions should account for the accumulated plastic flow. In the present paper, the evidence for such denuded zones is critically examined. These zones have been observed during creep of magnesium, aluminum, and nickel-base alloys. The investigation casts serious doubts on the apparently compelling evidence for the link between denuded zones and diffusional creep. Specifically, denuded zones are clearly observed under conditions that are explicitly not diffusional creep. Additionally, the denuded zones are often found in directions that are not orthogonal to the applied stress. Other mechanisms that can account for the observations of denuded zones are discussed. It is proposed that grain boundary sliding accommodated by slip is the rate-controlling process in the stress range where denuded zones have been observed. It is likely that the denuded zones are created by dissolution of precipitates at grain boundaries that are simultaneously sliding and migrating during creep.

Wadsworth, J; Ruano, O A; Sherby, O D

2001-06-27

414

Application of Sliding Mode Methods to the Design of Reconfigurable Flight Control Systems  

NASA Technical Reports Server (NTRS)

Observer-based sliding mode control is investigated for application to aircraft reconfigurable flight control. A comprehensive overview of reconfigurable flight control is given, including, a review of the current state-of-the-art within the subdisciplines of fault detection, parameter identification, adaptive control schemes, and dynamic control allocation. Of the adaptive control methods reviewed, sliding mode control (SMC) appears very promising due its property of invariance to matched uncertainty. An overview of sliding mode control is given and its remarkable properties are demonstrated by example. Sliding mode methods, however, are difficult to implement because unmodeled parasitic dynamics cause immediate and severe instability. This presents a challenge for all practical applications with limited bandwidth actuators. One method to deal with parasitic dynamics is the use of an asymptotic observer in the feedback path. Observer-based SMC is investigated, and a method for selecting observer gains is offered. An additional method for shaping the feedback loop using a filter is also developed. It is shown that this SMC prefilter is equivalent to a form of model reference hedging. A complete design procedure is given which takes advantage of the sliding mode boundary layer to recast the SMC as a linear control law. Frequency domain loop shaping is then used to design the sliding manifold. Finally, three aircraft applications are demonstrated. An F-18/HARV is used to demonstrate a SISO pitch rate tracking controller. It is also used to demonstrate a MIMO lateral-directional roll rate tracking controller. The last application is a full linear six degree-of-freedom advanced tailless fighter model. The observer-based SMC is seen to provide excellent tracking with superior robustness to parameter changes and actuator failures.

Wells, Scott R.

2002-01-01

415

Zooming in: high resolution 3D reconstruction of differently stained histological whole slide images  

NASA Astrophysics Data System (ADS)

Much insight into metabolic interactions, tissue growth, and tissue organization can be gained by analyzing differently stained histological serial sections. One opportunity unavailable to classic histology is three-dimensional (3D) examination and computer aided analysis of tissue samples. In this case, registration is needed to reestablish spatial correspondence between adjacent slides that is lost during the sectioning process. Furthermore, the sectioning introduces various distortions like cuts, folding, tearing, and local deformations to the tissue, which need to be corrected in order to exploit the additional information arising from the analysis of neighboring slide images. In this paper we present a novel image registration based method for reconstructing a 3D tissue block implementing a zooming strategy around a user-defined point of interest. We efficiently align consecutive slides at increasingly fine resolution up to cell level. We use a two-step approach, where after a macroscopic, coarse alignment of the slides as preprocessing, a nonlinear, elastic registration is performed to correct local, non-uniform deformations. Being driven by the optimization of the normalized gradient field (NGF) distance measure, our method is suitable for differently stained and thus multi-modal slides. We applied our method to ultra thin serial sections (2 ?m) of a human lung tumor. In total 170 slides, stained alternately with four different stains, have been registered. Thorough visual inspection of virtual cuts through the reconstructed block perpendicular to the cutting plane shows accurate alignment of vessels and other tissue structures. This observation is confirmed by a quantitative analysis. Using nonlinear image registration, our method is able to correct locally varying deformations in tissue structures and exceeds the limitations of globally linear transformations.

Lotz, Johannes; Berger, Judith; Müller, Benedikt; Breuhahn, Kai; Grabe, Niels; Heldmann, Stefan; Homeyer, André; Lahrmann, Bernd; Laue, Hendrik; Olesch, Janine; Schwier, Michael; Sedlaczek, Oliver; Warth, Arne

2014-03-01

416

PaperPoint: a paper-based presentation and interactive paper prototyping tool  

Microsoft Academic Search

Recent developments in digital pen and paper solutions ena- ble, not only the digital capture of handwriting, but also pa- per to be used as an interactive medium that links to digi- tal information and services. We present a tool that builds on technologies for interactive paper to enable PowerPoint presentations to be controlled from printed slide handouts. Furthermore, slides

Beat Signer; Moira C. Norrie

2007-01-01

417

Presented by Memphis: Finding and Fixing  

E-print Network

Presented by Memphis: Finding and Fixing NUMA-Related Performance Problems on Multi-core Platforms Access (NUMA) is a problem that will only get worse � However, trends in microprocessor design are pushing NUMA to ever-smaller scales � These slides* examine the current state of NUMA and � Demonstrate

418

Technical Presentations in Multimedia: A Modular Approach.  

ERIC Educational Resources Information Center

A unique system for writing and producing multimedia technical presentations is said to make it relatively easy for any communications professional to get involved with multimedia. Projection equipment and screen numbers are to be chosen strictly on the basis of content; dissolve effects with 35mm slides are described as the key. Central themes…

Harkins, Craig

419

Adapted from FDA refrigerator and freezer guidelines: http://www.fda.gov/downloads/Food/ResourcesForYou/HealthEducators/UCM109315.pdf Have you ever wondered how long you should keep things in the refrigerator or freezer? If so, then the chart below can he  

E-print Network

on food packages. Freezing food at 0 degrees or colder keeps food safe indefinitely so the recommendedAdapted from FDA refrigerator and freezer guidelines: http://www.fda.gov/downloads/Food in the refrigerator to prevent any juices from dripping on other foods. Follow handling and storage directions noted

420

Using slides to test for changes in crown defoliation assessment methods. Part I: Visual assessment of slides.  

PubMed

In this study we used photographs of tree crowns to test whether the assessment methods for tree defoliation in Switzerland have changed over time. We randomly selected 24 series of slides of Norway spruce with field assessments made between 1986 and 1995. The slides were randomly arranged and assessed by three experts without prior knowledge of the year when the slide was taken or the tree number. Defoliation was assessed using the Swiss reference photo guide. Although the correlations between the field assessments and slide assessments were high (Spearman's rank correlation coefficient ranged between 0.79 and 0.83), we found significant differences between field and slide assessments (4.3 to 9% underprediction by the slide assessors) and between the slide assessments. However, no significant trends in field assessment methods could be detected. When the mean differences between field and slide assessments were subtracted, in some years, field assessors consistently underpredicted (1990, 1992) or overpredicted defoliation (1987, 1991). Defoliation tended to be overpredicted in slides taken against the light, and underpredicted for trees with more than 25% crown overlap. We conclude that slide series can be used to detect changes in assessment methods. However, potential observer bias calls for more objective methods of assessment. PMID:15473542

Dobbertin, Matthias; Hug, Christian; Mizoue, Nobuya

2004-11-01

421

New drugs--reports of new drugs recently approved by the FDA. Dirithromycin.  

PubMed

Dirithromycin is a semisynthetic derivative of erythromycin, a 14-membered ring macrolide antibiotic. The drug is converted during absorption and distribution, to an active metabolite 9-(S)-erythromycylamine, which is the predominant compound found in plasma and extravascular tissues. High tissue concentration of erythromycylamine is achieved after oral doses of dirithromycin, with slow release back into the circulation. The mechanism of action of dirithromycin is like that of erythromycin and other macrolides. These compounds inhibit RNA-dependent protein synthesis. It has recently been suggested that all macrolides stimulate dissociation of peptidyl-tRNA from ribosomes during the elongation phase, leading to inhibited protein synthesis. The antimicrobial spectrum of dirithromycin is similar to that of erythromycin, although the drug offers no significant advantage with regard to MIC values. In vitro against Gram-positive isolates, dirithromycin exhibits similar potency to that of clarithromycin, erythromycin, roxithromycin, and clindamycin. In vivo, dirithromycin is active against penicillin-susceptible Staphylococcus aureus, beta-hemolytic streptococci, and Streptococcus pneumoniae. Dirithromycin is as effective as penicillin VK against streptococcal pharyngitis and tonsilitis, and as effective as erythromycin against acute superimposed chronic bronchitis and skin and soft-tissue infections. In comparison with other newer macrolides, dirithromycin has shown similar or lesser in vitro activity. In particular, Haemophilus influenzae, Bacteroides spp., Peptococcus-Peptostreprococcus spp., Clostridium perfringens, Legionella spp., Neisseria gonorrhoeae, and Chlamydia trachomatis were all less sensitive to dirithromycin than azithromycin or clarithromycin. Once-daily oral administration of dirithromycin (500 mg) has been demonstrated to be similar in efficacy to erythromycin (250 mg, 4 times daily), each for approximately 7 days, in the treatment of acute bronchitis or acute-exacerbations of chronic bronchitis in controlled studies. Proven or presumed pathogen eradication rates were 83 and 86% for acute bronchitis patients treated with dirithromycin and erythromycin, respectively. Corresponding bacteriological response rates in acute exacerbations of chronic bronchitis were 75 to 84% with dirithromycin and 75 to 82% with erythromycin. Both agents achieved clinical cure or improvement in over 85% of the patients with either condition. The main advantage of dirithromycin over erythromycin appears to be once-daily administration. Lilly launched dirithromycin in September 1993, in Spain, received approval from FDA in August 1995, and launched it during October 1995. PMID:8735838

Shinkai, I; Ohta, Y

1996-04-01

422

Return to ranger submarine slide, Baja California, Mexico  

Microsoft Academic Search

Ranger Slide is a modest (12 km3) slide deposit of Pliocene and younger sediment on the continental slope in northern Sebastian Vizcaino Bay, Mexico. A limited\\u000a survey using a deeply-towed instrument shows that hummocky terrain immediately downslope from the slide scar consists of large\\u000a blocks of semiconsolidated sediment, some exceeding a kilometer in length and 107 m3 in volume. Most

William R. Normark

1990-01-01

423

Aeronautical and space vehicle control in dynamic sliding manifolds  

Microsoft Academic Search

Multiple loop multiple time scale sliding mode control technique based on dynamic sliding manifold is developed and applied to aeronautical and space vehicle control. Minimum and non-minimum phase output tracking problems for aeronautical and space vehicles are addressed in dynamic sliding manifold. Numerical examples of the flight controller design for controlling minimum and non-minimum phase manoeuvres of an F-16 jet

Yuri B. Shtessel; Ilia A. Shkolnikov

2003-01-01

424

Second order sliding mode control for a quadrotor UAV.  

PubMed

A method based on second order sliding mode control (2-SMC) is proposed to design controllers for a small quadrotor UAV. For the switching sliding manifold design, the selection of the coefficients of the switching sliding manifold is in general a sophisticated issue because the coefficients are nonlinear. In this work, in order to perform the position and attitude tracking control of the quadrotor perfectly, the dynamical model of the quadrotor is divided into two subsystems, i.e., a fully actuated subsystem and an underactuated subsystem. For the former, a sliding manifold is defined by combining the position and velocity tracking errors of one state variable, i.e., the sliding manifold has two coefficients. For the latter, a sliding manifold is constructed via a linear combination of position and velocity tracking errors of two state variables, i.e., the sliding manifold has four coefficients. In order to further obtain the nonlinear coefficients of the sliding manifold, Hurwitz stability analysis is used to the solving process. In addition, the flight controllers are derived by using Lyapunov theory, which guarantees that all system state trajectories reach and stay on the sliding surfaces. Extensive simulation results are given to illustrate the effectiveness of the proposed control method. PMID:24751475

Zheng, En-Hui; Xiong, Jing-Jing; Luo, Ji-Liang

2014-07-01

425

21 CFR 864.3800 - Automated slide stainer.  

Code of Federal Regulations, 2012 CFR

...DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology Instrumentation and Accessories § 864.3800 Automated slide stainer. (a) Identification....

2012-04-01

426

21 CFR 864.3800 - Automated slide stainer.  

Code of Federal Regulations, 2010 CFR

...DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology Instrumentation and Accessories § 864.3800 Automated slide stainer. (a) Identification....

2010-04-01

427

21 CFR 864.3800 - Automated slide stainer.  

Code of Federal Regulations, 2011 CFR

...DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology Instrumentation and Accessories § 864.3800 Automated slide stainer. (a) Identification....

2011-04-01

428

21 CFR 864.3800 - Automated slide stainer.  

Code of Federal Regulations, 2013 CFR

...DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology Instrumentation and Accessories § 864.3800 Automated slide stainer. (a) Identification....

2013-04-01

429

21 CFR 864.3800 - Automated slide stainer.  

...DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Pathology Instrumentation and Accessories § 864.3800 Automated slide stainer. (a) Identification....

2014-04-01

430

Title Slide "Open source data handling  

E-print Network

constructs for m=1:10, a(m) = m^2, end s = 100; while s>50, disp(s^2), s = s-5, end x=10;y=5; if x>y disp Vectors v = [1,2], v', w = [3,4], w', v*w'; w'*v X=-10:2:10, y=sin(x*%pi/10), plot(x,y), help plot Diary. 1.3, 01/Oct/2009, (slide 1 - 10). Copyright Les Hatton 2007- Statistics Simple stats meuro = mean

Hatton, Les

431

3D Sedimentary Architecture of the Nidelva Delta (Trondheim, Norway): Implications for Regional Slope Instability and Slide Development  

NASA Astrophysics Data System (ADS)

The city of Trondheim, Norway is built on the Nidelv delta plain and urban development over the last hundred years has extended on the submarine part of the delta. A number of coastal slides are known to have occurred historically at the delta front. Skaven-Haug (1955) describes two large slides which occured in the Trondheim Harbor in 1888 and 1950 while Emdal and Janbu (1996) describes the slide at Lade peninsula that took place in 1990. From these events, damage to railways, roads and houses in addition to tsunami and loss of life occurred. In the last 15 years, land reclamation along the coast has been intensified for construction work and building activity. This has increased the concerns about the stability of the delta sediments and has highlighted the need for a regional stability assessment. This paper presents an ongoing study of the Nidelv delta, which includes in a first stage the construction of a 3D geological model of the raised subaerial portion of delta from a large data set comprising cone penetration tests (CPT), rotary pressure drilling tests and core sampling. The architectural model shows that the Nidelva delta reposes partly on bedrock, moraine material and on marine clays. The outskirts of the delta laps onto marine clays which form today's land surface. Different sedimentary facies have been recognized from the Nidelva delta: (1) prodelta clay and silts, prodelta silts, loose delta front silts and sands and alluvial sand and gravel. The materials, which have been involved in the mass movement, are delta front and prodelta sequences of loose fine sand and silt of Holocene age presenting low shear strength value based on the results from the geotechnical boreholes. The submarine part of the delta is constructed based on newly acquired high- resolution seismic data and swath bathymetry. The seismic data show numerous reflectors interpreted as sliding planes, shallow ruptures, slide scarps and slump debris in the delta deposit. The multibeam sonar data have revealed many slope instability features along the delta front and the prodelta such as rotational slide scars, fresh slide planes, surface creep, channels incisions and gullies and possibly local small-scale slumping. An interesting fact is that the type of sliding at the delta front differs from the 1888 slide (flow liquefaction) and the 1990 slide at Lade peninsula (retrogressive sliding). This is partly due to the presence of a large channel north of the 1888 slide that permitted the sliding mass to accelerate leading to total fluidisation of the soil. The fact that the sliding mass was able to accelerate could be the cause of the 2m high flood wave that was generated. The difference in the type of sliding is also attributed to the 3D variability in the sediment facies and different geotechnical properties of the transferred sediments. Finally, the geomorphological and geophysical signatures illustrate that slope instability has played an important role in the development of the Nidelv delta and that it must be taken into consideration when planning urban development along the coast. This emphasizes the fact that slope instability is a fundamental part of delta development and that it represents a hazard for urbanized areas situated on such coastal deposits.

L'Heureux, J.; Longva, O.; Hansen, L.

2006-12-01

432

Oral Presentation of a Fossil Group  

NSDL National Science Digital Library

Each student chooses a different fossil group that interests him/her and prepares a 10 minute PowerPoint presentation about that group, lavishly illustrated and richly illuminated with fascinating facts! This can be as large a group as a phylum or as small as a species. Powerpoint handouts are given out during the oral presentation. Students must have a concluding slide citing references. The discussion must go beyond what is presented by the professor in lecture.

Reams, Max

433

A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors  

PubMed Central

We compared and determined the reasons for any differences in the review and approval times of tyrosine kinase inhibitors (TKIs) by the US Food and Drug Administration (FDA) and the European EMA/CHMP. Applications for these novel cancer drugs were submitted to them within a mean of 31.2 days of each other, providing a fair basis for comparison. The FDA had granted priority review to 12 TKIs but the EMA/CHMP did not grant the equivalent accelerated assessment to any. The FDA granted accelerated approvals to six (38%) and CHMP granted (the equivalent) conditional approvals to four (29%) of these agents. On average, the review and approval times were 205.3 days in the US compared with 409.6 days in the European Union (EU). The active review times, however, were comparable (225.4 days in the EU and 205.3 days in the US). Since oncology drug development lasts about 7 years, the 20 days difference in review times between the two agencies is inconsequential. Clock stops during review and the time required to issue an approval had added the extra 184.2 days to review time in the EU. We suggest possible solutions to expedite the EU review and approval processes. However, post-marketing emergence of adverse efficacy and safety data on gefitinib and lapatinib, respectively, indicate potential risks of expedited approvals. We challenge the widely prevalent myth that early approval translates into early access or beneficial impact on public health. Both the agencies collaborate closely but conduct independent assessments and make decisions based on distinct legislation, procedures, precedents and societal expectations. PMID:23362829

Shah, Rashmi R; Roberts, Samantha A; Shah, Devron R

2013-01-01

434

FDA approval summary: sunitinib for the treatment of progressive well-differentiated locally advanced or metastatic pancreatic neuroendocrine tumors.  

PubMed

On May 20, 2011, the U.S. Food and Drug Administration (FDA) approved sunitinib malate capsules (Sutent®; Pfizer, Inc., New York) for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNETs) in patients with unresectable locally advanced or metastatic disease. In a phase III randomized trial, 171 patients received either sunitinib (37.5 mg) or placebo once daily. The progression-free survival (PFS) interval was the primary efficacy endpoint. Secondary endpoints included the overall survival (OS) time, objective response rate (ORR), patient-reported outcomes, and safety. Based on early results favoring sunitinib, the independent data monitoring committee recommended trial termination prior to the prespecified interim analysis. This premature analysis may have led to an overestimate of the treatment effect. In the FDA analysis of investigator-assessed PFS times, the median values for the sunitinib and placebo arms were 10.2 months and 5.4 months, respectively. The ORRs were 9.3% and 0% in the sunitinib and placebo arms, respectively. The OS data were not mature at the time of approval and were confounded by 69% crossover. Common adverse reactions in patients receiving sunitinib included diarrhea, nausea, asthenia, fatigue, neutropenia, hypertension, and palmar-plantar erythrodysesthesia syndrome. Two patients on sunitinib died as a result of cardiac failure. The Oncologic Drugs Advisory Committee voted eight to two that, despite residual uncertainty about the magnitude of the PFS effect because of early trial termination, sunitinib demonstrated a favorable benefit-risk profile in pNET patients. The FDA concurred with the committee's assessment and granted sunitinib regular approval for this rare malignancy with few available therapies. PMID:22836448

Blumenthal, Gideon M; Cortazar, Patricia; Zhang, Jenny J; Tang, Shenghui; Sridhara, Rajeshwari; Murgo, Anthony; Justice, Robert; Pazdur, Richard

2012-01-01

435

Infrared emission spectra from operating elastohydrodynamic sliding contacts  

NASA Technical Reports Server (NTRS)

Infrared emission spectra from an operating EHD sliding contact were obtained through a diamond window for an aromatic polymer solute present in equal concentration in four different fluids. Three different temperature ranges, three different loads, and three different speeds for every load were examined. Very sensitive Fourier spectrophotometric (Interferometric) techniques were employed. Band Intensities and band intensity ratios found to depend both on the operating parameters and on the fluid. Fluid film and metal surface temperatures were calculated from the spectra and their dependence on the mechanical parameters plotted. The difference between these temperatures could be plotted against shear rate on one curve for all fluids. However, at the same shear rate the difference between bulk fluid temperature and diamond window temperature was much higher for one of the fluids, a traction fluid, than for the others.

Lauer, J. L.

1976-01-01

436

Sliding backshorts for planar circuits. [strip transmission line tuning  

NASA Technical Reports Server (NTRS)

An adjustable planar imbedding circuit based on coplanar transmission lines is presented to deal with the impedance mismatch associated with the use of the Superconductor-Insulator-Superconductor tunnel junction. The planar embedding circuit is developed with movable noncontacting shorting elements that consist of thin metallic plates with optimized arrangements of rectangular holes. The rectangular holes are placed along the insulated metallic transmission line to provide a periodic variation of the line impedance. A large reflection coefficient is demonstrated with a scale model of the sliding backshort, and values of more than -0.5 dB are reported. The shorting elements are incorporated into a low-frequency tuning circuit to test the practical tuning ranges. The backshort can be used to fashion tuning stubs with variable post-fabrication electrical lengths which relaxes the design constraints of planar integrated circuits.

Lubecke, Victor M.; Rutledge, David B.; Mcgrath, William R.

1991-01-01

437

Reciprocating Sliding Wear Behavior of Newly Developed Bainitic Steels  

NASA Astrophysics Data System (ADS)

The present work discusses the mechanical properties and wear behavior of newly developed bainitic rail steels with nominal composition of 0.71 pct C, 0.35 pct Si, 1.15 pct Mn, 0.59 pct Cr, 0.40 pct Cu, and 0.20 pct Ni (all in wt pct)). Isothermal transformation has been carried out at different time and temperatures for obtaining different bainitic morphologies. Linearly reciprocating sliding wear behavior of the steels has been studied and compared with that of the conventional pearlitic rail steel. Considerable improvement in mechanical properties of the bainitic steels has been noticed. The hardness of the bainitic steels increases with decrease in isothermal transformation temperature. It leads to enhancement of wear resistance of the bainitic steels compared to the conventional rail steel. Finally, it clearly draws correlation between mechanical properties, wear resistance, and microstructural variation of a series of bainitic rail steels.

Sharma, S.; Sangal, S.; Mondal, K.

2014-11-01

438

Presentation Checklist Tracey Volz  

E-print Network

relationships Avoid nervous hand movements Stand straight Plant feet Smile Visuals Persuasive slide titles that make analysis or design choices clear and easy to evaluate Background does not interfere with diagrams

439

High-throughput screening of FDA-approved drugs using oxygen biosensor plates reveals secondary mitofunctional effects.  

PubMed

Repurposing of FDA-approved drugs with effects on mitochondrial function might shorten the critical path to mitochondrial disease drug development. We improved a biosensor-based assay of mitochondrial O2 consumption, and identified mitofunctional defects in cell models of LHON and FXTAS. Using this platform, we screened a 1600-compound library of clinically used drugs. The assay identified drugs known to affect mitochondrial function, such as metformin and decoquinate. We also identified several drugs not previously known to affect mitochondrial respiration including acarbose, metaraminol, gallamine triethiodide, and acamprosate. These previously unknown 'mitoactives' represent novel links to targets for mitochondrial regulation and potentially therapy, for mitochondrial disease. PMID:25034306

Sahdeo, Sunil; Tomilov, Alexey; Komachi, Kelly; Iwahashi, Christine; Datta, Sandipan; Hughes, Owen; Hagerman, Paul; Cortopassi, Gino

2014-07-01

440

Aggregation of heat-shock-denatured, endogenous proteins and distribution of the IbpA/B and Fda marker-proteins in Escherichia coli WT and grpE280 cells.  

PubMed

Submission of wild-type Escherichia coli to heat shock causes an aggregation of cellular proteins. The aggregates (S fraction) are separable from membrane fractions by ultracentrifugation in a sucrose density gradient. In contrast, no protein aggregation was detectable in an E. coli grpE280 mutant either by this technique or by electron microscopy. In search of an explanation for this observation at a molecular level, two kinds of marker proteins were used: Fda (fructose-1,6-biphosphate aldolase), the previously identified S fraction component, and IbpA/B, small heat-shock proteins abundantly associated with the S fraction proteins. Both types of marker proteins, normally never found in the outer-membrane (OM) fraction of WT cells, were present in the OM fraction from grpE cells after heat shock. This pointed to the presence of aggregates smaller than those in WT cells that cosedimented with the OM fraction. The OM fraction was enlarged in grpE cells. Although not proven directly, the presence of still smaller aggregates, not exceeding the solubility level and containing inactive Fda, was noted in the soluble CP fraction containing the cytoplasmic and periplasmic proteins. Therefore, aggregation occurred in both strains, but in a different way. The autoregulation of the heat-shock response causes a greater increase of DnaK/DnaJ and IbpAB levels in grpE cells than in WT after temperature elevation. This may explain the prevalence of the small-sized aggregates in the grpE cells. Estimation of total Fda protein before and after heat shock did not show any loss. This indicated that renaturation rather than proteolysis underlies the final disappearance of the aggregates. Though surprising at first, this is not contradictory with the participation of heat-shock proteases in removal of protein components of the S fraction as shown before, since proteins that are irreversibly denatured are probably substrates for the proteases. PMID:14702418

Laskowska, Ewa; Bohdanowicz, Jerzy; Kuczy?ska-Wi?nik, Dorota; Matuszewska, Ewelina; Kedzierska, Sabina; Taylor, Alina

2004-01-01

441

Sliding-spark spectrometry of sediment samples.  

PubMed

Direct analysis of non-conducting solids and dielectric surface layers for elements at trace levels has been shown to be feasible by the new so-called sliding-spark spectroscopy, in which a discharge plasma is bound by, and propagates on, the surface of a dielectric sample matrix. By using a river sediment as a model matrix, bound in PVC to improve elemental atomization and excitation efficiency, as a result of the formation of volatile chlorides, the potential of the technique for environmental applications has been investigated by studying the characteristic UV-visible radiation emitted in the wavelength range 210-510 nm for the elements Fe, Cr, Ni, Cu, Pb, Cd, Zn, Co, V, Ti, and Mn. The radiation was detected by means of a CCD spectrometer and analysed for spectral line identification, selection, and the linearity of the spectral response, to determine whether this was suitable for establishing a calibration strategy for quantitative analysis using the sliding-spark source. PMID:12397509

Angeyo, H; Flórían, K; Golloch, A; Vojtekovà, V

2002-10-01

442

An Experimental Study of Lubrication at Thrust Slide-Bearing of Scroll Compressors  

NASA Astrophysics Data System (ADS)

The previous studies have revealed that the wedge formation at the periphery of the thrust plate, caused by the elastic deformation due to pressure difference across the orbiting thrust plate, is a significant key factor to keep and improve the high performance in lubrication of the thrust-slide bearing. The present study focuses on the effect of the thickness and inner form of the thrust plate upon the lubrication features. A simplified model of cylindrical thrust slide-bearing with thinner thrust plate submerged in a refrigerant oil VG-56 was operated under pressurized conditions using R-22 as the pressurizing gas, where the pressure difference was adjusted from 0 to 1.0 MPa and the friction force and coefficient of friction were measured over a wide range of orbiting speeds, first. The wedge angle by elastic deformation is naturally increased with decreasing the thrust plate thickness, thus resulting in a clear improvement in lubrication at the thrust slide-bearing. On the contrast, secondly, the similar lubrication tests were conducted for the thrust plate with a real inner form, as complicated as in the real scroll compressors, where the thickness of the thrust plate was kept as in the original tests. As a result, no significant change in lubrication features, from those for the simplified cylindrical model, was not addressed, thus confirming that the test results addressed from the simplified cylindrical model tests can be effectively used to examine the basic characteristics in lubrication of thrust slide bearing of scroll compressors.

Ishii, Noriaki; Oku, Tatsuya; Anami, Keiko; Tsuji, Takuma; Ozasa, Toshihiro; Sawai, Kiyoshi; Morimoto, Takashi; Iida, Noboru

443

Measurement of glucose concentration by image processing of thin film slides  

NASA Astrophysics Data System (ADS)

Measurement of glucose concentration is important for diagnosis and treatment of diabetes mellitus and other medical conditions. This paper describes a novel image-processing based approach for measuring glucose concentration. A fluid drop (patient sample) is placed on a thin film slide. Glucose, present in the sample, reacts with reagents on the slide to produce a color dye. The color intensity of the dye formed varies with glucose at different concentration levels. Current methods use spectrophotometry to determine the glucose level of the sample. Our proposed algorithm uses an image of the slide, captured at a specific wavelength, to automatically determine glucose concentration. The algorithm consists of two phases: training and testing. Training datasets consist of images at different concentration levels. The dye-occupied image region is first segmented using a Hough based technique and then an intensity based feature is calculated from the segmented region. Subsequently, a mathematical model that describes a relationship between the generated feature values and the given concentrations is obtained. During testing, the dye region of a test slide image is segmented followed by feature extraction. These two initial steps are similar to those done in training. However, in the final step, the algorithm uses the model (feature vs. concentration) obtained from the training and feature generated from test image to predict the unknown concentration. The performance of the image-based analysis was compared with that of a standard glucose analyzer.

Piramanayagam, Sankaranaryanan; Saber, Eli; Heavner, David

2012-02-01

444

Quantification of methane emission from bacterial mat sites at Quepos Slide offshore Costa Rica  

NASA Astrophysics Data System (ADS)

Seafloor methane emission from the Quepos Slide on the submarine segment of the Costa Rica fore-arc margin was estimated by extrapolating flux measurements from individual seeps to the total area covered by bacterial mats. This approach is based on the combination of detailed mapping to determine the abundance of seeps and the application of a numerical model to estimate the amount of benthic methane fluxes. Model results suggest that the majority of the studied seeps transport rather limited amount of methane (on average: ~177 ?mol cm-2 a-1) into the water column due to moderate upward advection, allowing for intense anaerobic oxidation of methane (AOM; on average: 53 % of the methane flux is consumed). Depth-integrated AOM rates (56-1,538 ?mol CH4 cm-2 a-1) are comparable with values reported from other active seep sites. The overall amount of dissolved methane released into the water column from the entire area covered by bacterial mats on the Quepos Slide is estimated to be about 0.28 × 106 mol a-1. This conservative estimate which relies on rather accurate determinations of seafloor methane fluxes emphasizes the potential importance of submarine slides as sites of natural methane seepage; however, at present the global extent of methane seepage from submarine slides is largely unknown.

Karaca, Deniz; Schleicher, Tina; Hensen, Christian; Linke, Peter; Wallmann, Klaus

2014-10-01

445

Quantification of methane emission from bacterial mat sites at Quepos Slide offshore Costa Rica  

NASA Astrophysics Data System (ADS)

Seafloor methane emission from the Quepos Slide on the submarine segment of the Costa Rica fore-arc margin was estimated by extrapolating flux measurements from individual seeps to the total area covered by bacterial mats. This approach is based on the combination of detailed mapping to determine the abundance of seeps and the application of a numerical model to estimate the amount of benthic methane fluxes. Model results suggest that the majority of the studied seeps transport rather limited amount of methane (on average: ~177 ?mol cm-2 a-1) into the water column due to moderate upward advection, allowing for intense anaerobic oxidation of methane (AOM; on average: 53 % of the methane flux is consumed). Depth-integrated AOM rates (56-1,538 ?mol CH4 cm-2 a-1) are comparable with values reported from other active seep sites. The overall amount of dissolved methane released into the water column from the entire area covered by bacterial mats on the Quepos Slide is estimated to be about 0.28 × 106 mol a-1. This conservative estimate which relies on rather accurate determinations of seafloor methane fluxes emphasizes the potential importance of submarine slides as sites of natural methane seepage; however, at present the global extent of methane seepage from submarine slides is largely unknown.

Karaca, Deniz; Schleicher, Tina; Hensen, Christian; Linke, Peter; Wallmann, Klaus

2012-12-01

446

Sliding Mode Control of the X-33 with an Engine Failure  

NASA Technical Reports Server (NTRS)

Ascent flight control of the X-3 is performed using two XRS-2200 linear aerospike engines. in addition to aerosurfaces. The baseline control algorithms are PID with gain scheduling. Flight control using an innovative method. Sliding Mode Control. is presented for nominal and engine failed modes of flight. An easy to implement, robust controller. requiring no reconfiguration or gain scheduling is demonstrated through high fidelity flight simulations. The proposed sliding mode controller utilizes a two-loop structure and provides robust. de-coupled tracking of both orientation angle command profiles and angular rate command profiles in the presence of engine failure, bounded external disturbances (wind gusts) and uncertain matrix of inertia. Sliding mode control causes the angular rate and orientation angle tracking error dynamics to be constrained to linear, de-coupled, homogeneous, and vector valued differential equations with desired eigenvalues. Conditions that restrict engine failures to robustness domain of the sliding mode controller are derived. Overall stability of a two-loop flight control system is assessed. Simulation results show that the designed controller provides robust, accurate, de-coupled tracking of the orientation angle command profiles in the presence of external disturbances and vehicle inertia uncertainties, as well as the single engine failed case. The designed robust controller will significantly reduce the time and cost associated with flying new trajectory profiles or orbits, with new payloads, and with modified vehicles

Shtessel, Yuri B.; Hall, Charles E.

2000-01-01

447

Adaptive terminal sliding-mode control strategy for DC-DC buck converters.  

PubMed

This paper presents an adaptive terminal sliding mode control (ATSMC) strategy for DC-DC buck converters. The idea behind this strategy is to use the terminal sliding mode control (TSMC) approach to assure finite time convergence of the output voltage error to the equilibrium point and integrate an adaptive law to the TSMC strategy so as to achieve a dynamic sliding line during the load variations. In addition, the influence of the controller parameters on the performance of closed-loop system is investigated. It is observed that the start up response of the output voltage becomes faster with increasing value of the fractional power used in the sliding function. On the other hand, the transient response of the output voltage, caused by the step change in the load, becomes faster with decreasing the value of the fractional power. Therefore, the value of fractional power is to be chosen to make a compromise between start up and transient responses of the converter. Performance of the proposed ATSMC strategy has been tested through computer simulations and experiments. The simulation results of the proposed ATSMC strategy are compared with the conventional SMC and TSMC strategies. It is shown that the ATSMC exhibits a considerable improvement in terms of a faster output voltage response during load changes. PMID:22877744

Komurcugil, Hasan

2012-11-01

448

Delivery presentations  

MedlinePLUS

... for the delivery progress. If the presenting part lies above the ischial spines, the station is reported ... number is a centimeter). If the presenting part lies below the ischial spines, the station is reported ...

449

David Douglas Duncan's Changing Views on War: An Audio-Visual Presentation.  

ERIC Educational Resources Information Center

This paper is the script for a slide presentation about photographer David Douglas Duncan and his view of war. It is intended to be used with slides made from pictures Duncan took during World War II, the Korean War, and the war in Viet Nam and published in various books and periodicals. It discusses a shift in emphasis to be seen both in the…

Politowski, Richard

450

Significance of grain sliding mechanisms for ductile deformation of rocks  

NASA Astrophysics Data System (ADS)

Ductile shear zones at depth present polyphase and heterogeneous rocks and multi-scale strain localization patterns. Most strain concentrates in ultramylonitic layers, which exhibit microstructural signatures of several concomitant deformation mechanisms. The latter are either active in volume (dislocation creep), or in the vicinity and along interfaces (grain sliding and solution mass transfer). Because their chronology of appearance and interactions are unclear, inference of the overall rheology seems illusory. We have therefore characterized over a decade the rheology of synthetic lower crustal materials with different compositions and fluid contents, and for various microstructures. Non-Newtonian flow clearly related to dominant dislocation creep. Conversely, Newtonian behavior involved grain sliding mechanisms, but crystal plasticity could be identified as well. In order to clarify the respective roles of these mechanisms we underwent a multi-scale investigation of the ductile deformation of rock analog synthetic halite with controlled microstructures. The mechanical tests were combined with in-situ optical microscopy, scanning electron microscopy and X ray computed tomography, allowing for digital image correlation (DIC) techniques and retrieval of full strain field. Crystal plasticity dominated, as evidenced by physical slip lines and DIC computed slip bands. Crystal orientation mapping allowed to identify strongly active easy glide {110} <110> systems. But, all other slip systems were observed as well, and especially near interfaces, where their activity is necessary to accommodate for the plastic strain incompatibilities between neighboring grains. We also evidenced grain boundary sliding (GBS), which clearly occurred as a secondary, but necessary, accommodation mechanism. The DIC technique allowed the quantification of the relative contribution of each mechanism. The amount of GBS clearly increased with decreasing grain size. Finite element (FE) modeling of the viscoplastic polycrystalline behavior was started on the basis of our experimental data for coarse grained microstructures (c.a. 400 microns, with < 10 % GBS activity), considering an extruded columnar structure in depth and single crystal flow laws from literature. The results show that the computed strain fields do not sufficiently match the experimentally measured ones. The reasons for the discrepancies are likely related to the activity of GBS (which was not accounted for) and to the influence of the real microstructure at depth (underlying grains and orientations of interfaces), which strongly condition the surface response. Our major conclusion about ductile deformation of rocks is that crystal plasticity and GBS are not really dissociable. They appear as co-operative mechanisms, due to pronounced plastic anisotropy of minerals.

Dimanov, A.; Bourcier, M.; Gaye, A.; Héripré, E.; Bornert, M.; Raphanel, J.; Ludwig, W.

2013-12-01

451

Wind energy conversion systems using fuzzy sliding mode control  

Microsoft Academic Search

The paper describes a manner in which the energy-reliability optimization of wind energy conversion system's operation can be achieved by means of the fuzzy sliding mode control. An appropriate sliding surface has been found in the speed-power plane, which allows the operation more or less close to the optimal regimes characteristic. What is more, by torque controlling the generator, an

Qi Chen; LiangHai Chen; LinGao Wang

2011-01-01

452

35mm Slides: Storage and Retrieval for the Novice.  

ERIC Educational Resources Information Center

Recounts the development of a slide storage and retrieval system at the Philip Morris Research Center in Richmond, Virginia and describes the methods used to classify and access slides in the collection. A reference list and three appendices accompany the text. (JL)

DeBardeleben, Marian Z.; Lunsford, Carol G.

1982-01-01

453

Control of a Quadrotor Vehicle Using Sliding Mode Disturbance Observer  

Microsoft Academic Search

This paper uses the recently developed sliding mode control driven by sliding mode disturbance observer approach to design a robust flight controller for a small quadrotor vehicle. This technique allows for continuous control robust to external disturbance and model uncertainties to be computed without the use of high control gain or extensive computational power. The multiple-loop, multiple time-scale flight controller

Lénaïck Besnard; Yuri B. Shtessel; Brian Landrum

2007-01-01

454

Temperature effects on adhesive wear in dry sliding contacts  

Microsoft Academic Search

In many metal forming operations, frictional heating occurs at the interface due to a sliding contact. Generally, the controlling wear mechanism in the tribological system is attributed to adhesive wear. Understanding of the influence of temperature on wear mechanisms is needed for the development of materials and for optimization of the forming process. Dry sliding tests were conducted at different

A. Gåård; N. Hallbäck; P. Krakhmalev; J. Bergström

2010-01-01

455

Reduced order sliding mode control for pneumatic actuator  

Microsoft Academic Search

A new position control algorithm, based on sliding mode control, has been developed for a pneumatic cylinder. In the proposed pneumatic system, commercially available two-way on-off solenoid valves have been used. The inherent robustness property of the sliding mode controller makes it easier to select the switching gains of the controller. Moreover, approximate dynamic modeling of the system makes the

Arun K. Paul; J. E. Mishra; M. G. Radke

1994-01-01

456

Dynamic Wavelet Synopses Management over Sliding Windows in Sensor Networks  

Microsoft Academic Search

Due to the dynamic nature of data streams, a sliding window is used to generate synopses that approximate the most recent data within the retrospective horizon to answer queries or discover patterns. In this paper, we propose a dynamic scheme for wavelet synopses management in sensor networks. We define a data structure sliding dual tree, abbreviated as SDT, to generate

Ken-Hao Liu; Wei-Guang Teng; Ming-Syan Chen

2010-01-01

457

Online dectection device for assembly of automotive sliding york bracket  

Microsoft Academic Search

This Online Sliding york bracket is one of the most important shift parts in automotive transmission. The traditional detection mostly depends on artificial methods, which cost large amount of labor and easily lead to the fatigue of naked eyes. In this article we have developed the object, clearance detection sensor. Considering the assembly feature of the sliding york bracket, we

Chundong Zhu; Zhiliang Zhu

2010-01-01

458

Sliding performance of unilateral external fixators for tibia  

Microsoft Academic Search

Some unilateral external fixators have a sliding mechanism to achieve dynamic axial fixation. However, it has been reported that binding of this mechanism occurs during routine ambulation. The Hifixator, a unilateral external fixator, has been developed which has a new type of sliding mechanism. The mechanism of the Hifixator was tested by connecting it to a fractured bone model with

Takashi Matsushita; Kozo Nakamura; Isao Ohnishi; Takahide Kurokawa

1998-01-01

459

Performance of sliding systems under near-fault motions  

Microsoft Academic Search

Response of structures supported on the sliding systems under near-fault earthquake ground motion is investigated. The fault normal and parallel components are applied in two horizontal direction of the system. The superstructure is considered to be rigid and the frictional forces mobilized at the interface of the sliding system are assumed to be velocity dependent. The interaction between frictional forces

P. Bhasker Rao; R. S. Jangid

2001-01-01

460

Pleasant and unpleasant slides: Their effects on pain tolerance  

Microsoft Academic Search

Pleasant imagery and focusing on pleasant slides have been found to be effective in increasing pain tolerance during noxious stimulation. However, since studies have not systematically varied the affective quality of the imagery or slides, there has been no way of determining whether the affective quality of the techniques is critical to their effectiveness. This study intended to examine the

Sara Maltzman Greenstein

1984-01-01

461

Title Slide 2008-"Some notes on IT Law"  

E-print Network

Law ­ England and Wales, many Commonwealth countries and the USA v Civil (Roman) law ­ Scotland, manyTitle Slide 2008- "Some notes on IT Law" Professor Les Hatton, Ph.D, LL.M. CISM, University Seminars, Les Hatton, Kingston, February 2008 , (slide 1 - 2) The disclaimer Although qualified in law, I

Hatton, Les

462

Adaptive sliding mode neural net control for missile autopilot  

Microsoft Academic Search

An adaptive sliding mode neural net control algorithm is developed for a cruising missile with highly nonlinear aerodynamics. An adaptive switching gain based on the Lyapunov stability theory is proposed to suppress the chattering in the steady state. The gain varies with respect to the distance from the sliding surface. The controller with the adaptive switching gain also has robust

T. W. Hwang; M. Tahk

2005-01-01

463

Backstepping sliding mode control for missile systems via quaternions  

Microsoft Academic Search

A novel approach combining the sliding mode control and extended state observer is proposed for attitude control of a quaternion missile model which is nonlinear in aerodynamics. Combining the back-stepping technique, the corresponding sliding mode controller is designed to guarantee the state variables of the closed loop system to converge to the reference state with the help of the extended

Zheng Zhu; Yuanqing Xia; Mengyin Fu

2009-01-01

464

Longevity of reference slides of pollen mounted in silicone oil  

Microsoft Academic Search

A reference collection of microscope slides of modern pollen grains was established at the University of Minnesota in 1958 and has grown to nearly 10 thousand accessions prepared in our laboratories. The pollen grains are mounted in silicone oil, and the slides have been sealed with a variety of compounds: nail polishes, adhesives, paints, and paraffins. Each has deleterious effects

Edward J. Cushing

2011-01-01

465

Sliding mode drive line control for an electrically driven vehicle  

Microsoft Academic Search

A sliding mode controller for the drive line of an electrically driven vehicle with unknown backlash is derived. The controller is based on a sliding mode observer which estimates the drive shaft and load torque where the load torque results from the unknown tire-road contact forces. The drive line control was evaluated with a multi body system simulation model of

Ulrich Angeringer; Martin Horn

2011-01-01

466

AFRD WAREHOUSE, WEST SIDE DETAIL OF ALTERED SLIDING DOORS, FACING ...  

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

AFRD WAREHOUSE, WEST SIDE DETAIL OF ALTERED SLIDING DOORS, FACING EAST. WEATHER COVER OVER RAIL IS ORIGINAL. SHEET METAL SIDING HAS BEEN INSERTED BETWEEN TWO HALVES OF SLIDING DOORS. - Minidoka Relocation Center Warehouse, 111 South Fir Street, Shoshone, Lincoln County, ID

467

Workshop on nuclear structure at moderate and high spin: Slide report  

SciTech Connect

The workshop was scheduled to coincide with the beginning of operation of a number of large arrays of Compton-suppressed germanium detectors. The workshop was divided into 14 sessions containing 3 presentations each. The topics of these sessions were superdeformation, heavy rare earths, single-particle configurations, band termination, continuum properties, light rare-earths, new techniques, high temperatures, transfer reactions, transition region, shapes, lifetimes, and moments. This publication consists of the slides used in all of the presentations at the workshop.

Not Available

1986-10-01

468

[Whole slide imaging technology: from digitization to online applications].  

PubMed

As e-health becomes essential to modern care, whole slide images (virtual slides) are now an important clinical, teaching and research tool in pathology. Virtual microscopy consists of digitizing a glass slide by acquiring hundreds of tiles of regions of interest at different zoom levels and assembling them into a structured file. This gigapixel image can then be remotely viewed over a terminal, exactly the way pathologists use a microscope. In this article, we will first describe the key elements of this technology, from the acquisition, using a scanner or a motorized microscope, to the broadcasting of virtual slides through a local or distant viewer over an intranet or Internet connection. As virtual slides are now commonly used in virtual classrooms, clinical data and research databases, we will highlight the main issues regarding its uses in modern pathology. Emphasis will be made on quality assurance policies, standardization and scaling. PMID:23171902

Ameisen, David; Le Naour, Gilles; Daniel, Christel

2012-11-01

469

Effective Presentations  

PubMed Central

Where the purpose of presentations is to inform, effective delivery is important to ensure that audiences receive the educational message. We offer six suggestions: introduce the topic in an interesting way; speak loudly enough; do not read; involve the audience actively; respect the attention span of the audience; and limit the amount of content. We conclude that the skills of live public presentation can be learned, but that the art of presentation is innate. Imagesp2063-ap2064-a PMID:21233951

Spooner, H. James; Swanson, Richard W.

1990-01-01

470

Poster Presentation  

NSDL National Science Digital Library

To prepare their presentations students do background reading on a topic of their choosing. They are required to prepare a visual poster presentation of their topic that incorporates graphic elements and a short written summary of their topic. In class students are required to give a five minute oral presentation using their poster to illustrate their talk. They must then answer questions from their classmate and instructor. The final element of this assignment requires students to evaluate the work of their classmates and to ask questions about the topics other students present.

Hoppe, Kathryn

471

Use of FDA approved therapeutics with hNTCP metabolic inhibitory properties to impair the HDV lifecycle.  

PubMed

Worldwide there are approximately 240million individuals chronically infected with the hepatitis B virus (HBV), including 15-20million coinfected with the hepatitis delta virus (HDV). Treatments available today are not fully efficient and often associated to important side effects and development of drug resistance. Targeting the HBV/HDV entry step using preS1-specific lipopeptides appears as a promising strategy to block viral entry for both HBV and HDV (Gripon et al., 2005; Petersen et al., 2008). Recently, the human Sodium Taurocholate Cotransporting Polypeptide (hNTCP) has been identified as a functional, preS1-specific receptor for HBV and HDV. This groundbreaking discovery has opened a very promising avenue for the treatment of chronic HBV and HDV infections. Here we investigated the ability of FDA approved therapeutics with documented inhibitory effect on hNTCP cellular function to impair viral entry using a HDV in vitro infection model based on a hNTCP-expressing Huh7 cell line. We demonstrate the potential of three FDA approved molecules, irbesartan, ezetimibe, and ritonavir, to alter HDV infection in vitro. PMID:24717262

Blanchet, Matthieu; Sureau, Camille; Labonté, Patrick

2014-06-01

472

Organohalogen and organophosphorus pesticides in mixed feed rations: findings from FDA's domestic surveillance during fiscal years 1989-1994.  

PubMed

During Fiscal Years 1989-1994, the U.S. Food and Drug Administration (FDA) collected and analyzed 545 domestic surveillance samples of mixed feed rations (172 for cattle, 125 for poultry, 83 for swine, 61 for pets, 56 for fish, and 48 miscellaneous). All samples were analyzed by gas-liquid chromatography for organohalogen and organophosphorus pesticides. Of the 545 samples, 88 (16.1%) did not contain detectable pesticide residues. In the 457 samples with detectable pesticide levels, 804 residues (654 quantitable and 150 trace) were found. None of these 804 residues exceeded regulatory guidance. Malathion, chlorpyrifos-methyl, diazinon, chlorpyrifos, and pirimiphos-methyl were the most commonly detected pesticides. These 5 organophosphorus pesticides accounted for 93.4% of all pesticide residues detected (malathion, 52.9%; chlorpyrifos-methyl, 25.2%; diazinon, 7.7%; chlorpyrifos, 4.9%; and pirimiphos-methyl, 2.7%). Their median values in samples containing quantitable levels ranged from 0.014 to 0.098 ppm. The most commonly detected organohalogen compounds were methoxychlor, DDE, PCB, dieldrin, pentachloronitrobenzene, and lindane. These 6 compounds combined accounted for only 4.1% of all residues detected. FDA is continuing its pesticide surveillance of feeds to help ensure animal safety and prevent violative residues in food derived from animals. PMID:8920144

Lovell, R A; McChesney, D G; Price, W D

1996-01-01

473

Structure Activity Relationship for FDA Approved Drugs as Inhibitors of the Human Sodium Taurocholate Co-transporting Polypeptide (NTCP)  

PubMed Central

The hepatic bile acid uptake transporter Sodium Taurocholate Cotransporting Polypeptide (NTCP) is less well characterized than its ileal paralog, the Apical Sodium Dependent Bile Acid Transporter (ASBT), in terms of drug inhibition requirements. The objectives of this study were a) to identify FDA approved drugs that inhibit human NTCP, b) to develop pharmacophore and Bayesian computational models for NTCP inhibition, and c) to compare NTCP and ASBT transport inhibition requirements. A series of NTCP inhibition studies were performed using FDA approved drugs, in concert with iterative computational model development. Screening studies identified 27 drugs as novel NTCP inhibitors, including irbesartan (Ki =11.9 ?M) and ezetimibe (Ki = 25.0 ?M). The common feature pharmacophore indicated that two hydrophobes and one hydrogen bond acceptor were important for inhibition of NTCP. From 72 drugs screened in vitro, a total of 31 drugs inhibited NTCP, while 51 drugs (i.e. more than half) inhibited ASBT. Hence, while there was inhibitor overlap, ASBT unexpectedly was more permissive to drug inhibition than was NTCP, and this may be related to NTCP’s possessing fewer pharmacophore features. Findings reflected that a combination of computational and in vitro approaches enriched the understanding of these poorly characterized transporters and yielded additional chemical probes for possible drug-transporter interaction determinations. PMID:23339484

Dong, Zhongqi; Ekins, Sean; Polli, James E.

2013-01-01

474

A systematic approach to biomarker discovery; Preamble to "the iSBTc-FDA taskforce on immunotherapy biomarkers"  

PubMed Central

The International Society for the Biological Therapy of Cancer (iSBTc) has initiated in collaboration with the United States Food and Drug Administration (FDA) a programmatic look at innovative avenues for the identification of relevant parameters to assist clinical and basic scientists who study the natural course of host/tumor interactions or their response to immune manipulation. The task force has two primary goals: 1) identify best practices of standardized and validated immune monitoring procedures and assays to promote inter-trial comparisons and 2) develop strategies for the identification of novel biomarkers that may enhance our understating of principles governing human cancer immune biology and, consequently, implement their clinical application. Two working groups were created that will report the developed best practices at an NCI/FDA/iSBTc sponsored workshop tied to the annual meeting of the iSBTc to be held in Washington DC in the Fall of 2009. This foreword provides an overview of the task force and invites feedback from readers that might be incorporated in the discussions and in the final document. PMID:19105846

Butterfield, Lisa H; Disis, Mary L; Fox, Bernard A; Lee, Peter P; Khleif, Samir N; Thurin, Magdalena; Trinchieri, Giorgio; Wang, Ena; Wigginton, Jon; Chaussabel, Damien; Coukos, George; Dhodapkar, Madhav; Hakansson, Leif; Janetzki, Sylvia; Kleen, Thomas O; Kirkwood, John M; Maccalli, Cristina; Maecker, Holden; Maio, Michele; Malyguine, Anatoli; Masucci, Giuseppe; Palucka, A Karolina; Potter, Douglas M; Ribas, Antoni; Rivoltini, Licia; Schendel, Dolores; Seliger, Barbara; Selvan, Senthamil; Slingluff, Craig L; Stroncek, David F; Streicher, Howard; Wu, Xifeng; Zeskind, Benjamin; Zhao, Yingdong; Zocca, Mai-Britt; Zwierzina, Heinz; Marincola, Francesco M

2008-01-01

475

A systematic approach to biomarker discovery; preamble to "the iSBTc-FDA taskforce on immunotherapy biomarkers".  

PubMed

The International Society for the Biological Therapy of Cancer (iSBTc) has initiated in collaboration with the United States Food and Drug Administration (FDA) a programmatic look at innovative avenues for the identification of relevant parameters to assist clinical and basic scientists who study the natural course of host/tumor interactions or their response to immune manipulation. The task force has two primary goals: 1) identify best practices of standardized and validated immune monitoring procedures and assays to promote inter-trial comparisons and 2) develop strategies for the identification of novel biomarkers that may enhance our understating of principles governing human cancer immune biology and, consequently, implement their clinical application. Two working groups were created that will report the developed best practices at an NCI/FDA/iSBTc sponsored workshop tied to the annual meeting of the iSBTc to be held in Washington DC in the Fall of 2009. This foreword provides an overview of the task force and invites feedback from readers that might be incorporated in the discussions and in the final document. PMID:19105846

Butterfield, Lisa H; Disis, Mary L; Fox, Bernard A; Lee, Peter P; Khleif, Samir N; Thurin, Magdalena; Trinchieri, Giorgio; Wang, Ena; Wigginton, Jon; Chaussabel, Damien; Coukos, George; Dhodapkar, Madhav; Håkansson, Leif; Janetzki, Sylvia; Kleen, Thomas O; Kirkwood, John M; Maccalli, Cristina; Maecker, Holden; Maio, Michele; Malyguine, Anatoli; Masucci, Giuseppe; Palucka, A Karolina; Potter, Douglas M; Ribas, Antoni; Rivoltini, Licia; Schendel, Dolores; Seliger, Barbara; Selvan, Senthamil; Slingluff, Craig L; Stroncek, David F; Streicher, Howard; Wu, Xifeng; Zeskind, Benjamin; Zhao, Yingdong; Zocca, Mai-Britt; Zwierzina, Heinz; Marincola, Francesco M

2008-01-01

476

Bisphosphonates and Nonhealing Femoral Fractures: Analysis of the FDA Adverse Event Reporting System (FAERS) and International Safety Efforts  

PubMed Central

Background: In the United States, hip fracture rates have declined by 30% coincident with bisphosphonate use. However, bisphosphonates are associated with sporadic cases of atypical femoral fracture. Atypical femoral fractures are usually atraumatic, may be bilateral, are occasionally preceded by prodromal thigh pain, and may have delayed fracture-healing. This study assessed the occurrence of bisphosphonate-associated nonhealing femoral fractures through a review of data from the U.S. FDA (Food and Drug Administration) Adverse Event Reporting System (FAERS) (1996 to 2011), published case reports, and international safety efforts. Methods: We analyzed the FAERS database with use of the proportional reporting ratio (PRR) and empiric Bayesian geometric mean (EBGM) techniques to assess whether a safety signal existed. Additionally, we conducted a systematic literature review (1990 to February 2012). Results: The analysis of the FAERS database indicated a PRR of 4.51 (95% confidence interval [CI], 3.44 to 5.92) for bisphosphonate use and nonhealing femoral fractures. Most cases (n = 317) were attributed to use of alendronate (PRR = 3.32; 95% CI, 2.71 to 4.17). In 2008, international safety agencies issued warnings and required label changes. In 2010, the FDA issued a safety notification, and the American Society for Bone and Mineral Research (ASBMR) issued recommendations about bisphosphonate-associated atypical femoral fractures. Conclusions: Nonhealing femoral fractures are unusual adverse drug reactions associated with bisphosphonate use, as up to 26% of published cases of atypical femoral fractures exhibited delayed healing or nonhealing. PMID:23426763

Edwards, Beatrice J.; Bunta, Andrew D.; Lane, Joseph; Odvina, Clarita; Rao, D. Sudhaker; Raisch, Dennis W.; McKoy, June M.; Omar, Imran; Belknap, Steven M.; Garg, Vishvas; Hahr, Allison J.; Samaras, Athena T.; Fisher, Matthew J.; West, Dennis P.; Langman, Craig B.; Stern, Paula H.

2013-01-01

477

Copyright 2003 LeslieCopyright 2003 Leslie ASA 2003 NashvilleASA 2003 Nashville SlideSlide 11  

E-print Network

Copyright 2003 © LeslieCopyright 2003 © Leslie SmithSmith ASA 2003 NashvilleASA 2003 Nashville Leslie Smith, Department of Computing Science and mathematics,Leslie Smith, Department of Computing Copyright 2003 © LeslieCopyright 2003 © Leslie SmithSmith ASA 2003 NashvilleASA 2003 Nashville SlideSlide 22

Smith, Leslie S.

478

Pine Island Glacier - basal properties and sliding laws  

NASA Astrophysics Data System (ADS)

The dynamics of the Antarctic Ice Sheet can be well seen and studied on the behavior of Pine Island Glacier. Despite the long time believe in a slow response of the ice sheet to changing atmospheric and oceanic forcing, Pine Island has shown acceleration, thinning and a significant grounding line retreat in the past decades. These ongoing processes are coinciding with a concentrated mass loss in the area around Pine Island Glacier, the Amundsen Sea Embayment. The area is of additional interest due to its retrograde bed slope below the glacier. The postulated instability of the setting turns the glacier into an even more suitable object for modeling studies. Plenty of working groups have conducted modeling studies of Pine Island Glacier with varying model complexity and diverse focuses. We want to add to this by conducting model experiments with a diagnostic 3D full-stokes model of Pine Island Glacier. The model is thermo-mechanically coupled and implemented with the commercial finite-element package COMSOL Multiphysics©. We use remotely sensed surface velocity data to validate our results. The focus of our work lies on the basal properties below the glacier and the connection to sliding behavior. We believe that this is a crucial part, as different basal conditions might cause different responses to ongoing changes in the area. Recent studies presented evidence for the existence of a water saturated sediment basin below the main trunk of the glacier. We conduct a variety a numerical experiments with which we test different approaches of combining information about the basal properties with sliding laws.

Wilkens, Nina; Humbert, Angelika

2013-04-01

479

Presenters University  

NSDL National Science Digital Library

Everyone has to give presentations at some point in their career, whether they are in the field of criminal justice or animal husbandry. Fortunately for all such persons who might be experiencing presentation anxiety, there is the Presenters University website. While this âÂÂuniversityâ does not grant any honorary doctorates, they have assembled a fine selection of articles on presentation âÂÂdoâÂÂs and donâÂÂtsâÂÂ, along with a section where visitors can âÂÂAsk The Professorâ about their most vexing presentation quandaries. The most useful material on this site is contained in the âÂÂCoursesâ area. Here, visitors can read such timely pieces as âÂÂStorytelling-A Leadership Development ToolâÂÂ, âÂÂThemes in PowerPoint 2007âÂÂ, and âÂÂHow to Write and Deliver a Dynamite SpeechâÂÂ.

480

A micromechanical study of rolling and sliding contacts in assemblies of oval granules  

NASA Astrophysics Data System (ADS)

The evolution of the microstructure of an assembly of cohesionless granular materials with associated pores, which carry the overall applied stresses through frictional contacts is a complex phenomenon. The macroscopic flow of such materials take place by the virtue of the relative rolling and sliding of the grains on the micro-scale. A new discrete element method for biaxial compression simulations of random assemblies of oval particles with mixed sizes is introduced. During the course of deformation, the new positions of the grains are determined by employing the static equilibrium equations. A key aspect of the method is that, it is formulated for ellipse cross-sectional particles, hence desirable inherent anisotropies are possible. A robust algorithm for the determination of the contact points between neighbouring grains is given. Employing the present methodology, many aspects of the behaviour of two-dimensional assemblies of oval cross-sectional rods have been successfully addressed. The effects of initial void ratio, interparticle friction angle, aspect ratio, and bedding angle on the rolling and sliding contacts are examined. The distribution of normals to the rolling and sliding contacts have different patterns and are concentrated along directions, which are approximately perpendicular to one another. On the other hand, the distribution of all contact normals (combined rolling and sliding) are close to that of rolling contacts, which confirm that rolling is the dominant mechanism. This phenomenon becomes more pronounced for higher intergranular friction angle. Characteristics of the rolling and sliding contacts are also discussed in the context of the force angle, which is the inclination of contact force with respect to the contact normal.

Shodja, Hossein M.; Nezami, Erfan G.

2003-04-01

481

Darkfield Adapter for Whole Slide Imaging: Adapting a Darkfield Internal Reflection Illumination System to Extend WSI Applications  

PubMed Central

We present a new method for whole slide darkfield imaging. Whole Slide Imaging (WSI), also sometimes called virtual slide or virtual microscopy technology, produces images that simultaneously provide high resolution and a wide field of observation that can encompass the entire section, extending far beyond any single field of view. For example, a brain slice can be imaged so that both overall morphology and individual neuronal detail can be seen. We extended the capabilities of traditional whole slide systems and developed a prototype system for darkfield internal reflection illumination (DIRI). Our darkfield system uses an ultra-thin light-emitting diode (LED) light source to illuminate slide specimens from the edge of the slide. We used a new type of side illumination, a variation on the internal reflection method, to illuminate the specimen and create a darkfield image. This system has four main advantages over traditional darkfield: (1) no oil condenser is required for high resolution imaging (2) there is less scatter from dust and dirt on the slide specimen (3) there is less halo, providing a more natural darkfield contrast image, and (4) the motorized system produces darkfield, brightfield and fluorescence images. The WSI method sometimes allows us to image using fewer stains. For instance, diaminobenzidine (DAB) and fluorescent staining are helpful tools for observing protein localization and volume in tissues. However, these methods usually require counter-staining in order to visualize tissue structure, limiting the accuracy of localization of labeled cells within the complex multiple regions of typical neurohistological preparations. Darkfield imaging works on the basis of light scattering from refractive index mismatches in the sample. It is a label-free method of producing contrast in a sample. We propose that adapting darkfield imaging to WSI is very useful, particularly when researchers require additional structural information without the use of further staining. PMID:23520500

Kawano, Yoshihiro; Higgins, Christopher; Yamamoto, Yasuhito; Nyhus, Julie; Bernard, Amy; Dong, Hong-Wei; Karten, Harvey J.; Schilling, Tobias

2013-01-01

482

Darkfield adapter for whole slide imaging: adapting a darkfield internal reflection illumination system to extend WSI applications.  

PubMed

We present a new method for whole slide darkfield imaging. Whole Slide Imaging (WSI), also sometimes called virtual slide or virtual microscopy technology, produces images that simultaneously provide high resolution and a wide field of observation that can encompass the entire section, extending far beyond any single field of view. For example, a brain slice can be imaged so that both overall morphology and individual neuronal detail can be seen. We extended the capabilities of traditional whole slide systems and developed a prototype system for darkfield internal reflection illumination (DIRI). Our darkfield system uses an ultra-thin light-emitting diode (LED) light source to illuminate slide specimens from the edge of the slide. We used a new type of side illumination, a variation on the internal reflection method, to illuminate the specimen and create a darkfield image. This system has four main advantages over traditional darkfield: (1) no oil condenser is required for high resolution imaging (2) there is less scatter from dust and dirt on the slide specimen (3) there is less halo, providing a more natural darkfield contrast image, and (4) the motorized system produces darkfield, brightfield and fluorescence images. The WSI method sometimes allows us to image using fewer stains. For instance, diaminobenzidine (DAB) and fluorescent staining are helpful tools for observing protein localization and volume in tissues. However, these methods usually require counter-staining in order to visualize tissue structure, limiting the accuracy of localization of labeled cells within the complex multiple regions of typical neurohistological preparations. Darkfield imaging works on the basis of light scattering from refractive index mismatches in the sample. It is a label-free method of producing contrast in a sample. We propose that adapting darkfield imaging to WSI is very useful, particularly when researchers require additional structural information without the use of further staining. PMID:23520500

Kawano, Yoshihiro; Higgins, Christopher; Yamamoto, Yasuhito; Nyhus, Julie; Bernard, Amy; Dong, Hong-Wei; Karten, Harvey J; Schilling, Tobias

2013-01-01

483

Information Presentation  

NASA Technical Reports Server (NTRS)

The goal of the Information Presentation Directed Research Project (DRP) is to address design questions related to the presentation of information to the crew on flight vehicles, surface landers and habitats, and during extra-vehicular activities (EVA). Designers of displays and controls for exploration missions must be prepared to select the text formats, label styles, alarms, electronic procedure designs, and cursor control devices that provide for optimal crew performance on exploration tasks. The major areas of work, or subtasks, within the Information Presentation DRP are: 1) Controls, 2) Displays, 3) Procedures, and 4) EVA Operations.

Holden, Kritina; Sandor, A.; Thompson, S. G.; McCann, R. S.; Kaiser, M. K.; Begault, D. R.; Adelstein, B. D.; Beutter, B. R.; Stone, L. S.

2008-01-01

484

A Communication Device for Interfacing Slide/Audio Tape Programs with the Microcomputer for Computer-Assisted Self-Instruction.  

ERIC Educational Resources Information Center

Presents description of an interface device which ties in microcomputers and slide/tape presentations for computer assisted instruction. Highlights include the use of this technology in an introductory undergraduate zoology course; a discussion of authoring languages with emphasis on SuperPILOT; and hardware and software design for the interface.…

Hostetler, Jerry C.; Englert, Duwayne C.

1987-01-01

485

Presentation Extensions of the SOAP  

NASA Technical Reports Server (NTRS)

A set of extensions of the Satellite Orbit Analysis Program (SOAP) enables simultaneous and/or sequential presentation of information from multiple sources. SOAP is used in the aerospace community as a means of collaborative visualization and analysis of data on planned spacecraft missions. The following definitions of terms also describe the display modalities of SOAP as now extended: In SOAP terminology, View signifies an animated three-dimensional (3D) scene, two-dimensional still image, plot of numerical data, or any other visible display derived from a computational simulation or other data source; a) "Viewport" signifies a rectangular portion of a computer-display window containing a view; b) "Palette" signifies a collection of one or more viewports configured for simultaneous (split-screen) display in the same window; c) "Slide" signifies a palette with a beginning and ending time and an animation time step; and d) "Presentation" signifies a prescribed sequence of slides. For example, multiple 3D views from different locations can be crafted for simultaneous display and combined with numerical plots and other representations of data for both qualitative and quantitative analysis. The resulting sets of views can be temporally sequenced to convey visual impressions of a sequence of events for a planned mission.

Carnright, Robert; Stodden, David; Coggi, John

2009-01-01

486

Sliding Mode Control of Steerable Needles  

PubMed Central

Steerable needles can potentially increase the accuracy of needle-based diagnosis and therapy delivery, provided they can be adequately controlled based on medical image information. We propose a novel sliding mode control law that can be used to deliver the tip of a flexible asymmetric-tipped needle to a desired point, or to track a desired trajectory within tissue. The proposed control strategy requires no a priori knowledge of model parameters, has bounded input speeds, and requires little computational resources. We show that if the standard nonholonomic model for tip-steered needles holds, then the control law will converge to desired targets in a reachable workspace, within a tolerance that can be defined by the control parameters. Experimental results validate the control law for target points and trajectory following in phantom tissue and ex vivo liver. Experiments with targets that move during insertion illustrate robustness to disturbances caused by tissue deformation. PMID:25400527

Rucker, D. Caleb; Das, Jadav; Gilbert, Hunter B.; Swaney, Philip J.; Miga, Michael I.; Sarkar, Nilanjan; Webster, Robert J.

2014-01-01

487

The Fields Institute: Lecture Audio and Slides  

NSDL National Science Digital Library

The Fields Institute for Research in Mathematical Sciences aims to "enhance mathematical activity in Canada by bringing together mathematicians from Canada and abroad, and by promoting contact and collaboration between professional mathematicians and the increasing numbers of users of mathematics." They support research in pure and applied mathematics, statistics and computer science, as well as collaborative projects between mathematicians and those applying mathematics in areas such as engineering, the physical and biological sciences, medicine, economics and finance, telecommunications and information systems. They offer this website with audio files and slides from events and lectures at the Fields Institute. The lectures, given by scientists from around the world, address such topics as Quantitative Finance, String Theory, Homological Algebra, Combinatorics, and much more. The files are organized by academic year and series title. In cases where the files are not available to download, they provide information on how to obtain the files.

488