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1

Preparing Slide Presentations on Computers.  

ERIC Educational Resources Information Center

Suggest use of well-organized slide presentation as effective way to introduce computers to large audiences and discusses how to get started--state objective, analyze audience, outline presentation, prepare slides--and equipment needed to obtain slides from television screens, miniature components, and book illustrations. References and sources…

Elberfeld, John K.

1982-01-01

2

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

3

Insert presenter logo here on slide master.  

E-print Network

University of Auckland PKI: Lemon Markets and Lemonade Session ID: STAR-304 Session Classification: Intermediate Insert presenter logo here on slide master. See hidden slide 2 for directions Agenda 2 Lemon master. See hidden slide 2 for directions3 Lemon Markets / PKI Markets Insert presenter logo here

Gutmann, Peter

4

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

5

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

6

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

7

Alternative Films for Making Presentation Slides for the Occasional User.  

ERIC Educational Resources Information Center

As alternatives to the well-known Kodak Kodalith film for making presentation slides, suggests using Kodak Technical Pan Film, 2415 and Kodak Precision Fine Film LPD4. Although less known, both films are capable of making excellent quality slides with minimum effort and, for the occasional user, offer advantages over the Kodalith-Diazochrome…

Hunt, Harold R., Jr.

1985-01-01

8

Slides  

NSDL National Science Digital Library

If you're looking for a great way to create and share beautiful presentations at no cost, you should give Slides a look. The program gives visitors the ability to use the software on many devices, add audio to each slide, import PDF files seamlessly, and much more. Presentations will be publicly available, unless visitors elect for the paid version, in which case they can be kept private. This version is compatible with all operating systems.

2013-08-15

9

Epson Data Projector and Slide Presenter  

E-print Network

the projector to your laptop - the plug is "keyed" so it will only connect one way round. Apple Mac laptops must There is a small USB adapter slid inside the end of the presenter which needs to be attached to a free USB port projector to a Windows laptop Solution This generally easily fixed with a simple key combination

Capdeboscq, Yves

10

Reaching the People: Using a Sound/Slide Budget Presentation.  

ERIC Educational Resources Information Center

A multimedia (sound/slide) presentation translates numbers of a school budget into a living representation of the schools served by the school district. Such a presentation was tested with positive results in a New York school district. This article was originally submitted for, and the author received, a 1993 Pinnacle of Achievement Award from…

Kerr, Sharon A.

1994-01-01

11

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 consciousness and emotions. Architecture-based concepts are better. What is an architecture? How many kinds are there? ÂŻ Section 2: Reactive, deliberative and meta-management layers in the human architecture, and how

Sloman, Aaron

12

Planning and Producing Effective Outdoor Education Instructional Slide Presentations.  

ERIC Educational Resources Information Center

Describes the steps in developing an instructional audiovisual presentation: (1) the conceptualization stage (identify goals and instructional objectives); (2) the planning stage (define skills and instructional sequence); and (3) the development stage (take slides, write story line, evaluate field test data, and revise). (LC)

Swiderski, Michael J.

1982-01-01

13

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.

14

Incorporating Concept Maps in a Slide Presentation Tool for the Classroom Environment.  

ERIC Educational Resources Information Center

This paper presents a slide presentation software that incorporates a concept map, which explicitly shows how the various slides (and other multimedia components) presented are related to each other. Furthermore, presentations are conceived as hypermedia systems, where the presenter can navigate among slides (and the concept map) instead of the…

Gopal, Kreshna; Morapakkam, Karthik

15

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

16

SLIDE PRESENTATION ON EMSP PROJECT 65328: ELECTRICALLY DRIVEN TECHNOLOGIES FOR RADIOACTIVE AEROSOL ABATEMENT  

EPA Science Inventory

These are the Powerpoint slides from a presentation on electrically driven technologies for radioactive aerosol abatement. The overall objectives of this project were:(1) to generate a scientific basis for developing innovative electrically based filtration systems that are appl...

17

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

18

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

19

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

20

Tips for giving a memorable presentation, Part IV: Using and composing PowerPoint slides.  

PubMed

Visual aids such as PowerPoint slides can be helpful or deleterious to the quality of the talk, depending on how they are done and how they are used. This article will discuss ways to optimize the composition of PowerPoint presentations. This includes the appropriate composition of word slides and the use of the right font size and style of letters. It also includes tips in the use of color, special effects, and graphs. Pointers on how to properly anonymize patient images are also given. PMID:22899205

Harolds, Jay A

2012-10-01

21

Automated Registration of High Resolution Images from Slide Presentation and Whiteboard Handwriting via a Video Camera  

E-print Network

Handwriting via a Video Camera Weihong Li+ , Hao Tang§ and Zhigang Zhu§+ * § Department of Computer SciencePoint© (PPT) slide presentation and a whiteboard handwriting capture system, when used together, could provide with printing notes and the other with handwriting notes, we use a low-cost digital camera as a bridge to align

Zhu, Zhigang

22

Drugs@FDA: FDA Approved Drug Products  

MedlinePLUS

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

23

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

24

FDA Kids' Home Page  

MedlinePLUS

... Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive Links on this page:

25

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

26

FDA 101: Product Recalls  

MedlinePLUS Videos and Cool Tools

... A to Z Index Follow FDA En Espańol 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 ...

27

Reporting Problems to FDA  

MedlinePLUS

... A to Z Index Follow FDA En Espańol 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 ...

28

Methodology for Preparing an Oral Presentation of a Scientific Paper (I assume the talk is organized around slides/overheads)  

E-print Network

Methodology for Preparing an Oral Presentation of a Scientific Paper (I assume the talk understand its content 3) List the following - the problem to be solved - the method(s) used - the data constraints on your talk (time, method of presentation, etc.) 5) Determine how many slides/overheads you can

Dibble, Theodore

29

Text and slides of presentation originally presented to the Nova Scotia Utility and Review Board regarding the province's Demand Side Management program,19 April 2010.  

E-print Network

Text and slides of presentation originally presented to the Nova Scotia Utility and Review Board regarding the province's Demand Side Management program,19 April 2010. ERG/201003 Nova Scotia's Demand Side of Electrical and Computer Engineering Dalhousie University http://lh.ece.dal.ca/enen 19 April 2010 #12;Nova

Hughes, Larry

30

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

31

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

E-print Network

out of the Exxon Valdez spill. We are in the Restoration Planning Phase of the Natural Resource Damage Assessment trustees for the Deepwater BP oil spill. The trustees are the National Oceanic and Atmospheric in March and April 2011 for the BP oil spill Programmatic Environmental Impact Statement, or PEIS. Slide 2

32

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 ...

33

Slide 1  

Cancer.gov

Presentation Title Presenter Title, Affiliation Date 1, 2012 Secondary Slide Title Bullet point Bullet point Bullet point DEPARTMENT OF HEALTH AND HUMAN SERVICES • National Institutes of Health • National Cancer Institute Frederick National Laboratory

34

Decoding Deficits of Different Types of Batterers During Presentation of Facial Affect Slides  

Microsoft Academic Search

The ability to decode emotional cues is associated with both personality disorders and violence. This study investigated whether\\u000a subtypes of intimate partner abusers differ in their ability to label facial affect displays. Intimate partner violent (IPV;\\u000a n?=?69) and nonviolent (NV; n?=?32) men were asked to label slides of facial affect. Cluster analyses classified the IPV men into three different types

Julia C. Babcock; Charles E. Green; Sarah A. Webb

2008-01-01

35

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

36

Electric Slide  

NSDL National Science Digital Library

To some the electric slide may just be a novelty dance. Astute readers of technology blogs will know that this Electric Slide happens to be a application that allows visitors to wirelessly present their PowerPoint slides, documents, and videos using just their iPhone or iPad. First-time visitors can watch an instructional video and then go ahead and get started. The Features area contains details on the operations of the program and the Help section offers up some useful suggestions. This version is compatible with all operating systems running iOS 5.1.1 and newer.

2013-07-11

37

Slide 1  

Cancer.gov

Handout #1: Slides Slide 1 Does It Work? Evaluating Your Program ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________

38

Slide 1  

Cancer.gov

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

39

Slide 1  

Cancer.gov

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

40

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.

41

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.

42

280 Slides  

NSDL National Science Digital Library

There are many different types of presentation software packages, and making a selection out of the variety of options can be hard. 280 Slides is quite a good option, and one distinct feature is that you never have to download any additional software on to your computer to use it. Visitors can upload their existing PowerPoint presentations, and they'll have access to them from any computer with an Internet connection. Users will also appreciate that there is an autosave function, and a built-in media search for adding helpful interactive elements to any presentation. This version of 280 slides requires Google Chrome.

43

FDA Warns of Bogus Botox  

MedlinePLUS

... not be used -- was sold by an unlicensed supplier not authorized to ship or distribute drug products ... the FDA said. Allergan's website lists authorized Botox suppliers. Suspected counterfeit Botox products should be reported to ...

44

Slide 1  

Cancer.gov

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

45

ADA/EEO Talking Notes Slide 1-Welcome to the New Employee Orientation session presented by the Office of Equal  

E-print Network

discrimination in the workplace. The Equal Pay Act of 1963, prohibits discrimination with respect to the payment by the Office of Equal Opportunity & Compliance or EOC. Slide2-This overview will cover EEO, ADA, Retaliation entitlements and protections are otherwise known as equal employment opportunities. Slide 6-Equal Employment

Weston, Ken

46

Automatic Organization and Generation of Presentation Slides for E-Learning  

ERIC Educational Resources Information Center

The effectiveness of an e-learning system for distance education to a large extent depends on the relevancy and presentation of learning content to the learner. The ability to gather documents on a particular topic from the web and adapt the contents of the document to suit the learner is an important task from the content creation perspective of…

Sathiyamurthy, K.; Geetha, T. V.

2012-01-01

47

Slide Tutorials Slide Tutorials  

E-print Network

for several end-member examples of terrigenous and volcanogenic sediment types, all of which are included in the shipboard/repository smear-slide reference sets. Each tutorial example is first introduced with a written/tnotes/digital/tnote_08.pdf). The first step in a smear-slide description is determining the texture of the sediment being

48

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.

49

FDA Approves Rapivab to Treat Flu Infection  

MedlinePLUS

... FDA News Release FDA approves Rapivab to treat flu infection For Immediate Release December 22, 2014 Release ... infection in adults. Influenza, commonly known as the flu, is a contagious respiratory illness caused by influenza ...

50

FDA Approves New Psoriasis Drug Cosentyx  

MedlinePLUS

... Press Announcements FDA News Release FDA approves new psoriasis drug Cosentyx For Immediate Release January 21, 2015 ... to treat adults with moderate-to-severe plaque psoriasis. Psoriasis is a skin condition that causes patches ...

51

FDA Warns About Stem Cell Claims  

MedlinePLUS

... Home For Consumers Consumer Updates FDA Warns About Stem Cell Claims Search the Consumer Updates Section Researchers hope ... blood-forming system. back to top Regulation of Stem Cells FDA regulates stem cells in the U.S. to ...

52

Adaptation of Vocational Education Programs for Special Needs: A Slide/Tape Presentation. Final Report. Research Series Number 62.  

ERIC Educational Resources Information Center

A slide/tape series entitled "Vocational Education and the Special Needs Student" was developed in North Dakota to illustrate adaptations that vocational education teachers have made for special needs students (mentally handicapped, physically handicapped, and disadvantaged) and to serve as a basis for discussion at inservice and preservice levels…

North Dakota Univ., Grand Forks. Dept. of Home Economics and Nutrition.

53

Internet Database Review: The FDA BBS.  

ERIC Educational Resources Information Center

Describes the electronic bulletin board system (BBS) of the Food and Drug Administration (FDA) that is accessible through the Internet. Highlights include how to gain access; the menu-driven software; other electronic sources of FDA information; and adding value. Examples of the FDA BBS menu and the help screen are included. (LRW)

Tomaiuolo, Nicholas G.

1993-01-01

54

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.9) 2. FDA & HHS Similarities and Differences( (To teaching team: the differences are essential points), and applicability of each. b. FDA and HHS differences in mission and oversight c. Monitoring differences d

Biederman, Irving

55

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.

56

The sawtooth cover slide  

NASA Technical Reports Server (NTRS)

A novel cover slide is reported which increases solar cell output by reducing the reflection of light from the cover slide surface and by redirecting incident light so that none falls on the collection grids of the cell. The new cover slide is fabricated with a sawtooth surface having a periodicity equal to that of the solar cell grids. This configuration refracts the light so that it is directed onto the semiconductor surface between the grid lines. Conventional grid patterns obstruct 7-10 percent of the light incident on the cell; at least half of this loss has been recovered by using the sawtooth cover slide. In addition, surface reflection from the conventional coated cover slide is suppressed by presenting a second surface to any light reflected at the first plane of contact. This double reflection results in a greater reduction of the reflection loss from the cover slide than does an antireflection coating on a flat surface.

Meulenberg, A., Jr.

1977-01-01

57

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

58

Slide Classification and Cataloging.  

ERIC Educational Resources Information Center

Follows up an August 1978 article on the cataloging of slides using color photocopying, and presents unsolicited reactions to that article from librarians who were interested in the slide system developed for use in the C-E Refractories Research and Development Library. Twelve references are listed. (FM)

Clawson, Catherine R.; Ronkowski, Charles A.

1981-01-01

59

78 FR 14309 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...  

Federal Register 2010, 2011, 2012, 2013, 2014

...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring...Improvement of Tracking and Tracing of Food; Request for Comments and for...

2013-03-05

60

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.

61

Paleoclimatology Slides  

NSDL National Science Digital Library

These slide sets have been produced by the National Oceanic and Atmospheric Administration (NOAA) to illustrate some of the concepts and methods involved in paleoclimate research. Each set of 20-40 slides includes vivid photographs of field research conducted around the globe, high-quality graphics of important datasets, and descriptive diagrams, making these sets ideal instructional aides. The slide sets can be purchased as 35 mm slides or viewed online. The online version includes a glossary, detailed background information and large, high-resolution versions of each slide. Included is a detailed narrative that is designed to accompany the slides. Topics include the ice ages, climate and the classic Maya civilization, coral paleoclimatology, polar ice cores, pack rat middens, tree rings, Heinrich events, and low latitude ice cores.

2001-10-12

62

DESIGN FOR SAFETY OF RECREATIONAL WATER SLIDES  

Microsoft Academic Search

This article presents an integrated modeling, analysis, and design method for the safety of recreational water slides. Safety and excitement levels of riding on the water slide are the two common criteria for water slide design. Between the two, safety is far more critical than excitement. The safety aspect of the water slide design is ensured by restricting the riding

Sung-Hwan Joo; Kuang-Hua Chang

2001-01-01

63

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.

64

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

65

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.

66

Scam Alert: Beware of Bogus FDA Agents  

MedlinePLUS

... this page Home For Consumers Consumer Updates Scam Alert: Beware of Bogus FDA Agents Search the Consumer ... or via telephone, you may also want to alert your credit card company and make sure that ...

67

How FDA Evaluates Regulated Products: Cosmetics  

MedlinePLUS

... a cosmetic that does not comply with the law, FDA may ask a federal court to issue an injunction request that U.S. marshals seize the products initiate criminal action refuse entry of an imported cosmetic request ...

68

FDA Approves Opdivo for Advanced Melanoma  

MedlinePLUS

... therapies based on our increasing understanding of tumor immunology and molecular pathways are changing the treatment paradigm ... when the agency was scheduled to complete its review of the application. The FDA granted Opvido breakthrough ...

69

FDA Weighs Tighter Regulation of Homeopathic Medicines  

MedlinePLUS

... please enable JavaScript. FDA Weighs Tighter Regulation of Homeopathic Medicines Critics say these natural remedies are ineffective, ... this class of products for safety and efficacy." Homeopathy's champions say current oversight 'working well' Supporters of ...

70

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.

71

Pharmacogenomic Biomarker Information in FDA-approved Paediatric Drug Labels.  

PubMed

Gene maturation differs between paediatric and adult populations, and the extrapolation of adult pharmacogenomic information to paediatrics is not always appropriate. We sought to determine the extent of paediatric pharmacogenomic trial translation into US FDA-approved labels and to evaluate needs for biomarker studies. Using FDA's Table of Genomic Biomarkers and Drugs@FDA website, 38 pharmacogenomic biomarkers in 56 drug labels were identified with possible application in paediatrics. Of these 56 drugs, biomarker comparison against 'Very Important Pharmacogenes (VIPs)' defined in PharmGKB's database revealed a total of eight VIPs labelled among 41 drugs. One hundred and thirty-nine product reviews posted on the FDA website under the Best Pharmaceuticals for Children Act and Paediatric Research Equity Act between October 2007 and July 2014 were examined. Review screening identified 43 drugs with 'pharmacogenomic' content, of which only three were true genotyping study reviews for proton pump inhibitors, all evaluating CYP2C19 polymorphisms. Pantoprazole was the sole drug labelled with pharmacogenomic information obtained specifically from paediatric trials. Clinicaltrials.gov was searched to further evaluate the current availability of pharmacogenomic studies in the paediatric population. Of the 33,132 trials registered on Clinicaltrials.gov, 137 were labelled as paediatric pharmacogenetic and pharmacogenomic studies. Pharmacogenomic studies directly conducted in paediatric patients are lacking, and thus, pharmacogenomic biomarker information based on adult studies is commonly presented in FDA-approved labels for use in paediatric patients. Considering differences in gene expression and physiological maturation between paediatric and adult populations, studies investigating pharmacogenomic effects specifically in paediatric patients should be conducted whenever significant biomarkers are available. PMID:25348905

Kim, Therasa; Han, Nayoung; Sohn, Minji; Oh, Jung Mi; Lee, Eui-Kyung; Ji, Eunhee; Kim, In-Wha

2015-05-01

72

METHOD OF PRESENTATION: Two 90-minute class sessions per week based on lecture class discussions, and slide presentations illustrating historical and theoretical background information covered. Students are required to actively participate in class discussions. Visits take place outside of class hours. REQUIRED WORK AND FORM OF ASSESSMENT  

Microsoft Academic Search

1. Term project: In-depth written analysis of paintings viewed (25%) 2. Mid-term exam based on slide presentation (25%) 3. Final exam: Either an essay\\/analysis of a slide presentation or a research paper based on application of theory to concrete examples and works of art (50%) CONTENT: Part I : Late 19th century Emphasis on selected highlights of the period, including

73

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

74

Medical device data systems and FDA regulation. Should medical device data systems require FDA clearance?  

PubMed

It is widely understood why medical devices need to be regulated by the FDA and other governing bodies. However medical software does not typically require the same level of regulation. Currently the FDA is investigating whether one type of medical software, Medical Device Data Systems (MDDS), should require FDA clearance because of the potential risk they impose when interconnected with medical devices. Hospitals are looking to implement MDDS because the technology allows nursing staff to spend more time on direct patient care and reduces charting errors. This article will explore the FDA's proposal and will review the possible risks and provide a rationale for why MDDS should be regulated by the FDA and why MDDS vendors should have the right level of quality and risk management procedures in place to ensure that they are developing and bringing to market the safest products possible. PMID:20677470

Kelley, Peter

2010-01-01

75

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

MedlinePLUS

... and can lead to a lifetime of tobacco addiction. The FDA is encouraging parents to understand the ... feeds Follow FDA on Twitter Follow FDA on Facebook View FDA videos on YouTube View FDA photos ...

76

[Supervised feature extraction based on FDA and galaxy spectra classification].  

PubMed

With the recent technological advances in wide field survey astronomy and the implementation of several large scale astronomical survey proposals, celestial spectra are becoming very rich and the study of automated processing methods is attracting more and more attention. In the present work, the authors pointed out that it is necessary to investigate supervised feature extraction by analyzing the characteristics of the spectra classification research in literature and the limitations of unsupervised feature extraction methods. And the authors studied supervised feature extraction based on Fisher discriminant analysis (FDA) and its application in galaxy spectra classification. FDA could effectively reduce dimension and extract the features based on the classifying capability by fusing information in training data. Experiments show its superior performance in dimensional reduction for galaxy spectra classification. PMID:18051557

Li, Xiang-Ru; Hu, Zhan-Yi; Zhao, Yong-Heng

2007-09-01

77

FDA approved drugs as potential Ebola treatments  

PubMed Central

In the search for treatments for the Ebola Virus, multiple screens of FDA drugs have led to the identification of several with promising in vitro activity. These compounds were not originally developed as antivirals and some have been further tested in mouse in vivo models. We put forward the opinion that some of these drugs could be evaluated further and move into the clinic as they are already FDA approved and in many cases readily available. This may be important if there is a further outbreak in future and no other therapeutic is available. PMID:25789163

Ekins, Sean; Coffee, Megan

2015-01-01

78

FDA Approves New Breast Cancer Drug  

MedlinePLUS

... play a role in the growth of cancer cells. It is intended for postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have not yet received endocrine-based therapy, the FDA said. Ibrance is to be used ...

79

FDA Approves Weight-Management Drug Saxenda  

MedlinePLUS

... dosing, safety, and efficacy in pediatric patients; a study to assess potential effects on growth, sexual maturation, and central nervous ... related to Saxenda; and an evaluation of the potential risk of breast ... is being investigated in an ongoing cardiovascular outcomes trial. The FDA ...

80

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.

2014-09-12

81

Apr. 2012 Cryptography Slide 1 Cryptography  

E-print Network

Apr. 2012 Cryptography Slide 1 Cryptography A Lecture in CE Freshman Seminar Series: Ten Puzzling Problems in Computer Engineering #12;Apr. 2012 Cryptography Slide 2 About This Presentation Apr. 2012 #12;Apr. 2012 Cryptography Slide 3 Puzzles and Cryptograms in Archeology #12;Apr. 2012

Liebling, Michael

82

21 CFR 806.30 - FDA access to records.  

Code of Federal Regulations, 2010 CFR

...2010-04-01 false FDA access to records. 806.30 Section 806.30...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to...

2010-04-01

83

FDA OKs First Generic Version of Heartburn Drug Nexium  

MedlinePLUS

... consumers can be assured that these FDA-approved generic drugs have met our rigorous standards," Dr. Kathleen Uhl, director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and ...

84

21 CFR 806.30 - FDA access to records.  

Code of Federal Regulations, 2014 CFR

...2014-04-01 false FDA access to records. 806.30 Section 806.30...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to...

2014-04-01

85

21 CFR 806.30 - FDA access to records.  

Code of Federal Regulations, 2011 CFR

...2011-04-01 false FDA access to records. 806.30 Section 806.30...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to...

2011-04-01

86

21 CFR 806.30 - FDA access to records.  

Code of Federal Regulations, 2012 CFR

...2012-04-01 false FDA access to records. 806.30 Section 806.30...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to...

2012-04-01

87

21 CFR 806.30 - FDA access to records.  

Code of Federal Regulations, 2013 CFR

...2013-04-01 false FDA access to records. 806.30 Section 806.30...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.30 FDA access to...

2013-04-01

88

21 CFR 314.102 - Communications between FDA and applicants.  

Code of Federal Regulations, 2010 CFR

...2010-04-01 2010-04-01 false Communications between FDA and applicants. ...ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS...Abbreviated Applications § 314.102 Communications between FDA and applicants....

2010-04-01

89

21 CFR 312.86 - Focused FDA regulatory research.  

Code of Federal Regulations, 2011 CFR

... Focused FDA regulatory research. At the discretion...undertake focused regulatory research on critical rate-limiting aspects of the preclinical, chemical/manufacturing...FDA will undertake such research efforts as a means...

2011-04-01

90

21 CFR 312.86 - Focused FDA regulatory research.  

Code of Federal Regulations, 2013 CFR

... Focused FDA regulatory research. At the discretion...undertake focused regulatory research on critical rate-limiting aspects of the preclinical, chemical/manufacturing...FDA will undertake such research efforts as a means...

2013-04-01

91

21 CFR 312.86 - Focused FDA regulatory research.  

Code of Federal Regulations, 2012 CFR

... Focused FDA regulatory research. At the discretion...undertake focused regulatory research on critical rate-limiting aspects of the preclinical, chemical/manufacturing...FDA will undertake such research efforts as a means...

2012-04-01

92

21 CFR 312.86 - Focused FDA regulatory research.  

Code of Federal Regulations, 2014 CFR

... Focused FDA regulatory research. At the discretion...undertake focused regulatory research on critical rate-limiting aspects of the preclinical, chemical/manufacturing...FDA will undertake such research efforts as a means...

2014-04-01

93

21 CFR 312.86 - Focused FDA regulatory research.  

Code of Federal Regulations, 2010 CFR

... Focused FDA regulatory research. At the discretion...undertake focused regulatory research on critical rate-limiting aspects of the preclinical, chemical/manufacturing...FDA will undertake such research efforts as a means...

2010-04-01

94

FDA Approves First-of-Kind Device to Treat Obesity  

MedlinePLUS

... FDA approves first-of-kind device to treat obesity For Immediate Release January 14, 2015 Release Espańol ... The Maestro Rechargeable System, the first FDA-approved obesity device since 2007, is approved to treat patients ...

95

42 CFR 405.203 - FDA categorization of investigational devices.  

Code of Federal Regulations, 2014 CFR

...HUMAN SERVICES MEDICARE PROGRAM FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED Medical Services Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA...

2014-10-01

96

42 CFR 405.203 - FDA categorization of investigational devices.  

Code of Federal Regulations, 2011 CFR

...HUMAN SERVICES MEDICARE PROGRAM FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED Medical Services Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA...

2011-10-01

97

42 CFR 405.203 - FDA categorization of investigational devices.  

Code of Federal Regulations, 2013 CFR

...HUMAN SERVICES MEDICARE PROGRAM FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED Medical Services Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA...

2013-10-01

98

42 CFR 405.203 - FDA categorization of investigational devices.  

Code of Federal Regulations, 2010 CFR

...HUMAN SERVICES MEDICARE PROGRAM FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED Medical Services Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA...

2010-10-01

99

42 CFR 405.203 - FDA categorization of investigational devices.  

Code of Federal Regulations, 2012 CFR

...HUMAN SERVICES MEDICARE PROGRAM FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED Medical Services Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA...

2012-10-01

100

Revisit FDA & OHRP, ICH & GCP, International Research Kathy and Kristin  

E-print Network

. Emergency use of a test article f. Audits & inspections g. SAE / UPX discuss in terms of FDA, PI, HHS, IRB, Sponsor (reporting responsibilities and definitions) h. FDA required IC to say FDA can inspect, but HHS intl (no idea of local customs, etc.) Money: IF HHS gives money for research ­HHS wants an FWA

Biederman, Irving

101

CI Slide: calibration slide for quantitative microscopy imaging in absorbance  

NASA Astrophysics Data System (ADS)

New imaging technologies are changing the field of digital pathology. This field faces numerous challenges and there is a pressing need for standardization, calibration protocols, quality control and quantitative assessment. We have designed a new calibration imaging slide (Cancer Imaging Slide), specifically to measure the characteristics of old or new imaging systems or scanners. The layout of the slide consists of 138 boxes with the side length of 1.6 mm, containing objects of known morphologic and photometric characteristics. Among them, 112 boxes contain different permutations of circles, ovals, and squares. The circles have different radii, radius/pitch ratios and step transmissions. The ovals have different sizes and orientations. The squares are consistent in size and orientation but have different step transmission values. Also, 16 boxes contain three resolution test targets: crosses, USAF target and Siemens star. The last 10 boxes are blank boxes with different transmission values. Four slides were scanned and imaged on one commercial whole-slide scanner and one high resolution imaging system. After segmenting the images, about 200 features (photometric, morphologic and architectural) were measured with our in-house image processing software. The objective of the project is to develop a statistical process control using this new slide. In this paper, we describe the characteristics of the slide and present our preliminary results.

Sheikhzadeh, Fahime; Ye, Qian; Zulkafly, Nasir; Carraro, Anita; Korbelic, Jagoda; Chen, Zhaoyang; Harrison, Alan; Follen, Michele; MacAulay, Calum; Ward, Rabab K.; Guillaud, Martial

2014-03-01

102

ADHD Medication Use Following FDA Risk Warnings  

PubMed Central

Background In 2006, the U.S. Food and Drug Administration (FDA) investigated cardiac and psychiatric risks associated with attention deficit/hyperactivity disorder (ADHD) medication use. Aims of the Study To examine how disclosure of safety risks affected pediatric ADHD use, and to assess news media coverage of the issue to better understand trends in treatment patterns. Methods We used the AHRQ’s Medical Expenditure Panel Survey (MEPS), a nationally representative household panel survey, to calculate unadjusted rates of pediatric ADHD use from 2002 to 2008 overall and by parents’ education. We examined whether children (ages 0 to 20) filled a prescription for any ADHD medication during the calendar year. Next, we used content analysis methods to analyze news coverage of the issue in 10 high-circulation newspapers, the 3 major television networks and a major cable news network in the U.S. We examined 6 measures capturing information conveyed on risk and benefits of ADHD medication use. Results No declines in medication use following FDA safety warnings overall or by parental education level were observed. News media coverage was relatively balanced in its portrayal of the risks and benefits of ADHD medication use by children. Discussion ADHD risk warnings were not associated with large declines in medication use, and balanced news coverage may have contributed to the treatment patterns observed. Self-reported surveys like the MEPS rely on the recall of respondents and may be subject to reporting bias. However, the validity of these data is supported by their consistency with other data on drug use from other sources. Implications for Health Care Provision and Use These findings are in direct contrast to the substantial declines in use observed after pediatric antidepressant risk warnings in the context of a news media environment that emphasized risks over benefits. Implications for Health Policies Our findings are relevant to the ongoing discussion about improving the FDA’s ability to monitor drug safety. Safety warnings occur amid ongoing concern that the agency has insufficient authority and resources to fulfill its mission to protect the public’s health. Efforts to bolster the FDA’s postmarketing surveillance system have the potential to incorporate more data in decision making to allow for earlier detection of health risks. Implications for Further Research Further research is needed to assess whether other treatment changes occurred following risk warnings. For example, it is important to determine whether an increase in cardiac screening prior to medication initiation occurred. Likewise, the FDA advises that children experiencing hallucinations or other psychiatric responses to medication be discontinued from drug treatment. If it is determined that instead of being discontinued from medication treatment, children experiencing hallucinations are put on additional medication (e.g., antipsychotics), additional efforts by the FDA to better inform the public are warranted. PMID:23001280

Barry, Colleen L.; Martin, Andres; Busch, Susan H.

2013-01-01

103

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.

104

Rheological behavior of Slide Ring Gels  

Microsoft Academic Search

Slide ring gels were synthesized by chemically crosslinking, sparsely populated alpha-cyclodextrin (alpha-CD) present on the polyrotaxanes consisting of alpha-CD and polyethylene glycol (PEG). [1] Unlike physically or chemically crosslinked gels, slide ring gels are topological gels where crosslinks can slide along the chain. [2] We investigate the rheological behavior of these gels swollen in water and compare their viscoelastic properties

Vivek Sharma; Jong Seung Park; Jung O. Park; Mohan Srinivasarao

2006-01-01

105

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

106

Sliding order and sliding accuracy in sliding mode control  

Microsoft Academic Search

The synthesis of a control algorithm that stirs a nonlinear system to a given manifold and keeps it within this constraint is considered. Usually, what is called sliding mode is employed in such synthesis. This sliding mode is characterized, in practice, by a high-frequency switching of the control. It turns out that the deviation of the system from its prescribed

ARIE LEVANT; L. V. Levantovsky

1993-01-01

107

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

108

The growing debate over FDA reform. Food and Drug Administration.  

PubMed

Advocates for revamping the Food and Drug Administration (FDA) began a major public relations campaign shortly after the 1994 Republican takeover of Congress. FDA-regulated industries released reform proposals and AIDS activists are working with Congress to ensure FDA reform legislation serves patients' true interests. Legislative efforts, however, have been very slow. Senator Kassebaum proposed a reform bill that, among other provisions, speeds up FDA bureaucracy in approving new drugs, and allows promotion of off-label uses of drugs. Off-label promotion is believed by some to potentially harm drug development for treating rare diseases. Among all the reform efforts, the FDA Act is considered important to preserve because its high standards protect the public against dubious or fraudulent drug data. PMID:11363372

Link, D

1996-01-01

109

FDA toxicity databases and real-time data entry  

SciTech Connect

Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared.

Arvidson, Kirk B. [Division of Food Contact Notifications, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, 5100 Paint Branch Parkway, HFS-275, College Park, MD, 20740 (United States)], E-mail: kirk.arvidson@fda.hhs.gov

2008-11-15

110

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

111

Sliding vane geometry turbines  

DOEpatents

Various systems and methods are described for a variable geometry turbine. In one example, a turbine nozzle comprises a central axis and a nozzle vane. The nozzle vane includes a stationary vane and a sliding vane. The sliding vane is positioned to slide in a direction substantially tangent to an inner circumference of the turbine nozzle and in contact with the stationary vane.

Sun, Harold Huimin; Zhang, Jizhong; Hu, Liangjun; Hanna, Dave R

2014-12-30

112

76 FR 34715 - Draft Guidance for Industry; Considering Whether an FDA-Regulated Product Involves the...  

Federal Register 2010, 2011, 2012, 2013, 2014

...whether FDA-regulated products contain nanomaterials or otherwise involve the application...whether FDA-regulated products contain nanomaterials or otherwise involve the application...whether FDA-regulated products include nanomaterials or otherwise involve...

2011-06-14

113

FDA's Report on New Health Care Products Approved in 1999  

NSDL National Science Digital Library

Released on January 18 by the US Food and Drug Administration (FDA), this report highlights some of the approximately 140 medications and medical devices approved by the FDA last year. The highlighted products are listed by the groups of patients or diseases they are designed to help. The report also discusses FDA approval and application procedures. While neither extensive nor particularly easy to read, the report still contains a useful overview of the most important new drugs and treatments to enter the market in 1999.

114

Classification and Cataloging of Slides Using Color Photocopying  

ERIC Educational Resources Information Center

The classification and cataloging of slides pose unique and critical problems in every field where they are used. A brief overview of the literature is presented, along with observations on local area slide systems and a description of a slide system developed for use in C-E Refractories' Research and Development Library utilizing color…

Clawson, Catherine R.; Rankowski, Charles A.

1978-01-01

115

Force\\/motion control of constrained robots using sliding mode  

Microsoft Academic Search

A sliding mode control algorithm is presented for trajectory tracking of an end-effector on a constrained surface with specified constraint forces by using the theory of variable structure systems. The development of the algorithm is based on a new formulation of the dynamic model and the expansion of sliding surfaces to include the constraint force error. The proposed sliding controller

Chun-Yi Su; Tin-hi Leung; Qi-Jie Zhou

1992-01-01

116

A control engineer's guide to sliding mode control  

Microsoft Academic Search

Presents a guide to sliding mode control for practicing control engineers. It offers an accurate assessment of the so-called chattering phenomenon, catalogs implementable sliding mode control design solutions, and provides a frame of reference for future sliding mode control research

K. David Young; Vadim I. Utkin; U. Ozguner

1999-01-01

117

Hierarchical Sliding Mode Control to Swing up a Pendubot  

Microsoft Academic Search

To swing up a Pendubot, a pendulum robot, this paper presents a hierarchical sliding mode controller with limited control torque. The structure characteristic of the Pendubot system is that it can be treated as two subsystems. Thus, the hierarchical structure of the sliding mode surfaces is designed as follows. The sliding mode surfaces of the two subsystems are defined at

Dianwei Qian; Jianqiang Yi; Dongbin Zhao

2007-01-01

118

Applying the FDA definition of whole grains to the evidence for cardiovascular disease health claims.  

PubMed

The U.S. FDA defines whole grains as consisting of the intact, ground, cracked, or flaked fruit of the grains whose principal components, the starchy endosperm, germ, and bran, are present in the same relative proportions as they exist in the intact grain. We evaluated the effect of applying the FDA definition of whole grains to the strength of scientific evidence in support of claims for risk reduction of cardiovascular disease (CVD). We concluded that using the FDA definition for whole grains as a selection criterion is limiting, because the majority of existing studies often use a broader meaning to define whole grains. When considering only whole grain studies that met the FDA definition, we found insufficient scientific evidence to support a claim that whole grain intake reduces the risk of CVD. However, a whole grain and reduced risk of CVD health claim is supported when using a broader concept of whole grain to include studies that considered intake of fiber-rich bran and germ as well as whole grain. This type of analysis is complicated by diversity in nutrients and bioactive components among different types of whole grains. PMID:19776180

De Moura, Fabiana F; Lewis, Kara D; Falk, Michael C

2009-11-01

119

FDA regulation of adult stem cell therapies as used in sports medicine.  

PubMed

In sports medicine, adult stem cells are the subject of great interest. Several uses of stem cells are under investigation including cartilage repair, meniscal regeneration, anterior cruciate ligament reconstruction, and tendinopathy. Extensive clinical and basic science research is warranted as stem cell therapies become increasingly common in clinical practice. In the United States, the Food and Drug Administration (FDA) is responsible for regulating the use of stem cells through its "Human Cells, Tissues, and Cellular and Tissue-Based Products" regulations. This report provides a brief overview of FDA regulation of adult stem cells. Several common clinical case scenarios are then presented that highlight how stem cells are currently being used in sports medicine and how current FDA regulations are likely to affect the physicians who use them. In the process, it explains how a variety of factors in sourcing and handling these cells, particularly the extent of cell manipulation, will affect what a physician can and cannot do without first obtaining the FDA's express approval. PMID:25603042

Chirba, Mary Ann; Sweetapple, Berkley; Hannon, Charles P; Anderson, John A

2015-02-01

120

Adaptive sliding mode controller for an underactuated manipulator  

Microsoft Academic Search

A new type of adaptive sliding-mode control method (ASMC) for an underactuated manipulator called Pendubot is presented in This work. The ASMC adapts a kind of hierarchical structure. Firstly the Pendubot system is divided into two subsystems. For each subsystem, we define first-layer sliding plane. From these two first-layer sliding planes, we further define a second-layer sliding plane. Using Lyapunov

Wei Wang; Jian-Qiang Yi; Dong-Bin Zhao; Xiao-Jing Liu

2004-01-01

121

Reporting Complaints Related to FDA-Regulated Clinical Trials  

MedlinePLUS

... Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive Links on this page:

122

FDA Approves First Pathogen Reduction System to Treat Plasma  

MedlinePLUS

... FDA approves first pathogen reduction system to treat plasma For Immediate Release December 16, 2014 Release The ... Administration today approved the Intercept Blood System for plasma, the first pathogen reduction system for use by ...

123

FDA OKs New Drug for Diabetes-Linked Eye Condition  

MedlinePLUS

... on this page, please enable JavaScript. FDA OKs New Drug for Diabetes-Linked Eye Condition Eylea injections ... diabetes, and diabetes remains the leading cause of new blindness among people aged 20 to 74, the ...

124

FDA Approves New Device Aimed At Easing Stroke Risk  

MedlinePLUS

... on this page, please enable JavaScript. FDA Approves New Device Aimed at Easing Stroke Risk ENROUTE system ... Stroke MONDAY, Feb. 9, 2015 (HealthDay News) -- A new technology designed to reduce stroke risk in certain ...

125

Public Affairs Specialists: On the FDA's Front Line  

MedlinePLUS

... But today the inquiries may include concerns about biotechnology, fears about "mad cow" disease, or questions about ... Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive Links on this page:

126

FDA Approves Viekira Pak to Treat Hepatitis C  

MedlinePLUS

... News Release FDA approves Viekira Pak to treat hepatitis C For Immediate Release December 19, 2014 Release ... with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those ...

127

21 CFR 316.34 - FDA recognition of exclusive approval.  

Code of Federal Regulations, 2010 CFR

...HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition...approval once the marketing application for a designated orphan-drug product has been approved. The written...

2010-04-01

128

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 ...

129

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

130

21 CFR 316.34 - FDA recognition of exclusive approval.  

Code of Federal Regulations, 2011 CFR

...HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition...approval once the marketing application for a designated orphan-drug product has been approved. The written...

2011-04-01

131

21 CFR 316.34 - FDA recognition of exclusive approval.  

Code of Federal Regulations, 2012 CFR

...HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition...approval once the marketing application for a designated orphan-drug product has been approved. The written...

2012-04-01

132

21 CFR 316.34 - FDA recognition of exclusive approval.  

Code of Federal Regulations, 2013 CFR

...HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Orphan-drug Exclusive Approval § 316.34 FDA recognition...approval once the marketing application for a designated orphan-drug product has been approved. The written...

2013-04-01

133

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

134

Effect of the FDA on health care investments  

NASA Astrophysics Data System (ADS)

The cost of securing FDA approval has long been an important consideration in funding projects involving new medical technologies, but the more stringent regulatory behavior of the FDA in the past few years has led to a discernable decrease in the funding of start-up medical device companies. An abundance of anecdotal evidence, supported with surveys of venture capital firms, investment groups and medical device corporations, indicates a serious shortage of funds available for the development of certain medical technologies.

Cleary, David J.

1994-12-01

135

77 FR 52036 - Privacy Act of 1974; Report of a New System of Records; FDA Records Related to Research...  

Federal Register 2010, 2011, 2012, 2013, 2014

...System of Records; FDA Records Related to Research Misconduct Proceedings AGENCY: Food...records entitled ``FDA Records Related to Research Misconduct Proceedings, HHS/FDA...Department's) Public Health Service Policies on Research Misconduct, FDA has...

2012-08-28

136

Slide 1  

Cancer.gov

John E. Niederhuber, M.D. Presentation to the National Cancer Advisory Board September 6, 2006 NCI Community-Based Cancer Centers Pilot Program 61 major academic and research institutes making significant contributions

137

Slide 1  

Cancer.gov

HMO Cancer Research Network (CRN) Research Resource Concept Rachel Ballard-Barbash, MD, MPH Martin Brown, PhD (CRN Program Director) NCI Board of Scientific Advisors June 20, 2011 Presentation Outline • Need for National Research Resource • Unique

138

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

139

Slide 1  

Cancer.gov

1 Using Social Media to Understand and Address Substance Use and Addiction Trans-NIH RFA Concept presentation to NCI Board of Scientific Advisors Wen-ying Sylvia Chou, PhD, MPH Health Communication and Informatics Research Branch November 7,

140

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

141

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

142

Slide 1  

Cancer.gov

Kevin W. Dodd, PhD National Cancer Institute Accounting for complex survey design in modeling usual intake 2 Sharon Kirkpatrick Series Organizer Regan Bailey Laurence Freedman Douglas Midthune Dennis Buckman Patricia Guenther Amy Subar Raymond Carroll Victor Kipnis Fran Thompson Kevin Dodd Susan Krebs-Smith Janet Tooze Presenters and Collaborators Accounting for complex survey design in modeling usual intake 3 In recognition of his internationally renowned contributions to the field of nutrition epidemiology and his commitment to understanding measurement error associated with dietary assessment.

143

NCL Partnerships - U.S. Food and Drug Administration (FDA)- Nanotechnology Characterization Laboratory  

Cancer.gov

The NCL serves as a bridge to take promising cancer nanotechnology research to the FDA. FDA provides input to NCL on the type of testing needed to evaluate nanomaterials for regulatory review, and data generated at NCL inform FDA on which nanoparticle properties contribute most to safety and toxicity. Additionally, the NCL provides the FDA with collaborative research resources.

144

MOSFET Converter-Fed Position Servo System with Sliding Mode Control  

Microsoft Academic Search

Sliding mode control is an effective means to keep a system insensitive to parametric variations and disturbances. In the conventional sliding mode control applied to position servo systems, the sliding mode regime is restricted near the origin, and, therefore, insensitivity cannot be ensured throughout an entire response. This paper presents a new method in which a sliding curve is used

Fumio Harashima; Hideki Hashimoto; Seiji Kondo

1985-01-01

145

U.S. Food & Drug Administration (FDA) From: FY14 Lapse in Appropriation Notification [mailto:FY14LapseInApproNotif@fda.hhs.gov  

E-print Network

LapseInApproNotif@fda.hhs.gov] Sent: Tuesday, October 01, 2013 6:25 AM Subject: Grants Administration imminent threatto the safetyof humanlife orthe protection of property,youshouldcontactYemisi Akinneye atOluyemisi.Akinneye@fda.hhs

Eichler, Evan

146

Rheological behavior of Slide Ring Gels.  

NASA Astrophysics Data System (ADS)

Slide ring gels were synthesized by chemically crosslinking, sparsely populated ?-cyclodextrin (?-CD) present on the polyrotaxanes consisting of ?-CD and polyethylene glycol (PEG). [1] Unlike physically or chemically crosslinked gels, slide ring gels are topological gels where crosslinks can slide along the chain. [2] We investigate the rheological behavior of these gels swollen in water and compare their viscoelastic properties to those of physical and chemical gels. We also study the equilibrium swelling behavior of these gels. [1] Okumura and Ito, Adv. Mater. 2001, 13, 485 [2] C. Zhao et al, J. Phys. Cond. Mat. 2005, 17, S2841

Sharma, Vivek; Park, Jong Seung; Park, Jung O.; Srinivasarao, Mohan

2006-03-01

147

Characteristics of pivotal trials and FDA review of innovative devices.  

PubMed

When patients lack sufficient treatment options for serious medical conditions, they rely on the prompt approval and development of new therapeutic alternatives, such as medical devices. Understanding the development of innovative medical devices, including the characteristics of premarket clinical trials and length of Food and Drug Administration (FDA) review, can help identify ways to expedite patient access to novel technologies and inform recent efforts by FDA to more quickly get these products to patients and physicians. We analyzed publicly available information on clinical trials and premarket FDA review for innovative medical devices that fill an unmet medical need. In this first-of-its-kind study focusing on these products, we extracted data on the length of the pivotal trials, primary study endpoint and FDA review; number of patients enrolled in trials; and in what country the device was available first. We identified 27 approved priority review devices from January 2006 through August 2013. The median duration of pivotal clinical trials was 3 years, ranging from 3 months to approximately 7 years. Trials had a median primary outcome measure evaluation time of one year and a median enrollment of 297 patients. The median FDA review time was 1 year and 3 months. Most priority review devices were available abroad before they were approved in the United States. Our study indicates that addressing the length of clinical studies--and contributing factors, such as primary outcome measures and enrollment--could expedite patient access to innovative medical devices. FDA, manufacturers, Congress and other stakeholders should identify the contributing factors to the length of clinical development, and implement appropriate reforms to address those issues. PMID:25651420

Rising, Joshua P; Moscovitch, Ben

2015-01-01

148

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

149

Temperature measurements in sliding elastohydrodynamic point contacts  

NASA Technical Reports Server (NTRS)

Techniques using the infrared radiation emitted by a sliding elastohydrodynamic (EHD) point contact to measure oil film and surface temperature are discussed. Temperature distributions in the EHD contact are presented for a naphthenic mineral oil at 1.04 GN/sq m (150,000 psi) Hertz pressure and several sliding velocities. Film temperatures as high as 360 C are reported at locations near the points of minimum film thickness in the contact side lobes.

Turchina, V.; Sanborn, D. M.; Winer, W. O.

1973-01-01

150

The Munson-Nygren slide: A major lower-slope slide off Georges Bank  

USGS Publications Warehouse

The Munson-Nygren slide is a large compound slide located between Munson and Nygren Canyons below 1900 m depth on the Continental Slope off Georges Bank. Its structural and morphological features are recognized in high-resolution seismic-reflection profiles. The slide comprises an axial trough which has a relief as great as 325 m and a width of 6-10 km. The trough is flanked by displaced and disrupted strata for a total lateral extent of approximately 20 km and a downslope extent of at least 35 km. The slide is unrelated genetically to the adjacent canyons and may postdate Munson Canyon. There is evidence of plastic deformation at the base of the section subjected to sliding. Certain features of the slide complex resemble those seen in landforms on the Laurentian Rise and attributed by Emery et al.* * Emery et al. (1970). to the 1929 Grand Banks earthquake. The Munson-Nygren slide may have been triggered by a large earthquake in late Pleistocene time or later. Destructional landforms associated with the slide are similar to those widely present along the lower slope off Georges Bank. ?? 1986.

O'Leary, D. W.

1986-01-01

151

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!

152

Regulatory administrative databases in FDA's Center for Biologics Evaluation and Research: convergence toward a unified database.  

PubMed

Regulatory administrative database systems within the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) are essential to supporting its core mission, as a regulatory agency. Such systems are used within FDA to manage information and processes surrounding the processing, review, and tracking of investigational and marketed product submissions. This is an area of increasing interest in the pharmaceutical industry and has been a topic at trade association conferences (Buckley 2012). Such databases in CBER are complex, not for the type or relevance of the data to any particular scientific discipline but because of the variety of regulatory submission types and processes the systems support using the data. Commonalities among different data domains of CBER's regulatory administrative databases are discussed. These commonalities have evolved enough to constitute real database convergence and provide a valuable asset for business process intelligence. Balancing review workload across staff, exploring areas of risk in review capacity, process improvement, and presenting a clear and comprehensive landscape of review obligations are just some of the opportunities of such intelligence. This convergence has been occurring in the presence of usual forces that tend to drive information technology (IT) systems development toward separate stovepipes and data silos. CBER has achieved a significant level of convergence through a gradual process, using a clear goal, agreed upon development practices, and transparency of database objects, rather than through a single, discrete project or IT vendor solution. This approach offers a path forward for FDA systems toward a unified database. PMID:23269527

Smith, Jeffrey K

2013-04-01

153

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

154

The reality of the FDA's approval of the female condom.  

PubMed

Many family planning experts are concerned that labeling requirements stipulated by the US Food and Drug Administration (FDA) will create an unfounded bias against the newly approved Reality female condom. Wisconsin Pharmacal Company, the US licensee of Reality, has been directed to include the message that the female condom should be used only if the male condom (claimed to be more protective against sexually transmitted diseases) cannot or will not be used. Also included on all labels, advertising, and promotion must be statistics comparing the pregnancy rates for Reality and other barrier methods. The failure rate the FDA has determined that must be cited for Reality--26%--is considered by many family planning experts to be based on dubious scientific methodology and at least 5% too high. It has been speculated that the FDA's bias against the female condom reflects a lack of confidence in women's ability to use the device correctly. Others have noted that the FDA's handling of the new condom has been based on the issue of user efficacy rather than produce safety. Wisconsin Pharmacal is in the process of distributing Reality condoms for at least half the commercial cost of US $2.50 to public sector clinics that serve women deemed to be at highest risk of human immunodeficiency virus infection. PMID:12286995

1993-07-01

155

The FDA Food Code: What should you know?  

E-print Network

. INFORMATION TO ASSIST THE USER · 9. THE CODE REVISION PROCESS · 10. ACKNOWLEDGMENTS 12 #12;Components of Food ­ Food Warehouses ­ Seafood Markets ­ Poultry & Egg Processing ­ Food Manufacturing ­ Soft Drink BottlingThe FDA Food Code: What should you know? Amy Simonne, Ph.D. Professor, Food Science University

Jawitz, James W.

156

FDA Approves Lenvatinib for Radioactive Iodine-Refractory Thyroid Cancer  

Cancer.gov

The Food and Drug Administration (FDA) has approved lenvatinib (Lenvima) to treat some patients with the most common type of thyroid cancer, differentiated thyroid cancer (DTC). The approval is for patients with DTC whose disease has progressed following radioactive iodine therapy (radioactive iodine-refractory disease).

157

FDA Approves Panobinostat for Some Patients with Multiple Myeloma  

Cancer.gov

The Food and Drug Administration (FDA) has granted accelerated approval of panobinostat (Farydak) for the treatment of patients with multiple myeloma whose cancer has progressed after treatment with at least two prior standard therapies. Panobinostat is a type of drug called a histone deacetylase (HDAC) inhibitor. The approval is for use of panobinostat in combination with bortezomib (Velcade) and dexamethasone.

158

Fundamentals of the Slide Library.  

ERIC Educational Resources Information Center

This paper is an introduction to the fundamentals of the art (including architecture) slide library, with some emphasis on basic procedures of the science slide library. Information in this paper is particularly relevant to the college, university, and museum slide library. Topics addressed include: (1) history of the slide library; (2) duties of…

Boerner, Susan Zee

159

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

160

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.

161

Slides, Swings and Science.  

ERIC Educational Resources Information Center

Described are eight science activities that may take place on a school playground using a parachute, balls, swings, slides, and a balance beam. Procedures and questions for each activity are included. (CW)

Dreyer, Kay Jardon; Bryte, Janelle

1990-01-01

162

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.

Bob Miller

2013-01-30

163

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.

2012-08-03

164

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

Federal Register 2010, 2011, 2012, 2013, 2014

...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

165

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

Federal Register 2010, 2011, 2012, 2013, 2014

...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

166

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

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA's responses to the most frequently asked questions regarding financial...before it begins work on the final version of the guidance, electronic...FDA's responses to the most frequently asked questions regarding...

2011-05-24

167

21 CFR 14.15 - Committees working under a contract with FDA.  

Code of Federal Regulations, 2011 CFR

... 2011-04-01 false Committees working under a contract with FDA. 14.15...General Provisions § 14.15 Committees working under a contract with FDA. ...committees. Whether a particular committee working under such a contract is an...

2011-04-01

168

21 CFR 14.15 - Committees working under a contract with FDA.  

Code of Federal Regulations, 2010 CFR

... 2010-04-01 false Committees working under a contract with FDA. 14.15...General Provisions § 14.15 Committees working under a contract with FDA. ...committees. Whether a particular committee working under such a contract is an...

2010-04-01

169

Computer Slide Shows: A Trap for Bad Teaching  

ERIC Educational Resources Information Center

Slide shows presented with software such as PowerPoint or WordPerfect Presentations can trap instructors into bad teaching practices. Research on memory suggests that slide-show instruction can actually be less effective than traditional lecturing when the teacher uses a blackboard or overhead projector. The author proposes a model of classroom…

Klemm, W. R.

2007-01-01

170

Assessing the FDA via the Anomaly of Off-Label Drug Prescribing  

Microsoft Academic Search

t is commonly thought that the U.S. Food and Drug Administration (FDA) regulates the use of all pharmaceutical drugs in the United States. In fact, most hospital patients are given drugs that are not FDA-approved for the prescribed use. The FDA does require that drugs undergo extensive testing before they are re- leased onto the market and, if it concludes

ALEXANDER T. TABARROK

171

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

MedlinePLUS

... See the list of CCC's on FDA's Web site at Consumer Complaint Coordinators . Some examples of complaints that your CCC wants ... FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website ... Education Inspections/Compliance State & Local Officials Consumers Industry Health ...

172

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

173

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.

174

Recruitment Tips: Slides  

NSDL National Science Digital Library

These are the slides for the webinar that was recorded 2/13/09. This presentation is a significantly refined repeat of a NetWorks webinar given in February of 2008 that was titled "Ten-Recruiting Tips - Thinking Outside the Box." While Technical Programs can use these tips, many of the tips will work for all different types of programs. Terry Bartelt, an instructor and former chair of the Electromechanical Program at Fox Valley Technical College, identifies proven recruitment and retention strategies that have enabled FVTC and other colleges to build and maintain high enrollments in technical programs. One segment of the presentation will be how to initiate small but meaningful strategic points of contact by faculty from a student's first college inquiry to his or her graduation. The other segment describes alternative program structuring to reach a larger student population.Despite the 60% decline in the enrollment of electronics technology programs over the past few years at community colleges across the United States, Fox Valley Technical College (FVTC) in Appleton, Wisconsin, has maintained strong enrollment numbers. Terry Bartelt, an instructor at FVTC, has more than 25 years experience in his field; his electromechanical technology program was recognized as one of the top ten programs in the country. Mr. Bartelt will present successful recruitment & retention practices, including effective and creative strategies for electronics, manufacturing, and other related technology programs. This is a high demand topic as he has spoken on this subject at several national conferences. Discover a multitude of proven recruitment tips to engage students and revitalize your programs.

175

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

176

The role of the FDA in the effort against AIDS.  

PubMed

The Food and Drug Administration has instituted several pro-active measures to expedite the review of treatments, diagnostics, and vaccines for AIDS and related conditions. In particular, the agency has established a special designation--1-AA--for a potential AIDS product which gives top priority to its review. This special expedited review process for AIDS products has provided for greater cooperation between their sponsors and FDA's reviewers. AIDS products also receive prompt consideration for orphan product status--a status providing financial incentives to the developers of treatments for certain rare and complex diseases. FDA's special procedures for AIDS drugs have resulted in several major advances in available AIDS treatments. Foremost among these was the FDA's review and approval of zidovudine (commonly known as AZT) as the first effective palliative for AIDS within 107 days--an agency record. Similarly, the agency quickly evaluated and approved ELISA and Western blot diagnostic kits for detecting the presence of HIV antibody. These test kits have made an important contribution to safeguarding the nation's blood supply. The agency has also instituted new "treatment" investigational new drug regulations to allow earlier pre-approval distribution of promising experimental treatments to patients with immediately life-threatening conditions, including persons with AIDS. Under this system and its earlier prototype, eligible AIDS patients were able to receive pre-approval treatment with zidovudine and trimetrexate (an experimental drug for the treatment of AIDS patients with Pneumocystis carinii pneumonia who have experienced severe adverse reactions using standard approved therapies). The agency has made institutional reforms to effectively streamline the review of candidate AIDS treatments and vaccines. Two new centers within the agency have been established for the processing of drug and biologics. In addition,reviewing divisions have been created within these centers to give specialized attention to drugs and biologics designed to treat AIDS or related conditions.These efforts and the other aforementioned reforms, in part, have lead to the initiation of more than 100 ongoing clinical studies of potential drugs for AIDS and related conditions, as well as the clinical testing of two candidate vaccines against HIV. In other areas, FDA has increased inspections of the manufacturing and processing of condoms and begun a surveillance and sampling program to insure the quality of latex surgical gloves. The agency has worked with other authorities to move against quack AIDS products and to educate the public concerning this health fraud.FDA hopes that through all these efforts it can help researchers in government, academia, and industry advance the development, testing, and review of safe and effective therapies, preventatives,and diagnostics for AIDS and related conditions. PMID:3131814

Young, F E

1988-01-01

177

Classic Slide Rule  

NSDL National Science Digital Library

In this activity, students construct classic slide rules and use them like calculators. Students use the slide rules to read scales, determine significant figures, and estimate decimal places.  This is activity D3 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.

178

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

179

Photography by Political Scientists: The Slide as a Classroom Supplement.  

ERIC Educational Resources Information Center

Describes how faculty-produced 35 mm slides can be used to enhance student interest in political science in undergraduate college level courses. Emphasis is placed on copying existing photos and on fieldwork where political events are photographed. Information is presented on copyright law, photographic equipment, and slide program technique.…

Gregory, Donald D.; Claunch, Ronald G.

1981-01-01

180

Adaptive sliding controller synthesis for non-linear systems  

Microsoft Academic Search

Classical ‘sliding mode control’, as investigated mostly in Soviet literature, features excellent robustness properties in relation to parametric uncertainty, but presents several important drawbacks that severely limit its practical applicability. These drawbacks, including large control authority and control chattering, were remedied by Slotine and Sastry (1983) and Slotine (1984) by replacing control switching at a fixed sliding surface by a

J.-J. E. SLOTINE; J. A. COETSEE

1986-01-01

181

Learning to slide a magnetic card through a card reader  

Microsoft Academic Search

This paper describes a set of experiments in which an upper-torso humanoid robot learned to slide a card through a card reader. The small size and the flexibility of the card presented a number of manipulation challenges for the robot. First, because most of the card is occluded by the card reader and the robot's hand during the sliding process,

Vladimir Sukhoy; Veselin Georgiev; Todd Wegter; Ramy Sweidan; Alexander Stoytchev

2012-01-01

182

Simple sliding mode control scheme applied to robot manipulators  

Microsoft Academic Search

We present a simple sliding mode control scheme for robot manipulators that does not rely upon the construction of individually stable discontinuity surfaces, thus greatly reducing the complexity of design. We utilize the structure of the manipulator dynamics and Lyapunov's second method in order to establish a sliding surface on the intersection of the switching surfaces in a direct manner.

ERIC BAILEY; ARISTOTLE ARAPOSTATHIS

1987-01-01

183

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

184

Sliding Mode Controller-observer Design for Siso Linear Systems  

Microsoft Academic Search

A new method is proposed for the asymptotically stable sliding mode observer design for SISO linear systems including disturbance inputs which may not satisfy the matching conditions. A sliding observer design method is presented such that, in the presence of the unmatched uncertainty, the estimated state nearly approaches the actual state. Certain sufficient conditions should be satisfied for the asymptotic

A. Jafari Koshkouei; Alan Solon Ivor Zinober

1998-01-01

185

A Computer System for Making Quick and Economical Color Slides.  

ERIC Educational Resources Information Center

A computer-based method for producing 35mm color slides has been used in Ohio State University's College of Dentistry. The method can produce both text and slides in less than two hours, providing substantial flexibility in planning and revising visual presentations. (Author/MLW)

Pryor, Harold George

1986-01-01

186

Determining the Ecosystem Services Important for Urban Landscapes-Slides  

EPA Science Inventory

This presentation consists of introductory slides on ecosystem services in urban landscapes and then a discussion of two case studies concerning the provision of water quality in urban landscapes. The introductory slides will explore the range of ecosystem services provided by u...

187

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

188

Exploring Meteorite Mysteries: Slide Set  

NSDL National Science Digital Library

This set of slides is designed to accompany the teacher's guide 'Exploring Meteorite Mysteries.' The slides include images of recent and historic meteorites, impact sites and craters, collecting sites, and a sequence of slides on where meteorites come from and how they reach the Earth. They can be viewed online and are also available in a downloadable, printable format.

189

The Glaucoma Research Community and FDA Look to the Future: A Report from the NEI\\/FDA CDER Glaucoma Clinical Trial Design and Endpoints Symposium  

Microsoft Academic Search

n March 13-14, 2008, the National Eye Institute (NEI), of the National Institutes of Health (NIH), and the Food and Drug Administration Center for Drug Evaluation and Research (FDA CDER) held the NEI\\/FDA CDER Glaucoma Clinical Trial Design and Endpoints Symposium to discuss the possible use of new structural and functional endpoints for evaluating glau- coma therapies in clinical trials.

Robert N. Weinreb; Paul L. Kaufman

190

Influence of sliding speed on the dry sliding wear behaviour and the subsurface deformation on hybrid metal matrix composite  

Microsoft Academic Search

In recent years, more attention is being paid to the structure of both the surface and the subsurface of a material being subjected to wear. Surface and subsurface deformation can cause a considerable change in the microstructure of the material leading to a change in its properties. The present study investigates the influence of sliding speed on dry sliding wear

S. Basavarajappa; G. Chandramohan; Arjun Mahadevan; Mukundan Thangavelu; R. Subramanian; P. Gopalakrishnan

2007-01-01

191

Flip-n-Slide  

NSDL National Science Digital Library

This interactive game gives students practice in using slides, flips and turns (i.e. translations, reflections and rotations) to maneuver a triangle. The object is to capture fireflies and ladybugs to earn more points than the computer (or an online opponent).

2011-01-01

192

Temperature Regulation Powerpoint Slides  

NSDL National Science Digital Library

Lecture slides provided by the Department of Physiology at the Texas Tech University Health Sciences Center are a self-contained resource to teach the concept of thermoregulation. Examples of extreme temperature responses in the cinema are included to build student interest.

Thomas A. Pressley

193

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,

194

Slowing the Summer Slide  

ERIC Educational Resources Information Center

Research shows that summer slide--the loss of learning over the summer break--is a huge contributor to the achievement gap between low-income students and their higher-income peers. In fact, some researchers have concluded that two-thirds of the 9th-grade reading achievement gap can be explained by unequal access to summer learning opportunities…

Smith, Lorna

2012-01-01

195

FDA's Laser Notice 50: a step toward global harmonization  

NASA Astrophysics Data System (ADS)

The US Food and Drug Administration, Center of Devices and Radiological Health issued Laser Notice 50 in July 2001. This Notice is a preliminary step that FDA has taken to harmonize US regulations for laser products (21 Code of Federal Regulations) with the IEC (International Electrotechnical Commission) standards for Safety of Laser Products. The paper discusses rationale for the changes and describes some of the implementation issues, including comparisons between the current standards. The impact on the regulated industry and the user community is that the same laser hazard classification scheme is used and that engineered safety features are consistentin the world markets.

Kent, Suzie L. B.; Dennis, Jerome E.; Zaharek, Gary L.; Eng, Francis J.

2003-06-01

196

An analysis of FDA-approved drugs for oncology.  

PubMed

Cancer remains the second leading cause of death globally. The number of new medicines targeting cancer has grown impressively since the 1990s. On average, ten new drugs are introduced each year. Such growth has partly been achieved by emphasizing biologics and orphan indications, which account for one-quarter and one-half of new oncology drugs, respectively. The biotechnology industry likewise has become the primary driver of cancer drug development in terms of patents, preclinical and clinical research, although pharmaceutical companies are granted more FDA approvals. Many targeting strategies have been successful but recent trends suggest that kinase targets, although tractable, might be overemphasized. PMID:25172803

Kinch, Michael S

2014-12-01

197

Chattering reduction in the position control of induction motor using the sliding mode  

Microsoft Academic Search

An induction motor position control system based on the sliding mode control is presented. In the sliding mode control, the control function is discontinuous on the hyperplane, which causes harmful effects such as current harmonics and acoustic noise in the motor drive application. A low-pass filter is introduced between the sliding mode controller output and the motor controller input to

Min-Ho Park; Kyung-Seo Kim

1991-01-01

198

A second-order sliding mode controller for active suspension systems  

Microsoft Academic Search

This paper presents a second-order sliding mode controller for active suspension systems. The proposed controller, which occurs a limit cycle as the second-order sliding mode, is designed by the integral sliding mode control theory with the twisting algorithm. With the block diagram algebra, the proposed control system can be converted into a nonlinear feedback system consisting of a linear transfer

Shigehiro Toyama; Fujio Ikeda; Yoshio Sorimachi

2008-01-01

199

A new method for suppressing high-frequency chattering in sliding mode control system  

Microsoft Academic Search

A method for suppressing high-frequency chattering in a sliding mode control system is presented. A conception of sliding region is introduced and the switching surface is replaced by two acceptable switching surfaces. Then the control is designed according to the reaching law when the system state is outside the sliding region, and a set of equivalent controls are adopted when

Dongyong Yang; Yuzo YAMANE; Xiaojun ZHANG; Rongyan ZHU

1997-01-01

200

Single-phase active power filter with improved sliding mode control  

Microsoft Academic Search

This paper presents a study about a single-phase shunt active power filter with sliding mode control. The operation mode of the shunt active filter is detailed, introducing a new operating mode for the inverter in order to improve the behavior of the line current during the zero-passings. Regarding sliding mode control, the sliding surface, the existence condition and the equivalent

D. Stanciu; M. Teodorescu; A. Florescu; D. A. Stoichescu

2010-01-01

201

Large eddy simulation of the FDA benchmark nozzle for a Reynolds number of 6500.  

PubMed

This work investigates the flow in a benchmark nozzle model of an idealized medical device proposed by the FDA using computational fluid dynamics (CFD). It was in particular shown that a proper modeling of the transitional flow features is particularly challenging, leading to large discrepancies and inaccurate predictions from the different research groups using Reynolds-averaged Navier-Stokes (RANS) modeling. In spite of the relatively simple, axisymmetric computational geometry, the resulting turbulent flow is fairly complex and non-axisymmetric, in particular due to the sudden expansion. The resulting flow cannot be well predicted with simple modeling approaches. Due to the varying diameters and flow velocities encountered in the nozzle, different typical flow regions and regimes can be distinguished, from laminar to transitional and to weakly turbulent. The purpose of the present work is to re-examine the FDA-CFD benchmark nozzle model at a Reynolds number of 6500 using large eddy simulation (LES). The LES results are compared with published experimental data obtained by Particle Image Velocimetry (PIV) and an excellent agreement can be observed considering the temporally averaged flow velocities. Different flow regimes are characterized by computing the temporal energy spectra at different locations along the main axis. PMID:24561349

Janiga, Gábor

2014-04-01

202

Smokers’ and Nonsmokers’ Beliefs About Harmful Tobacco Constituents: Implications for FDA Communication Efforts  

PubMed Central

Introduction: Legislation requires the U.S. Food and Drug Administration (FDA) to release information to the public about harmful constituents in tobacco and tobacco smoke. To inform these efforts, we sought to better understand how smokers and nonsmokers think about tobacco constituents. Methods: In October 2012, 300U.S. adults aged 18–66 years completed a cross-sectional Internet survey. The questions focused on 20 harmful tobacco constituents that the FDA has prioritized for communicating with the public. Results: Most participants had heard of 7 tobacco constituents (ammonia, arsenic, benzene, cadmium, carbon monoxide, formaldehyde, and nicotine), but few participants had heard of the others (e.g., acrolein). Few participants correctly understood that many constituents were naturally present in tobacco. Substances that companies add to cigarette tobacco discouraged people from wanting to smoke more than substances that naturally occur in cigarette smoke (p < .001). Ammonia, arsenic, carbon monoxide, and formaldehyde being in cigarettes elicited the most discouragement from smoking. Constituents elicited greater discouragement from wanting to smoke if respondents were nonsmokers (? = ?.34, p < .05), had negative images of smokers (i.e., negative smoker prototypes; ? = .19, p < .05), believed constituents are added to tobacco (? = .14, p < .05), or were older (? = .16, p < .05). Conclusions: Our study found low awareness of most tobacco constituents, with greater concern elicited by additives. Efforts to communicate health risks of tobacco constituents should consider focusing on ones that elicited the most discouragement from smoking. PMID:24151139

2014-01-01

203

BIOCHEMISTRY: RT Slides Homeâ?¦  

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)

2008-11-14

204

Presentations Giving Effective Presentations  

E-print Network

://www.lib.sfu.ca/researchhelp/tutorials/startyourresearchhere.htm. Second ­ focus on technique, style, and delivery. Identify your specific purpose or thesis. o Analyze or too much animation. Use 3-5 bulleted points per slide. Clutter slides with a lot of text. Provide

205

Presentations: Giving Effective Presentations  

E-print Network

://www.lib.sfu.ca/researchhelp/tutorials/startyourresearchhere.htm. Second ­ focus on technique, style and delivery. Identify your specific purpose or thesis. o Analyze animation. Use 35 bulleted points per slide. Clutter slides with a lot of text. Provide basic points

206

Tort reform by regulation: FDA prescription drug labeling rules and preemption of state tort claims.  

PubMed

In 2006, the Food and Drug Administration (FDA) asserted in the preamble to a revised physician labeling rule for prescription drugs that FDA labeling requirements preempt state common law failure to warn claims. The FDA's action reflects a wider effort of administrative agencies to preempt conflicting state law requirements. The debate over preemption raises a set of difficult issues, including the sufficiency of agency safety review, the scope of administrative deference, and federalism. This article surveys the background to the 2006 FDA labeling rule and the Supreme Court's recent preemption jurisprudence in leading cases such as Cippollone v. Liggett Group, Inc., and Geier v. American Honda Motor Corp. PMID:18610730

Moreland, Michael P

2007-01-01

207

The FDA's new advice on fish: it's complicated.  

PubMed

The Food and Drug Administration and Environmental Protection Agency recently issued an updated draft of advice on fish consumption for pregnant and breastfeeding women, after survey data indicated that the majority of pregnant women do not eat much fish and thus may have inadequate intake of the omega 3 fatty acids eicosapentaenoic acid [EPA] and ducosahexaenoic acid [DHA]. Omega 3 fatty acids are essential components of membranes in all cells of the body and are vitally important for normal development of the brain and retinal tissues (especially myelin and retinal photoreceptors) and for maintenance of normal neurotransmission and connectivity. They also serve as substrates for the synthesis of a variety of antiinflammatory and inflammation-resolving mediators, favorably alter the production of thromboxane and prostaglandin E2, and improve cardiovascular health by preventing fatal arrhythmias and reducing triglyceride and C-reactive protein levels. Maternal ingestion of adequate quantities of fish (defined in many studies as at least 340 g of oily fish each week) has been associated with better childhood IQ scores, fine motor coordination, and communication and social skills, along with other benefits. Although the FDA did not clarify which fish to eat, it specifically advised against eating fish with the highest mercury levels and implied that fish with high levels of EPA and DHA and low levels of mercury are ideal. The FDA draft did not recommend taking omega 3 fatty acid or fish oil supplements instead of eating fish, which is advice that may reflect the fact that randomized controlled trials of DHA and EPA or fish oil supplementation generally have been disappointing and that the ideal daily dose of DHA and EPA is unknown. It seems safe to conclude that pregnant and nursing women should be advised to eat fish to benefit from naturally occurring omega 3 fatty acids, to avoid fish with high levels of mercury and other contaminants, and, if possible, to choose fish with high levels of EPA and DHA. PMID:25072735

Wenstrom, Katharine D

2014-11-01

208

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

209

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

210

Sliding and Stuttering  

NSDL National Science Digital Library

Learners 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, learners can find out what kinds of surfaces generate more or less friction. After completing this activity, learners can further their investigation of friction by completing one of the related activities: "Does Contact Area Matter?" or "Does Weight Matter?"

Mary R. Hebrank

2013-01-01

211

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.

212

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

213

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

E-print Network

Andrew A. Strasser, Ph.D. #12;Outline Focus: FDA Regulation and the Family Smoking Prevention and Tobacco ­ increasing burn rate ­ increasing paper porosity ­ puffing up tobacco 2) Reduce the concentration of smokeNew Low-Nicotine Cigarettes Are Still as Harmful: Implications for FDA Regulation of Tobacco

Illinois at Chicago, University of

214

FDA Procedures for Standardization and Certification of Retail Food Inspection/Training Officers, 2000.  

ERIC Educational Resources Information Center

This document provides information, standards, and behavioral objectives for standardization and certification of retail food inspection personnel in the Food and Drug Administration (FDA). The procedures described in the document are based on the FDA Food Code, updated to reflect current Food Code provisions and to include a more refined focus on…

Food and Drug Administration (DHHS/PHS), Rockville, MD.

215

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

E-print Network

HRC Exec. Recomm./FDA/Blood Ban End Discrimination against Gay and Bisexual Blood Donors Issue with men ("MSM") from donating blood is discriminatory and medically unnecessary. Short Answer The FDA's Center for Biologics Evaluation and Research ("CBER") should abolish its blood donation deferral policy

Khan, Javed I.

216

78 FR 19492 - Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Consultants. 13. A List of FDA Staff, if Known...Suggested Dates and Times (e.g., morning...Beyond the Appropriate Time Frame of the Meeting Type...FDA requests that a sponsor or applicant...Following: a. A brief history of the...

2013-04-01

217

Robust sliding mode control applied to double Inverted pendulum system  

SciTech Connect

A three hierarchical sliding mode control is presented for a class of an underactuated system which can overcome the mismatched perturbations. The considered underactuated system is a double inverted pendulum (DIP), can be modeled by three subsystems. Such structure allows the construction of several designs of hierarchies for the controller. For all hierarchical designs, the asymptotic stability of every layer sliding mode surface and the sliding mode surface of subsystems are proved theoretically by Barbalat's lemma. Simulation results show the validity of these methods.

Mahjoub, Sonia; Derbel, Nabil [Research unit on Intelligent Control, design and Optimization of complex Systems (ICOS) National engineering school of sfax, BP W, 3038 Sfax (Tunisia); Mnif, Faical [Department of Electrical and Computer Engineering Sultan Qaboos University, Muscat (Oman)

2009-03-05

218

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

219

1 Copyright 2013 by ASME Proceedings of the ASME/FDA 2013 1st Annual Frontiers in Medical Devices: Applications of Computer Modeling  

E-print Network

1 Copyright © 2013 by ASME Proceedings of the ASME/FDA 2013 1st Annual Frontiers in Medical Devices as provide instruction. Since previous work has shown that medical students perform no better than random angles, subjects were presented with an atrial view, the perspective seen intraoperatively

220

Solar-Cell Slide Rule  

NASA Technical Reports Server (NTRS)

Slide rule relates efficiency, impurity types, impurity concentrations, and process types. Solar cell slide rule calculations are determination of allowable impurity concentration for nonredistributive process, determination of impurity buildup factor for redistributive process and determination of allowable impurity concentration for redistributive process.

Yamakawa, K. A.

1983-01-01

221

Single molecule study of a processivity clamp sliding on DNA  

SciTech Connect

Using solution based single molecule spectroscopy, we study the motion of the polIII {beta}-subunit DNA sliding clamp ('{beta}-clamp') on DNA. Present in all cellular (and some viral) forms of life, DNA sliding clamps attach to polymerases and allow rapid, processive replication of DNA. In the absence of other proteins, the DNA sliding clamps are thought to 'freely slide' along the DNA; however, the abundance of positively charged residues along the inner surface may create favorable electrostatic contact with the highly negatively charged DNA. We have performed single-molecule measurements on a fluorescently labeled {beta}-clamp loaded onto freely diffusing plasmids annealed with fluorescently labeled primers of up to 90 bases. We find that the diffusion constant for 1D diffusion of the {beta}-clamp on DNA satisfies D {le} 10{sup -14} cm{sup 2}/s, much slower than the frictionless limit of D = 10{sup -10} cm{sup 2}/s. We find that the {beta} clamp remains at the 3-foot end in the presence of E. coli single-stranded binding protein (SSB), which would allow for a sliding clamp to wait for binding of the DNA polymerase. Replacement of SSB with Human RP-A eliminates this interaction; free movement of sliding clamp and poor binding of clamp loader to the junction allows sliding clamp to accumulate on DNA. This result implies that the clamp not only acts as a tether, but also a placeholder.

Laurence, T A; Kwon, Y; Johnson, A; Hollars, C; O?Donnell, M; Camarero, J A; Barsky, D

2007-07-05

222

The US FDA and animal cloning: risk and regulatory approach.  

PubMed

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, humans, or other animals by consuming food from those animals, compared with any other assisted reproductive technology (ART) currently in use. Following a comprehensive review, no anomalies were observed in animals produced by cloning that have not also been observed in animals produced by other ARTs and natural mating. Further systematic review on the health of, and composition of meat and milk from, cattle, swine, and goat clones and the progeny of cattle and sheep did not result in the identification of any food-consumption hazards. The agency therefore concluded that food from cattle, swine, and goat clones was as safe to eat as food from animals of those species derived by conventional means. The agency also concluded that food from the progeny of the clone of any species normally consumed for food is as safe to eat as those animals. The article also describes the methodology used by the agency to analyze data and draw these conclusions, the plans the agency has proposed to manage any identified risks, and the risk communication approaches the agency has used. PMID:17055042

Rudenko, Larisa; Matheson, John C

2007-01-01

223

FDA regulation of clinical high intensity focused ultrasound (HIFU) devices.  

PubMed

In the U. S., medical devices are regulated under the authority of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act, with the Food and Drug Administration's Center for Devices and Radiological Health having primary responsibility. The Act defines several regulatory paths to market depending on the complexity of the device and indications for use. For most high intensity focused ultrasound (HIFU) devices the premarket submissions include both pre-clinical and clinical data. Pre-clinical testing generally comprises ultrasound power measurements and field characterization, in vitro and in vivo temperature measurements, thermal computational modeling, and demonstrating the accuracy for targeting the region of interest and monitoring treatment progress. Protocols for clinical trials are developed by the device sponsor in conjunction with FDA medical and scientific staff. Currently there are no recognized guidance or standards documents for HIFU testing that could be used in the regulatory review process, but such work is underway within the International Electrotechnical Commission. PMID:19963452

Harris, Gerald R

2009-01-01

224

T-Slide Linear Actuators  

NASA Technical Reports Server (NTRS)

T-slide linear actuators use gear bearing differential epicyclical transmissions (GBDETs) to directly drive a linear rack, which, in turn, performs the actuation. Conventional systems use a rotary power source in conjunction with a nut and screw to provide linear motion. Non-back-drive properties of GBDETs make the new actuator more direct and simpler. Versions of this approach will serve as a long-stroke, ultra-precision, position actuator for NASA science instruments, and as a rugged, linear actuator for NASA deployment duties. The T slide can operate effectively in the presence of side forces and torques. Versions of the actuator can perform ultra-precision positioning. A basic T-slide actuator is a long-stroke, rack-and-pinion linear actuator that, typically, consists of a T-slide, several idlers, a transmission to drive the slide (powered by an electric motor) and a housing that holds the entire assembly. The actuator is driven by gear action on its top surface, and is guided and constrained by gear-bearing idlers on its other two parallel surfaces. The geometry, implemented with gear-bearing technology, is particularly effective. An electronic motor operating through a GBDET can directly drive the T slide against large loads, as a rack and pinion linear actuator, with no break and no danger of back driving. The actuator drives the slide into position and stops. The slide holes position with power off and no brake, regardless of load. With the T slide configuration, this GBDET has an entire T-gear surface on which to operate. The GB idlers coupling the other two T slide parallel surfaces to their housing counterpart surfaces provide constraints in five degrees-of-freedom and rolling friction in the direction of actuation. Multiple GB idlers provide roller bearing strength sufficient to support efficient, rolling friction movement, even in the presence of large, resisting forces. T-slide actuators can be controlled using the combination of an off-the-shelf, electric servomotor, a motor angle resolution sensor (typically an encoder or resolver), and microprocessor-based intelligent software. In applications requiring precision positioning, it may be necessary to add strain gauges to the T-slide housing. Existing sensory- interactive motion control art will work for T slides. For open-loop positioning, a stepping motor emulation technique can be used.

Vranish, John

2009-01-01

225

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

Federal Register 2010, 2011, 2012, 2013, 2014

...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos...2011-N-0145, and FDA-2011-N-0146] FDA Food Safety Modernization Act: Title III...for Importers; Public Meeting AGENCY: Food and Drug Administration, HHS....

2011-03-14

226

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.

2012-08-03

227

Design and implementation of fuzzy sliding mode controllers for generalized projective synchronization of chaos horizontal platform systems  

Microsoft Academic Search

This paper presents robust chattering-free fuzzy sliding mode control (FSMC) as a way to achieve generalized projective synchronization (GPS) of two horizontal chaos platform vibration systems with system uncertainty and external disturbance. An appropriate sliding surface is acquired through an SMC design such that the error state trajectories of a master–slave system will reach such a sliding surface and approaches

Neng-Sheng Pai; Shih-Ping Chang

228

Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing  

PubMed Central

In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified medical device, which requires premarket approval or de novo classification. Opponents of the FDA's action expressed their concerns, saying that the FDA is overcautious and paternalistic, which violates consumers' rights and might stifle the consumer genomics field itself, and insisted that the agency should not restrict direct-to-consumer (DTC) genomic testing without empirical evidence of harm. Proponents support the agency's action as protection of consumers from potentially invalid and almost useless information. This action was also significant, since it reflected the FDA's attitude towards medical application of next-generation sequencing techniques. In this review, we followed up on the FDA-23andMe incident and evaluated the problems and prospects for DTC genetic testing. PMID:25705152

2014-01-01

229

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

230

Constraining the characteristics of tsunami waves from deformable submarine slides  

NASA Astrophysics Data System (ADS)

As a marine hazard, submarine slope failures have the potential to directly destroy offshore infrastructure, and, if a tsunami is generated, it also endangers the life of those who live and work at the coastline. The hazard and risk from tsunamis generated by submarine mass failure is difficult to quantify and evaluate due to the problems to constrain the characteristics of the triggered submarine landslide, which introduces unquantifiable uncertainty to hazard assessments based on numerical modelling. To lower the uncertainty, we present a method that determines material parameters for the slide body to constrain the generated tsunami waves. Our method employs the distribution of landslide run-out masses and their comparison with simulations. It assumes that the slide material can be approximated by bulk values during the slide motion. To demonstrate our method, we make use of Valdes slide run-out masses off the Chilean coast.

Weiss, Robert; Krastel, Sebastian; Anasetti, Andreas; Wünnemann, Kai

2013-07-01

231

Stanford London 2005 Slide 1 Technology Entrepreneurship  

E-print Network

Stanford London 2005 Slide 1 Technology Entrepreneurship: A Personal Top 10 List Stanford Club;Stanford London 2005 Slide 2 "Don't Hate Me `Cause I'm a Weenie!" Then... Now... #12;Stanford London 2005 Slide 3 A Stanford University Legacy #12;Stanford London 2005 Slide 4 Stanford and Silicon Valley

Prinz, Friedrich B.

232

Sliding mode time-delay systems  

Microsoft Academic Search

The sliding mode control of time-delay systems is considered. Time-delay sliding system stability is studied for the cases of some information about the delay and also lack of information. The sliding surface is delay-independent as for the traditional sliding surface and the reaching condition is achieved by applying a conventional discontinuous control

A. Jafari Koshkouei; A. S. I. Zinober

1996-01-01

233

Implications of the FDA statement on transvaginal placement of mesh: the aftermath.  

PubMed

The release of the U.S. Food and Drug Administration (FDA) safety communication on the use of transvaginal mesh (TVM) for pelvic organ prolapse (POP) has resulted in changes in the pelvic reconstruction community. This monograph reviews the implications of the FDA statements over the last 18-24 months. Recent findings show that there have been significant developments in the areas of regulatory mandates, media and medico-legal activity, and statements from surgical societies. In summary, well-publicized communications from the FDA and major medical organizations are defining a change in the use of TVM for POP. PMID:24384996

Koski, Michelle E; Rovner, Eric S

2014-02-01

234

Constraining the characteristics of tsunami waves from deformable submarine slides  

NASA Astrophysics Data System (ADS)

As a marine hazard, submarine slope failures have the potential to directly destroy offshore infrastructure, and, if a tsunami is generated, it also endangers the life of those who live and work at the coastline. The hazard and risk from tsunamis generated by submarine mass failure is difficult to quantify and evaluate due to difficulties to estimate the time of trigger for submarine slide bodies, and the problems to constrain the characteristics of the triggered submarine landslide. The missing age constraint and the unconstrained tsunami-wave characteristics generate unquantifiable uncertainties in hazard assessments. To lower the uncertainty from the unconstrained tsunami-characteristic, we present a method that determines material parameters for the slide body to constrain the generated tsunami waves with an iterative method. Our method employs the mapped distribution of landslide run-out masses and their comparison with simulations. It assumes that the slide material can be approximated by bulk values during the slide motion. The free parameter that will be changed during in iterations is the viscosity of the slide body. The goal of the procedure is to find the optimal viscosity, which represents the viscosity for which the slide body matches well with the mapped slide run-out masses. The tsunami waves generated in the simulations employing the optimal viscosity are then considered constrained within the framework of our work. While we understand that viscosity does not accurately describe the dynamics of the slide body, we argue that viscosity can be employed as a first-order approximation to constrain the tsunami wave characteristics. To demonstrate our method, we make use of Valdes slide run-out masses off the Chilean coast. We show the difference in tsunami characteristics for slides whose viscosity is too low, too high and optimal. Furthermore, we will present an overview on how these differences result in dramatically different wave amplitudes as functions of the distance to the landslide-trigger area in general and for the Chilean coast due to the Valdes slide.

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

2012-12-01

235

Coating for hot sliding seals  

NASA Technical Reports Server (NTRS)

Heat resistant paint is effective surface coating for sliding seals that must operate at elevated temperatures. Economical paint is easy to apply, offers minimal friction, and improves reliability of seals.

Stock, J.

1979-01-01

236

Morphologic and sedimentologic characteristics of continental slope box slides offshore Fraser Island, Queensland, Australia  

NASA Astrophysics Data System (ADS)

The Fraser Island Slide complex is located on eastern Australia's continental slope offshore Fraser Island in southern Queensland. Morphologic, sedimentologic and geomechanical properties data for two submarine landslides, the 'North Fraser Island Upper Slope Slide' (upper slope slide) and the 'Fraser Island Middle Slope Slide' (middle slope slide) are described. Both of these features are box-shaped, slide scars from which rectangular slabs of material have been shed. The upper slope slide is situated at a water depth of approximately 750 m at the northern end of the Fraser Canyon. The head of this slide has apparently detached from a structural surface comprised of a Miocene reef complex located beneath the continental shelf edge; this slide is estimated to be 25 square kilometres in area and an average of 100m thick. The middle slope slide is situated in 1500 m of water at the southern end of the Fraser Canyon. It estimated to be 12 square kilometres in area and 50 m thick. Cores taken in the continental slope within both slides are long (upper slope 5.65 m, middle slope 3.64 m) and are dominantly comprised of hemipelagic mud. Cores taken adjacent to both slides are short (upper slope 1.33m, middle slope 0.43m) and terminate in stiff muds of suspected Miocene or Pliocene age. Additionally, the 1.33 m core on the slope adjacent to the upper slide presents a near surface layer of upper-fining of coarse to fine shelly sand which we interpret to be a turbidite deposit, this layer was deposited within hemipelagic muds which are ubiquitously present on the upper eastern Australian Continental Slope in New South Wales and Southern Queensland.

Fletcher, Melissa; Hubble, Thomas; Clarke, Samantha; Airey, David; Yu, Phyllis; Southern Surveyor V01-2013, Scientific Party RV

2014-05-01

237

The debate on FDA reform: a view from the U.S. Senate. Food and Drug Administration.  

PubMed

The recently released concept paper on Food and Drug Administration (FDA) reform from Republican Senator, Nancy Kassebaum, is reviewed. Senator Kassebaum chairs the Senate Committee on Labor and Human Resources that will influence the Senate's action on FDA reform. The paper outlines the Senator's priorities for Congressional legislation on FDA reform in the following areas: the FDA mission and its accountability; creation of a Performance Review Panel and Industry Advisory Council; approval and access of products for seriously ill patients; the FDA's responsibility for good manufacturing practices; establishment of an Ombudsman Office for resolving disputes; dissemination of information on unapproved uses of approved products; and approval standards for new drugs. PMID:11362892

Baker, R

1995-09-01

238

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

MedlinePLUS

... Radiological Health 10903 New Hampshire Avenue WO66-5521 Silver Spring, MD 20993 More in Products and Medical ... Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1- ...

239

MedWatch, the FDA Safety Information and Adverse Event Reporting Program  

MedlinePLUS

... important safety information and reporting serious problems with human medical products. Report a Problem Safety Information Stay Informed What's New Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication - FDA Review of Study Sheds Light on Two ...

240

76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry  

Federal Register 2010, 2011, 2012, 2013, 2014

...public meetings,\\1\\ launched an online blog (http://fdatransparencyblog.fda.gov/), and opened a docket. The online blog and the docket received over 1,500 comments. The blog, which is ongoing, has offered an...

2011-01-07

241

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

Federal Register 2010, 2011, 2012, 2013, 2014

...11 months, the Task Force has held two public meetings, launched an online blog (http://fdatransparencyblog.fda.gov/ ), and opened a docket. The online blog and the docket have received over 1,500 comments. The Task Force is...

2010-05-21

242

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

E-print Network

://www.fda.gov/AnimalVeterinary/, then Click on Animal Health Literacy Click on Animal Health Literacy Campaign Aquaculture-specific references: A Quick Reference Guide to Approved Drugs for Use in Aquaculture Aquaculture and Aquaculture

243

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).

244

FDA Response to the Fukushima Dai-ichi Nuclear Power Facility Incident  

MedlinePLUS

... not expected to experience any harmful levels of radioactivity. Based on this, it is not expected that ... not expected to experience any harmful levels of radioactivity. The FDA is alerting consumers to be wary ...

245

User attitudes in analyzing digital slides in a quality control test bed: a preliminary study.  

PubMed

The pathologist examines suitably stained glass slides through a bright field microscope in order to render histopathological or cytological diagnosis by looking at tissues and cells. Glass slides serve as a permanent record of the patient disease. Over the course of a patient's treatment slides may need to be reviewed at other institutions before treatment can commence. Due to their fragile nature a transportable permanent digital facsimile of the glass slide would be ideal. A digital slide is a set of digital images representing the whole slide normally used by the pathologist, or a significant part of it; it is usually made by a large amount of images, up to thousands, which makes its management difficult. The present paper provides a description of the requirements needed to reproduce glass slides and of the available technological equipment, then the features of the two systems we implemented on different hardware are described, together with those of the digital slide viewer. The viewer was evaluated in two experimental test phases, during which user behaviour and diagnostic reports were measured. Digital slides used in the two experiments were acquired with either system. Possible applications of digital slides are then discussed, including undergraduate and professional education, quality control, and image analysis on full samples as well as on tissue microarrays. PMID:16632072

Della Mea, Vincenzo; Demichelis, Francesca; Viel, Federico; Dalla Palma, Paolo; Beltrami, Carlo Alberto

2006-05-01

246

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

247

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.

248

[Discussion about traditional Chinese medicine pharmacokinetics study based on first botanical drug approved by FDA].  

PubMed

Pharmacokinetics study is one of main components of pharmaceuticals development. Food and Drug Administration (FDA) approved Veregen as the first botanical drug in 2006. This article introduced FDA's requirement on pharmacokinetics study of botanical drug and pharmacokinetics studies of Veregen, summarized current requirement and status quo of pharmacokinetics study on traditional Chinese medicine (TCM) and natural medicine in China, and discussed about pharmacokinetics study strategy for TCM and natural medicine. PMID:20575403

Huang, Fanghua

2010-04-01

249

Sliding temperature and wear behaviour of cast Al–Si–Mg alloys  

Microsoft Academic Search

In present paper the influence of sliding interface temperature on friction and wear behaviour of cast Al–(4–20%) Si–0.3% Mg has been reported. Wear and friction tests were performed under dry sliding conditions using pin on disc type of friction and wear monitor with the data acquisition system conforming to ASTM G99 standard. It was found that sliding interface temperature has

Dheerendra Kumar Dwivedi

2004-01-01

250

Sliding mode state observer for 2DOF twin rotor MIMO system  

Microsoft Academic Search

This paper presents a sliding mode state observer for the 2-DOF twin rotor MIMO (multi-input-multi-output) system which belongs to a class of inherently nonlinear systems. Design parameters are selected such that on the defined switching surface, asymptotically stable sliding mode is always generated. Robust sliding and global asymptotic stability conditions are derived by using Lyapunov method. The unknown nonlinearities are

Bhanu Pratap; Shubhi Purwar

2010-01-01

251

Robustness and Actuator Bandwidth of MRP-Based Sliding Mode Control for Spacecraft Attitude Control Problems  

NASA Astrophysics Data System (ADS)

Nonlinear sliding surface design in variable structure systems for spacecraft attitude control problems is studied. A robustness analysis is performed for regular form of system, and calculation of actuator bandwidth is presented by reviewing sliding surface dynamics. To achieve non-singular attitude description and minimal parameterization, spacecraft attitude control problems are considered based on modified Rodrigues parameters (MRP). It is shown that the derived controller ensures the sliding motion in pre-determined region irrespective of unmodeled effects and disturbances.

Keum, Jung-Hoon; Ra, Sung-Woong

2009-12-01

252

Managing and Querying Whole Slide Images  

PubMed Central

High-resolution pathology images provide rich information about the morphological and functional characteristics of biological systems, and are transforming the field of pathology into a new era. To facilitate the use of digital pathology imaging for biomedical research and clinical diagnosis, it is essential to manage and query both whole slide images (WSI) and analytical results generated from images, such as annotations made by humans and computed features and classifications made by computer algorithms. There are unique requirements on modeling, managing and querying whole slide images, including compatibility with standards, scalability, support of image queries at multiple granularities, and support of integrated queries between images and derived results from the images. In this paper, we present our work on developing the Pathology Image Database System (PIDB), which is a standard oriented image database to support retrieval of images, tiles, regions and analytical results, image visualization and experiment management through a unified interface and architecture. The system is deployed for managing and querying whole slide images for In Silico brain tumor studies at Emory University. PIDB is generic and open source, and can be easily used to support other biomedical research projects. It has the potential to be integrated into a Picture Archiving and Communications System (PACS) with powerful query capabilities to support pathology imaging. PMID:22844574

Wang, Fusheng; Oh, Tae W.; Vergara-Niedermayr, Cristobal; Kurc, Tahsin; Saltz, Joel

2012-01-01

253

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

254

Synchronization of lecture videos and electronic slides by video text analysis  

Microsoft Academic Search

An essential goal of structuring lecture videos captured in live presentation is to provide a synchronized view of video clips and electronic slides. This paper presents an automatic approach to match video clips and slides based on the analysis of text embedded in lecture videos. We describe a method to reconstruct high-resolution video texts from multiple keyframes for robust OCR

Feng Wang; Chong-Wah Ngo; Ting-Chuen Pong

2003-01-01

255

The Introduction of Crystallographic Concepts Using Lap-Dissolve Slide Techniques.  

ERIC Educational Resources Information Center

Describes a method using lap-dissolve slide techniques with two or more slide projectors focused on a single screen for presenting visual effects that show structural features in extended arrays of atoms, or ions involving up to several hundred atoms. Presents an outline of an introduction to the structures of crystalline solids. (CS)

Bodner, George M.; And Others

1980-01-01

256

Dynamic output feedback sliding mode control for uncertain mechanical systems without velocity measurements.  

PubMed

For MIMO mechanical systems using position measurements only, this paper presents a dynamic output feedback sliding mode control algorithm in which an additional dynamics is introduced into the design of the sliding surface. Although the system has the mismatched uncertainty and external disturbance, once the system is in the sliding mode, the proposed method can guarantee robust stabilization and sustain the nature of performing disturbance attenuation through utilizing H(infinity) control analytical technique. A controller is then designed to drive the system to the sliding surface in a finite time and stay on it thereafter. Finally, a numerical example is explained for demonstrating the applicability of the proposed scheme. PMID:20006329

Chang, Jeang-Lin

2010-04-01

257

Mapping stain distribution in pathology slides using whole slide imaging  

PubMed Central

Background: Whole slide imaging (WSI) offers a novel approach to digitize and review pathology slides, but the voluminous data generated by this technology demand new computational methods for image analysis. Materials and Methods: In this study, we report a method that recognizes stains in WSI data and uses kernel density estimator to calculate the stain density across the digitized pathology slides. The validation study was conducted using a rat model of acute cardiac allograft rejection and another rat model of heart ischemia/reperfusion injury. Immunohistochemistry (IHC) was conducted to label ED1+ macrophages in the tissue sections and the stained slides were digitized by a whole slide scanner. The whole slide images were tessellated to enable parallel processing. Pixel-wise stain classification was conducted to classify the IHC stains from those of the background and the density distribution of the identified IHC stains was then calculated by the kernel density estimator. Results: The regression analysis showed a correlation coefficient of 0.8961 between the number of IHC stains counted by our stain recognition algorithm and that by the manual counting, suggesting that our stain recognition algorithm was in good agreement with the manual counting. The density distribution of the IHC stains showed a consistent pattern with those of the cellular magnetic resonance (MR) images that detected macrophages labeled by ultrasmall superparamagnetic iron-oxide or micron-sized iron-oxide particles. Conclusions: Our method provides a new imaging modality to facilitate clinical diagnosis. It also provides a way to validate/correlate cellular MRI data used for tracking immune-cell infiltration in cardiac transplant rejection and cardiac ischemic injury. PMID:24672736

Yeh, Fang-Cheng; Ye, Qing; Hitchens, T. Kevin; Wu, Yijen L.; Parwani, Anil V.; Ho, Chien

2014-01-01

258

Brookhaven National Laboratory presentation 2007 Peer Review  

E-print Network

Brookhaven National Laboratory presentation 2007 Peer Review August 7- 9, 2007, Arlington, VA Slide Laboratory, Upton, NY 11973 DOE Peer Review, Arlington VA, August 7-9 2007 #12;Brookhaven National Laboratory presentation 2007 Peer Review August 7- 9, 2007, Arlington, VA Slide 2 2 Outline Program objective

Homes, Christopher C.

259

Paleo Slide Set: Packrat Middens  

NSDL National Science Digital Library

This slide show discusses plant-rich deposits called middens, that are found in caves and rock shelters in the arid southwestern United States. Middens are an amalgamation of plant and animal remains encased in crystallized packrat urine, and can be used to reconstruct past vegetation and climate in the immediate area of the midden deposit. This slide set outlines past climate variability by reconstructing vegetation change in the southwestern US as preserved in packrat middens. The set contains a comprehensive text and accompanying color photographs of middens, packrats, desert vegetation, and laboratory techniques which can be enlarged for better viewing.

260

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

261

Analysis of whole slide images of equine tendinopathy M. Toutain1  

E-print Network

Analysis of whole slide images of equine tendinopathy M. Toutain1 , O. L´ezoray1 , F. Audigi´e2 , V Abstract. We present a method for the automatic analysis of whole slide his- tological images of equine of muscle to bone. During locomotion, they act as viscoelastic structures submitted to great tensile

Lezoray, Olivier

262

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...

263

Sliding mode tracking for pneumatic muscle actuators in bicep\\/tricep pair configuration  

Microsoft Academic Search

This paper presents a robust motion control of pneumatic muscle actuators arranged in bicep\\/tricep pair configuration to deal with system and environmental uncertainties using the sliding mode approach. A mathematical model is derived for an arm with PMs in bicep\\/tricep pair configuration. A sliding mode controller is designed to yield asymptotic tracking of elbow angle. The results of simulations are

Liang Yang; John H. Lilly

2003-01-01

264

An Antique Microscope Slide Brings the Thrill of Discovery into a Contemporary Biology Classroom  

ERIC Educational Resources Information Center

The discovery of a Victorian-era microscope slide titled "Grouped Flower Seeds" began an investigation into the scientific and historical background of the antique slide to develop its usefulness as a multidisciplinary tool for PowerPoint presentations usable in contemporary biology classrooms, particularly large-enrollment sections. The resultant…

Reiser, Frank

2012-01-01

265

Particle swarm optimization based fuzzy sliding mode controller for the Twin Rotor MIMO system  

Microsoft Academic Search

In this paper, the application of Particle Swarm Optimization (PSO) on the optimization of the membership functions and the sliding surface constants of the decentralized fuzzy sliding mode controller (FSMC) is presented. This technique is used in order to find an optimal, decentralized, intelligent controller for a nonlinear aerodynamic, Twin Rotor Multi-input, multi-output System (TRMS). Simulation results show the effectiveness

F. Allouani; D. Boukhetala; F. Boudjema

2012-01-01

266

Sliding contacts: Wear and lubrication. (Latest citations from the NTIS data base). Published Search  

SciTech Connect

The bibliography contains citations concerning friction wear and the behavior and properties of sliding and sliding-roll contact lubricants. Topics include lubrication mechanism descriptions, failure reduction of mechanical components for specific contacts, and lubricant performance evaluations. Both electrical and mechanical contact applications are presented. (Contains 250 citations and includes a subject term index and title list.)

Not Available

1992-10-01

267

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

268

The flawed basis for FDA post-marketing safety decisions: the example of anti-depressants and children.  

PubMed

The FDA (February 3, 2005) issued a black box warning that all antidepressants increase the risk of suicidal thinking and behavior in children and adolescents that must be cited in all advertising as well as included in the package insert. Following this, there was a sharp decrease in antidepressant prescriptions for children with uncertain public health impact. The current black box does not claim that these medications increase the risk of completed suicides, although this is the clear implication of the term 'suicidality'. The interpretation by the press is unequivocal that lethal outcomes prompted this action. This review concludes the following: (1) Since no suicide occurred in clinical trials of approximately 4400 children, the analyses relied upon 'suicidality' as a surrogate. (2) The classification of adverse events by the Columbia group necessarily relied on inferences, because the available evidence was not prospectively collected for this purpose. (3) The data analysis relied on a composite variable labeled 'suicidality', an unvalidated, inappropriate surrogate. Specific criticisms of analytic procedures and inferences are presented. The failure of the FDA's post-marketing surveillance system is reviewed. The data necessary for objective evaluations of possible post-marketing harm cannot be gathered by the current process. Proper prospective post-marketing surveillance by linked computerized medical records is a crucial issue that deserves major public and political attention and prompt action. PMID:16395296

Klein, Donald F

2006-04-01

269

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...

270

CSc 165 Lecture Note Slides Game Engines  

E-print Network

CSc 165 Lecture Note Slides Game Engines CSc 165 Lecture Note Slides Game Engines 2 Basic GameGame() Game Main Loop shutdown() Exit while (!gameOver) initSystem() CSc 165 Lecture Note Slides Game Engines 3 Game ENGINE A reusable collection of modules Independent of any particular Game Logic

Gordon, Scott

271

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

272

CSc 165 Lecture Note Slides Model Animation  

E-print Network

CSc 165 Lecture Note Slides Model Animation CSc 165 Lecture Note Slides Model Animation 2 Overview · Approaches to Animation · Skeletal Animation · Animation Transformations · Keyframe Interpolation · Keyframe Sequences CSc 165 Lecture Note Slides Model Animation Approaches to Animation · Traditional or Cel animation

Gordon, Scott

273

Approved Practices in Dairy Reproduction. 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 approved practices in dairy reproduction. Included in the guide are narrations for use with 200 slides dealing with the following topics: the importance of good reproduction, the male and female roles in reproduction, selection of…

Roediger, Roger D.; Barr, Harry L.

274

ABB Group April 14, 2009 | Slide 1  

E-print Network

behaviour of light #12;© ABB Group April 14, 2009 | Slide 5 Early influences ­ science fiction books Frank ­ mechanical engineer, automation #12;© ABB Group April 14, 2009 | Slide 4 Early influences ­ science books Computer Science #12;© ABB Group April 14, 2009 | Slide 8 How I found my research topic From a popular

Basse, Nils Plesner

275

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

276

US FDA's revised consumption factor for polystyrene used in food-contact applications.  

PubMed

US FDA's continual effort to evaluate the safety of food-contact materials includes periodically re-examining our established packaging factors, such as consumption and food-type distribution factors. The use of polystyrene in food-contact and disposable food-packaging applications has expanded and is expected to continue to increase in the future. Therefore, it is important to revise the polystyrene consumption factor to account for increases in consumer exposure to substances migrating from styrenic food packaging. The currently used consumption factor for polystyrene is 0.1, which is based on market data collected around 1980. US FDA has revised the polystyrene consumption factor utilizing three different sources of market data. Using consumption and population data, US FDA calculated a new consumption factor of 0.14 for polystyrene. This consumption factor has been further subdivided to allow for the refinement of exposure estimates for uses limited to specific subcategories of polystyrene packaging. PMID:17691017

Cassidy, K; Elyashiv-Barad, S

2007-09-01

277

FDA designations for therapeutics and their impact on drug development and regulatory review outcomes.  

PubMed

New prescription drugs receive approval from the US Food and Drug Administration (FDA) based on tests establishing safety and adequate and well-controlled trials demonstrating "substantial evidence" of efficacy. However, a number of legislative and regulatory initiatives, the most recent being the breakthrough therapy designation created in 2012, give the FDA flexibility to approve drugs on the basis of less rigorous data in situations of greater clinical need. These expedited development and review pathways now contribute to a majority of all new drug approvals and have important benefits in encouraging efficient availability of transformative drugs. They also have a number of risks, including a heightened possibility that the drugs will be discovered to be ineffective or unsafe after widespread use, and confusion by patients and physicians over what it means for a product to be "FDA approved." PMID:25670381

Kesselheim, A S; Darrow, J J

2015-01-01

278

Smoke Conditions from Slide Fire  

USGS Multimedia Gallery

Smoke from the Slide fire, a major wildfire near Flagstaff, Arizona, is apparent in this hemispheric, natural-color image of sky conditions.  The image was acquired at the USGS Flagstaff Science Campus at 3:00 p.m. MST on May 21, 2014 by the High Dynamic Range All-Sky Imaging System (...

279

Herbaceous Ornamental Plants. Slide Script.  

ERIC Educational Resources Information Center

This document, which is one in a series of curriculum materials that has been developed for use in Ohio agricultural education programs, contains 338 black-and-white photographs of a set of color slides and an accompanying script that, together, are intended as an aid in the study and identification of 150 different commercially important…

Still, Steven

280

Title Slide "Memorability and Invisibility  

E-print Network

lawyers ­ Some case histories N A tale of two alarm clocks N Bugs in the underlying infrastructure N general comments on complexity ­ A categorisation of complexity stolen from lawyers ­ Some case histories made with intent to deceive Dancing with wolves: stealing from lawyers #12;v. 1.1, 26/Aug/2002, (slide

Hatton, Les

281

RecA filament sliding on DNA facilitates homology search  

PubMed Central

During homologous recombination, RecA forms a helical filament on a single stranded (ss) DNA that searches for a homologous double stranded (ds) DNA and catalyzes the exchange of complementary base pairs to form a new heteroduplex. Using single molecule fluorescence imaging tools with high spatiotemporal resolution we characterized the encounter complex between the RecA filament and dsDNA. We present evidence in support of the ‘sliding model’ wherein a RecA filament diffuses along a dsDNA track. We further show that homology can be detected during sliding. Sliding occurs with a diffusion coefficient of approximately 8000 bp2/s allowing the filament to sample several hundred base pairs before dissociation. Modeling suggests that sliding can accelerate homology search by as much as 200 fold. Homology recognition can occur for as few as 6 nt of complementary basepairs with the recognition efficiency increasing for higher complementarity. Our data represents the first example of a DNA bound multi-protein complex which can slide along another DNA to facilitate target search. DOI: http://dx.doi.org/10.7554/eLife.00067.001 PMID:23240082

Ragunathan, Kaushik; Liu, Cheng; Ha, Taekjip

2012-01-01

282

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

283

Clinical and regulatory features of drugs not initially approved by the FDA.  

PubMed

US Food and Drug Administration (FDA) denials of New Drug Applications (NDAs) are often controversial, yet little is known about the basis and characteristics of these decisions. We reviewed new drugs and biologics evaluated by FDA advisory committees between 2007 and 2009 and found that half (27/52, 52%) were unapproved in the first cycle. By 2013, 63% had been approved. Products with initial safety concerns (62%) were much more likely to be approved eventually than drugs with efficacy concerns (8%). PMID:23963252

Wang, B; Avorn, J; Kesselheim, A S

2013-12-01

284

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

285

A sliding Goertzel algorithm for adaptive passive neutralizers  

NASA Astrophysics Data System (ADS)

A common method used in tuning adaptive-passive tuned vibration neutralizers is to adjust its resonance frequency to match the excitation frequency, which has the characteristic that the phase angle between its vibrating mass and its support is -90°. A sliding-Goertzel algorithm is presented and demonstrated for extracting the vibration signals at the frequency of interest. The benefit of using the sliding Goertzel algorithm compared to other methods when used in vibration environments with multiple tones is that additional band-pass notch filtering is not required. This algorithm could also be used for adaptive tuned mass dampers, adaptive Helmholtz resonators, and adaptive quarter-wave tubes.

Howard, Carl Q.

2012-04-01

286

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

287

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

288

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.

289

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

290

Development of Wall-climbing Robots with Sliding Suction Cups  

Microsoft Academic Search

This paper investigates the development of wall-climbing robots (WCRs) with sliding suction cups (SSCs) based on the authors' recent research work. The merits and the challenges of the SSCs are analyzed in detail aiming at wheeled WCRs (WWCRs). The dynamic model of WWCRs is presented. It should be noted that the suction force derived from SSCs has great influence on

Zhi-yuan Qian; Yan-zheng Zhao; Zhuang Fu

2006-01-01

291

Chattering avoidance by second-order sliding mode control  

Microsoft Academic Search

Relying on the possibility of generating a second-order sliding motion by using, as control, the first derivative of the control signal instead of the actual control, a new solution to the problem of chattering elimination in variable structure control (VSC) is presented. Such a solution, inspired by the classical bang-bang optimal control strategy, is first depicted and expressed in terms

G. Bartolini; A. Ferrara; E. Usani

1998-01-01

292

The Edison Environmental Center Permeable Pavement Site - slides  

EPA Science Inventory

This is a presentation for a second Community Outreach Event called "Chemistry Works!" at West Windsor Public Library on Saturday, November 5th. It will review the permeable pavement research project at the Edison Environmental center. Besides slide persentation, two demo units w...

293

Slide 1 Fig 7-1, p.154 Planet Earth  

E-print Network

Slide 1 Fig 7-1, p.154 Planet Earth #12;Slide 2 The New Solar System ch9 #12;Slide 3 Fig 7-2, p.155 Interior Structure of the Earth #12;Slide 4 Fig 7-4, p.156 Earth!s Magnetosphere #12;Slide 5 The New Solar System ch9 #12;Slide 6 Fig 7-3, p.155 Earth!s Crust #12;Slide 7 Fig 7-6, p.157 Earth!s Continental Plates

Wardle, Mark

294

No Slide Title  

Cancer.gov

NCCCP Pilot Site Presentation June 25, 2007 Helen F. Graham Cancer Center at Christiana Care Newark, Delaware Nicholas Petrelli, M.D. Medical Director, HFGCC Principal Investigator, NCCCP Gary Ferguson Executive Vice President & COO, CCHS DELA

295

APPENDIX FOR "THE FDA AND ABCS: UNINTENDED CONSEQUENCES OF ANTIDEPRESSANT WARNINGS ON HUMAN CAPITAL"  

E-print Network

trends, 58 % decline in antidepressant use among individuals newly diagnosed with depression (within 30 in antidepressant use among individuals newly diagnosed with depression (within 30 days post diagnosis.) Valluri etAPPENDIX FOR "THE FDA AND ABCS: UNINTENDED CONSEQUENCES OF ANTIDEPRESSANT WARNINGS ON HUMAN CAPITAL

Sprott, Julien Clinton

296

FDA - A Scalable Evolutionary Algorithm for the Optimization of Additively Decomposed Functions  

Microsoft Academic Search

FDA - the Factorized Distribution Algorithm - is an evolutionary algorithm whichcombines mutation and recombination by using a distribution instead. The distributionis estimated from a set of selected points. In general a discrete distributiondefined for n binary variables has 2nparameters. Therefore it is too expensive to compute.For additively decomposed discrete functions (ADFs) there exist algorithmswhich factor the distribution into conditional

Heinz Mühlenbein; Thilo Mahnig

1999-01-01

297

PREPARATION OF SPREAD OILS MEETING FDA LABELING REQUIREMENTS FOR TRANS FATTY ACIDS  

Technology Transfer Automated Retrieval System (TEKTRAN)

On July 11, 2003, the Food and Drug Administration (FDA) announced final regulations for trans fatty acid (TFA) labeling. By January 1, 2006, TFA content of foods must be labeled as a separate line on the Nutrition Facts label. Products containing less than 0.5 gm TFA/14 gm serving may be declared...

298

DMSO, Hobby Shops and the FDA: The Diffusion of a Health Policy Dilemma.  

ERIC Educational Resources Information Center

Despite being banned by the FDA, DMSO (dimethyl sulfoxide) usage has spread rapidly among arthritic victims and weekend athletes. This study looked at current and past users to learn how they discovered DMSO, their reactions to buying an illegal drug, and possible implications for public health policy. (MT)

Weinstock, Edward; Davis, Phillip

1985-01-01

299

Research paper Screen of FDA-approved drug library reveals compounds that protect hair cells  

E-print Network

Research paper Screen of FDA-approved drug library reveals compounds that protect hair cells from Accepted 9 August 2012 Available online xxx a b s t r a c t Loss of mechanosensory hair cells in the inner cause hair cell death as a side effect. These include amino- glycoside antibiotics, such as neomycin

Rubel, Edwin

300

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.

301

FDA--China Seafood Shippers List -Updated 2014 October 10 Registration  

E-print Network

FDA--China Seafood Shippers List - Updated 2014 October 10 Registration No. Name Registered Address 3010787115 AA USA Trading, Inc. 154 42nd Street Brooklyn NY PP 3004959551 Absolute Fresh Seafoods, Inc 236 Lincoln St., #100 Sitka AK PP 3006789521 Absolute Fresh Seafoods, Inc 504 Front St. Craig AK PP BMS

302

FDA--China Seafood Shippers List -Updated 2014 July 10 Registration  

E-print Network

FDA--China Seafood Shippers List - Updated 2014 July 10 Page 1 Registration No. Name Registered 3004959551 Absolute Fresh Seafoods, Inc 236 Lincoln St., #100 Sitka AK PP 3006789521 Absolute Fresh Seafoods, Inc 504 Front St. Craig AK PP BMS 3007894879 Absolute Fresh Seafoods, Inc 4049 Tongass Ave. Ketchikan

303

THE FDA AND ABCS: UNINTENDED CONSEQUENCES OF ANTIDEPRESSANT WARNINGS ON HUMAN  

E-print Network

THE FDA AND ABCS: UNINTENDED CONSEQUENCES OF ANTIDEPRESSANT WARNINGS ON HUMAN CAPITAL* Susan Busch and non-cognitive aspects of human capital. *This work was supported by funding from the National that compared with cognitive aspects of human capital, "non-cognitive" aspects of human capital are equally

Mateo, Jill M.

304

Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.  

PubMed

Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval. PMID:15082674

Deyo, Richard A

2004-01-01

305

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

306

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...

307

FDA Bioinformatics Tool for Microbial Genomics Research on Molecular Characterization of Bacterial Foodborne Pathogens Using Microarrays  

Technology Transfer Automated Retrieval System (TEKTRAN)

Background: Advances in microbial genomics and bioinformatics are offering greater insights into the emergence and spread of foodborne pathogens in outbreak scenarios. The Food and Drug Administration (FDA) has developed the genomics tool ArrayTrackTM, which provides extensive functionalities to man...

308

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

MedlinePLUS

... increasing evidence that tanning in childhood to early adult life increases the risk of skin cancer, including melanoma,” says FDA dermatologist Markham Luke, M.D., Ph.D. In fact, according to an overview of studies published in the journal Pediatrics , melanoma is the second most common cancer in ...

309

A Good Year: FDA Approved Nine New Cancer Drugs in 2014  

Cancer.gov

In 2014, the Food and Drug Administration (FDA) approved 41 drugs that had not been approved previously for any indication, the most in nearly 20 years. Of these 41 novel drugs, 9 were approved for the treatment of cancer or cancer-related conditions.

310

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 by David André Broniatowski S.B., Aeronautics and Astronautics, Massachusetts Institute of Technology, 2004 S.M., Aeronautics and Astronautics, Massachusetts Institute of Technology, 2006 S.M., Technology

de Weck, Olivier L.

311

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 with tremendous benefits for both human and animal health. One of the concerns regarding the use of antibiotics is the development of resistance to this class of drugs. This resistance could result in an antibiotic's loss

Watson, Craig A.

312

Suppression of chaotic behavior in horizontal platform systems based on an adaptive sliding mode control scheme  

NASA Astrophysics Data System (ADS)

This work presents an adaptive sliding mode control scheme to elucidate the robust chaos suppression control of non-autonomous chaotic systems. The proposed control scheme utilizes extended systems to ensure that continuous control input is obtained in order to avoid chattering phenomenon as frequently in conventional sliding mode control systems. A switching surface is adopted to ensure the relative ease in stabilizing the extended error dynamics in the sliding mode. An adaptive sliding mode controller (ASMC) is then derived to guarantee the occurrence of the sliding motion, even when the chaotic horizontal platform system (HPS) is undergoing parametric uncertainties. Based on Lyapunov stability theorem, control laws are derived. In addition to guaranteeing that uncertain horizontal platform chaotic systems can be stabilized to a steady state, the proposed control scheme ensures asymptotically tracking of any desired trajectory. Furthermore, the numerical simulations verify the accuracy of the proposed control scheme, which is applicable to another chaotic system based on the same design scheme.

Pai, Neng-Sheng; Yau, Her-Terng

2011-01-01

313

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

USGS Publications Warehouse

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.

2007-01-01

314

STS-80 Post Flight Presentation  

NASA Technical Reports Server (NTRS)

The flight crew of STS-80, Cmdr. Kenneth D. Cockrell, Pilot Kent V. Rominger, Mission Specialists, Tamara E. Jernigan, Thomas D. Jones, and F. Story Musgrave give a post flight presentation of their mission. This presentation is divided into two parts first a slide presentation of still shots, and the second is a video presentation.

1996-01-01

315

Archive: FDA/NSTA Symposium: Teach Science Concepts and Inquiry with Food, New Orleans, Louisiana: March 20, 2009  

NSDL National Science Digital Library

During this half-day Symposium, experts and educators from FDA explained how foodborne pathogens are tracked in an outbreak investigation and the scientific basis for the percent daily values (%DVs) on the Nutrition Facts Label. FDA experts and master edu

1900-01-01

316

Toxicological and clinical computational analysis by the Informatics and Computational Safety Analysis Staff of the US FDA\\/CDER  

Microsoft Academic Search

The Informatics and Computational Safety Analysis Staff at US FDA\\/CDER has established a consortium of collaborators who are engaged in harvesting data from FDA archives and creating QSAR models of animal toxicological and human health effect endpoints. Databases of animal toxicology studies and human clinical trial and surveillance data have been compiled and the non-proprietary portions are being made publicly

Daniel R. Benz; Edwin J. Matthews; Naomi L. Kruhlak; Anna A. Frid; Barbara L. Minnier; Joseph F. Contrera

317

Copyright @ 200 American Federation for Medical Research. Unauthorized reproduction of this article is prohibited.9 Understanding FDA Regulatory Requirements for  

E-print Network

approved by the Food and Drug Administration (FDA) or for indications not in the approved labeling may to the FDA. Key Words: food and drug administration, investigational new drug, sponsor-investigator, federal and efficacy issues unique to the use of pharmaceuticals in the clinical research setting. The US Food and Drug

Nguyen, Danh

318

An evaluation of the FDA's analysis of the costs and benefits of the graphic warning label regulation  

PubMed Central

The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over other tobacco products. As with other Federal agencies, FDA is required to assess the costs and benefits of its significant regulatory actions. To date, FDA has issued economic impact analyses of one proposed and one final rule requiring graphic warning labels (GWLs) on cigarette packaging and, most recently, of a proposed rule that would assert FDA’s authority over tobacco products other than cigarettes and smokeless tobacco. Given the controversy over the FDA's approach to assessing net economic benefits in its proposed and final rules on GWLs and the importance of having economic impact analyses prepared in accordance with sound economic analysis, a group of prominent economists met in early 2014 to review that approach and, where indicated, to offer suggestions for an improved analysis. We concluded that the analysis of the impact of GWLs on smoking substantially underestimated the benefits and overestimated the costs, leading the FDA to substantially underestimate the net benefits of the GWLs. We hope that the FDA will find our evaluation useful in subsequent analyses, not only of GWLs but also of other regulations regarding tobacco products. Most of what we discuss applies to all instances of evaluating the costs and benefits of tobacco product regulation and, we believe, should be considered in FDA's future analyses of proposed rules. PMID:25550419

Chaloupka, Frank J; Warner, Kenneth E; Acemo?lu, Daron; Gruber, Jonathan; Laux, Fritz; Max, Wendy; Newhouse, Joseph; Schelling, Thomas; Sindelar, Jody

2015-01-01

319

An evaluation of the FDA's analysis of the costs and benefits of the graphic warning label regulation.  

PubMed

The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over other tobacco products. As with other Federal agencies, FDA is required to assess the costs and benefits of its significant regulatory actions. To date, FDA has issued economic impact analyses of one proposed and one final rule requiring graphic warning labels (GWLs) on cigarette packaging and, most recently, of a proposed rule that would assert FDA's authority over tobacco products other than cigarettes and smokeless tobacco. Given the controversy over the FDA's approach to assessing net economic benefits in its proposed and final rules on GWLs and the importance of having economic impact analyses prepared in accordance with sound economic analysis, a group of prominent economists met in early 2014 to review that approach and, where indicated, to offer suggestions for an improved analysis. We concluded that the analysis of the impact of GWLs on smoking substantially underestimated the benefits and overestimated the costs, leading the FDA to substantially underestimate the net benefits of the GWLs. We hope that the FDA will find our evaluation useful in subsequent analyses, not only of GWLs but also of other regulations regarding tobacco products. Most of what we discuss applies to all instances of evaluating the costs and benefits of tobacco product regulation and, we believe, should be considered in FDA's future analyses of proposed rules. PMID:25550419

Chaloupka, Frank J; Warner, Kenneth E; Acemo?lu, Daron; Gruber, Jonathan; Laux, Fritz; Max, Wendy; Newhouse, Joseph; Schelling, Thomas; Sindelar, Jody

2015-03-01

320

3D DEM analyses of the 1963 Vajont rock slide  

NASA Astrophysics Data System (ADS)

The 1963 Vajont rock slide has been modelled using the distinct element method (DEM). The open-source DEM code, YADE (Kozicki & Donzé, 2008), was used together with the contact detection algorithm proposed by Boon et al. (2012). The critical sliding friction angle at the slide surface was sought using a strength reduction approach. A shear-softening contact model was used to model the shear resistance of the clayey layer at the slide surface. The results suggest that the critical sliding friction angle can be conservative if stability analyses are calculated based on the peak friction angles. The water table was assumed to be horizontal and the pore pressure at the clay layer was assumed to be hydrostatic. The influence of reservoir filling was marginal, increasing the sliding friction angle by only 1.6?. The results of the DEM calculations were found to be sensitive to the orientations of the bedding planes and cross-joints. Finally, the failure mechanism was investigated and arching was found to be present at the bend of the chair-shaped slope. References Boon C.W., Houlsby G.T., Utili S. (2012). A new algorithm for contact detection between convex polygonal and polyhedral particles in the discrete element method. Computers and Geotechnics, vol 44, 73-82, doi.org/10.1016/j.compgeo.2012.03.012. Kozicki, J., & Donzé, F. V. (2008). A new open-source software developed for numerical simulations using discrete modeling methods. Computer Methods in Applied Mechanics and Engineering, 197(49-50), 4429-4443.

Weng Boon, Chia; Houlsby, Guy; Utili, Stefano

2013-04-01

321

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

322

Apparatus Would Stain Microscope Slides  

NASA Technical Reports Server (NTRS)

Proposed apparatus meters specific amounts of fluid out of containers at specific times to stain microscope slides. Intended specifically for semiautomated staining of microbiological and hematological samples in microgravity, leakproof apparatus used in other environments in which technicians have little time to allocate to staining procedures and/or exposure to toxic staining agents or to micro-organisms to be stained hazardous. Apparatus adapted to perform almost any staining procedure and accommodates multiple staining reagents, useful for small or remote clinical laboratories.

Breeding, James D.

1993-01-01

323

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

324

Slide 1: Asthma Basics  

E-print Network

provide environmental professionals working in tribal communities with basic information on asthma. Certain factors in the indoor and outdoor environment can cause, trigger or exacerbate asthma symptoms. However, simple actions can reduce the impact of these environmental triggers, as well as reduce the burden of asthma in tribal communities. The presentation is divided into the following sections:

unknown authors

325

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

Dr. Julie Moss

1900-01-01

326

Sliding Sensor and Soft Grasping of Electron Hydraulic Servo Manipulator  

Microsoft Academic Search

Robot's soft grasping function relies on the fine-performance force sensor, position sensor and sliding sensor. The micro-vibration measurement based sliding sensor employs the elastomer and the photoelectric apparatus installed in the manipulator to transform the object's slide against the manipulator into an electronic signal to detect the slide at the moment of grasping. The object's slide against the manipulator causes

SHANG Zhen dong; Wang Qunyan; Han Jianhai; Xianhong Xu

2006-01-01

327

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

328

Pharmacotherapeutics of Intranasal Scopolamine: FDA Regulations and Procedures for Clinical Applications  

NASA Technical Reports Server (NTRS)

Space Motion Sickness (SMS) is commonly experienced by astronauts and often requires treatment with medications during the early flight days of a space mission. Bioavailability of oral (PO) SMS medications is often low and highly variable; additionally, physiological changes in a microgravity environment exacerbate variability and decrease bioavailability. These factors prompted NASA to develop an intranasal dosage form of scopolamine (INSCOP) suitable for the treatment of SMS. However, to assure safety and efficacy of treatment in space, NASA physicians prescribe commercially available pharmaceutical products only. Development of a pharmaceutical preparation for clinical use must follow distinct clinical phases of testing, phase I through IV to be exact, before it can be approved by the FDA for approval for clinical use. After a physician sponsored Investigative New Drug (IND) application was approved by the FDA, a phase I clinical trial of INSCOP formulation was completed in normal human subjects and results published. The current project includes three phase II clinical protocols for the assessment of pharmacokinetics and pharmacodynamics (PK/PD), efficacy, and safety of INSCOP. Three clinical protocols that were submitted to FDA to accomplish the project objectives: 1) 002-A, a FDA Phase II dose ranging study with four dose levels between 0.1 and 0.4 mg in 12 subjects to assess PK/PD, 2) 002-B, a phase II clinical efficacy study in eighteen healthy subjects to compare efficacy of 0.2 (low dose) and 0.4 mg (high dose) INSCOP for prophylactic treatment of motion-induces (off-axis vertical rotation) symptoms, and (3) 002-C, a phase II clinical study with twelve subjects to determine bioavailability and pharmacodynamics of two doses (0.2 and 0.4 mg) of INSCOP in simulated microgravity, antiorthostatic bedrest. All regulatory procedures were competed that include certification for Good laboratory Procedures by Theradex , clinical documentation, personnel training, selection of clinical research operations contractor, data capturing and management, and annual reporting of results to FDA were successfully completed. Protocol 002-A was completed and sample and data analysis is currently in progress. Protocol 002-B is currently in progress at Dartmouth Hitchcock Medical Center and Protocol 002-C has been submitted to the FDA and will be implemented at the same contractor site as 002-A. An annual report was filed as required by FDA on the results of Protocol 002-A. Once all the three Phase II protocols are completed, a New Drug Administration application will be filed with FDA for Phase III clinical assessment and approval for marketing of the formulation. A commercial vendor will be identified for this phase. This is critical for making this available for treatment of SMS in astronauts and military personnel on duty. Once approved by FDA, INSCOP can be also used by civilian population for motion sickness associated with recreational travel and other ailments that require treatment with anticholinergic drugs.

Das, H.; Daniels, V. R.; Vaksman, Z.; Boyd, J. L.; Buckey, J. C.; Locke, J. P.; Putcha, L.

2007-01-01

329

SLIDING MODE CONTROL OF PIEZOELECTRIC VALVE REGULATED PNEUMATIC ACTUATOR FOR MRI-COMPATIBLE ROBOTIC INTERVENTION  

E-print Network

SLIDING MODE CONTROL OF PIEZOELECTRIC VALVE REGULATED PNEUMATIC ACTUATOR FOR MRI-COMPATIBLE ROBOTIC regulated by piezoelectric valve for image guided robotic intervention. After comparing pneumatic, hydraulic and piezoelectric MRI compatible actuation technologies, we present a piezoelectric valve regulated pneumatic

Camesano, Terri

330

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

331

DOE/FDA/EPA: Workshop on methylmercury and human health  

SciTech Connect

In the US the general population is exposed to methylmercury (MeHg) principally through the consumption of fish. There is continuing discussion about the sources of this form of mercury (Hg), the magnitudes and trends in exposures to consumers, and the significance of the sources and their contributions to human health. In response to these discussions, the US Department of Energy, the US Food and Drug Administration, and the US Environmental Protection Agency cosponsored a two-day workshop to discuss data and methods available for characterizing the risk to human health presented by MeHg. This workshop was attended by 45 individuals representing various Federal and state organizations and interested stakeholders. The agenda covered: Agency interests; probabilistic approach to risk assessment; emission sources; atmospheric transport; biogeochemical cycling; exposure assessment; health effects of MeHg; and research needs.

Moskowitz, P.D.; Saroff, L.; Bolger, M.; Cicmanec, J.; Durkee, S. [eds.

1994-12-31

332

Robust sliding mode control for fractional-order chaotic economical system with parameter uncertainty and external disturbance  

NASA Astrophysics Data System (ADS)

This paper presents a modified sliding mode control for fractional-order chaotic economical systems with parameter uncertainty and external disturbance. By constructing the suitable sliding mode surface with fractional-order integral, the effective sliding mode controller is designed to realize the asymptotical stability of fractional-order chaotic economical systems. Comparing with the existing results, the main results in this paper are more practical and rigorous. Simulation results show the effectiveness and feasibility of the proposed sliding mode control method. Project supported by the National Natural Science Foundation of China (Grant Nos. 51207173 and 51277192).

Zhou, Ke; Wang, Zhi-Hui; Gao, Li-Ke; Sun, Yue; Ma, Tie-Dong

2015-03-01

333

21 CFR 864.3800 - Automated slide stainer.  

Code of Federal Regulations, 2011 CFR

... § 864.3800 Automated slide stainer. (a) Identification. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis. (b) Classification. Class I (general controls). This...

2011-04-01

334

21 CFR 864.3800 - Automated slide stainer.  

Code of Federal Regulations, 2013 CFR

... § 864.3800 Automated slide stainer. (a) Identification. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis. (b) Classification. Class I (general controls). This...

2013-04-01

335

21 CFR 864.3800 - Automated slide stainer.  

Code of Federal Regulations, 2012 CFR

... § 864.3800 Automated slide stainer. (a) Identification. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis. (b) Classification. Class I (general controls). This...

2012-04-01

336

21 CFR 864.3800 - Automated slide stainer.  

Code of Federal Regulations, 2014 CFR

... § 864.3800 Automated slide stainer. (a) Identification. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis. (b) Classification. Class I (general controls). This...

2014-04-01

337

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.

338

Use of vaginal mesh in the face of recent FDA warnings and litigation.  

PubMed

Choosing to use mesh in vaginal reconstructive surgery for pelvic organ prolapse or stress urinary incontinence is perplexing in the face of recent US Food and Drug Administration (FDA) warnings. In October 2008, the FDA alerted practitioners to complications associated with transvaginal placement of surgical mesh. Litigation is another concern. A Google search of "transvaginal mesh" results in numerous hits for plaintiff attorneys seeking patients with complications related to use of mesh. In light of a recent decision by the US Supreme Court and strategies by manufactures of medical devices to escape liability, it is imperative that gynecologic surgeons using transvaginal mesh document proper informed consent in the medical records. The purpose of this commentary is not to deter gynecologic surgeons from using transvaginal mesh when appropriate, but to provide an overview of current medical-legal controversies and stress the importance of documenting informed consent. PMID:20227672

Mucowski, Sara J; Jurnalov, Catalin; Phelps, John Y

2010-08-01

339

Bodies of evidence: activists, patients, and the FDA regulation of Depo-Provera.  

PubMed

In January 1983, the FDA held one of only two scientific "Public Boards of Inquiry" in the history of the administration to determine whether to approve Depo-Provera for use as a contraceptive in the United States. At the hearing, ideas about gender and power played a central role in negotiations between scientists, doctors, patients, and women's health activists. The nature of the Depo-Provera Public Board of Inquiry lends itself to analysis of the interaction between and among these groups, each of which had a vested interest in the outcome of the FDA decision. The stories and strategies emerging from the actors involved in the Public Board of Inquiry reveal the enormous complexity of regulating reproduction in the late twentieth century. PMID:20857592

Kline, Wendy

2010-01-01

340

The complications of controlling agency time discretion: FDA review deadlines and postmarket drug safety.  

PubMed

Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses. PMID:22400144

Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan; Nall, Clayton

2012-01-01

341

The characterization of the Frank Slide deposit  

NASA Astrophysics Data System (ADS)

On the night of the 29th April 1903, approximately 30 millions of cubic meters of limestone slided down the east face of Turtle Mountain (Alberta, Canada). Having killed about 80 people in the village of Frank, the rock avalanche was named after it. The characteristics of this large event are an especially long runout distance of 3 km, a primary fall of 1000 m and an average speed of 30 m/s. The produced deposit has a surface area of 3 km2, its mean thickness is 15 m and it presents an inverse grading with fine grains at its base and boulders at its top. In this study, based on field work, GIS and statistical analysis, more characteristics of the deposit are examined. An analysis of the block size at the surface of the deposit along three profiles is performed in order to determine the granulometry curve of the blocks. This is completed by a remote sensing analysis. Similarly the morphology and lithology of the deposit is studied. The results show a chaotic morphology, a partially homogenous distribution of the geologic formations and a relation between blocks' diameter and the distance to the scarp. In addition, a distinct element numerical model PFC2D is executed to simulate the transportation of this massive rock avalanche. This complete analysis provides information about the fragmentation and propagation processes that took place in 1903. Preliminary outcomes show a significant pattern: the lowest in altitude the lithologies are in the cliff, the furthest they have been transported by the slide. Indeed, the Banff Formation which was positioned at the base of the fallen mass, is presently placed in the distal part of the deposit. The interest of this study is to gather the more details possible on the deposition and transportation in order to understand better the processes that engender the propagation of a large rock avalanche.

Charričre, Marie; Pedrazzini, Andrea; Güell Pons, Maria; Volpi, Michele; Jaboyedoff, Michel; Froese, Corey; Kanevski, Mikhaďl.

2010-05-01

342

Comments on "Sliding mode closed-loop control of FES: controlling the shank movement".  

PubMed

There are some essential problems with the arguments presented in the above paper about the design of a sliding-mode controller for functional electrical simulation (FES) induced control of knee-joint angle. In this note, we show that applying some approximations in derivation of the control law violates the reaching condition and could introduce some parasitic unmodeled dynamics in the sliding-mode control loop. Therefore, the proposed controller cannot force the system into a sliding-mode regime, and its ability of producing a robust control loop with good tracking performance is theoretically under question. PMID:19126468

Ebrahimpour, Mir-Mahdi; Erfanian, Abbas

2008-12-01

343

FDA Advisory Meeting Clinical Pharmacology Review Utilizes a Quantitative Systems Pharmacology (QSP) Model: A Watershed Moment?  

PubMed Central

In the evolving discipline of quantitative systems pharmacology (QSP), QSP model (QSPM) applications are expanding. Recently, a QSPM was used by US Food and Drug Administration (FDA) clinical pharmacologists to evaluate the appropriateness of a proposed dosing regimen for a new biologic. This application expands the use-horizon for QSPMs into the regulatory domain. Here we retrace the evolution of the model and suggest a question-based approach to directing model scope, identifying applications, and understanding overall QSPM value.

Peterson, MC; Riggs, MM

2015-01-01

344

COMPUTER APPLICATIONS IN THE GEOSCIENCES POWERPOINT PRESENTATION TIPS  

E-print Network

for you. If the audience can read everything you say there is no point in you making a presentation supporting PowerPoint slides and in practicing the presentation. If given 15 minutes for a presentation, one that each slide must have maximum impact in helping you communicate with the audience. A general rule

Smith-Konter, Bridget

345

Thoughts on Presentations Related to Geostatistics Clayton V. Deutsch  

E-print Network

the presentation. Avoid too much text; just put the main points. Avoid disclosing points in animation style with a set of PowerPoint slides. Some basic design tips should be considered. You give the presentation the full slide at once. Also, animation makes it difficult to navigate quickly through your presentation

Boisvert, Jeff

346

Improving Student Group Marketing Presentations: A Modified Pecha Kucha Approach  

ERIC Educational Resources Information Center

Student presentations can often seem like a formality rather than a lesson in representing oneself or group in a professional manner. To improve the quality of group presentations, the authors modified the popular presentation style of Pecha Kucha (20 slides, 20 seconds per slide) for marketing courses to help students prepare and deliver…

Oliver, Jason; Kowalczyk, Christine

2013-01-01

347

Effects of FDA Advisories on the Pharmacologic Treatment of ADHD, 2004–2008  

PubMed Central

Objective This study assessed the effect of public health advisories issued between 2005 and 2007 by the U.S. Food and Drug Administration (FDA) on treatments of attention-deficit hyperactivity disorder (ADHD) and physician prescribing practices. Methods Data obtained from the IMS Health National Disease and Therapeutic Index, a nationally representative audit of ambulatory physicians, were used to examine trends in office visits by children and adolescents (under age 18) during which ADHD was treated with Adderall, other psychostimulants, or atomoxetine. Segmented time series regressions were conducted to determine changes in use associated with three advisories issued between 2005 and 2007. Results In 2004, before the first FDA advisory, Adderall accounted for 36% of ADHD pharmacotherapy treatment visits. Other stimulants accounted for 46%, and atomoxetine accounted for 19%. Overall pharmacotherapy treatment rates were stable over the study period, but by 2008 the treatment visits accounted for by Adderall (that is, market share) declined to 24%, and the market share for atomoxetine declined to 8%. The market share for substitute therapies—clonidine, guanfacine, and bupropion—was stable over this period, ranging from 5% to 7%. Despite the declines in the use of Adderall and atomoxetine over the study period, results from the regression models suggest that the advisories did not have a statistically significant effect on ADHD medication prescribing. Conclusions FDA advisories regarding potential cardiovascular and other risks of ADHD medications had little discernible incremental effect on the use of these medicines in this nationally representative ambulatory audit. PMID:23318985

Kornfield, Rachel; Watson, Sydeaka; Higashi, Ashley S.; Conti, Rena M.; Dusetzina, Stacie B.; Garfield, Craig F.; Dorsey, E. Ray; Huskamp, Haiden A.; Alexander, G. Caleb

2014-01-01

348

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

349

Tobramycin and FDA-Approved Iron Chelators Eliminate Pseudomonas aeruginosa Biofilms on Cystic Fibrosis Cells  

PubMed Central

The ability of Pseudomonas aeruginosa to form antibiotic-resistant biofilms is thought to account for the inability of current therapies to resolve bacterial infections in the lungs of patients with cystic fibrosis (CF). We recently described a system in which highly antibiotic-resistant P. aeruginosa biofilms grow on human CF airway epithelial cells, and using this system we showed that enhanced iron release from CF cells facilitates the development of such highly antibiotic-resistant biofilms. Given the positive role for iron in biofilm development, we investigated whether the FDA-approved iron chelators deferoxamine and deferasirox would enhance the ability of tobramycin, the primary antibiotic used to treat CF lung infections, to eliminate P. aeruginosa biofilms. The combination of tobramycin with deferoxamine or deferasirox reduced established biofilm biomass by approximately 90% and reduced viable bacteria by 7-log units. Neither tobramycin nor deferoxamine nor deferasirox alone had such a marked effect. The combination of tobramycin and FDA-approved iron chelators also prevented the formation of biofilms on CF airway cells. These data suggest that the combined use of tobramycin and FDA-approved iron chelators may be an effective therapy to treat patients with CF and other lung disease characterized by antibiotic-resistant P. aeruginosa biofilms. PMID:19168700

Moreau-Marquis, Sophie; O'Toole, George A.; Stanton, Bruce A.

2009-01-01

350

A common feature pharmacophore for FDA-approved drugs inhibiting the Ebola virus  

PubMed Central

We are currently faced with a global infectious disease crisis which has been anticipated for decades. While many promising biotherapeutics are being tested, the search for a small molecule has yet to deliver an approved drug or therapeutic for the Ebola or similar filoviruses that cause haemorrhagic fever. Two recent high throughput screens published in 2013 did however identify several hits that progressed to animal studies that are FDA approved drugs used for other indications. The current computational analysis uses these molecules from two different structural classes to construct a common features pharmacophore. This ligand-based pharmacophore implicates a possible common target or mechanism that could be further explored. A recent structure based design project yielded nine co-crystal structures of pyrrolidinone inhibitors bound to the viral protein 35 (VP35). When receptor-ligand pharmacophores based on the analogs of these molecules and the protein structures were constructed, the molecular features partially overlapped with the common features of solely ligand-based pharmacophore models based on FDA approved drugs. These previously identified FDA approved drugs with activity against Ebola were therefore docked into this protein. The antimalarials chloroquine and amodiaquine docked favorably in VP35. We propose that these drugs identified to date as inhibitors of the Ebola virus may be targeting VP35. These computational models may provide preliminary insights into the molecular features that are responsible for their activity against Ebola virus in vitro and in vivo and we propose that this hypothesis could be readily tested. PMID:25653841

Ekins, Sean; Freundlich, Joel S.; Coffee, Megan

2014-01-01

351

21 CFR 864.3800 - Automated slide stainer.  

Code of Federal Regulations, 2010 CFR

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

2010-04-01

352

Sliding along Coulombic shear faults in ice  

NASA Astrophysics Data System (ADS)

New experiments have been performed on the resistance to inelastic deformation through frictional sliding along naturally-formed Coulombic shear faults in ice Ih. Coulombic faults mark terminal failure of virgin material when loaded rapidly under a moderate degree of confinement. The experiments were performed on S2 fresh-water ice at -10degreesC, proportionally loaded biaxially across the columns along a variety of all-compressive paths. Two kinds of behavior were observed. At higher sliding velocities (8 x 10(-2) and 8 x 10(-1) mm s(-1)) sliding was noisy and the process exhibited velocity weakening. At a lower sliding velocity (8 x 10(-4) mm s(-1)) sliding was quiet and fault healing occurred. The two kinds of sliding are indicative of brittle-like (at higher speeds) and ductile-like (at lower speeds) behavior, and are explained in terms of fracture and creep. Within the brittle regime, a power law describes the relationship between the shear strength of the fault and the normal stress across it at the onset of sliding, while Coulomb's law describes the relationship once sliding has progressed by about 2 mm.

Fortt, A.; Schulson, E. M.; Russell, E.

2003-01-01

353

Sliding Mode Control with Chattering Reduction  

Microsoft Academic Search

In variable structure control algorithms, sliding mode plays a key role in desensitizing the closed loop system with respect to parameter variations, in rejecting unknown disturbances, and in reducing the systems dynamics to a prescribed lower dimension manifold on which desirable dynamic behavior of the plant is attained. In its original theoretical developement, sliding mode corresponds to a special class

K. David Young; Sergey V. Drakunov

1992-01-01

354

Chattering Problem in Sliding Mode Control Systems  

Microsoft Academic Search

In practical applications of sliding mode control, engineers may experience undesirable phenomenon of oscillations having finite frequency and amplitude, which is known as `chattering'. At the first stage of sliding mode control theory development the chattering was the main obstacle for its implementation. The major attention was paid to the systems with motion equations in canonical space - space of

V. Utkin; Hoon Lee

2006-01-01

355

Coupled Masses: Pendulum on Sliding Support  

NSDL National Science Digital Library

A simple pendulum is attached to a mass which can slide freely on a horizontal frictionless surface. Predictions can be made about the motion of the system and what the graph of x positions of the pendulum bob and the sliding mass will look like as a function of time.

Wolfgang Christian

356

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

357

Slides  

E-print Network

I will not formulate Mukhometov's theorem in exact form, but instead I reformulate it in a ... curves obtained by shift of a parameter to be the same curve). Yernat M. ... one-forms instead of functions, a vector integral geometry problem or Doppler.

Yernat M. Assylbekov

2012-06-23

358

Slides  

E-print Network

Motivation. Question: Given a P.c.f. self-similar structure, when can we .... L p.c.f. implies that elements in C have a recurring tail, so we can write ..... Vector analysis on Dirichlet Spaces. Michael ..... As well as Magnetic Schödinger operators.

*D. J. Kelleher

2013-12-08

359

Slides  

E-print Network

Nov 12, 2014 ... Post-Critically Finite fractals are self-similar structures with the boundary .... Further there is a matrix-valued function. Zx, such that ... obtained by factoring out zero seminorm elements and ... Magnetic Schrödinger operators.

Daniel J. Kelleher

2014-11-13

360

Computer-aided prognosis of neuroblastoma: classification of stromal development on whole-slide images  

NASA Astrophysics Data System (ADS)

Neuroblastoma is a cancer of the nervous system and one of the most common tumors in children. In clinical practice, pathologists examine the haematoxylin and eosin (H&E) stained tissue slides under the microscope for the diagnosis. According to the International Neuroblastoma Classification System, neuroblastoma tumors are categorized into favorable and unfavorable histologies. The subsequent treatment planning is based on this classification. However, this qualitative evaluation is time consuming, prone to error and subject to inter- and intra-reader variations and sampling bias. To overcome these shortcomings, we are developing a computerized system for the quantitative analysis of neuroblastoma slides. In this study, we present a novel image analysis system to determine the degree of stromal development from digitized whole-slide neuroblastoma samples. The developed method uses a multi-resolution approach that works similar to how pathologists examine slides. Due to their very large resolutions, the whole-slide images are divided into non-overlapping image tiles and the proposed image analysis steps are applied to each image tile using a parallel computation infrastructure developed earlier by our group. The computerized system classifies image tiles as stroma-poor or stroma-rich subtypes using texture characteristics. The developed method has been independently tested on 20 whole-slide neuroblastoma slides and it has achieved 95% classification accuracy.

Sertel, Olcay; Kong, Jun; Shimada, Hiroyuki; Catalyurek, Umit; Saltz, Joel H.; Gurcan, Metin

2008-03-01

361

Acoustic evidence of a submarine slide in the deepest part of the Arctic, the Molloy Hole  

NASA Astrophysics Data System (ADS)

The western Svalbard continental margin contains thick sediment sequences with areas known to contain gas hydrates. Together with a dynamic tectonic environment, this makes the region prone to submarine slides. This paper presents results from geophysical mapping of the deepest part of the high Arctic environment, the Molloy Hole. The mapping includes multibeam bathymetry, acoustic backscatter and sub-bottom profiling. The geophysical data reveal seabed features indicative of sediment transport and larger-scale mass wasting. The large slide scar is here referred to as the Molloy Slide. It is located adjacent to the prominent Molloy Hole and Ridge system. The slide is estimated to have transported >65 km3 of sediments over the deep axial valley of the Molloy Ridge, and further into the Molloy Hole. A unique feature of this slide is that, although its run-out distance is relatively short (<5 km), it extends over an enormous vertical depth (>2,000 m) as a result of its position in a complex bathymetric setting. The slide was most likely triggered by seismic activity caused by seafloor spreading processes along the adjacent Molloy Ridge. However, gas-hydrate destabilization may also have played a role in the ensuing slide event.

Freire, Francis; Gyllencreutz, Richard; Jafri, Rooh Ullah; Jakobsson, Martin

2014-08-01

362

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

363

Thermal and thermomechanical effects in dry sliding  

NASA Technical Reports Server (NTRS)

Developments in the study of interrelated thermal and mechanical phenomena in sliding systems are reviewed. The topics reviewed include mechanisms of frictional heating and the distribution of heat during sliding friction, the experimental measurement and analysis of surface and near-surface temperatures resulting from frictional heating, thermal deformation around sliding contacts and the changes in contact geometry caused by thermal deformation and thermoelastic instability, and the thermomechanical stress distribution around the frictionally heated and thermally deformed contact spots. The influence of the thermal and thermomechanical contact phenomena on friction and wear, surface melting, softening, chemical deterioration, and thermocracking are discussed. The phenomena have important implications in the design and application of sliding or sliding-rolling mechanical components such as dynamic seals, brakes, clutches, plastic bearings, solid or boundary-lubricated bearings, and gears.

Kennedy, F. E., Jr.

1984-01-01

364

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

365

Experimental study of flow pattern and heat transfer associated with a bubble sliding on downward facing inclined surfaces  

Microsoft Academic Search

During boiling, heat transfer can be significantly enhanced by motion of the bubbles sliding along the heater surface. In the present study, sliding bubble dynamics and associated flow pattern and heat transfer over a downward facing inclined heater surface were experimentally investigated in the subcooled and nearly saturated high performance liquid PF-5060. The heat transfer surface was a polished silicon

D. Qiu; V. K. Dhir

2002-01-01

366

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.

367

Fuel Cells Presentation  

NSDL National Science Digital Library

This presentation from Thomas G. Benjamin and J. David Carter of Argonne National Laboratory introduces the topic of fuel cells. The presentation examines the history and basic operation of fuel cells, types of fuel cells, PEM fuel cells, hydrogen storage and more. The presentation includes fifty slides, many of which include graphics to support the text. This presentation would be a good general starting point for a casual learner curious about fuel cells, or could be used to support energy curriculum. This document may be downloaded in Microsoft PowerPoint file format.

Benjamin, Thomas G.

368

An evaluation of the FDA's analysis of the costs and benefits of the graphic warning label regulation  

E-print Network

The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over ...

Acemoglu, Daron

369

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

Code of Federal Regulations, 2013 CFR

...ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food and Drug Administration's (FDA's) determination that a...

2013-04-01

370

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

Code of Federal Regulations, 2011 CFR

...ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food and Drug Administration's (FDA's) determination that a...

2011-04-01

371

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

Code of Federal Regulations, 2010 CFR

...ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food and Drug Administration's (FDA's) determination that a...

2010-04-01

372

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

Code of Federal Regulations, 2012 CFR

...ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Premarket Notifications § 170.105 The Food and Drug Administration's (FDA's) determination that a...

2012-04-01

373

Research on the methods of detecting and removing slide valve failure  

Microsoft Academic Search

Various ways for detecting slide valve failure are discussed in the paper. Specifically, a new method for detecting slide\\u000a valve sticking state is first presented. The method does not depend on any special sensor and is only based on the detection\\u000a of oscillation current wave within a valve coil. Results of theoretical analysis and experimental research are given for comparison.

Li Wei; Li Wei-bo; Wu Gen-mao; Wei Jian-hua

2000-01-01

374

Time-varying sliding mode control for spacecraft attitude tracking maneuvers with a quadratic cost  

Microsoft Academic Search

com Abstract: In this paper, the problem of spacecraft attitude tracking maneuvers in the presence of parametric uncertainty and external disturbance is addressed. A time-varying sliding mode controller with an exponential time-varying sliding surface is presented. The attitude of spacecraft is represented by modified Rodrigues parameters for the non-redundancy. The proposed control algorithm eliminates the reaching phase of conventional time-invariant

Binglong Cong; LIU Xiangdongl; Zhen Chen; Yongjiang Xia

2011-01-01

375

Chattering free with noise reduction in sliding-mode observers using frequency domain analysis  

Microsoft Academic Search

This paper presents analysis and regulation of switching in the sliding-mode observers for nonlinear systems. First, the high gain property of the sliding observer is employed in order to obtain fast convergence of the estimated states to the system ones. Then, when the system is in the switching condition, signals are decomposed into two modes: the slow-mode and the fast-mode.

M. Hajatipour; M. Farrokhi

2010-01-01

376

Implementation of speed-sensor-less field-oriented vector control using adaptive sliding observers  

Microsoft Academic Search

The authors describe the design method for a robust adaptive sliding observer which realizes speed-sensorless field-oriented vector control of AC motor drives. The speed-sensorless field oriented vector control system using the adaptive sliding observer was implemented. The basic characteristics of the proposed system and the design method against parameter deviation were studied experimentally. In the present system, the steady state

Shinji Doki; Somboon Sangwongwanich; Shigeru Okuma

1992-01-01

377

Synchronization of Uncertain Fractional-Order Duffing-Holmes Chaotic System via Sliding Mode Control  

E-print Network

In this paper, a sliding mode controller is designed to synchronize a chaotic fractional-order system. To construct a corrective control input, a saturation function sat(.), with a modified sliding surface is proposed. Finally, Chaos in the Duffing-Holmes system with fractional orders is investigated, and a numerical simulation (synchronizing fractional-order Duffing-Holmes _ Duffing-Holmes system) are presented to show the effectiveness of the proposed controller.

S. H. Hosseinnia; R. Ghaderi; A. Ranjbar N.; S. Momani

2012-06-12

378

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

379

NCI-FDA Interagency Oncology Task Force Workshop Provides Guidance for Analytical Validation of Protein-based Multiplex Assays  

Cancer.gov

An NCI-FDA Interagency Oncology Task Force (IOTF) Molecular Diagnostics Workshop was held on October 30, 2008 in Cambridge, MA, to discuss requirements for analytical validation of protein-based multiplex technologies in the context of its intended use. This workshop developed through NCI's Clinical Proteomic Technologies for Cancer initiative and the FDA focused on technology-specific analytical validation processes to be addressed prior to use in clinical settings.

380

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

381

Sliding controller design for non-linear systems  

Microsoft Academic Search

New results are presented on the sliding control methodology introduced by Slotine and Sastry (1983) to achieve accurate tracking for a class of non-linear time-varying multivariate systems in the presence of disturbances and parameter variations. An explicit trade-off is obtained between tracking precision and robustness to modelling uncertainty : tracking accuracy is sot according to the extent, of parametric uncertainty

JEAN-JACQUES E. SLOTINE

1984-01-01

382

Angular particle sliding down a transversally vibrated smooth plane.  

PubMed

We present a theoretical, numerical, and experimental study about the sliding motion of an angular particle down a vibrated smooth plane. The model is based on a Coulomb's friction law with a unique friction coefficient. The model is solved numerically and is tested with controlled experiments. Different motion regimes are identified and the particle behavior is governed by two dimensionless parameters. The comparison between experimental and numerical results gives an indirect access to the dynamic friction coefficient. PMID:22400565

Benedetti, Arnaud; Sornay, Philippe; Dalloz, Blanche; Nicolas, Maxime

2012-01-01

383

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. 

384

On the method of moving planes and the sliding method  

Microsoft Academic Search

The method of moving planes and the sliding method are used in proving monotonicity or symmetry in, say, thex1 direction for solutions of nonlinear elliptic equationsF(x, u, Du, D2u)=0 in a bounded domain O in Rn which is convex in thex1 direction. Here we present a much simplified approach to these methods; at the same time it yields improved results.

H. Berestycki; L. Nirenberg

1991-01-01

385

Brittingham Family Lantern Slide Collection  

NSDL National Science Digital Library

For many well-to-do American families in the late 19th century, tours of the Continent were quite fashionable, and in some quarters, almost expected. The Brittingham family of Madison, Wisconsin, was no exception, and they spent a great deal of time documenting their travels (and home life) through a wide range of photographic images. This collection, created by the University of Wisconsin Digital Collections Center, brings together over 1600 of these lantern slides, all of which were created between 1897 and 1922. In the collection, visitors will find images of scenic landscapes, street scenes, and domestic life from 22 states and 32 countries. Here visitors can delight in seeing the entire clan at their homestead in Wisconsin as well as in Port Antonio, Jamaica. Overall, the site provides insight into both the life of the Brittinghams and the social and cultural world they were a part of during the Gilded Age.

386

Whole slide imaging for educational purposes  

PubMed Central

Digitized slides produced by whole slide image scanners can be easily shared over a network or by transferring image files to optical or other data storage devices. Navigation of digitized slides is interactive and intended to simulate viewing glass slides with a microscope (virtual microscopy). Image viewing software permits users to edit, annotate, analyze, and easily share whole slide images (WSI). As a result, WSI have begun to replace the traditional light microscope, offering a myriad of opportunities for education. This article focuses on current applications of WSI in education and proficiency testing. WSI has been successfully explored for graduate education (medical, dental, and veterinary schools), training of pathology residents, as an educational tool in allied pathology schools (e.g., cytotechnology), for virtual tracking and tutoring, tele-education (tele-conferencing), e-learning, virtual workshops, at tumor boards, with interactive publications, and on examinations. WSI supports flexible and cost-effective distant learning and augments problem-oriented teaching, competency evaluation, and proficiency testing. WSI viewed on touchscreen displays and with tablet technology are especially beneficial for education. Further investigation is necessary to develop superior WSI applications that better support education and to design viewing stations with ergonomic tools that improve the WSI-human interface and navigation of virtual slides. Studies to determine the impact of training pathologists without exposure to actual glass slides are also needed. PMID:23372987

Pantanowitz, Liron; Szymas, Janusz; Yagi, Yukako; Wilbur, David

2012-01-01

387

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

388

Fast Algorithms for the Computation of Sliding Sequency-Ordered Complex Hadamard Transform  

PubMed Central

Fast algorithms for computing the forward and inverse sequency-ordered complex Hadamard transforms (SCHT) in a sliding window are presented. The first algorithm consists of decomposing a length-N inverse SCHT (ISCHT) into two length-N/2 ISCHTs. The second algorithm, calculating the values of window i+N/4 from those of window i and one length-N/4 ISCHT and one length-N/4 modified ISCHT (MISCHT), is implemented by two schemes to achieve a good compromise between the computation complexity and the implementation complexity. The forward SCHT algorithm can be obtained by transposing the signal flow graph of the ISCHT. The proposed algorithms require O(N) arithmetic operations and thus are more efficient than the block-based algorithms as well as those based on the sliding FFT or the sliding DFT. The application of the sliding ISCHT in transform domain adaptive filtering (TDAF) is also discussed with supporting simulation results. PMID:21909229

Wu, Jiasong; Shu, Huazhong; Wang, Lu; Senhadji, Lotfi

2010-01-01

389

Fast Algorithms for the Computation of Sliding Sequency-Ordered Complex Hadamard Transform.  

PubMed

Fast algorithms for computing the forward and inverse sequency-ordered complex Hadamard transforms (SCHT) in a sliding window are presented. The first algorithm consists of decomposing a length-N inverse SCHT (ISCHT) into two length-N/2 ISCHTs. The second algorithm, calculating the values of window i+N/4 from those of window i and one length-N/4 ISCHT and one length-N/4 modified ISCHT (MISCHT), is implemented by two schemes to achieve a good compromise between the computation complexity and the implementation complexity. The forward SCHT algorithm can be obtained by transposing the signal flow graph of the ISCHT. The proposed algorithms require O(N) arithmetic operations and thus are more efficient than the block-based algorithms as well as those based on the sliding FFT or the sliding DFT. The application of the sliding ISCHT in transform domain adaptive filtering (TDAF) is also discussed with supporting simulation results. PMID:21909229

Wu, Jiasong; Shu, Huazhong; Wang, Lu; Senhadji, Lotfi

2010-11-01

390

SLIDING MODE VARIABLE STRUCTURE CONTROL FOR UNCERTAIN STOCHASTIC SYSTEMS  

Microsoft Academic Search

Abstract. In this paper, the sliding mode variable structure control for a class of uncer- tain stochastic systems is investigated . Firstly, the sliding surface is established and the variable structure control law of the system is designed. Then it is proved that the sliding mode,is subordinated reachable and a sufficient condition for mean-square asymptotical stability of the sliding mode

Xiaozhu Zhong; Hailong Xing; Kuniaki Fujimoto

391

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

392

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

393

Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies  

PubMed Central

Background The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997–2000) the average number of regulatory letters per year was 242.8?±?45.6, during the Bush Administration (2001–2008) it was 120.4?±?33.7, and during the first three years of the Obama administration (2009–2011) it was 177.7.0?±?17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3?±?36.4), Bush (29.5?±?16.2) and Obama (41.7?±?11.1). Conclusions Most regulatory letters released by FDA headquarters were related to marketing and advertising activities of pharmaceutical companies. The number of regulatory letters was highest during the second Clinton administration, diminished during the Bush administrations, and increased again during the Obama administration. A further assessment of the impact of changes in federal administration on the enforcement activities of the FDA is required. PMID:23339419

2013-01-01

394

Novel anti-glioblastoma agents and therapeutic combinations identified from a collection of FDA approved drugs  

PubMed Central

Background Glioblastoma (GBM) is a therapeutic challenge, associated with high mortality. More effective GBM therapeutic options are urgently needed. Hence, we screened a large multi-class drug panel comprising the NIH clinical collection (NCC) that includes 446 FDA-approved drugs, with the goal of identifying new GBM therapeutics for rapid entry into clinical trials for GBM. Methods Screens using human GBM cell lines revealed 22 drugs with potent anti-GBM activity, including serotonergic blockers, cholesterol-lowering agents (statins), antineoplastics, anti-infective, anti-inflammatories, and hormonal modulators. We tested the 8 most potent drugs using patient-derived GBM cancer stem cell-like lines. Notably, the statins were active in vitro; they inhibited GBM cell proliferation and induced cellular autophagy. Moreover, the statins enhanced, by 40-70 fold, the pro-apoptotic activity of irinotecan, a topoisomerase 1 inhibitor currently used to treat a variety of cancers including GBM. Our data suggest that the mechanism of action of statins was prevention of multi-drug resistance protein MDR-1 glycosylation. This drug combination was synergistic in inhibiting tumor growth in vivo. Compared to animals treated with high dose irinotecan, the drug combination showed significantly less toxicity. Results Our data identifies a novel combination from among FDA-approved drugs. In addition, this combination is safer and well tolerated compared to single agent irinotecan. Conclusions Our study newly identifies several FDA-approved compounds that may potentially be useful in GBM treatment. Our findings provide the basis for the rational combination of statins and topoisomerase inhibitors in GBM. PMID:24433351

2014-01-01

395

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

396

Adaptive fuzzy sliding mode control of smart structures  

NASA Astrophysics Data System (ADS)

Smart structures are usually designed with a stimulus-response mechanism to mimic the autoregulatory process of living systems. In this work, in order to simulate this natural and self-adjustable behavior, an adaptive fuzzy sliding mode controller is applied to a shape memory two-bar truss. This structural system exhibits both constitutive and geometrical nonlinearities presenting the snap-through behavior and chaotic dynamics. On this basis, a variable structure controller is employed for vibration suppression in the chaotic smart truss. The control scheme is primarily based on sliding mode methodology and enhanced by an adaptive fuzzy inference system to cope with modeling inaccuracies and external disturbances. The robustness of this approach against both structured and unstructured uncertainties enables the adoption of simple constitutive models for control purposes. The overall control system performance is evaluated by means of numerical simulations, promoting vibration reduction and avoiding snap-through behavior.

Bessa, W. M.; de Paula, A. S.; Savi, M. A.

2013-09-01

397

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

398

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.

399

Isotretinoin and inflammatory bowel disease: trial lawyer misuse of science and FDA warnings.  

PubMed

Based on the Food and Drug Administration Adverse Event Reporting System (FAERS), the FDA and Hoffman La Roche issued warnings of a possible causal association between isotretinoin and inflammatory bowel disease. While scientists studied the association, trial lawyers used the courts to award large sums of money to plaintiffs despite the absence of clear scientific evidence of a causal effect. In this Issue of the Journal, a well-designed, large pharmaco-epidemiologic study shows no association. The story of isotretinoin highlights the problems that occur when the FAERS is used in litigation prior to further study and scientific analysis. PMID:24698863

Tenner, Scott

2014-04-01

400

A sliding cell technique for diffusion measurements in liquid metals  

SciTech Connect

The long capillary and shear cell techniques are the usual methods for diffusion measurements in liquid metals. Here we present a new “sliding cell technique” to measure interdiffusion in liquid alloys, which combines the merits of these two methods. Instead of a number of shear cells, as used in the shear cell method, only one sliding cell is designed to separate and join the liquid diffusion samples. Using the sliding cell technique, the influence of the heating process (which affects liquid diffusion measurements in the conventional long capillary method) can be eliminated. Time-dependent diffusion measurements at the same isothermal temperature were carried out in Al-Cu liquids. Compared with the previous results measured by in-situ X-ray radiography, the obtained liquid diffusion coefficient in this work is believed to be influenced by convective flow. The present work further supports the idea that to obtain accurate diffusion constants in liquid metals, the measurement conditions must be well controlled, and there should be no temperature gradients or other disturbances.

Geng, Yongliang; Zhu, Chunao; Zhang, Bo, E-mail: bo.zhang@hfut.edu.cn [School of Material Science and Engineering, Hefei University of Technology, Hefei 230009 (China) [School of Material Science and Engineering, Hefei University of Technology, Hefei 230009 (China); Anhui Provincial Key Lab of Advanced Functional Materials and Devices, Hefei University of Technology, Hefei 230009 (China)

2014-03-15

401

Aerospace Materials Quality Control Presentation  

NSDL National Science Digital Library

This PowerPoint document from the Aerospace Manufacturing Education Project looks into the topic of quality control of materials used in the aerospace industry. The presentation includes 27 slides and covers why quality control is important in this field. It also includes details about aerospace QC teams and techniques, including non-destructive testing.

402

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

403

Stereoscopic Projection of 35mm Slides.  

ERIC Educational Resources Information Center

Describes ways of projecting stereoscopic images of geologic environments for students with difficulty reasoning in three-dimensions. The photographic procedures needed to produce stereo slides are included. (MA)

Carey, Edward F.

1978-01-01

404

TITLE SLIDE DESIGN? Lessons learned from the  

E-print Network

1 · TITLE SLIDE DESIGN? Lessons learned from the cyber infrastructure for microbiologist · Cruise planning: Where can we find the ETM? Where can we find the edge of the plume? Forecasts have become powerful tools for guiding ship

405

Superlubric sliding of graphene nanoflakes on graphene.  

PubMed

The lubricating properties of graphite and graphene have been intensely studied by sliding a frictional force microscope tip against them to understand the origin of the observed low friction. In contrast, the relative motion of free graphene layers remains poorly understood. Here we report a study of the sliding behavior of graphene nanoflakes (GNFs) on a graphene surface. Using scanning tunneling microscopy, we found that the GNFs show facile translational and rotational motions between commensurate initial and final states at temperatures as low as 5 K. The motion is initiated by a tip-induced transition of the flakes from a commensurate to an incommensurate registry with the underlying graphene layer (the superlubric state), followed by rapid sliding until another commensurate position is reached. Counterintuitively, the average sliding distance of the flakes is larger at 5 K than at 77 K, indicating that thermal fluctuations are likely to trigger their transitions from superlubric back to commensurate ground states. PMID:23327483

Feng, Xiaofeng; Kwon, Sangku; Park, Jeong Young; Salmeron, Miquel

2013-02-26

406

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

407

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.

408

"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

409

An adaptive supervisory sliding fuzzy cerebellar model articulation controller for sensorless vector-controlled induction motor drive systems.  

PubMed

This paper presents the implementation of an adaptive supervisory sliding fuzzy cerebellar model articulation controller (FCMAC) in the speed sensorless vector control of an induction motor (IM) drive system. The proposed adaptive supervisory sliding FCMAC comprised a supervisory controller, integral sliding surface, and an adaptive FCMAC. The integral sliding surface was employed to eliminate steady-state errors and enhance the responsiveness of the system. The adaptive FCMAC incorporated an FCMAC with a compensating controller to perform a desired control action. The proposed controller was derived using the Lyapunov approach, which guarantees learning-error convergence. The implementation of three intelligent control schemes-the adaptive supervisory sliding FCMAC, adaptive sliding FCMAC, and adaptive sliding CMAC-were experimentally investigated under various conditions in a realistic sensorless vector-controlled IM drive system. The root mean square error (RMSE) was used as a performance index to evaluate the experimental results of each control scheme. The analysis results indicated that the proposed adaptive supervisory sliding FCMAC substantially improved the system performance compared with the other control schemes. PMID:25815450

Wang, Shun-Yuan; Tseng, Chwan-Lu; Lin, Shou-Chuang; Chiu, Chun-Jung; Chou, Jen-Hsiang

2015-01-01

410

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

411

Smokers' reactions to FDA regulation of tobacco products: Findings from the 2009 ITC United States survey  

PubMed Central

Background On June 22, 2009, the US FDA was granted the authority to regulate tobacco products through the Family Smoking Prevention and Tobacco Control Act (FSPTCA). The intent is to improve public health through regulations on tobacco product marketing and tobacco products themselves. This manuscript reports baseline data on smokers' attitudes and beliefs on specific issues relevant to the FSPTCA. Method Between November 2009 and January 2010, a telephone survey among a nationally representative sample of n = 678 smokers in the US was performed as part of the International Tobacco Control (ITC) United States Survey. Participants answered a battery of questions on their attitudes and beliefs about aspects of the FSPTCA. Results Most smokers were unaware of the new FDA tobacco regulations. Smokers indicated support for banning cigarette promotion and nearly a quarter supported requiring tobacco companies to sell cigarettes in plain packaging. Seventy two percent of smokers supported reducing nicotine levels to make cigarettes less addictive if nicotine was made easily available in non-cigarette form. Conclusion Most smokers were limited in their understanding of efforts to regulate tobacco products in general. Smokers were supportive of efforts to better inform the public about health risks, restrict advertising, and make tobacco products less addictive. PMID:22177316

2011-01-01

412

FDA News Release: Approval of Irradiation of Meat for Pathogen Control  

NSDL National Science Digital Library

Previously approved for use on poultry and fruits and vegetables in the US, irradiation can kill disease-causing bacteria like Salmonella and Escherichia coli 0157:H7 (discussed in the Scout Report for Science and Engineering's In the News section, September 17, 1997), and molds and funguses that cause rot. With recent US Food and Drug Administration (FDA) approval, irradiation can now be used to process red meat (e.g., beef, pork, lamb, and byproducts). The process involves exposing food to a source of radiation such as gamma rays from radioactive cobalt 60, cesium 137, or x-rays. No radioactive material is added to the product, and the technique is routinely used on grains and spices, as well as for sterilizing disposable medical devices. In spite of a number of tests conducted over the last 30 years substantiating its safety, irradiation has not gained widespread public acceptance in the US. This is largely due to the public's general fear of processes utilizing radiation. Supporters of the technology claim that it will virtually eliminate food-borne illness in the US, while skeptics feel that technology such as steam treatment can accomplish adequate sterilization without the purported risks and public concern associated with irradiation. The US Food and Drug Administration (FDA) News Release contains the Agency's brief statement outlining its policy.

United States. Food and Drug Administration.

1997-01-01

413

Evaluation of FDA licensed HIV assays using plasma from Cameroonian blood donors.  

PubMed

Several diagnostic assays for the detection of HIV infection have been approved and licensed by the FDA for blood donor screening. However, the performance of these assays is unknown when testing genetically divergent blood specimens. To evaluate the performance of these assays with diverse HIV strains, we chose to study specimens collected from blood donors in Cameroon where genetic diversity and recombinant variants are prevalent. In this study, we tested 240 human plasma specimens collected from two blood centers in Cameroon. These samples were screened initially in Cameroon for antibody to HIV using a rapid assay. We also performed sequencing to determine subtype. Our evaluation has demonstrated that HIV infection in most HIV plasma samples could be detected by most of the US FDA licensed diagnostic assays. With the exception of a few specimens, HIV-1 p24 antigen was not detected in any of the samples. In addition, some nucleic acid tests (NAT) assays were not able to detect a few serologic reactive samples and all new variants including some CRF02_AG variants. PMID:16622873

Lee, Sherwin; Hu, Jinjie; Tang, Shixing; Wood, Owen; Francis, Kori; Machuca, Ana; Rios, Maria; Daniel, Sylvester; Vockley, Christopher; Awazi, Bih; Zekeng, Leopold; Hewlett, Indira

2006-01-01

414

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

415

Virtual slide telepathology with scanner systems for intraoperative frozen-section consultation.  

PubMed

Telepathology provides pathology services over a distance using digital imaging and telecommunication for primary diagnostic practice, including intraoperative frozen sections. Virtual slide technology provides digitizing of histological slides by scanner systems and improved remote assessment substantially. In this retrospective study, diagnostic accuracy of intraoperative frozen sections assessed as virtual slide was determined. Tissue assessment was mainly requested for urological, gynecological and dermatological resections. Issues of time consumption, cost and cost effectiveness of this diagnostic method are discussed. 1204 intraoperative frozen sections were conducted in the course of this study at our department over a period of 2.5 years. 98.59% of all intraoperative frozen sections were accurately diagnosed in the initial telepathological assessment. Tumor affection was present in 15.6% of frozen sections, in 174 instances already assessed in the initial slides (sensitivity 92.6%). Discrepant diagnoses compared to the final diagnosis occurred in 1.41%. Our determined averaged time for virtual slide technology of 10.58±8.19min can be ranged in well. Our study did not allow a full economic assessment, but some preliminary insights are pointed out. The quality of services is highly acceptable and the investment costs and the labor cost of virtual slide technology are lower than those of robotic microscopy. PMID:24674453

Ribback, Silvia; Flessa, Steffen; Gromoll-Bergmann, Katrin; Evert, Matthias; Dombrowski, Frank

2014-06-01

416

Universal fuzzy integral sliding-mode controllers for stochastic nonlinear systems.  

PubMed

In this paper, the universal integral sliding-mode controller problem for the general stochastic nonlinear systems modeled by Itô type stochastic differential equations is investigated. One of the main contributions is that a novel dynamic integral sliding mode control (DISMC) scheme is developed for stochastic nonlinear systems based on their stochastic T-S fuzzy approximation models. The key advantage of the proposed DISMC scheme is that two very restrictive assumptions in most existing ISMC approaches to stochastic fuzzy systems have been removed. Based on the stochastic Lyapunov theory, it is shown that the closed-loop control system trajectories are kept on the integral sliding surface almost surely since the initial time, and moreover, the stochastic stability of the sliding motion can be guaranteed in terms of linear matrix inequalities. Another main contribution is that the results of universal fuzzy integral sliding-mode controllers for two classes of stochastic nonlinear systems, along with constructive procedures to obtain the universal fuzzy integral sliding-mode controllers, are provided, respectively. Simulation results from an inverted pendulum example are presented to illustrate the advantages and effectiveness of the proposed approaches. PMID:24718584

Gao, Qing; Liu, Lu; Feng, Gang; Wang, Yong

2014-12-01

417

FDA perspective on objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia.  

PubMed

The article by Conte et al.(1) on behalf of the Society for Vascular Surgery (SVS) in this issue of the Journal of Vascular Surgery provides guidelines for improving the consistency and interpretability of clinical trials intended to evaluate treatment options for patients with critical limb ischemia (CLI). This article identifies a number of key challenges with conducting and comparing CLI trials, including the wide spectrum of clinical presentations that CLI encompasses, the use of disparate eligibility criteria and endpoint measurements, and logistical and economic considerations that can limit study initiation and completion. The authors propose definitions for a number of performance goals derived from historical surgical literature as a means of reducing the negative impact of these factors. The current editorial reviews aspects of this proposal from the perspective of the authors in terms of their understanding of the statutory obligations of the U.S. Food and Drug Administration (FDA) to regulate the marketing of cardiovascular devices based on valid scientific evidence. PMID:19897334

Kumar, Allison; Brooks, Steven S; Cavanaugh, Kenneth; Zuckerman, Bram

2009-12-01

418

Devil's Slide: An evolving feature of California's coastal landscape  

NASA Astrophysics Data System (ADS)

Coastal landslides in the United States remain a persistent threat to human life and urban development. The focus of this study is a landslide-prone section of the central California coastline, approximately 20 km south of San Francisco, known as Devil's Slide. This investigation employs an extensive aerial image inventory, digital elevation models (DEMs), and a water balance / limit-equilibrium approach to better understand the spatial and temporal characteristics of deep-seated bedrock slides at the site. Photographic surveys of the area reveal nearly three kilometers of headscarp and a complex network of slope failures that respond to hydrologic, seismic, and anthropogenic perturbations. DEM analysis suggests that, for a 145-year period (1866 to 2010), the study area experienced an average coastal retreat rate of 0.14 m yr-1 and an average volumetric loss of 11,216 m3 yr-1. At least 38% of the landscape evolution in the steep coastal terrain has been driven by slope failure events. A loosely coupled water balance / limit-equilibrium analysis quantitatively illustrates the precarious nature of the active landslide zone at the site. The slope is shown to be unstable for a large suite of equally-likely scenarios. The analyses presented herein suggest that future work should include a rigorous characterization of pore-water pressure development, driven by comprehensive simulations of subsurface hydrologic response, to improve our understanding of slope failure initiation at the Devil's Slide site.

Thomas, M.; Loague, K.

2013-12-01

419

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

420

Synthetic Biology Slides by Daisuke KigaSlides by Daisuke Kiga  

E-print Network

(100kB) encodes components for autonomous transcription, translation, and replication massive DNA #12; DNA RNA DNA DNA #12; DNA RNA DNA DNA #12; DNA RNA DNA DNA #12; DNA RNA #12;Synthetic Biology Slides by Daisuke KigaSlides by Daisuke Kiga #12;Two

Hagiya, Masami

421

FDA-approved biosimilar insulin: good enough for critical care, adulterated, or counterfeit? How can we tell?  

PubMed

If a biosimilar insulin is discovered postmarketing to be subpotent, superpotent, or contaminated or the contents mislabeled, it is an adulterated product and must be quarantined for removal including from a patient's home. Adulterated products could be considered "counterfeit" since they do not meet the original standards established by the FDA. The FDA must establish a method of regularly assaying samples of biosimilar insulin drawn directly from the supply pipeline to help ensure patient safety and evaluate clinical performance. Independent groups without conflict of interest would perform confidential comparison assay. For less than 5 cents per vial/pen, manufacturers could easily support an independent, FDA-recognized, random sample program and create a functional postmarket surveillance system that better protects the public and the manufacturer from undesired outcomes. PMID:25172881

Carter, Alan W

2014-09-01

422

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

423

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

424

US Definitions, Current Use, and FDA Stance on Use of Platelet-Rich Plasma in Sports Medicine.  

PubMed

With increased utilization of platelet-rich plasma (PRP), it is important for clinicians to understand the United States, the Food and Drug Administration (FDA) regulatory role and stance on PRP. Blood products such as PRP fall under the prevue of FDA's Center for Biologics Evaluation and Research (CBER). CBER is responsible for regulating human cells, tissues, and cellular and tissue-based products. The regulatory process for these products is described in the FDA's 21 CFR 1271 of the Code of Regulations. Under these regulations, certain products including blood products such as PRP are exempt and therefore do not follow the FDA's traditional regulatory pathway that includes animal studies and clinical trials. The 510(k) application is the pathway used to bring PRP preparation systems to the market. The 510(k) application allows devices that are "substantially equivalent" to a currently marketed device to come to the market. There are numerous PRP preparation systems on the market today with FDA clearance; however, nearly all of these systems have 510(k) clearance for producing platelet-rich preparations intended to be used to mix with bone graft materials to enhance bone graft handling properties in orthopedic practices. The use of PRP outside this setting, for example, an office injection, would be considered "off label." Clinicians are free to use a product off-label as long as certain responsibilities are met. Per CBER, when the intent is the practice of medicine, clinicians "have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects." Finally, despite PRP being exempted, the language in 21 CFR 1271 has caused some recent concern over activated PRP; however to date, the FDA has not attempted to regulate activated PRP. Clinicians using activated PRP should be mindful of these concerns and continued to stay informed. PMID:25268794

Beitzel, Knut; Allen, Donald; Apostolakos, John; Russell, Ryan P; McCarthy, Mary Beth; Gallo, Gregory J; Cote, Mark P; Mazzocca, Augustus D

2015-02-01

425

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

426

Resistance to Sliding on Atomic Scales  

NASA Technical Reports Server (NTRS)

The structure and stability of agglomerates of micron-sized particles is determined by the mechanical properties of the individual contacts between the constituent particles. In this paper we study the possibility of aggregate rearrangements by sliding. Since the contacts between (sub)micron particles are only a few hundred atoms in diameter, processes on atomic levels will play the dominating roll. We study a theoretical model of sliding friction for surfaces that are either flat or contain steps in their grids. The results show that sliding over flat surfaces may produce a large range of friction coefficients, including zero if the adhesive forces are small compared to the binding forces inside a body. However, both grid alignment and steps in the surface will lead to high values for friction. These processes combined virtually eliminate the possibility of sliding in a collision of two (sub)micron sized particles at velocities low enough for sticking to occur. On the other hand we show that in collisions between aggregates sliding may be an important factor for energy dissipation and compaction.

Dominik, C.; Tielens, A.; Cuzzi, Jeffrey (Technical Monitor)

1995-01-01

427

The Effects of the FDA Warning on the Use of Droperidol by U.S. Emergency Physicians  

PubMed Central

Objectives: To determine if emergency physicians’ (EP) use of droperidol has changed since the United States Food and Drag Administration (FDA) warning of December 2001 concerning QT interval prolongation, torsade de pointes, and sudden death; and to query EP opinions regarding droperidol before and after the FDA warning and regarding potential alternative drugs. Methods: An internet-based survey was designed with questions regarding droperidol use in the emergency department (ED). Data collected included EP demographics, use of droperidol before and after the FDA warning, use of alternative drugs, and incidence of arrhythmias. A representative sample of EPs were contacted by e-mail and asked to complete the survey. Results: A total of 2,000 e-mails resulted in 506 (25%) completed surveys. There was no second mailing. Responders’ average years practicing was 12.6 ± 9.2. EP responders worked in private/community (n=278, 55%), academic/county (n=187, 37%), and HMO (n=41, 8%) hospitals. The. majority (n=455, 90%) used droperidol and were aware of the FDA warning (n=460, 91%). Droperidol was no longer available at 122 (24%) of the respondents’ EDs as a result of the FDA warning. Prior to the FDA warning, EPs who had used droperidol used it as an antiemetic (n=408, 90%), for control of agitation (n=330, 73%), for treatment of headache (n=247, 54%), and for treatment of vertigo (n=106, 23%). After the FDA warning, 387 (85%) of EPs reported their use of droperidol had decreased or ceased altogether, and 68 (15%) always obtained an electrocardiogram prior to administration. Of those who used droperidol for agitation, 137 (42%) felt there were no other drugs with greater efficacy. Haloperidol was the most cited alternative agent (n=260, 79%) followed by benzodiazepines (n=223, 68%). Of those who used droperidol for antiemesis, 116 (28%) felt there were no other drugs with greater efficacy than droperidol; promethazine was the most cited alternative agent (n=260, 64%). Two (0.4%) EPs reported arrhythmias in patients who received droperidol. Only 37 (8%) EPs reported they were unconcerned with potential loss of droperidol from the market. Conclusion: Based on this survey, EP use of droperidol has decreased dramatically as a result of the FDA warning. However, EPs believe that there are few or no alternative antiemetic drugs that have an improved adverse effect profile. PMID:20852711

Richards, John R.; Weiss, Steven J.; Bretz, Stephen W.; Schneir, Aaron B.; Rinetti, Dauna; Derlet, Robert W.

2003-01-01

428

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; Massó, Joan; Mińano, Borja; Bona, Carles

2014-01-01

429

Catalyzing the Critical Path Initiative: FDA's progress in drug development activities.  

PubMed

The US Food and Drug Administration (FDA) has directed considerable effort towards modernizing its regulatory processes over the past decade to address the challenges in the drug development sector. Through partnerships and input from stakeholders, multiple initiatives are under way, many projects have been launched, several have resulted in tangible results, and many are ongoing and under discussion. We are learning that collaborative efforts can better inform and leverage existing knowledge, that the challenges of data sharing and intellectual property can be overcome, and that there is wide interest in partnering to address key public health regulatory science issues. It is crucial that we continue to build on these initial efforts to facilitate drug development. PMID:25670629

Parekh, A; Buckman-Garner, S; McCune, S; ONeill, R; Geanacopoulos, M; Amur, S; Clingman, C; Barratt, R; Rocca, M; Hills, I; Woodcock, J

2015-03-01

430

A Case Study of the Evolving Software Architecture for the FDA Generic Drug Application Process  

PubMed Central

This primary goal of this project was to develop a software architecture to support the Food and Drug Administration (FDA) generic drug application process by making it more efficient and effective. The secondary goal was to produce a scalable, modular, and flexible architecture that could be generalized to other contexts in interorganizational health care communications. The system described here shows improvements over the old system for the generic drug application process for most of the defined design objectives. The modular, flexible design that produced this new system offers lessons for the general design of distributed health care information systems and points the way to robust application frameworks that will allow practical development and maintenance of a distributed infrastructure. PMID:9760391

Canfield, Kip; Ritondo, Michele; Sponaugle, Richard

1998-01-01

431

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

432

Synergy Testing of FDA-Approved Drugs Identifies Potent Drug Combinations against Trypanosoma cruzi  

PubMed Central

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

Ranade, Ranae M.; Don, Robert; Buckner, Frederick S.

2014-01-01

433

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

434

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

435

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

436

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

437

Could FDA approval of pre-exposure prophylaxis make a difference? A qualitative study of PrEP acceptability and FDA perceptions among men who have sex with men  

PubMed Central

The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while others perceived approval as irrelevant or less significant than other sources of information. Our results suggest that FDA approval sends a signal that directly shapes PrEP acceptability among some MSM, while indirect influences of approval may affect uptake by others. Efforts to educate MSM about PrEP can increase acceptability by incorporating information about FDA approval, and outreach strategies should consider how this information may factor into personal decisions about PrEP use. PMID:23673790

Underhill, Kristen; Morrow, Kathleen M.; Operario, Don; Mayer, Kenneth H.

2013-01-01

438

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

439

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

440

Slide Set - Unit 4 - 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

441

Slide Set - Unit 6 - 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

442

Slide Set - Unit 9 - 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

443

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

444

Slide Set - Unit 8 - 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

445

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

446

7 CFR 3201.73 - Slide way lubricants.  

Code of Federal Regulations, 2013 CFR

...FEDERAL PROCUREMENT Designated Items § 3201.73 Slide way lubricants. (a) Definition. Products used to provide lubrication and eliminate stick-slip and table chatter by reducing friction between mating surfaces, or slides, found in...

2013-01-01

447

7 CFR 3201.73 - Slide way lubricants.  

Code of Federal Regulations, 2012 CFR

...FEDERAL PROCUREMENT Designated Items § 3201.73 Slide way lubricants. (a) Definition. Products used to provide lubrication and eliminate stick-slip and table chatter by reducing friction between mating surfaces, or slides, found in...

2012-01-01

448

Linear-Grating Triboelectric Generator Based on Sliding Electrification  

E-print Network

surfaces of opposite triboelectric polarities generates uncompensated surface triboelectric charges: Electrification, triboelectric generator, sliding, energy harvesting The triboelectric effect is a type of chargeLinear-Grating Triboelectric Generator Based on Sliding Electrification Guang Zhu,,§ Jun Chen

Wang, Zhong L.

449

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.

450

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

451

"PowerPoint": Just Another Slide Show or a Useful Learning Aid?  

ERIC Educational Resources Information Center

Extols the virtues of PowerPoint as a teaching aid yet cautions against inappropriate use of it which may cause students to learn very little. Explains a number of features of slide preparation and presentation techniques that enable teachers to give effective lessons. Includes examples of PowerPoint presentations. (Author/NB)

Parkinson, John; Hollamby, Peter

2003-01-01

452

Chattering analysis in sliding mode systems with inertial sensors  

Microsoft Academic Search

Singularly-perturbed relay control systems with 2nd-order sliding modes (SP2SM) are considered for modeling sliding-mode control systems with inertial sensors. It is shown that the asymptotically stable slow-motions integral manifold (ASSMIM) of a smooth singularly-perturbed system, describing the motion of the original SP2SM in the 2nd-order sliding domain, is the ASSMIM of the original SP2SM. For sliding-mode control systems with inertial

Leonid M. Fridman

2001-01-01

453

Projecting a Better Image: Slides and the Foreign Language Teacher. CAL-ERIC/CLL Series on Languages and Linguistics, No. 48.  

ERIC Educational Resources Information Center

This handbook demonstrates how to make and present travel slides for the language and culture course with maximum effectiveness. There are six basic rules for the teacher to follow: (1) fill the frame; (2) suppress your ego; keep yourself and your relatives out of your picture; (3) leave the audience wishing for more slides, not fewer; (4) vary…

Galt, Alan

454

Inhomogeneity problem with a sliding interface under remote shearing stress  

NASA Astrophysics Data System (ADS)

The problem of an ellipsoidal inhomogeneity embedded in an infinitely extended elastic medium with sliding interfaces is investigated. An exact solution is presented for such an inhomogeneous system that is subject to remote uniform shearing stress. Both the elastic inclusion and matrix are considered isotropic with a separate elastic modulus. Based on Lur'e's approach to solving ellipsoidal cavity problems through Lamé functions, several harmonic functions are introduced for Papkovich-Neuber displacement potentials. The displacement fields inside and outside the ellipsoidal inclusion are obtained explicitly, and the stress field in the whole domain is consequently determined.

Zhao, YingTao; Gao, Yang; Wang, MinZhong

2012-11-01

455

Typical variability in drug dissolution testing: study with USP and FDA calibrator tablets and a marketed drug (glibenclamide) product  

Microsoft Academic Search

To evaluate variability in drug dissolution testing 28 laboratories analyzed USP calibrators, US FDA prednisone tablets and a marketed glibenclamide tablet product. The experiments were conducted using paddle and basket methods at 50 (calibrators) and 75 (glibenclamide) rpm. The media employed were deaerated by equilibrating at 37°C for 24 h and by the USP recommended method. The 95% CI values

Saeed A Qureshi; Iain J McGilveray

1999-01-01

456

Adequacy of FDA'S Prescription to over-the-Counter Switch Criteria in Physician Evaluation of Proposed Switches of Drug Products  

Microsoft Academic Search

Futurists have forecast that, by the turn of the century, a majority of today's prescription drugs will be switched to over-the-counter (OTC) status. Currently, the Food and Drug Administration (FDA) evaluates potential switch candidates primarily using safety, effectiveness, and labeling criteria. These criteria may not be adequate because of the reported mishaps associated with OTC drug use. The criteria implicitly

Suresh Madhavan

1994-01-01

457

The FDA's decision-making process: isn't it time to temper the principle of protective paternalism?  

PubMed

The authors conducted a well-designed, multinational, large study of women younger than 65 yr of age with irritable bowel syndrome (IBS) with a mixed pattern of diarrhea and constipation (IBS-M) or constipation (IBS-C) and showed that a statistically greater percentage of patients in each group responded to tegaserod compared with patients treated with placebo. Practicality looms large, however, in that the Food and Drug Administration (FDA) disallowed the continued marketing of tegaserod because of cardiovascular safety concerns, and it now is only available under a restricted access program. The wisdom of this decision aside, it is disturbing that the FDA revealed a zero-tolerance for any significant risk of disease when a drug (e.g., tegaserod) was used for a nonlife-threatening condition; the FDA chose to neglect any potential benefit of significant improvement in quality of life, while at the same time allowing the continued availability of sildenifil for erectile dysfunction and other medications (e.g., rosiglitazone and nonsteroidal anti-inflammatory drugs [NSAIDs]), each with a far greater risk of cardiovascular complications. Whether tegaserod will be re-released and, if so, under what conditions, is yet to be determined, as is the question of whether the FDA will decide to allow a more transparent decision-making process with input from all interested parties affected by their decision. PMID:18477347

Brandt, Lawrence J

2008-05-01

458

The FDA, contraceptive marketing approval and products liability litigation: Depo-Provera and the risk of osteoporosis.  

PubMed

The FDA approved Depo-Provera, an injectable contraceptive, in 1992 on the condition that its manufacturer conduct a post-approval study on the risk ofosteoporosis. Then in 2004, the agency revised the drug's labeling to include a boxed (i.e. Black Box) Warning on the risk ofosteoporosis. This article will analyze the FDA's Depo-Provera approval and label revision process: the agency's acceptance of Upjohn's New Drug Application, its Fertility and Maternal Health Advisory Committee's review of the human clinical studies and approval recommendation, its marketing approval of Depo-Provera, and its 2004 drug labeling revision. Then the article will analyze the post-2004 products liability litigation by women who claimed to have been injured by their use of the drug. None of the cases have survived the manufacturer's summary judgment motions, because the women have been unable to establish by expert and physician evidence that the FDA-approved labeling was inadequate to inform their physicians of the risk of osteoporosis, that the inadequate warnings caused their osteoporosis or osteopenia, and that these are compensable injuries. As a result, the manufacturer has been able to use the FDA labeling, state products liability law, and the learned intermediary doctrine to avoid liability. The conclusion will consider the lessons of these products liability cases for other women who have received Depo-Provera and suffered bone mineral density loss. PMID:24640465

Green, William

2013-01-01

459

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

460

Regulatory perspectives and research activities at the FDA on the use of phantoms with in vivo diagnostic devices  

NASA Astrophysics Data System (ADS)

For a number of years, phantoms have been used to optimize device parameters and validate performance in the primary medical imaging modalities (CT, MRI, PET/SPECT, ultrasound). Furthermore, the FDA under the Mammography Quality Standards Act (MQSA) requires image quality evaluation of mammography systems using FDA-approved phantoms. The oldest quantitative optical diagnostic technology, pulse oximetry, also benefits from the use of active phantoms known as patient simulators to validate certain performance characteristics under different clinically-relevant conditions. As such, guidance provided by the FDA to its staff and to industry on the contents of pre-market notification and approval submissions includes suggestions on how to incorporate the appropriate phantoms in establishing device effectiveness. Research at the FDA supports regulatory statements on the use of phantoms by investigating how phantoms can be designed, characterized, and utilized to determine critical device performance characteristics. These examples provide a model for how novel techniques in the rapidly growing field of optical diagnostics can use phantoms during pre- and post-market regulatory testing.

Agrawal, Anant; Gavrielides, Marios A.; Weininger, Sandy; Chakrabarti, Kish; Pfefer, Joshua

2008-02-01

461

Slide Libraries: A Guide for Academic Institutions and Museums.  

ERIC Educational Resources Information Center

This is a manual for slide (transparency) libraries and a review of procedures in many libraries across the country. Within the book can be found a background of slide librarianship and a description of administration and staffing procedures and organization. The classification and cataloging of slides is detailed with descriptions of the systems…

Irvine, Betty Jo

462

ccsd00000893 Sliding Friction at a Rubber/Brush Interface  

E-print Network

ccsd­00000893 (version 1) : 28 Nov 2003 Sliding Friction at a Rubber/Brush Interface Lionel Bureau(dimethylsiloxane) (PDMS) rubber network sliding, at low velocity, on a substrate on which PDMS chains are end-tethered. We studied the behaviour of such rubber/brush interfaces at high sliding velocities and showed

463

Mitosis Extraction in Breast-Cancer Histopathological Whole Slide Images  

E-print Network

histological whole slide im- ages. The proposed segmentation uses a multi-resolution approach which reproduces rate appraisal. If the advent of such digital whole slide scanners has triggered a revolution in literature have considered the processing of whole slide images and most of these works rely only on machine

Lezoray, Olivier

464

New approach to chattering analysis in systems with sliding modes  

Microsoft Academic Search

A chattering phenomenon as a low frequency oscillation in systems with sliding modes is analyzed via the describing functions technique. It is proposed to design a sliding surface to provide the passivity condition to the open loop dynamics of a modeled plant. It is shown that first order stable lag unmodeled dynamics does not imply chattering in a real sliding

Yuri B. Shtessel; Young-Ju Lee

1996-01-01

465

May 2012 Sorting Networks Slide 1 Sorting Networks  

E-print Network

2012 #12;May 2012 Sorting Networks Slide 3 Railroad Tracks and Switches #12;May 2012 Sorting Networks;May 2012 Sorting Networks Slide 5 Railroad Yards Have Many Tracks and Switches #12;May 2012 Sorting Station and Its Siding #12;May 2012 Sorting Networks Slide 8 Model Railroad YardModel Railroad Yard

Liebling, Michael

466

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

467

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

Ańez, Germán

2014-01-01

468

Proceedings From FDA/A.S.P.E.N. Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products, October 29, 2013.  

PubMed

The development of intravenous fat emulsion (IVFE) is the culmination of physiological, biochemical, nutritional, and medical scientific advancements. IVFEs have the ability to deliver critical nutritional substrates to the patient. Recent literature purports that they may also play roles in modulation of immune functionality and pulmonary physiology, but data supporting these potential benefits are limited. While soybean-based IVFEs have comprised the dominant fat in U.S. markets, a number of other novel IVFEs may prove to optimize the care of children and adults in both hospitalized and home settings. The October 2013 U.S. Food and Drug Administration (FDA)/American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Public Workshop brought together scientists, researchers, and clinical experts to present updated clinical perspectives of IVFEs, including historical development, current state of usage throughout the world, and considerations for the regulatory approval of new IVFEs in the United States. PMID:25475623

Teitelbaum, Daniel H; Guenter, Peggi; Griebel, Donna; Abrams, Steven A; Bark, Staffan; Baker, Mary; Berry, Karyn L; Bistrian, Bruce R; Brenna, J Thomas; Bonnot, Denis; Carpentier, Yvon A; Deckelbaum, Richard J; Hise, Mary; Koletzko, Berthold; Mirtallo, Jay M; Mulberg, Andrew E; O'Reilly, Randall C; Shaffer, Jonathan; von Kleist, Elke; Zaloga, Gary P; Ziegler, Thomas R

2014-12-01

469

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

470

A PSO-Based Neuro-Sliding Mode Controller for the Stability Enhancement of Power Systems with UPFC  

Microsoft Academic Search

This paper presents a particle swarm optimization (PSO)-based neuro-sliding mode controller for the transient stability enhancement of multimachine power systems with unified power flow controller (UPFC). The UPFC is modeled as controllable loads. These controllable parameters are obtained using the sliding mode control (SMC) strategy. A PSO-based single neuron controller is used to adapt the parameters of the SMC. The

STELLA MORRIS; P. K. DASH; EZRA MORRIS

471

Discrete-time passivity-based sliding-mode control of single-phase current-source inverter  

Microsoft Academic Search

This paper presents a novel discrete-time passivity-based sliding-mode control (PB-SMC) strategy which has been applied to control the current-source inverter (CSI). The proposed control strategy is obtained by combining sliding-mode control (SMC) with passivity-based control (PBC), which not only maintains the good robustness and dynamic performances of the two control methods, but also reduces the chattering problem and overshoot. Based

Hao Ma; Fei Xu; Li Du; Xuebing Chen

2009-01-01

472

Dynamic Programming Slides by Kevin Wayne.  

E-print Network

1 Chapter 6 Dynamic Programming Slides by Kevin Wayne. Copyright © 2005 Pearson-Addison Wesley. All-problem independently, and combine solution to sub-problems to form solution to original problem. Dynamic programming and larger sub-problems. 3 Dynamic Programming History Bellman. Pioneered the systematic study of dynamic

Kosecka, Jana

473

Sliding thermoelastodynamic instability BY L. AFFERRANTE  

E-print Network

-like materials (Barquins et al. 1996), the generation of noise and vibration in automotive brakes (Kincaid et al. These can generally be characterized as either elastodynamic (e.g. `brake squeal') or thermoelastic in more complex practical sliding systems such as brakes and clutches, implying the need

Daly, Samantha

474

Slide #1CENTER FOR INTEGRATED ACCESS NETWORKS  

E-print Network

James Clerk Maxwell (1831­1879) #12;Slide #9CENTER FOR INTEGRATED ACCESS NETWORKS Maxwell's equations All-time top ten: 1. Albert Einstein 2. Isaac Newton 3. James Clerk Maxwell 4. Niels Bohr 5. Werner propagation Outline: · Maxwell's equations · Wave equation · Boundary conditions · Wave propagation through

Kieu, Khanh

475

Bruce Jacob SLIDE 1 Sensing, Actuation, Control  

E-print Network

.g. disk) · Manual activation · Separate hydraulic networks (per brake or per opposite pair) · Additional Power Brakes (e.g. disk) · Manual activation · Separate hydraulic networks (per brake or per opposite level · Failsafe: overflow tube #12;SENSORS & CONTROL ENES 100 Bruce Jacob SLIDE 4 Power Brakes (e

Jacob, Bruce

476

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

477

Dynamic Programming Slides by Kevin Wayne.  

E-print Network

9/17/2009 1 Chapter 6 Dynamic Programming 1 Slides by Kevin Wayne. Copyright © 2005 Pearson dynamic programming algorithms. Unix diff for comparing two files. Viterbi for hidden Markov models. Smith( )()()1( 22 +- - = -+- -+- = ij xay b xxij yxyxij a k k kk k k kk k k kk kkk ij ijij #12;9/17/2009 4

Srinivasan, Padmini

478

Maintaining Stream Statistics over Sliding Windows  

Microsoft Academic Search

We consider the problem of maintaining aggregates and statistics over data streams, with respect to the last N data elements seen so far. We refer to this model as the sliding window model. We consider the following basic problem: Given a stream of bits, maintain a count of the number of 1's in the last N elements seen from the

Mayur Datar; Aristides Gionis; Piotr Indyk; Rajeev Motwani

2002-01-01

479

Slide 1 Lecture 20 Amitabh Varshney  

E-print Network

· Also known as blobby models · Useful for modeling soft contours: typically muscles for humans, animals·1 Slide 1 Lecture 20 Copyright Amitabh Varshney Modeling Overview · Goal: Represent 3D objects efficiently allowing for their easy design and modification · Modeling versus rendering primitives · Implicit

Jacobs, David

480

CSc 155 Lecture Note Slides Tessellation  

E-print Network

: http://fgiesen.wordpress.com/2011/09/06/ a-trip-through-the-graphics-pipeline-2011-part-12/ OL0 = 1 OL1 = 2 OL2 = 3 OL3 = 4 OL0 = 1 OL1 = 2 OL2 = 3 IL1 = 2IL0 = 1 IL0 = 1 #12;CSc 155 Lecture Note Slides

Gordon, Scott

481

Scanning Slides Using the Nikon LS2000  

E-print Network

and install onto the front of the scanner body. #12;2. Open up Photoshop 6.0 through the start menu: 3. Once by clicking on the scan button. After this the image will be chached on the screen in Photoshop untilScanning Slides Using the Nikon LS2000 Jo Wozniak Research Programmer Imaging Technology Group Date

Illinois at Urbana-Champaign, University of

482

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

483

Sahara Slide: Age, initiation, and processes of a giant submarine slide  

Microsoft Academic Search

The Sahara Slide is a giant submarine landslide on the northwest African continental margin. The landslide is located on the open continental slope offshore arid Western Sahara, with a headwall at a water depth of ?2000 m. High primary productivity in surface waters drives accumulation of thick fine-grained pelagic\\/hemipelagic sediment sequences in the slide source area. Rare but large-scale slope

Aggeliki Georgiopoulou; Douglas G. Masson; Russell B. Wynn; Sebastian Krastel

2010-01-01

484

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

485

FDA drug approval summary: azacitidine (5-azacytidine, Vidaza) for injectable suspension.  

PubMed

On May 19, 2004, azacitidine (5-azacytidine; Vidaza(trade mark); Pharmion Corporation, Boulder, CO, http://www.pharmion.com) for injectable suspension received regular approval by the U.S. Food and Drug Administration (FDA) for the treatment of all subtypes of myelodysplastic syndrome (MDS). This report summarizes the basis for this approval. Effectiveness was demonstrated in one randomized, controlled trial comparing azacitidine administered s.c. with best supportive care (observation group) and in two single-arm studies, one in which azacitidine was administered s.c. and in the other in which it was administered i.v. The dose of azacitidine, 75 mg/m2/day for 7 days every 28 days, was the same in all three studies. In the randomized trial, study participants were well matched with respect to age, sex, race, performance status, MDS subtype, and use of transfusion during the 3 months before study entry. Patients in the observation arm were permitted by protocol to cross over to azacitidine treatment if their disease progressed according to prespecified criteria. During the course of the study, more than half of the patients in the observation arm did cross over to the azacitidine treatment arm. The primary efficacy end point was the overall response rate. Response consisted of complete or partial normalization of blood cell counts and of bone marrow morphology. The response rate in the azacitidine arm was about 16%; there were no responses in the observation arm. The response rates in the two single-arm studies were similar (13% and 19%). The responses were sustained, with median durations of 11 months and 17 months respectively. Responding patients who were transfusion dependent at study entry lost the need for transfusions. In addition, about 19% of patients had less than partial responses (termed improvement), and two-thirds of them became transfusion independent. Common adverse events associated with azacitidine treatment were gastrointestinal (nausea, vomiting, diarrhea, constipation, and anorexia), hematologic (neutropenia, thrombocytopenia), fevers, rigors, ecchymoses, petechiae, injection site events, arthralgia, headache, and dizziness. Liver function abnormalities occurred in 16% of patients with intercurrent hepatobiliary disorders and in two patients with previously diagnosed liver cirrhosis. Renal failure occurred in patients during sepsis and hypotension. There were no deaths attributed to azacitidine. Azacitidine, the first drug approved by the U.S. FDA for MDS, has a favorable safety profile and provides a clinical benefit of eliminating transfusion dependence and complete or partial normalization of blood counts and bone marrow blast percentages in responding patients. PMID:15793220

Kaminskas, Edvardas; Farrell, Ann T; Wang, Yong-Cheng; Sridhara, Rajeshwari; Pazdur, Richard

2005-03-01

486

Unknown Input and Sensor Fault Estimation Using Sliding-Mode Observers  

SciTech Connect

Sliding-mode observers are used to construct unknown input estimators. Then, these unknown input estimators are combined with sensor fault estimation schemes into one architecture that employs two sliding-mode observers for simultaneously estimating the plant’s actuator faults (part of the unknown input) and detecting sensor faults. Closed form expressions are presented for the estimates of unknown inputs and sensor faults. A benchmark example of a controlled inverted pendulum system from the literature is utilized in the simulation study. The study shows that the observers analyzed in this paper generate good estimates of the unknown input and sensor faults signals in noisy environments for nonlinear plants.

Kalsi, Karanjit; Hui, Stefen; Zak, Stanislaw

2011-06-29

487

A measure for characterizing sliding on lung boundaries  

PubMed Central

The lobes of the lungs slide relative to each other during breathing. Quantifying lobar sliding can aid in better understanding lung function, better modeling of lung dynamics, and a better understanding of the limits of image registration near fissures. We propose a novel measure to characterize lobe sliding in the lung based on the displacement field obtained from image registration of CT scans. When two sliding lobes are modeled as a continuum, the discontinuity in the displacement field at the fissure will manifest as elevated maximum shear – the proposed measure – which is capable of capturing both the level and orientation of sliding. Six human lungs were analyzed using scans spanning functional residual capacity (FRC) to total lung capacity (TLC). The lung lobes were segmented and registered on a lobe-by-lobe basis to obtain the displacement field from which the proposed sliding measure was calculated. The sliding measure was found to be insignificant in the parenchyma, as relatively little tissue shear occurs here. On the other hand, it was elevated along the fissures. Thus a map of the proposed sliding measure of the entire lung clearly delineates and quantifies sliding between lung lobes. Sliding is a key aspect of lung deformation during breathing. The proposed measure may help resolve artifacts introduced by sliding in deformation analysis techniques used for radiotherapy. PMID:24114112

Amelon, Ryan; Cao, Kunlin; Reinhardt, Joseph M.; Christensen, Gary E.; Raghavan, Madhavan

2013-01-01

488

FDA approval: siltuximab for the treatment of patients with multicentric castleman disease.  

PubMed

On April 22, 2014, the FDA granted full approval to siltuximab (SYLVANT for injection; Janssen Biotech, Inc.), a chimeric human-mouse monoclonal antibody to IL6, for the treatment of patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. The approval was primarily based on the results of a randomized, double-blind trial in which 79 symptomatic patients with MCD were allocated (2:1) to siltuximab plus best supportive care (BSC) or to placebo plus BSC. The primary efficacy endpoint was the proportion of patients in each arm achieving a durable tumor and symptomatic response that persisted for a minimum of 18 weeks without treatment failure. Tumor response was based on independent review of CT scans using the revised Response Criteria for Malignant Lymphoma, and symptomatic response was defined as complete resolution or stabilization of 34 MCD-related signs and symptoms as reported by the investigator. Thirty-four percent of patients in the siltuximab arm and no patients in the placebo arm met the primary endpoint (P = 0.0012). The most common adverse reactions (>10% compared with placebo) during treatment with siltuximab were pruritus, increased weight, rash, hyperuricemia, and upper respiratory tract infection. Clin Cancer Res; 21(5); 950-4. ©2015 AACR. PMID:25601959

Deisseroth, Albert; Ko, Chia-Wen; Nie, Lei; Zirkelbach, Jeanne F; Zhao, Liang; Bullock, Julie; Mehrotra, Nitin; Del Valle, Pedro; Saber, Haleh; Sheth, Christopher; Gehrke, Brenda; Justice, Robert; Farrell, Ann; Pazdur, Richard

2015-03-01

489

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; Lehár, Joseph; Hensley, Lisa E.; White, Judith M.; Olinger, Gene G.

2014-01-01

490

Repurposing the FDA-Approved Pinworm Drug Pyrvinium as a Novel Chemotherapeutic Agent for Intestinal Polyposis  

PubMed Central

Mutations in the WNT-pathway regulator ADENOMATOUS POLYPOSIS COLI (APC) promote aberrant activation of the WNT pathway that is responsible for APC-associated diseases such as Familial Adenomatous Polyposis (FAP) and 85% of spontaneous colorectal cancers (CRC). FAP is characterized by multiple intestinal adenomas, which inexorably result in CRC. Surprisingly, given their common occurrence, there are few effective chemotherapeutic drugs for FAP. Here we show that the FDA-approved, anti-helminthic drug Pyrvinium attenuates the growth of WNT-dependent CRC cells and does so via activation of CK1?. Furthermore, we show that Pyrvinium can function as an in vivo inhibitor of WNT-signaling and polyposis in a mouse model of FAP: APCmin mice. Oral administration of Pyrvinium, a CK1? agonist, attenuated the levels of WNT-driven biomarkers and inhibited adenoma formation in APCmin mice. Considering its well-documented safe use for treating enterobiasis in humans, our findings suggest that Pyrvinium could be repurposed for the clinical treatment of APC-associated polyposes. PMID:25003333

Giambelli, Camilla; Fei, Dennis Liang; Han, Lu; Hang, Brian I.; Bai, Feng; Pei, Xin-Hai; Nose, Vania; Burlingame, Oname; Capobianco, Anthony J.; Orton, Darren; Lee, Ethan; Robbins, David J.

2014-01-01

491

Cloned animal products in the human food chain: FDA should protect American consumers.  

PubMed

Animal cloning is "complex process that lets one exactly copy the genetic, or inherited, traits of an animal." In 1997, Dolly the sheep was the first animal cloned and since then "scientists have used animal cloning to breed dairy cows, beef cattle, poultry, hogs and other species of livestock." Cloned animals are highly attractive to livestock breeders because "cloning essentially produces an identical copy of an animal with superior traits." The main purpose of cloning livestock is "more focused on efficiency and economic benefits of the producer rather than the overall effect of cloning on an animal's physical and mental welfare." The focus of this article is threefold. First, the science behind animal cloning is explained and some potential uses and risks of this technology are explored. Second, FDA's historical evolution, current regulatory authority, and limitations of that authority, is described. Lastly, a new regulatory vision recognizes the realities of 21st century global markets and the dynamic evolution of scientific discovery and technology. PMID:19999640

Butler, Jennifer E F

2009-01-01

492

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

493

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

494

Translation of proteomic biomarkers into FDA approved cancer diagnostics: issues and challenges  

PubMed Central

Tremendous efforts have been made over the past few decades to discover novel cancer biomarkers for use in clinical practice. However, a striking discrepancy exists between the effort directed toward biomarker discovery and the number of markers that make it into clinical practice. One of the confounding issues in translating a novel discovery into clinical practice is that quite often the scientists working on biomarker discovery have limited knowledge of the analytical, diagnostic, and regulatory requirements for a clinical assay. This review provides an introduction to such considerations with the aim of generating more extensive discussion for study design, assay performance, and regulatory approval in the process of translating new proteomic biomarkers from discovery into cancer diagnostics. We first describe the analytical requirements for a robust clinical biomarker assay, including concepts of precision, trueness, specificity and analytical interference, and carryover. We next introduce the clinical considerations of diagnostic accuracy, receiver operating characteristic analysis, positive and negative predictive values, and clinical utility. We finish the review by describing components of the FDA approval process for protein-based biomarkers, including classification of biomarker assays as medical devices, analytical and clinical performance requirements, and the approval process workflow. While we recognize that the road from biomarker discovery, validation, and regulatory approval to the translation into the clinical setting could be long and difficult, the reward for patients, clinicians and scientists could be rather significant. PMID:24088261

2013-01-01

495

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

496

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

497

FDA approval: idelalisib monotherapy for the treatment of patients with follicular lymphoma and small lymphocytic lymphoma.  

PubMed

On July 23, 2014, the FDA granted accelerated approval to idelalisib (Zydelig tablets; Gilead Sciences, Inc.) for the treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma or relapsed small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies. In a multicenter, single-arm trial, 123 patients with relapsed indolent non-Hodgkin lymphomas received idelalisib, 150 mg orally twice daily. In patients with follicular lymphoma, the overall response rate (ORR) was 54%, and the median duration of response (DOR) was not evaluable; median follow-up was 8.1 months. In patients with SLL, the ORR was 58% and the median DOR was 11.9 months. One-half of patients experienced a serious adverse reaction of pneumonia, pyrexia, sepsis, febrile neutropenia, diarrhea, or pneumonitis. Other common adverse reactions were abdominal pain, nausea, fatigue, cough, dyspnea, and rash. Common treatment-emergent laboratory abnormalities were elevations in alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase, absolute lymphocytes, and triglycerides. Continued approval may be contingent upon verification of clinical benefit in confirmatory trials. Clin Cancer Res; 21(7); 1525-9. ©2015 AACR. See related article by Gandhi et al., p. 1537. PMID:25645861

Miller, Barry W; Przepiorka, Donna; de Claro, R Angelo; Lee, Kyung; Nie, Lei; Simpson, Natalie; Gudi, Ramadevi; Saber, Haleh; Shord, Stacy; Bullock, Julie; Marathe, Dhananjay; Mehrotra, Nitin; Hsieh, Li Shan; Ghosh, Debasis; Brown, Janice; Kane, Robert C; Justice, Robert; Kaminskas, Edvardas; Farrell, Ann T; Pazdur, Richard

2015-04-01

498

Too fast or not too fast: the FDA's approval of Merck's HPV vaccine Gardasil.  

PubMed

There are not many public health issues where views are as extremely polarized as those concerning vaccines, and Merck's HPV vaccine Gardasil is a case in point. Ever since gaining the FDA's approval in 2006, Merck has been heavily criticized for their overly aggressive marketing strategies and lobbying campaigns aimed at promoting Gardasil as a mandatory vaccine. Subsequently, questions have been raised as to whether it was appropriate for vaccine manufacturers to partake in public health policies when their conflicts of interests are so obvious. Some of their advertising campaign slogans, such as "cervical cancer kills x women per year" and "your daughter could become one less life affected by cervical cancer," seemed more designed to promote fear rather than evidence-based decision making about the potential benefits of the vaccine. Although, conflicts of interests do not necessarily mean that the product itself is faulty, marketing claims should be carefully examined against factual science data. Currently Gardasil vaccination is strongly recommended by the U.S. and other health authorities while public concerns about safety and efficacy of the vaccine appear to be increasing. This discrepancy leads to some important questions that need to be resolved. The current review examines key issues of this debate in light of currently available research evidence. PMID:23061593

Tomljenovic, Lucija; Shaw, Christopher A

2012-01-01

499

Awareness of the role of science in the FDA regulatory submission process: a survey of the TERMIS-Americas membership.  

PubMed

The Industry Committee of the Tissue Engineering Regenerative Medicine International Society, Americas Chapter (TERMIS-AM) administered a survey to its membership in 2013 to assess the awareness of science requirements in the U.S. Food and Drug Administration (FDA) regulatory process. One hundred forty-four members responded to the survey. Their occupational and geographical representation was representative of the TERMIS-AM membership as a whole. The survey elicited basic demographic information, the degree to which members were involved in tissue engineering technology development, and their plans for future involvement in such development. The survey then assessed the awareness of general FDA scientific practices as well as specific science requirements for regulatory submissions to the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), and the Office of Combination Projects (OCP). The FDA-specific questions in the survey were culled from guidance documents posted on the FDA web site ( www.fda.gov ). One of the answer options was an opt-out clause that enabled survey respondents to claim a lack of sufficient awareness of the topic to answer the question. This enabled the stratification of respondents on the basis of confidence in the topic. Results indicate that across all occupational groups (academic, business, and government) that are represented in the TERMIS-AM membership, the awareness of FDA science requirements varies markedly. Those who performed best were for-profit company employees, consultants, and government employees; while students, professors, and respondents from outside the USA performed least well. Confidence in question topics was associated with increased correctness in responses across all groups, though the association between confidence and the ability to answer correctly was poorest among students and professors. Though 80% of respondents claimed involvement in the development of a tissue engineering technology, their responses were no more correct than those who were not. Among those developing tissue engineering technologies, few are taking advantage of existing standards organizations to strengthen their regulatory submissions. The data suggest that early exposure to regulatory experts would be of value for those seeking to bring their technology to the market. For all groups studied but especially for students and professors, formal initial or continuing education in Regulatory Science should be considered to best support translational tissue engineering research and development. In addition, the involvement of standards development organizations during tissue engineering technology development is strongly recommended. PMID:24665855

Johnson, Peter C; Bertram, Tim A; Carty, Neal R; Hellman, Kiki B; Tawil, Bill J; Van Dyke, Mark

2014-06-01

500

Instabilities in the sliding of continua with surface inertias: An initiation mechanism for brake noise  

Microsoft Academic Search

This paper presents a model for friction-induced vibration in brake systems, which takes a homogeneous tribological layer on the brake pad into account. The derived model consists of two flat elastic bodies sliding against each other with a constant coefficient of friction. In brake tribology, like in most tribological processes, a surface structure is observed, which can be modeled as

M. Graf; G.-P. Ostermeyer

2011-01-01