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Last update: August 15, 2014.
1

iPhone Programming Presentation: Slides  

NSDL National Science Digital Library

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

Qaissaunee, Michael

2010-05-14

2

Slide Composition for Electronic Presentations  

ERIC Educational Resources Information Center

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

Larson, Ronald B.

2004-01-01

3

An Easy Method for Preparing Presentation Slides.  

ERIC Educational Resources Information Center

Describes a simplified method of preparing 35mm projection slides with a minimum of equipment and expertise. The quality of these slides compares favorably to professionally produced diazo slides. Twenty-five slides can easily be prepared in less than three hours. Material cost per slide is comparable to professional color slide processing. (JN)

Wright, Norman A.; Blevins, Dennis D.

1984-01-01

4

iPhone Programming Presentation - Slides with Narration  

NSDL National Science Digital Library

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

Qaissaunee, Mike

2012-07-30

5

Presentation video retrieval using automatically recovered slide and spoken text  

NASA Astrophysics Data System (ADS)

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

Cooper, Matthew

2013-03-01

6

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

7

Robust spatiotemporal matching of electronic slides to presentation videos.  

PubMed

We describe a robust and efficient method for automatically matching and time-aligning electronic slides to videos of corresponding presentations. Matching electronic slides to videos provides new methods for indexing, searching, and browsing videos in distance-learning applications. However, robust automatic matching is challenging due to varied frame composition, slide distortion, camera movement, low-quality video capture, and arbitrary slides sequence. Our fully automatic approach combines image-based matching of slide to video frames with a temporal model for slide changes and camera events. To address these challenges, we begin by extracting scale-invariant feature-transformation (SIFT) keypoints from both slides and video frames, and matching them subject to a consistent projective transformation (homography) by using random sample consensus (RANSAC). We use the initial set of matches to construct a background model and a binary classifier for separating video frames showing slides from those without. We then introduce a new matching scheme for exploiting less distinctive SIFT keypoints that enables us to tackle more difficult images. Finally, we improve upon the matching based on visual information by using estimated matching probabilities as part of a hidden Markov model (HMM) that integrates temporal information and detected camera operations. Detailed quantitative experiments characterize each part of our approach and demonstrate an average accuracy of over 95% in 13 presentation videos. PMID:21292597

Fan, Quanfu; Barnard, Kobus; Amir, Arnon; Efrat, Alon

2011-08-01

8

FDA Almanac  

NSDL National Science Digital Library

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

Administration., United S.

1999-01-01

9

Producing Media Software: A Slides-with-Commentary Presentation.  

ERIC Educational Resources Information Center

This article outlines the steps followed by the author in creating a teaching package consisting of a taped commentary accompanying a set of slides about settlements in Jamaica. It is suggested that the same procedures could be adapted for use in any subject area at any grade level. (Author/RLV)

Morrissey, Michael

1979-01-01

10

FDA Kids' Home Page  

MedlinePLUS

... Food & Drug Administration A to Z Index Follow FDA FDA Voice Blog Enter Search terms Home Food Drugs ... Instructions for Downloading Viewers and Players . Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site ...

11

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...

12

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

13

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

14

FDA Certified Mammography Facilities  

MedlinePLUS

... Food & Drug Administration A to Z Index Follow FDA FDA Voice Blog Enter Search terms Home Food Drugs ... Search for a Certified Facility This list of FDA Certified Mammography Facilities is updated weekly. If you ...

15

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

ERIC Educational Resources Information Center

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

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

2011-01-01

16

Survey of the Use of Slide/Tape Presentations for Orientation and Instruction Purposes in Academic Libraries.  

ERIC Educational Resources Information Center

Eighty-eight academic libraries were surveyed to determine what kinds of slide/tape library instruction materials are available for purchase or loan. The conclusions reached were: (1) there are less than a dozen libraries that have produced presentations of sufficient quality and adaptability to be widely used; and (2) the slide/tape format…

Hardesty, Larry

17

Survey of the Use of Slide/Tape Presentations for Orientation and Instruction Purposes in Academic Libraries.  

National Technical Information Service (NTIS)

Eighty-eight academic libraries were surveyed to determine what kinds of slide/tape library instruction materials are available for purchase or loan. The conclusions reached were: (1) there are less than a dozen libraries that have produced presentations ...

L. Hardesty

1976-01-01

18

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

19

FDA Pesticide Analytical Manual, Volume I Updates.  

National Technical Information Service (NTIS)

The FDA Pesticides Analytical Manual is a laboratory manual describing methods for the analysis of pesticide residues in food and feeds. Details are presented for the methods used by FDA to enforce the pesticide tolerances set by EPA. Periodic revisions a...

1982-01-01

20

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

21

Introduction to the Newspaper. A Teacher's Guide for Slide and Transparency Presentations.  

ERIC Educational Resources Information Center

The Teacher's guide contains seven lesson plans integrating slides and transparencies with other class activities to provide knowledge and understanding of the newspaper. The lesson topics are: the four purposes of the newspaper, fact and opinion, the front page, basic structure of news story, the blind ad and the public ad, the novelty lead, and…

Makuka, Kathleen D.

22

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 ...

23

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

Federal Register 2010, 2011, 2012, 2013

...No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...product tracing pilot projects as described in the FDA Food Safety Modernization Act (FSMA). FDA recently released...

2013-03-05

24

Slide 1  

Cancer.gov

Handout #1: Slides Slide 1 Introduction: What Do We Mean by “Evidence-Based?” ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________

25

Slide 1  

Cancer.gov

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

26

Slide 1  

Cancer.gov

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

27

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

28

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.

29

How FDA Evaluates Regulated Products: Cosmetics  

MedlinePLUS

... look at how FDA's Office of Cosmetics and Colors evaluates the safety of cosmetics. The Regulation of Cosmetics Under the ... to a cosmetic product? Does FDA approve the color additives used in cosmetics? If so, how does FDA ... FDA Evaluates Regulated Products: Cosmetics FDA Basics ...

30

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

Federal Register 2010, 2011, 2012, 2013

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

2013-04-02

31

FDA Approves Cyramza for Stomach Cancer  

MedlinePLUS

... Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for ... Eli Lilly. For more information: FDA: Office of Hematology and Oncology Products FDA: Approved Drugs: Questions and ...

32

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.

33

Slide 1  

Cancer.gov

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

34

Working Capital Management (Slides)  

Microsoft Academic Search

This is a course material (slides in pdf format) for Financial Analysis and Control already in SSRN. In these slides I present a detailed explanation of different tools commonly used in financial management and specifically Working Capital Management. We introduce some examples in the slides and they serve more as quick review for the written material of the main chapter

Ignacio Velez Pareja

2010-01-01

35

FDA Approves Inhaled Diabetes Medication  

MedlinePLUS

... Friday of the first inhaled medicine for the blood sugar disease. The drug, Afrezza, "is a new treatment option for patients with diabetes requiring mealtime insulin," Dr. Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for ...

36

FDA Warns About Stem Cell Claims  

MedlinePLUS

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

37

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

38

75 FR 76992 - Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing...  

Federal Register 2010, 2011, 2012, 2013

...SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0072] (formerly Docket No. 2005D-0042) Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA...

2010-12-10

39

Slide 1  

Cancer.gov

The figure shows the number of submissions of new molecular entities (NMEs)—drugs with a novel chemical structure—and the number of biologics license application (BLA) submissions to FDA over a 10-year period.

40

Slide 1  

Cancer.gov

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH Working with FDA: Biological Products and Clinical Development IND Regulatory Requirements and Recommendations Karen D. Jones Chief, Project Management Staff Division of Biologic

41

Access to F.D.A. Information.  

ERIC Educational Resources Information Center

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

Sinovic, Dianna

42

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

43

Evaluation of efficacy of heartworm preventive products at the FDA.  

PubMed

The Center for Veterinary Medicine, U.S. Food and Drug Administration (FDA/CVM) has authority under the United States Code 21 under Section 514.80 to monitor for adverse experiences of approved animal products. Although veterinarians voluntarily report suspect drug-related events to manufacturers, firms that market FDA-approved animal products must report serious events to the FDA within 15 working days of the veterinarian or pet-owner's call to them. Under the present regulations, canine heartworm preventatives are approved for 100% efficacy after testing in laboratory and field conditions. The report of lack of efficacy against heartworm larvae is a serious adverse drug event because the resulting condition or the treatment of the condition is life threatening. Information on lack of effect that are deemed possibly, probably, or definitely drug-related available for review under generic product on the FDA/CVM website Surveillance of these reports indicates there are some failures for virtually all heartworm prevention product categories. Most failures have been reported in heartworm-endemic states. At this time, it is unclear whether these are representative of the rare occurrences of failure that have been in existence for a long time, but not reported regularly or promptly, or whether there is a true increase in complaints of ineffectiveness and real variability between products. This paper discusses methods, personnel, and procedures in place in the Division of Surveillance that will aid the FDA to better assess heartworm preventive treatment failures. It discusses scoring paradigms presently utilized by FDA/CVM to assess severity of complaints of lack of efficacy against heartworms, and welcomes audience input as to how to improve existing processes. Results suggest that more comprehensive reporting will provide FDA/CVM more accurate surveillance information regarding efficacy problems. Such practices will permit FDA/CVM to better interpret both incidence and severity of in-effect and possible patterns of emerging resistance and to convey this in any necessary updated labeling. It also indicates that as part of that process, practitioners should return to a more conservative testing schedule. PMID:16099105

Hampshire, Victoria A

2005-10-24

44

Opportunities at FDA: Bench Science and Regulatory Review of Science  

NSDL National Science Digital Library

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

PhD Kevin J Greenlees (Food and Drug Administration)

2010-04-25

45

Opportunities at FDA: Bench Science and Regulatory Review of Science  

NSDL National Science Digital Library

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

PhD Kevin J Greenlees (Food and Drug Administration)

2010-04-25

46

Comparative History of FDA'S (Food and Drug Administration) Retrospective Reviews.  

National Technical Information Service (NTIS)

This study presents a comparison of the four retrospective reviews initiated by FDA since 1962. It provides the reader with a framework with which to understand the Drug Efficacy Study Implementation (DESI), the Over-the-Counter (OTC) Review, the Biologic...

S. J. Condraski

1982-01-01

47

FDA (Food and Drug Administration) Pesticide Analytical Manual. Volume 1 Updates.  

National Technical Information Service (NTIS)

The FDA Pesticide Analytical Manual is a laboratory manual describing methods for the analysis of pesticide residues in foods and feeds. Details are presented for the methods used by FDA to enforce the pesticide tolerances set by EPA. Periodic revisions a...

1986-01-01

48

FDA (Food and Drug Administration) Pesticide Analytical Manual, Volumes 1 and 2.  

National Technical Information Service (NTIS)

The FDA Pesticide Analytical Manual is a laboratory manual describing methods for the analysis of pesticide residues in foods and feeds. Details are presented for the methods used by FDA to enforce pesticide tolerances set by EPA. Periodic revisions are i...

1985-01-01

49

FDA's preferred MPN methods for standard, large or unusual tests, with a spreadsheet  

Microsoft Academic Search

The US Food and Drug Administration (FDA) presents its preferred methods for statistical interpretation of serial dilution tests for microbes in the Bacteriological Analytical Manual (BAM) of the FDA and the AOAC. This article explains why the particular methods in the manual were selected and describes the adjustments chosen to create a new, flexible method for calculating most probable numbers

W. E Garthright; R. J Blodgett

2003-01-01

50

36 CFR 13.980 - Other FDA closures and restrictions.  

Code of Federal Regulations, 2010 CFR

...1 2009-07-01 2009-07-01 false Other FDA closures and restrictions. 13.980 Section 13...National Park and Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent...

2009-07-01

51

21 CFR 314.102 - Communications between FDA and applicants.  

Code of Federal Regulations, 2010 CFR

... 2010-04-01 false Communications between FDA and applicants. 314.102 Section 314.102...CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated...

2010-04-01

52

21 CFR 314.102 - Communications between FDA and applicants.  

Code of Federal Regulations, 2010 CFR

... 2009-04-01 false Communications between FDA and applicants. 314.102 Section 314.102...CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated...

2009-04-01

53

36 CFR 13.980 - Other FDA closures and restrictions.  

Code of Federal Regulations, 2010 CFR

...1 2010-07-01 2010-07-01 false Other FDA closures and restrictions. 13.980 Section 13...National Park and Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent...

2010-07-01

54

FDA Approves Zykadia for Late-Stage Lung Cancer  

MedlinePLUS

... Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for ... N.J. For more information: FDA: Office of Hematology and Oncology Products FDA: Approved Drugs: Questions and ...

55

FDA Approves New Treatment for Advanced Colorectal Cancer  

MedlinePLUS

... Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug ... sanofi-aventis. For more information: FDA: Office of Hematology and Oncology Products FDA: Approved Drugs: Questions and ...

56

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, S.S.; Green, W.L.

1980-06-12

57

77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...  

Federal Register 2010, 2011, 2012, 2013

...SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049...for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA Staff: Public Availability of Advisory...

2012-03-09

58

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.

59

Guidance for Industry: FDA Export Certificates.  

National Technical Information Service (NTIS)

This guidance document is intended to provide a general description of Food and Drug Administration (FDA) Export Certificates to industry and foreign governments. Firms exporting products from the United States are often asked by foreign customers or fore...

J. Lewis K. Bell K. Cressotti L. Lawrence R. Woo

2005-01-01

60

FDA Expands Advice on Statin Risks  

MedlinePLUS

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

61

FDA Approves Afrezza to Treat Diabetes  

MedlinePLUS

... The FDA is requiring the following post-marketing studies for Afrezza: a clinical trial to evaluate pharmacokinetics, safety and efficacy in pediatric patients; a clinical trial to evaluate the potential risk ...

62

FDA Enforcement Report: May 11, 2011.  

National Technical Information Service (NTIS)

The FDA Enforcement Report is published weekly by the Food and Drug Administration. It contains information on actions taken in connection with agency regulatory activities. Inquiries about individual actions should be directed to the companies involved. ...

2011-01-01

63

FDA Enforcement Report: May 4, 2011.  

National Technical Information Service (NTIS)

The FDA Enforcement Report is published weekly by the Food and Drug Administration. It contains information on actions taken in connection with agency regulatory activities. Inquiries about individual actions should be directed to the companies involved. ...

2011-01-01

64

FDA Enforcement Report: April 6, 2011.  

National Technical Information Service (NTIS)

The FDA Enforcement Report is published weekly by the Food and Drug Administration. It contains information on actions taken in connection with agency regulatory activities. Inquiries about individual actions should be directed to the companies involved. ...

2011-01-01

65

FDA Enforcement Report: March 16, 2011.  

National Technical Information Service (NTIS)

The FDA Enforcement Report is published weekly by the Food and Drug Administration. It contains information on actions taken in connection with agency regulatory activities. Inquiries about individual actions should be directed to the companies involved. ...

2011-01-01

66

FDA Enforcement Report: February 2, 2011.  

National Technical Information Service (NTIS)

The FDA Enforcement Report is published weekly by the Food and Drug Administration. It contains information on actions taken in connection with agency regulatory activities. Inquiries about individual actions should be directed to the companies involved. ...

2011-01-01

67

Scam Alert: Beware of Bogus FDA Agents  

MedlinePLUS

... Products Vaccines, Blood & Biologics Articulos en Espanol 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 ...

68

Painful decision-making at FDA.  

PubMed

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

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

2014-04-01

69

PREFACE: Fractional Differentiation and its Applications (FDA08) Fractional Differentiation and its Applications (FDA08)  

NASA Astrophysics Data System (ADS)

The international workshop, Fractional Differentiation and its Applications (FDA08), held at Cankaya University, Ankara, Turkey on 5-7 November 2008, was the third in an ongoing series of conferences dedicated to exploring applications of fractional calculus in science, engineering, economics and finance. Fractional calculus, which deals with derivatives and integrals of any order, is now recognized as playing an important role in modeling multi-scale problems that span a wide range of time or length scales. Fractional calculus provides a natural link to the intermediate-order dynamics that often reflects the complexity of micro- and nanostructures through fractional-order differential equations. Unlike the more established techniques of mathematical physics, the methods of fractional differentiation are still under development; while it is true that the ideas of fractional calculus are as old as the classical integer-order differential operators, modern work is proceeding by both expanding the capabilities of this mathematical tool and by widening its range of applications. Hence, the interested reader will find papers here that focus on the underlying mathematics of fractional calculus, that extend fractional-order operators into new domains, and that apply well established methods to experimental and theoretical problems. The organizing committee invited presentations from experts representing the international community of scholars in fractional calculus and welcomed contributions from the growing number of researchers who are applying fractional differentiation to complex technical problems. The selection of papers in this topical issue of Physica Scripta reflects the success of the FDA08 workshop, with the emergence of a variety of novel areas of application. With these ideas in mind, the guest editors would like to honor the many distinguished scientists that have promoted the development of fractional calculus and, in particular, Professor George M Zaslavsky who supported this special issue but passed away recently. The organizing committee wishes to thank the sponsors and supporters of FDA08, namely Cankaya University represented by the President of the Board of Trustees Sitki Alp and Rector Professor Ziya B Güvenc, The Scientfic and Technological Research Council of Turkey (TUBITAK) and the IFAC for providing the resources needed to hold the workshop, the invited speakers for sharing their expertise and knowledge of fractional calculus, and the participants for their enthusiastic contributions to the discussions and debates.

Baleanu, Dumitru; Tenreiro Machado, J. A.

2009-10-01

70

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

71

Spermicide effects questioned by FDA panel.  

PubMed

Spermicides clearly work better than no contraceptive at all, but there's no way to say how effective they are or whether women should opt for a gel, foam, suppository, or film, a scientific panel concluded. The advisors to the US Food and Drug Administration (FDA) heard disturbing evidence that women who rely on spermicides as their sole contraceptive have anywhere from a 9% to a 57% chance of becoming pregnant within a year. Spermicides appear to work best when used just 30 minutes before intercourse, said Dr. James Trussell of Princeton University. Nobody knows for sure how well spermicides work, and which work best, because the only studies ever performed were flawed. The manufacturers never proved how well their products work because they hit the market in 1950, before the FDA required such proof. The US National Institutes of Health (NIH) plans to begin a study comparing one brand of each type of commercially available spermicide to see how effective they are. The results will not be available for at least 4 years, so the FDA is debating what to tell consumers in the meantime and if that study will be enough. The FDA may soon change spermicide labels at least to rank the products as less effective than other contraceptives, Dr. Lisa Rarick, FDA reproductive health chief, said. Spermicides also should bear a warning that they may cause vaginal irritation, a condition one study suggests might increase a woman's chances of catching HIV, the scientific panel told the FDA. The same panel agreed, however, that spermicides can help protect women against two other sexually transmitted diseases, gonorrhea and chlamydia. PMID:12320492

1996-12-01

72

Sliding device  

US Patent & Trademark Office Database

A sliding device provides a binding-free apparatus suitable for trick and other riding on snow, sand, ice and other surfaces. An elongated deck to support the rider is elevated from and attached to an elongated runner, which provides a surface that slides on the snow, sand, etc. The runner may be made more narrow than the deck to provide leverage for the rider to tilt the device onto an edge of the runner to steer the device. The device may not have any defined front or back portion and thus be adapted for riding in either direction.

2005-03-15

73

Education Statistics Slide Show  

NSDL National Science Digital Library

Created by Grace York, coordinator of the University of Michigan's Documents Center, the Education Statistics Slide Show is an online presentation demonstrating how to locate, obtain, and manipulate educational data on the Web. The presentation consists of 72 slides and offers instruction on the use of several Websites including the US Census Bureau's American Factfinder site (see the April 2, 1999 Scout Report), the Center for International Earth Science Information Network (CIESIN) Census Mapping site, the National Center for Education Statistics (NCES) site, the FEDSTATS site (see the May 30, 1997 Scout Report), and many more. The tutorial presentation also provides ten practice questions and a detailed Webliography.

74

Slide Whistle  

NSDL National Science Digital Library

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

Workshop, Watsonville E.

2011-01-01

75

AIDS and FDA Drug-Approved Policy  

Microsoft Academic Search

AIDS treatment policy has become controversial in recent years as the Gay AIDS Movement has challenged FDA drug-testing and approval policies. Based on the Social Movements Model (Frierson, 1985) this movement has reached the stage of establishing a compelling trend of public pressure and is moving toward the stage of the enactment of policy change. Gays have demanded a number

Stephen J Gould

1991-01-01

76

FDA’S food ingredient approval process  

Microsoft Academic Search

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

Alan M. Rulis; Joseph A. Levitt

2009-01-01

77

Slid.es  

NSDL National Science Digital Library

If you're looking for a new way to present your work, you might do well to look at Slid.es. The application stores users' presentations in the cloud and it's quite intuitive in terms of adding audio, video, images, and text. The site contains a helpful tutorial and this particular version is compatible with all operating systems.

2013-08-15

78

Public voices in pharmaceutical deliberations: negotiating "clinical benefit" in the FDA's Avastin Hearing.  

PubMed

This article offers a hybrid rhetorical-qualitative discourse analysis of the FDA's 2011 Avastin Hearing, which considered the revocation of the breast cancer indication for the popular cancer drug Avastin. We explore the multiplicity of stakeholders, the questions that motivated deliberations, and the kinds of evidence presented during the hearing. Pairing our findings with contemporary scholarship in rhetorical stasis theory, Mol's (2002) construct of multiple ontologies, and Callon, Lascoumes, and Barthe's (2011) "hybrid forums," we demonstrate that the FDA's deliberative procedures elides various sources of evidence and the potential multiplicity of definitions for "clinical benefit." Our findings suggest that while the FDA invited multiple stakeholders to offer testimony, there are ways that the FDA might have more meaningfully incorporated public voices in the deliberative process. We conclude with suggestions for how a true hybrid forum might be deployed. PMID:24682644

Teston, Christa B; Graham, S Scott; Baldwinson, Raquel; Li, Andria; Swift, Jessamyn

2014-06-01

79

FDA Updates Information on Use of Bisphosphonates to Treat Osteoporosis  

MedlinePLUS

FDA Updates Information on Use of Bisphosphonates to Treat Osteoporosis On May 10, 2012 the United States ... May 9th. One summarized the finding of the FDA review committee that met in September, 2011 and ...

80

Prospects for FDA use of third-party certification.  

PubMed

At the AAMI/Food and Drug Administration (FDA) International Standards Conference in March, Ronald Chesemore, associate commissioner for regulatory affairs at the FDA, explained the agency's rationale for several pilot programs announced the following week. The programs involve preannounced inspections, annotations of items on form FDA-483-List of Inspectional Observations (FDA 483), and postinspectional correspondence. The Associate Commissioner also discussed the advantages of implementation of a third-party inspection pilot program at a future date. PMID:8909708

Chesemore, R

1996-01-01

81

21 CFR 812.30 - FDA action on applications.  

Code of Federal Regulations, 2010 CFR

...2010-04-01 2010-04-01 false FDA action on applications. 812.30 Section...Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of...

2010-04-01

82

21 CFR 812.30 - FDA action on applications.  

Code of Federal Regulations, 2010 CFR

...2009-04-01 2009-04-01 false FDA action on applications. 812.30 Section...Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of...

2009-04-01

83

Changes in Biologic Drug Approval at FDA  

Microsoft Academic Search

Over the next 5 yr at FDA, there is a great need for the agency to continue its efforts to evolve and collaborate with the\\u000a pharmaceutical industry to promote rationale drug development. The agency is dynamic, and whereas plans are in place that\\u000a may provide some concept of the direction of future changes for both drug and biologics reviews, local

Richard E. Lowenthal; Robert G. Bell

84

Mining FDA drug labels for medical conditions  

PubMed Central

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

2013-01-01

85

Current Issues in Human Subject Protection: An FDA Perspective. Current Challenges in FDA Regulation of Human Subject Protection.  

National Technical Information Service (NTIS)

Contents: FDA Organizational Chart; Access to Investigational Drugs for Treatment Purposes; FDA Sanctions of Practitioners for Violations of Clinical Trial Regulations and Other Misconduct; International Harmonization: The ICH Process as a Model for Gover...

S. Nightingale

1996-01-01

86

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

Federal Register 2010, 2011, 2012, 2013

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

2011-04-13

87

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.

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

2013-01-01

88

RU 486, the FDA and free enterprise.  

PubMed

The legal question whether RU-486 can meet the standards for US Food and Drug Administration (FDA) approval for a drug indicated for abortion can be answered in the affirmative. Under the Food, Drug, and Cosmetic Act, efficacy must be demonstrated by evidence consisting of adequate and well-controlled investigations to show that a drug is safe and effective for its intended use. The FDA will approve it if on the basis of the clinical trials it could be concluded that the drug will have the effect it purports as prescribed in the labeling, and if the drug is safe. In congressional hearings and in the newspapers the so-called import alert issued by the FDA to prevent the importing of RU-486 under certain circumstances has been publicized. The import alert is no bar to conducting clinical studies in the US under an investigational new drug application (IND) nor is the import alert a bar to the filing and the pursuit of a new drug application (NDA) to allow marketing in the US. The import alert is no bar to anything except importation without an IND or NDA. The real problem is that there is no seller of RU-486 in the US and no sponsor of an NDA offering clinical evidence of safety and efficacy as well as the ability to manufacture the drug and the necessary prostaglandins properly. In additions to abortion, other uses of RU-486 include contraception, breast cancer, and Cushing syndrome. Some limited research could be done under INDs with small supplies of the drug obtained elsewhere on the world market. There are only 2 solutions to this problem. One is that Roussel must change its mind or have its mind changed as the example of the AIDS community showed, which has managed to induce the development of drugs that were impossible 8 or 10 years ago. The other solution is to found a pharmaceutical company that could induce competition for manufacturing RU-486. PMID:1434765

Buc, N L

1992-01-01

89

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

90

FDA and CPMP rulings on subgroup analyses.  

PubMed

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

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

2007-01-01

91

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

NSDL National Science Digital Library

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

1900-01-01

92

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

NSDL National Science Digital Library

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

Fda

1900-01-01

93

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

NSDL National Science Digital Library

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

1900-01-01

94

SlideRocket  

NSDL National Science Digital Library

As this is a New Year, there will be a need for new presentations. SlideRocket makes pesky presentation troubles go away, as you can access PowerPoint presentations from any locations, collaborate with colleagues around the world, and also integrate dynamic data, charts, and graphs quite seamlessly. Some of the more advanced features are only available via the pay versions of the product, but the free version is easy and engaging. This version is compatible with all operating systems, including Linux.

95

The FDA's Medical Dictionary for Drug Regulatory Affairs Alpha Test  

Microsoft Academic Search

The Food and Drug Administration (FDA), in conjunction with the International Conference on Harmonization (ICH), is pursuing a medical language thesaurus that could be used internationally for premarketing and postmarketing regulatory purposes regarding drugs, biologics, and devices. As part of a thorough, worldwide review of the Medical Dictionary for Drug Regulatory Affairs (MEDDRA) terminology by various interested parties, FDA, along

Kathryn Huntley; Mary Jo Veverka; Minna Golden

1995-01-01

96

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

PubMed Central

In this paper we present a new pharmacovigilance data mining technique based on the biclustering paradigm, which is designed to identify drug groups that share a common set of adverse events in FDA’s spontaneous reporting system. A taxonomy of biclusters is developed, revealing that a significant number of bone fide adverse drug event (ADE) biclusters are identified. Statistical tests indicate that it is extremely unlikely that the discovered bicluster structures as well as their content arose by chance. Some of the biclusters classified as indeterminate provide support for previously unrecognized and potentially novel ADEs. In addition, we demonstrate the importance of the proposed methodology to several important aspects of pharmacovigilance such as: providing insight into the etiology of ADEs, facilitating the identification of novel ADEs, suggesting methods and rational for aggregating terminologies, highlighting areas of focus, and as a data exploratory tool.

Harpaz, Rave; Perez, Hector; Chase, Herbert S.; Rabadan, Raul; Hripcsak, George; Friedman, Carol

2012-01-01

97

FDA toxicity databases and real-time data entry.  

PubMed

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. PMID:18656494

Arvidson, Kirk B

2008-11-15

98

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

99

Sliding bearings lubricated with magnetic fluids  

Microsoft Academic Search

Purpose – This paper seeks to present some new designs of sliding bearings lubricated with magnetic fluids (ferrofluids) and the possibility of using them in modern bearing technology, in new computer and audiovisual equipment among others. Design\\/methodology\\/approach – The paper presents new designs of journal, thrust and journal-thrust sliding bearings lubricated and sealed with magnetic fluids such as: magnetic fluid

W. Ocho?ski

2007-01-01

100

Instant slides of radiographs for lectures.  

PubMed

High quality slides of radiographs may be made with a simple, fast, and inexpensive technique using Kodak Rapid Process Copy film. Lecture presentations may include a slide of a pertinent plain radiograph, computed tomography (CT) scan, or magnetic resonance imaging (MRI). Although these slides may be made with a 35 mm SLR camera and flash or with a 35 mm SLR camera and a lighted viewbox, an alternative method is available that is easy to perform, inexpensive, and can produce quality slides in as little as 30 minutes. PMID:2477785

Rothstein, S G; Stewart, P L

1989-10-01

101

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

Federal Register 2010, 2011, 2012, 2013

...AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-0792] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators;...

2011-05-24

102

76 FR 38184 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Recall...  

Federal Register 2010, 2011, 2012, 2013

...Food and Drug Administration [Docket No. FDA-2011-N-0439] Agency Information Collection...Proposed Collection; Comment Request; FDA Recall Regulations AGENCY: Food and Drug...SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for...

2011-06-29

103

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

Federal Register 2010, 2011, 2012, 2013

...Food and Drug Administration [Docket No. FDA-2011-N-0708] Agency Information Collection...Proposed Collection; Comment Request; FDA Form 3728, Animal Generic Drug User Fee...SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for...

2011-10-05

104

76 FR 32367 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...  

Federal Register 2010, 2011, 2012, 2013

...Food and Drug Administration [Docket No. FDA-1999-D-0742 (formerly Docket No...Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical...SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared...

2011-06-06

105

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.

106

FDA regulation of cardiovascular devices and opportunities for improvement.  

PubMed

Medical devices are of increasing importance in cardiovascular disease and have made important contributions to patient care. These devices continue to evolve with increasing complexity. FDA regulation of medical devices involves increased stringency for higher risk and novel devices. However, there are some current opportunities to strengthen the FDA's pre-approval regulatory process and improve post-marketing surveillance. This article reviews FDA regulation of cardiovascular devices and offers suggestions for strengthening the process while focusing on examples relevant to cardiac electrophysiologists. PMID:23263896

Dhruva, Sanket S; Redberg, Rita F

2013-03-01

107

Sliding sleeve casing tool  

SciTech Connect

This patent describes a sliding sleeve casing tool installed in a string of casing in a well bore intersecting a plurality of formations of the earth. The sliding sleeve casing tool for use in evaluating the characteristics of a formation surrounding the sliding sleeve casing tool of the plurality of formations. The sliding sleeve casing tool capable of being repeatedly opened and closed any desired number of times to allow fluids to be selectively produced from the formation and, if desired, fluids to flow from the casing into the formation when apertures allowing fluid communication between the exterior and interior of the sliding sleeve casing tool have been created therein.

Brandell, J.T.; Giroux, R.L.

1989-11-14

108

Modeling the Sliding/Falling Ladder Paradox  

ERIC Educational Resources Information Center

Recently we were presented with an interesting twist to the sliding ladder problem viewed in the related rates section of most calculus textbooks. Our problem concerning a sliding ladder that eventually hits the ground. At first, those attempting this problem fell into the calculus trap using only related rates. Previous work for this problem…

Fox, William P.; Fox, James B.

2003-01-01

109

DESIGN NONLINEAR SYSTEM WITH SLIDING MODE CONTROL  

Microsoft Academic Search

This paper presents result of a research and development of nonlinear system synthesis using sliding mode method to perfect the current sliding mode technique. Actually, the problem is the adjustment certain input control of nonlinear plant so the variable state system reaches the equilibrium point. It was done by choosing a manifol or certain area that once state system enter

Tedy Setiawan; R. J Widodo; Dimitri Mahayana; Iwan Pranoto

110

Sliding mode control for three phase rectifiers  

Microsoft Academic Search

A sliding mode control for a boost type three phase rectifier is presented. A new mathematical model whose state variables are the amplitude and the phase of the input current is achieved. Several problems related to the controller design are dealt with: a sliding manifold shaping which avoids the absence of permissible control configurations during start up operating conditions is

Pompeo Marino; Francesco Vasca

1995-01-01

111

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

112

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

113

PHOSPHOLIPID AND FDA ACTIVITY MEASUREMENTS ADAPTED TO BIOLOGICAL GAC  

EPA Science Inventory

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

114

Reporting Complaints Related to FDA-Regulated Clinical Trials  

MedlinePLUS

... hhs.gov (Division of Scientific Investigations, Office of Compliance, CDER) Medical Device studies: Call 301-796-5490 ... fda.gov (Division of Bioresearch Monitoring, Office of Compliance, CDRH) Studies regulated by CFSAN: Call 240-402- ...

115

Food Safety: Improvements Needed in FDA Oversight of Fresh Produce.  

National Technical Information Service (NTIS)

In recent years, both domestic and imported produce have been linked to reported outbreaks of foodborne illness. Contamination in produce is of particular concern because produce is often consumed raw. The Food and Drug Administration (FDA) has primary re...

2008-01-01

116

FDA Orders New Warning Labels for Tanning Beds  

MedlinePLUS

... require manufacturers to warn in their advertisements and marketing materials that these and other tanning devices put ... have to apply for FDA approval prior to marketing indoor tanning devices, which until now were exempt ...

117

21 CFR 60.10 - FDA assistance on eligibility.  

...OF HEALTH AND HUMAN SERVICES GENERAL PATENT TERM RESTORATION Eligibility Assistance...a) Upon written request from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in determining...

2014-04-01

118

Expediting drug development--the FDA's new "breakthrough therapy" designation.  

PubMed

The FDA's new "breakthrough therapy" designation for investigational drugs adds to the agency's portfolio of expedited programs for serious conditions. The designation requires preliminary clinical evidence demonstrating substantial improvement over existing therapies. PMID:24224621

Sherman, Rachel E; Li, Jun; Shapley, Stephanie; Robb, Melissa; Woodcock, Janet

2013-11-14

119

NIH-FDA Interagency Clinical Outcome Assessments Working Group  

Cancer.gov

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

120

FDA recognition of consensus standards in the premarket notification program.  

PubMed

"The FDA has long advocated the use of standards as a significant contributor to safety and effectiveness of medical devices," Center for Devices and Radiological Health's (CDRH) Donald E. Marlowe and Philip J. Phillips note in the following article, highlighting the latest U.S. Food and Drug Administration (FDA) plans for use of standards. They note that the important role standards can play has been reinforced as part of FDA reengineering efforts undertaken in anticipation of an increased regulatory work-load and declining agency resources. As part of its restructuring effort, the FDA announced last spring that it would recognize some consensus standards for use in the device approval process. Under the new 510(k) paradigm--the FDA's proposal to streamline premarket review, which includes incorporating the use of standards in the review of 510(k) submissions--the FDA will accept proof of compliance with standards as evidence of device safety and effectiveness. Manufacturers may submit declarations of conformity to standards instead of following the traditional review process. The International Electrotechnical Commission (IEC) 60601 series of consensus standards, which deals with many safety issues common to electrical medical devices, was the first to be chosen for regulatory review. Other standards developed by nationally or internationally recognized standards development organizations, such as AAMI, may be eligible for use to ensure review requirements. In the following article, Marlowe and Phillips describe the FDA's plans to use standards in the device review process. The article focuses on the use of standards for medical device review, the development of the standards recognition process for reviewing devices, and the anticipated benefits of using standards to review devices. One important development has been the recent implementation of the FDA Modernization Act of 1997 (FDAMA), which advocates the use of standards in the device review process. In implementing the legislation, the FDA published in the Federal Register a list of standards to which manufacturers may declare conformity. Visit AAMI's Web site at www.aami.org/news/fda.standards for a copy of the list and for information on nominating other standards for official recognition by the agency. The FDA expects that use of standards will benefit the agency and manufacturers alike: "We estimate that in time, reliance on declarations of conformity to recognized standards could save the agency considerable resources while reducing the regulatory obstacles to entry to domestic and international markets," state the authors. PMID:9619259

Marlowe, D E; Phillips, P J

1998-01-01

121

FDA Regulation of Stem CellâÂÂBased Products  

NSDL National Science Digital Library

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

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

2009-06-26

122

Imidization induced structural changes of 6FDA-ODA poly(amic acid) by two-dimensional (2D) infrared correlation spectroscopy  

NASA Astrophysics Data System (ADS)

Two-dimensional (2D) gradient mapping method and 2D correlation analysis of in situ FTIR spectra were used to probe the thermal imidization-induced spectral changes in 6FDA-ODA poly(amic acid) (PAA) films prepared by a reaction of 4,4?-(hexafluoroisopropylidene)diphthalic anhydride (6FDA) and 4,4?-oxydianiline (ODA) in N,N?-dimethylacetamide. Large spectral changes in the in situ FTIR spectra of 6FDA-ODA PAA film were observed in the range, 130-230 °C. The thermal imidization of 6FDA-ODA PAA films strongly affects the spectral changes in amic acid groups in the PAA unit. The spectral change in the amic acid groups occurred before those of the imide ring. The cyclic anhydrides, isoimdes and intermolecular links are present together with the imide ring in the thermally-cured 6FDA-ODA PAA films.

Seo, Hyemi; Chae, Boknam; Im, Ji Hyuk; Jung, Young Mee; Lee, Seung Woo

2014-07-01

123

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,

124

"Adulterated" Androstenedione: What FDA's Action against Andro Means for Industry  

PubMed Central

On March 11, 2004, the Food and Drug Administration (FDA) pronounced that dietary supplement products containing androstenedione were adulterated new dietary ingredients under the Dietary Supplement Health and Education Act of 1994 (DSHEA). The FDA issued a press release, held a news conference, and sent warning letters to 23 companies that had manufactured, marketed or distributed the products containing androstenedione. In its warning letters, FDA threatened possible enforcement actions for noncompliance. The authors have looked at the warning letters, statutes, regulations, and media reports to analyze the legal grounds and standards upon which FDA acted against androstenedione and question the appropriateness of the action taken. They have also looked at the negative impact that FDA's lack of communication and cooperation with Industry is having upon the fitness nutrition industry and the marketing of dietary supplements containing new dietary ingredients. The authors also suggest what might be done to ameliorate this escalating problem including more cooperation between FDA and Industry and more research into the benefits and use of supplement products.

Collins, Richard D; Feldstein, Alan H

2004-01-01

125

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

Federal Register 2010, 2011, 2012, 2013

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

2011-10-06

126

Manipulating and Annotating Slides in a Multi-Display Environment  

Microsoft Academic Search

In a meeting room environment with multiple public wall displays and personal notebook computers, it is possible to design a highly interactive experience for manipulating and annotating slides. For the public displays, we present the ModSlideShow system with a discrete modular model for linking the displays into groups, along with a gestural interface for manipulating the flow of slides within

Patrick Chiu; Qiong Liu; John S. Boreczky; Jonathan Foote; Don Kimber; Surapong Lertsithichai; Chunyuan Liao

2003-01-01

127

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

NSDL National Science Digital Library

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

Cardinal, Kristen

2009-10-27

128

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

129

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.

130

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

PubMed

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

Kay, G

2001-01-01

131

Aerial View of Slide  

USGS Multimedia Gallery

Aerial view of slide at Daly City. This is the largest slide triggered by the earthquake in San Mateo County, displacing approximately 36,700 cubic meters (48,000 cubic yards) of material. The base is about 152 me (500 ft) across at its widest point....

2009-01-26

132

The FDA's assessment of follow-on protein products: a historical perspective.  

PubMed

The scientific and regulatory issues that are associated with the possible introduction of 'follow-on' versions of protein drug products are the topic of considerable debate at present. Because of the differences between protein drug products and small-molecule drugs, the development of follow-on versions of protein products presents more complex scientific challenges than those presented by the development of generic versions of small-molecule drugs. Here, with a view to illustrating the Food and Drug Administration's (FDA's) scientific reasoning and experience in this area, we discuss past examples of the FDA's actions involving the evaluation of various types of follow-on and second-generation protein products and within-product manufacturing changes. The FDA believes its evaluation of the safety and effectiveness of follow-on protein products will evolve as scientific and technological advances in product characterization and manufacturing continue to reduce some of the complexity and uncertainty that are inherent in the manufacturing of protein products. PMID:17633790

Woodcock, Janet; Griffin, Joseph; Behrman, Rachel; Cherney, Barry; Crescenzi, Terrie; Fraser, Blair; Hixon, Dena; Joneckis, Christopher; Kozlowski, Steven; Rosenberg, Amy; Schrager, Lewis; Shacter, Emily; Temple, Robert; Webber, Keith; Winkle, Helen

2007-06-01

133

Position sensorless control for PMSM using sliding mode observer and phase-locked loop  

Microsoft Academic Search

In this paper, a novel sliding mode observer is presented for achieving the position sensorless vector control based on estimating the rotor position of permanent magnet synchronous machines. Compared to conventional sliding mode observer (SMO), the proposed observer based on sliding mode observer and phase-locked loop (PLL) can effectively reduce the influence of the sliding mode chattering and improve the

Ran Li; Guangzhou Zhao

2009-01-01

134

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

135

The high speed sliding wear behaviour of boronized medium carbon steel  

Microsoft Academic Search

Steels provided with boronized diffusion coatings are known to exhibit excellent wear resistance at low sliding speeds. However, the sliding wear behaviour of boronized coatings at high sliding speed is not known. In the present study, the high speed sliding wear and friction behaviour of a boronized medium carbon steel has been characterized using a friction dynamometer. The boronized samples

B. Venkataraman; G. Sundararajan

1995-01-01

136

Medical devices, the FDA, and the home healthcare clinician.  

PubMed

This article introduces the U.S. Food and Drug Administration's (FDA's) MedWatch adverse event reporting program that consumers and healthcare professionals can use to voluntarily report potential problems associated with medical devices. It discusses devices commonly used in the home and other "nonclinical" environments and suggests what clinicians can do when encountering device problems or issues. With the increasing use of medical devices in the home and other nonclinical environments, it is becoming more important for users and caregivers to participate in voluntary reporting to help the FDA best address medical device problems that may be unique to these environments. PMID:24978574

Simone, Lisa K; Brumbaugh, JoAnn; Ricketts, Catherine

2014-01-01

137

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!

138

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

PubMed Central

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

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

2013-01-01

139

Testosterone Products Must Warn About Risk of Venous Clots: FDA  

MedlinePLUS

... with testosterone treatment. In its statement Friday, the FDA said that after receiving reports of blood clots in the veins unrelated to polycythemia in patients taking testosterone products, it has now decided to require a more general warning on venous blood clots on the labelling. Blood ...

140

Testing drugs in pediatric populations: The FDA mandate  

Microsoft Academic Search

On November 27, 1998 the Food and Drug Administration (FDA) issued a new rule requiring that drugs and biological products be tested in pediatric populations. Since voluntary testing in pediatric populations had not resulted in a significant increase in pediatric labeling of drugs, stronger measures were needed to ensure that infants and children would receive the benefits of properly tested

Carol A. Tauer

1999-01-01

141

FDA perspective on antivirals against biothreats: Communicate early and often  

Microsoft Academic Search

Development of antiviral products for certain highly pathogenic viruses with limited available treatments, such as viruses that may have biothreat potential, is critically important and challenging. The mission of the FDA is to protect the public health by assuring the safety, efficacy and quality of such products. Human clinical trials are critically important whenever relevant naturally occurring diseases can appropriately

Rosemary Roberts; Barbara Styrt; Susan McCune

2008-01-01

142

FDA may set stricter criteria for glans cap, intravaginal pouch.  

PubMed

The obstetric and gynecology device advisory panel to the FDA met with the National Women's Health Network in Washington, D.C. to discuss approval of 2 new contraceptive barrier methods: the glans cap and the intravaginal pouch. Both groups came to an agreement on the issue of stricter criteria for the new devices, and the panel subsequently recommended that the FDA approve the new methods with more strict criteria than those for condoms. Some concern over the size and opportunity for semen seepage and disease transmission with the glans cap has been raised. Both methods have received 510K clearance which will allow producers the chance to market their product without clinical trials. The clearance is granted if producers can prove that a similar device was marketed before 1976. Finally, the WPC 333, a female condom, is being currently considered by the FDA. The WPC 333 is made of polyurethane and has a flexible internal and external ring. The chairwoman of the OB/GYN advisory panel, however, argues that both the glans cap and the intravaginal pouch should be given a class III status by the FDA because of the great differences between them and the condom. PMID:12342314

1989-06-01

143

Nicotine Withdrawal: Assessing the FDA's Effort to Regulate Tobacco Products  

Microsoft Academic Search

At a press conference held on August 23, 1996, just one year after initially revealing his plans, President Clinton announced sweeping federal regulations to combat the underage use of tobacco products. The Food and Drug Administration (FDA) subsequently published a lengthy preamble to accompany the final regulations, detailing the Agency's assessment of the problem and responding to numerous public comments

Lars Noah; Barbara A. Noah

1996-01-01

144

Recent changes in FDA's good laboratory practice regulations  

Microsoft Academic Search

In the Federal Register of December 22, 1978, the Food and Drug Administration (FDA) published regulations which described Good Laboratory Practice for safety tests conducted on regulated products (Anonymous, 1978). The regulations, popularly known as GLPs, have become universally recognized as the basic criteria for the conduct of a valid safety test and for assuring the quality and integrity of

Paul D. Lepore

1990-01-01

145

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

146

Identification of FDA-approved drugs that computationally bind to MDM2  

PubMed Central

The integrity of the p53 tumor suppressor pathway is compromised in the majority of cancers. In 7% of cancers, p53 is inactivated by abnormally high levels of MDM2—an E3 ubiquitin ligase that polyubiquitinates p53, marking it for degradation. MDM2 engages p53 through its hydrophobic cleft and blockage of that cleft by small molecules can re-establish p53 activity. Small molecule MDM2 inhibitors have been developed, but there is likely to be a high cost and long time period before effective drugs reach the market. An alternative is to repurpose FDA-approved drugs. This report describes a new approach, called Computational Conformer Selection, to screen for compounds that potentially inhibit MDM2. This screen was used to computationally generate up to 600 conformers of 3,244 FDA-approved drugs. Drug conformer similarities to 41 computationally-generated conformers of MDM2 inhibitor nutlin 3a were ranked by shape and charge distribution. Quantification of similarities by Tanimoto combo scoring resulted in scores that ranged from 0.142 to 0.802. In silico docking of drugs to MDM2 was used to calculate binding energies and to visualize contacts between the top-ranking drugs and the MDM2 hydrophobic cleft. We present 15 FDA-approved drugs predicted to inhibit p53/MDM2 interaction.

Warner, Wayne A.; Sanchez, Ricardo; Dawoodian, Alex; Li, Esther; Momand, Jamil

2012-01-01

147

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

148

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

149

FDA investigates complaint of pain in spermicidal condom user.  

PubMed

Currently, the US Food and Drug Administration (FDA) is investigating a complaint that the Ramses Extra spermicidal condom may have caused severe pain in a user. The condom, which received marketing approval from FDA in 1982, contains the spermicidal lubricant nonoxynol-9, which reduces the number of active sperm and consequently decreases the risk of pregnancy. Lee Mathews of the FDA's office of compliance is investigating the complaint, filed in August 1983. The man experienced "excruciating pain" on urination after using the spermicidal condom, according to FDA documents. The woman indicated in the complaint that the pain possibly resulted from the condom's spermicide entering her husband's urethra. The pain subsided after several hours. She reported that her husband had never used the spermicidal condom before and had no known allergies or sensitivities. A spokeswoman for the manufacturer, Schmid Products, Company, reported after investigating the complaint that the company saw "no reason to believe that there was a batch problem or a problem with that particular condom." Company records revealed no other complaints with that batch. No other samples were available for testing from the woman filing the complaint, but "the fact that the wife did not have a problem also indicates there wasn't anything particularly wrong with that condom." Company officials did not interview the man who used the condom in question, but they did reply to him in writing and have heard nothing more from the couple. The Schmid spokeswoman indicated that there have been isolated instances of sensitivity to this product. A key factor behind FDA approval of the spermicidal condom was a study completed for Schmid by Dr. Edwin Dale. Dale's study involved 30 men, 19-46, who used both regular condoms and condoms treated with nonoxynol-9. He concluded that decreased sperm motility with the treated condoms was caused by cell fragmentation due to cell membrane disruption. PMID:12312848

1984-03-01

150

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

151

Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND Frequently Asked Questions.  

National Technical Information Service (NTIS)

On April 28, 2008, the Food and Drug Administration (FDA or Agency) amended its regulations on the acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) (non-IND foreign clinical studies) as support for a...

2012-01-01

152

Slide Projector Activities  

NSDL National Science Digital Library

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

Miller, Bob

2013-01-30

153

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.

154

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.

155

FDA Appoves First Human Papillomavirus Test for Primary Cervical Cancer Screening  

MedlinePLUS

... Español FDA approves first human papillomavirus test for primary cervical cancer screening The U.S. Food and Drug ... the safety and effectiveness when used as a primary screening tool for cervical cancer.” The FDA first ...

156

Trocar-associated injuries and fatalities: an analysis of 1399 reports to the FDA.  

PubMed

Laparoscopic trocars, medical devices used to gain access into the abdominal cavity, are the most common device named in malpractice injury claims associated with laparoscopic procedures. As part of its ongoing adverse event reporting program, the U.S. Food and Drug Administration (FDA) requires manufacturers and user facilities to file a report whenever a device was or may have been a factor in a death or serious injury. The FDA collects data from these reports in its Manufacturer and User Facility Device Experience (MAUDE) database. This study presents an analysis of fatality and injury data on laparoscopic trocars found in MAUDE reports received from January 1, 1997, through June 30, 2002, including 31 fatal injury cases and 1353 reports on nonfatal injuries. Cholecystectomy was the procedure most frequently associated with both fatal and nonfatal trocar injuries. Most fatalities involved vascular injuries. All fatality reports that identified the trocar design involved either a shielded trocar (which has a retractable shield that covers the trocar blade before and after insertion to help protect abdominal and pelvic organs from inadvertent puncture) or an optical trocar (which allows laparoscopists to view the cutting tip as it penetrates the tissues). Narrative comments cited surgical technique, device problems, and patient characteristics as contributing factors. Among nonfatal injuries, a change in surgical management such as additional surgical procedure--primarily laparotomy--prolonged surgery, or aborted surgery was reported most frequently for vascular and hollow viscus injuries. Many reports did not identify the device model, surgical procedure, or event timing, limiting Food and Drug Administration (FDA) and manufacturer investigations into whether the device contributed to the event. The most common manufacturer conclusions indicated the trocar was not returned, and no conclusions could be drawn about the trocar's contribution to the event. Fatalities occur with procedures in which shielded trocars and optical trocars are used. Further study is needed to evaluate the high proportion of reports associated with laparoscopic cholecystectomy. Laparoscopists should retain for evaluation any devices implicated in patient injuries and should ensure that detailed information on adverse events is provided in adverse event reports to the FDA. The FDA's Manufacturer and User Facility Device Experience (MAUDE) database can be a valuable source for information on adverse outcomes associated with medical devices and, given an understanding of its limitation, provides researchers with a viable adjunct to published literature and litigation surveys for obtaining this information. PMID:16036187

Fuller, Janie; Ashar, Binita S; Carey-Corrado, Julia

2005-01-01

157

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

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

2009-04-01

158

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

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

2010-01-01

159

21 CFR 1.393 - What information must FDA include in the detention order?  

Code of Federal Regulations, 2010 CFR

...2010-04-01 false What information must FDA include in the detention order? 1.393...for Human or Animal Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order?...

2010-04-01

160

21 CFR 1.393 - What information must FDA include in the detention order?  

Code of Federal Regulations, 2010 CFR

...2009-04-01 false What information must FDA include in the detention order? 1.393...for Human or Animal Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order?...

2009-04-01

161

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

MedlinePLUS

... to allowing the product back on the market back to top Problems to Report to MedWatch MedWatch is for reporting ... or call your local FDA Consumer Complaint Coordinator . back to top This article ... Your Guide to Reporting Problems to FDA FDA 101: Product Recalls - From First ...

162

Bioanalytical methods validation: A critique of the proposed FDA guidance  

Microsoft Academic Search

Summary  The criteria generally applied to the validation of bioanalytical methods are largely based on the Consensus meeting held\\u000a in Washington in 1990 in a number of Journals. In December 1998, the FDA published Draft Guidelines for Human Bioanalytical\\u000a studies, based on the 1990 Consensus report. Subsequently a meeting Bioval 99 was held in June 1999 in London and a workshop

H. M. Hill

2000-01-01

163

Informatic Tools and Approaches in Postmarketing Pharmacovigilance Used by FDA  

Microsoft Academic Search

The safety profile of newly approved drugs and therapeutic biologics is less well developed by pre-marketing clinical testing\\u000a than is the efficacy profile. The full safety profile of an approved product is established during years of clinical use.\\u000a For nearly 40 years, the FDA has relied on the voluntary reporting of adverse events by healthcare practitioners and patients\\u000a to help establish

Joyce Weaver; Mary Willy; Mark Avigan

2008-01-01

164

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

165

Sliding Mode Control as Applied to Drilling Rotary System  

Microsoft Academic Search

\\u000a This paper, using torsional multi-DOF model of drilling rotary system, presents the double surface sliding mode PID controller\\u000a with exponent reaching law in order to handle the system failure caused by stick-slip oscillation. The sliding mode controller\\u000a is applied two discontinuity surfaces as sliding surface, one of them is used to suppress the stick-slip oscillation at the\\u000a drill bit, and

Fubin Shi; Nurzat Rasol; Lin Li

2010-01-01

166

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.

2011-02-24

167

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

168

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

169

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.

170

Application of partial sliding mode in guidance problem.  

PubMed

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

Shafiei, M H; Binazadeh, T

2013-03-01

171

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.

172

Torpedo Tube Slide Valve.  

National Technical Information Service (NTIS)

A torpedo tube and slide valve assembly includes a torpedo tube having a plurality of circumferentially spaced slots therein and an impulse tank surrounding the torpedo tube wherein the slots provide a flow path between the impulse tank and the interior o...

P. E. Moody

1994-01-01

173

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

174

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

175

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.

Pressley, Thomas A.

176

Theory of sliding-mode triboelectric nanogenerators.  

PubMed

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

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

2013-11-20

177

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

178

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

179

Lectin approaches for glycoproteomics in FDA-approved cancer biomarkers.  

PubMed

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

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

2014-04-01

180

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

181

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

182

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 can find out what kinds of surfaces generate more or less friction.

Engineering K-Ph.d. Program

183

Toward an implantable wireless cardiac monitoring platform integrated with an FDA-approved cardiovascular stent.  

PubMed

Continuous monitoring of blood pressure from a minimally invasive device in the pulmonary artery can serve as a diagnostic and early warning system for cardiac health. The foremost challenge in such a device is the wireless transfer of data and power from within the blood vessel to an external device while maintaining unrestricted flow through the artery. We present a miniaturized system, which is attached to the outer surface of a regular or drug-eluting FDA-approved stent. When expanded, the stent maintains a patent vessel lumen while allowing contact between the electronic sensors and the blood supply. The stent-based antenna can be used for both wireless telemetry and power transfer for the implanted electronics. Using the stent platform as both a radiating antenna and a structural support allows us to take advantage of an FDA-approved device whose safety and surgical procedure are well established. The electronics package has been reduced to an area of less than 1 mm(2), with a thickness under 300 mum. A minimally invasive implantation procedure allows the delivery of the stent-based implant in nearly any major vessel of the body. This article describes an initial prototype with two stents configured as a single dipole, a 2.4-GHz transmitter microchip, and a battery, and validates transcutaneous transmission through ex vivo and in vivo porcine studies. The results demonstrate the feasibility of a stent-based wireless platform for continuous monitoring of blood pressure. PMID:19807844

Chow, Eric Y; Beier, Brooke L; Francino, Antonio; Chappell, William J; Irazoqui, Pedro P

2009-10-01

184

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

185

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

PubMed

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

Lerner, Herbert; Whang, Joyce; Nipper, Rebecca

2013-03-01

186

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

187

Sliding Fee Scales That Work: A Model for State Child Care Programs.  

ERIC Educational Resources Information Center

Guiding principles for using sliding fee scales are presented in this paper in an effort to help states plan new child care initiatives, coordinate or strengthen existing programs, and improve sliding fee scales for current programs. Introductory comments urge states to adopt a single sliding fee scale for all their child care programs. The report…

Lookner, Sherrie

188

Stochastic optimization of a chain sliding mode controller for the mobile robot maneuvering  

Microsoft Academic Search

In this study we present a chain sliding mode controller for the control of a four wheeled autonomous mobile robot performing aggressive turning maneuver to 90 degrees on a slippery surface. The controller consists of a set of local sliding mode controllers and the hyperplanes of switching between them. The parameters of the sliding mode controllers and the hyperplanes are

Alexander V. Terekhov; Jean-Baptiste Mouret; Christophe Grand

2011-01-01

189

Design of a Novel Fuzzy Sliding-Mode Control for Magnetic Ball Levitation System  

Microsoft Academic Search

This paper presents the design of a novel fuzzy sliding-mode control (NFSMC) for the magnetic ball levitation system. At first, we examine the nonlinear dynamic models of the magnetic ball system, where the singular perturbation method is used. Next, we address the design schemes of sliding mode control (SMC) and traditional fuzzy sliding-mode control (FSMC), where two kinds of FSMCs

Chao-lin Kuo; Tzuu-hseng S. Li; Nai Ren Guo

2005-01-01

190

Screening and dotting virtual slides: A new challenge for cytotechnologists.  

PubMed

Digital images are increasingly being used in cytopathology. Whole-slide imaging (WSI) is a digital imaging modality that uses computerized technology to scan and convert entire cytology glass slides into digital images that can be viewed on a digital display using the image viewer software. Digital image acquisition of cytology glass slides has improved significantly over the years due to the use of liquid-based preparations and advances in WSI scanning technology such as automatic multipoint pre-scan focus technology or z-stack scanning technology. Screening cytotechnologists are responsible for every cell that is present on an imaged slide. One of the challenges users have to overcome is to establish a technique to review systematically the entire imaged slide and to dot selected abnormal or significant findings. The scope of this article is to review the current user interface technology available for virtual slide navigation when screening digital slides in cytology. WSI scanner vendors provide tools, built into the image viewer software that allow for a more systematic navigation of the virtual slides, such as auto-panning, keyboard-controlled slide navigation and track map. Annotation tools can improve communication between the screener and the final reviewer or can be used for education. The tracking functionality allows recording of the WSI navigation process and provides a mechanism for confirmation of slide coverage by the screening cytotechnologist as well as a useful tool for quality assurance. As the WSI technology matures, additional features and tools to support navigation of a cytology virtual slide are anticipated. PMID:24379891

Khalbuss, Walid E; Cuda, Jackie; Cucoranu, Ioan C

2013-01-01

191

3D modeling of sliding electrical contact  

Microsoft Academic Search

The condition of the armature-rail interface is critical to the performance of a railgun system. A full understanding of sliding electrical contact (SEC) and an ability to model the phenomenon are needed to advance railgun technology. An SEC model which includes the friction and contact resistance is presented in this paper. The heat generated due to the friction and contact

K. T. Hsieh; B. K. Kim

1997-01-01

192

Metatarsal-slide lengthening without bone grafting.  

PubMed

Brachymetatarsia is a condition of premature closure of the epiphyseal plate of a metatarsal. The authors present a case of brachymetatarsia of the second metatarsal. Utilizing a review of the literature, various surgical procedures are discussed. Treatment in this case consisted of a metatarsal-slide lengthening osteotomy, a modification of the Giannestras step-down procedure. PMID:3950333

Tabak, B; Lefkowitz, H; Steiner, I

1986-01-01

193

Instructions for Authors of Presentations  

Microsoft Academic Search

Format: The text should include a brief abstract; the title, authors with the presenting author indicated; location, and dates of the meeting where the talk was initially presented; a description for each slide; and a reference section. All literature cited in the slides must also be cited in the text, although the text may include additional citations not used in

S. E. Henrickson; T. R. Mempel; I. B. Mazo; B. Liu; M. N. Artyomov; H. Zheng; A. Peixoto; M. Flynn; B. Senman; T. Junt; H. C. Wong; A. K. Chakraborty

194

Detection of felt tip markers on microscope slides  

NASA Astrophysics Data System (ADS)

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

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

2014-03-01

195

FDA approves fomivirsen, famciclovir, and Thalidomide. Food and Drug Administration.  

PubMed

The FDA has recently approved three new drugs. Fomivirsen (Vitravene), developed by Isis Pharmaceuticals, was approved as a treatment for cytomegalovirus (CMV) retinitis. The drug prevents CMV replication by binding with the virus' genetic material. It is the first drug using antisense technology to win approval and is injected into the eye weekly or every other week. Famciclovir (Famvir) was approved for the treatment of HIV-related herpes simplex virus (HSV) infection. It is the first oral anti-HSV drug to be approved for use in people with HIV-related herpes. Thalidomide (Synovir), developed by Celgene, has received limited approval for the treatment of leprosy. It has also been used successfully in trials involving AIDS-related wasting and recurrent aphthous ulcers, although it has not been approved for these conditions. PMID:11365993

Highleyman, L

1998-10-01

196

Discrete sliding-mode control of a PWM inverter for sinusoidal output waveform synthesis with optimal sliding curve  

SciTech Connect

This paper presents a discrete sliding-mode control scheme with feedforward compensation for the closed-loop regulation of the pulse-width modulated (PWM) inverter used in an uninterruptible power supply (UPS). The proposed feedforward controller can effectively improve the tracking performance of the PWM inverter. In designing the sliding-mode controller, the authors have taken load disturbance into consideration to enhance the robustness of the PWM inverter. Moreover, the upper bound of the load disturbance under which the sliding condition can be maintained has also been derived. The sliding curve of the sliding-mode controller is designed such that the behavior of the controlled PWM inverter is optimal subject to the selected cost function. Due to the coordinate transformation proposed in this paper, only the output voltage needs to be measured as feedback for the purpose of closed-loop regulation. Simulation and experimental results are given to show the effectiveness of the proposed control scheme.

Jung, S.L.; Tzou, Y.Y. [National Chiao Tung Univ., Hsinchu (Taiwan, Province of China). Dept. of Control Engineering

1996-07-01

197

Adding Slide Rule  

NSDL National Science Digital Library

In this activity, students construct adding slide rules, scaled with linear calibrations like ordinary rulers. Students learn to move these scales relative to each other in ways that add and subtract distances, thus calculating sums and differences. This is Activity A1 in the "Far Out Math" educator's guide. Lessons within the guide include activities in which students measure, compare quantities as orders of magnitude, use 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, the GLAST mission was renamed Fermi, for the physicist Enrico Fermi.

198

Rock Slide in Ophir  

NASA Technical Reports Server (NTRS)

7 May 2004 The dark streaks, just left of center, on the steep slope in this Mars Global Surveyor (MGS) Mars Orbiter Camera (MOC) image were formed by a relatively recent rock slide. The streak closest to the center of the image resolves into a series of small depressions, indicating the path of a large, rolling boulder. The rock slide is inferred to have been recent (i.e., within the past several Mars years) because it is so much darker than its surroundings--there has not been sufficient time for the streak surfaces to become mantled by dust. The other talus accumulations on this slope are most likely lighter in tone because they are older and coated with dust. These features are located in Ophir Chasma, part of the Valles Marineris trough system, near 4.2oS, 74.0oW. The picture is illuminated by sunlight from the lower left and covers an area about 3 km (1.9 mi) across.

2004-01-01

199

MedWatch, the FDA Safety Information and Adverse Event Reporting Program  

MedlinePLUS

... Contact Information MedWatch Partners MedWatch: The FDA Safety Information and Adverse Event Reporting Program Search the MedWatch ... 24/2014 More What's New FDA Approved Safety Information DailyMed (National Library of Medicine) Current Drug Prescribing ...

200

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

201

Medical Devices: FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer.  

National Technical Information Service (NTIS)

The Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) is responsible for overseeing the safety and effectiveness of medical devices sold in the United States. New devices are generally subject to FDA review via th...

2012-01-01

202

Development of a Course of Study in FDA Drug Regulatory Procedures  

ERIC Educational Resources Information Center

It is evident that more colleges of pharmacy should establish some major course of study in the area of governmental drug regulatory procedures. This study is aimed at expanding cooperative educational programs through an FDA residency for pharmacy students and preparing a didactic course in FDA procedures. (LBH)

Jacobs, Robin Wills; King, James C.

1977-01-01

203

Food Safety: FDA Can Better Oversee Food Imports by Assessing and Leveraging Other Countries' Oversight Resources.  

National Technical Information Service (NTIS)

We identified five major actions the Food and Drug Administration (FDA) is to complete under the FDA Food Safety Modernization Act (FSMA) to establish a reliable system that uses third-party audits conducted by foreign governments or other third parties t...

2012-01-01

204

Drug Safety: FDA Has Begun Efforts to Enhance Postmarket Safety, but Additional Actions Are Needed.  

National Technical Information Service (NTIS)

There have been long-standing concerns regarding the Food and Drug Administration's (FDA) oversight of postmarket drug safety. In 2006, GAO reported that FDA had not clearly defined the roles of two offices involved in making decisions about postmarket sa...

2009-01-01

205

Globalizing the FDA: Achieving safety, access, and transparency through a comprehensive Generic Drug User Fee Program  

Microsoft Academic Search

The globalization of drug manufacturing, supply and testing, and a growing workload that has far outpaced FDA’s resources has created new challenges. The US generic industry recognized the importance of working in partnership with FDA to increase critical agency capacity to address the need for globalization of the inspection process, and to speed the timely review of generic product applications

Debbie Jaskot; Gordon Johnston; Marcie E McClintic Coates; Charlie Mayr; Tom Moutvic; Lara Ramsburg; Richard Stec

2011-01-01

206

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

207

Digital slide reproduction using densitometry  

NASA Astrophysics Data System (ADS)

Many contemporary art collections contain important art installations where artists have used 35 mm slides as the primary medium. The number of ours these works are on show makes it necessary to regularly change the slides due to light fading. With funding from the Henry Moore Foundation. The conservation department at Tate initiated a project to examine ways in which digital technology could be used to aid the conservation of these works. The aim of the project was to place the original slides in cold storage and explored the possibility of using digital technology to make duplicate sets for display in the gallery. The reproductions needed to be of very high quality both in terms of resolution and color management. This paper discusses the use of densitometry to calibrate both device dependent and device independent systems for digitally reproducing 35 mm slides using a scanner and a film recorder and the effect of metamery when using slide films which employ different dyes.

Fornaro, Peter R.; Gschwind, Rudolf; Rosenthaler, Lukas; Laurenson, Pip

2002-06-01

208

Dynamics of Multibody Systems with Friction-Affected Sliding Joints  

Microsoft Academic Search

\\u000a In this paper, a new method for the modeling of planar multibody dynamics with friction-affected sliding joints is presented.\\u000a Each friction-affected sliding joint is split into two unilateral constraints opposite to each other, and the constraint equality\\u000a is replaced by unilateral inequalities that are expressed in complementary form. Time-stepping scheme is presented and carried\\u000a out in an example to analyze

Li Fu; Xinghua Ma; Yunchuan Liu; Zhihua Li; Yu Zheng; Yanhu Xu

209

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

210

Slide-Rule Graph  

NSDL National Science Digital Library

In this activity students use their Log Tapes as a reference for ordered pairs, and graph positive numbers as a function of their base-10 logarithms. They extend each plotted point to the vertical axis, thereby generating a logarithmic scale that cuts and folds into an improvised slide rule. This is activity E1 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. 

211

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.

212

Dissolution testing for generic drugs: an FDA perspective.  

PubMed

In vitro dissolution testing is an important tool used for development and approval of generic dosage forms. The objective of this article is to summarize how dissolution testing is used for the approval of safe and effective generic drug products in the United States (US). Dissolution testing is routinely used for stability and quality control purposes for both oral and non-oral dosage forms. The dissolution method should be developed using an appropriate validated method depending on the dosage form. There are several ways in which dissolution testing plays a pivotal role in regulatory decision-making. It may be used to waive in vivo bioequivalence (BE) study requirements, as BE documentation for Scale Up and Post Approval Changes (SUPAC), and to predict the potential for a modified-release (MR) drug product to dose-dump if co-administered with alcoholic beverages. Thus, in vitro dissolution testing plays a major role in FDA's efforts to reduce the regulatory burden and unnecessary human studies in generic drug development without sacrificing the quality of the drug products. PMID:21479700

Anand, Om; Yu, Lawrence X; Conner, Dale P; Davit, Barbara M

2011-09-01

213

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

214

Annulus sliding sleeve valve  

SciTech Connect

This patent describes, in a well having a tubing hanger for supporting a string of tubing within casing, the tubing hanger having a lower exterior cylindrical portion, a passage extending from an upper end of the tubing hanger to a port on the cylindrical portion in communication with an annulus between the tubing and casing, an improved valve for selectively opening and closing the port. It comprises in combination: a closure sleeve slidingly mounted to the exterior of the cylindrical portion and having a lower edge; means for moving the closure sleeve between a lower position in which the lower edge is below the port for blocking the port and an upper position in which the lower edge is above the port; a protector sleeve slidingly mounted to the exterior of the cylindrical portion below the closure sleeve and having an upper edge. The upper edge of the protector sleeve being engaged by the lower edge of the closure sleeve to push the protector sleeve downward with the closure sleeve as the closure sleeve moves to the lower position; means for urging the protector sleeve upward for causing the protector sleeve to move upward as the closure sleeve moves toward the upper position; and means for stopping upward movement of the protector sleeve before the upper edge of the protector sleeve passes the port and before the closure sleeve reaches the upper position, causing the lower edge of the closure sleeve to separate from the upper edge of the protector sleeve to expose the port to the annulus.

Lilley, R.O.

1989-07-18

215

77 FR 70955 - FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to...  

Federal Register 2010, 2011, 2012, 2013

...FDA-2012-N-1148] FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation...mechanisms and additional indications for nicotine replacement therapies (NRTs), and...indications for NRTs. Several NRTs, including nicotine-containing gums, patches, and...

2012-11-28

216

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

217

78 FR 29141 - Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and FDA Staff...  

Federal Register 2010, 2011, 2012, 2013

...Food and Drug Administration [Docket No. FDA-2011-D-0893] Center for Devices and...Appeals Processes; Guidance for Industry and FDA Staff; Availability AGENCY: Food and Drug...SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

2013-05-17

218

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

Federal Register 2010, 2011, 2012, 2013

...FDA-2011-N-0146] FDA Food Safety Modernization Act: Title III--A New Paradigm for Importers...FDA Food Safety Modernization Act: Title III--A New Paradigm for Importers...farm to U.S. table. In particular, title III of FSMA significantly enhances...

2011-03-14

219

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

220

An airship slide rule  

NASA Technical Reports Server (NTRS)

This report prepared for the National Advisory Committee for Aeronautics, describes an airship slide rule developed by the Gas-Chemistry Section of the Bureau of Standards, at the request of the Bureau of Engineering of the Navy Department. It is intended primarily to give rapid solutions of a few problems of frequent occurrence in airship navigation, but it can be used to advantage in solving a great variety of problems, involving volumes, lifting powers, temperatures, pressures, altitudes and the purity of the balloon gas. The rule is graduated to read directly in the units actually used in making observations, constants and conversion factors being taken care of by the length and location of the scales. It is thought that with this rule practically any problem likely to arise in this class of work can be readily solved after the user has become familiar with the operation of the rule; and that the solution will, in most cases, be as accurate as the data warrant.

Weaver, E R; Pickering, S F

1924-01-01

221

Rough viscoelastic sliding contact: Theory and experiments  

NASA Astrophysics Data System (ADS)

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

Carbone, G.; Putignano, C.

2014-03-01

222

Identifying, Understanding, and Communicating Medical Device Use Errors: Observations from an FDA Pilot Program.  

National Technical Information Service (NTIS)

The U.S. Food and Drug Administration (FDA) attempts to identify and understand new risks associated with medical device use; communicate information and recommendations to device users; help manage known risks by providing strategies to facilitate safe u...

M. Flack T. Reed J. Crowley S. Gardner

2005-01-01

223

Food Labeling: FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims.  

National Technical Information Service (NTIS)

The Food and Drug Administration (FDA) oversees federal requirements to prohibit false or misleading food labels; the Federal Trade Commission enforces the prohibition against false or misleading advertising. By statute, health claims on food labels must ...

2011-01-01

224

Prescription Drugs: FDA's Oversight of the Promotion of Drugs for Off-Label Uses.  

National Technical Information Service (NTIS)

The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), regulates the promotion of prescription drugs to ensure that promotional materials are not false and misleading and that they comply with applicabl...

2008-01-01

225

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

Federal Register 2010, 2011, 2012, 2013

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

2011-06-01

226

Guidance for Industry: Guidance for Submission of Immunohistochemistry Applications to the FDA.  

National Technical Information Service (NTIS)

This guidance document is intended to guide in (1) the processing, content, and evaluation/approval of submissions for immunohistochemistry devices (IHC's); (2) the design, production, manufacturing, and testing of IHC devices; (3) it establishes for FDA ...

1998-01-01

227

Start Sleep Drug Lunesta at Lower Dose for Safety, FDA Says  

MedlinePLUS

... features on this page, please enable JavaScript. Start Sleep Drug Lunesta at Lower Dose for Safety, FDA ... 2014 (HealthDay News) -- Some users of the popular sleep medicine Lunesta remain too drowsy for safety during ...

228

New Joint Program Announced by FDA and NCI Holds Promise for Cancer  

Cancer.gov

The Food and Drug Administration (FDA) and the National Cancer Institute (NCI) announced today a new joint research and clinical program that holds great promise for developing better and more targeted treatments for cancer.

229

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

230

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.

231

Advisory committees at FDA: the Hinchey Amendment and "conflict of interest" waivers.  

PubMed

In approving the Food and Drug Administration's (FDA) Fiscal Year 2007 budget, the House approved an amendment that would prevent the agency from using appropriated funds to waive certain conflicts of interest identified by members of its advisory committees. The amendment, introduced by Representative Hinchey and known as the Hinchey Amendment, provides that no funds may be used to: waive a conflict of interest under Section 505(n)(4) of the Federal Food, Drug, and Cosmetic Act (FDCA) for any voting member of an FDA advisory committee or panel; or make a certification under Section 208(b)(3) of Title 18 of the U.S. Code for any such voting member. This creates a problem, as ties to industry create the very expertise that FDA values in its outside advisors-under the Hinchey Amendment, these very ties would prevent them from serving as advisors to FDA during the drug approval process. The author opposes this change in the law and argues that the Hinchey Amendment would undermine congressional efforts in 1962 and 1989 to carefully balance the goals of attracting qualified experts and protecting agency decisionmaking. Further, the author argues, this change is unnecessary at FDA, because experts on FDA advisory committees divulge their connections to the industry, because the committees offer only advice and do not make agency decisions, and because the agency is under the watchful eye of Congress, the public, and public interest groups. The Article concludes that although FDA's advisory committee conflict-of-interest process can be improved, congressional action is unnecessary, and a change in the law through amendment to an appropriations bill that does not go through the ordinary legislative process (as an amendment to the FDCA or Title 18 would) is inappropriate. Instead, recommendations from organizations studying FDA practice, such as the OIG, GAO, and IOM, should be used to carefully and reflectively amend the process at the agency level, within the existing statutory framework. PMID:17402656

Lietzan, Erika

2006-01-01

232

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.

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

2012-01-01

233

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

234

The sliding-helix voltage sensor  

PubMed Central

The voltage sensor (VS) domain of voltage-gated ion channels underlies electrical excitability of living cells. We simulate a mesoscale model of the VS domain to determine the functional consequences of some of its physical elements. Our mesoscale model is based on VS charges, linear dielectrics and whole-body motion, applied to an S4 ‘sliding helix’. The electrostatics under voltage-clamped boundary conditions are solved consistently using a boundary element method. Based on electrostatic configurational energy, statistical-mechanical expectations of the experimentally observable relation between displaced charge and membrane voltage are predicted. Consequences of the model are investigated for variations of: S4 configuration (?- and 310-helical), countercharge alignment with S4 charges, protein polarizability, geometry of the gating canal, screening of S4 charges by the baths, and fixed charges located at the bath interfaces. The sliding helix VS domain has an inherent electrostatic stability in the explored parameter space: countercharges present in the region of weak dielectric always retain an equivalent S4 charge in that region but allow sliding movements displacing 3 to 4 e0. That movement is sensitive to small energy variations (< 2kT) along the path dependent on a number of electrostatic parameters tested in our simulations. These simulations show how the slope of the relation between displaced charge and voltage could be tuned in a channel.

Peyser, Alexander; Nonner, Wolfgang

2012-01-01

235

Managing and querying whole slide images  

NASA Astrophysics Data System (ADS)

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.

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

2012-02-01

236

PowerPoint Presentation  

Cancer.gov

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH Working with FDA: Biological Products and Clinical Development U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH Working with FDA: Biological Products

237

Registration of organs with sliding interfaces and changing topologies  

NASA Astrophysics Data System (ADS)

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

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

2014-03-01

238

Metabolic network analysis predicts efficacy of FDA-approved drugs targeting the causative agent of a neglected tropical disease  

PubMed Central

Background Systems biology holds promise as a new approach to drug target identification and drug discovery against neglected tropical diseases. Genome-scale metabolic reconstructions, assembled from annotated genomes and a vast array of bioinformatics/biochemical resources, provide a framework for the interrogation of human pathogens and serve as a platform for generation of future experimental hypotheses. In this article, with the application of selection criteria for both Leishmania major targets (e.g. in silico gene lethality) and drugs (e.g. toxicity), a method (MetDP) to rationally focus on a subset of low-toxic Food and Drug Administration (FDA)-approved drugs is introduced. Results This metabolic network-driven approach identified 15 L. major genes as high-priority targets, 8 high-priority synthetic lethal targets, and 254 FDA-approved drugs. Results were compared to previous literature findings and existing high-throughput screens. Halofantrine, an antimalarial agent that was prioritized using MetDP, showed noticeable antileishmanial activity when experimentally evaluated in vitro against L. major promastigotes. Furthermore, synthetic lethality predictions also aided in the prediction of superadditive drug combinations. For proof-of-concept, double-drug combinations were evaluated in vitro against L. major and four combinations involving the drug disulfiram that showed superadditivity are presented. Conclusions A direct metabolic network-driven method that incorporates single gene essentiality and synthetic lethality predictions is proposed that generates a set of high-priority L. major targets, which are in turn associated with a select number of FDA-approved drugs that are candidate antileishmanials. Additionally, selection of high-priority double-drug combinations might provide for an attractive and alternative avenue for drug discovery against leishmaniasis.

2012-01-01

239

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

Microsoft Academic Search

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

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

2006-01-01

240

Thermal non-Newtonian elastohydrodynamic lubrication of line contacts under sliding-rolling and simple sliding conditions  

NASA Astrophysics Data System (ADS)

A thermal Reynolds-Erying equation is derived to study the elastohydrodynamic lubrication of line contacts. This lubrication condition is usually found in spur gears, roller bearings, and cams. The inlet region with back-flow is treated with a control volume scheme to obtain the temperature solution. A computationally-simple formulation for the stationary surface temperature is developed for simple sliding conditions. The most influential dimensionless groups are identified from the complete sets of dimensionless groups. Numerical results obtained for sliding and rolling and for simple sliding conditions are used to develop formulas for the thermal and non-Newtonian (Ree-Eyring) film thickness reduction factor. Even when thermal effects are small, these formulas can still give a film thickness reduction due to the non-Newtonian effects. Results for the maximum temperatures and traction coefficient are also presented. The pressure dependence of lubricant thermal conductivity is found to significantly affect the maximum lubricant temperature. The thermal effects on film thickness and traction are found to be more pronounced for simple sliding than for combined sliding and rolling conditions. Under simple sliding, the heat transferred to the stationary surface is found to be very small compared to that transferred to the moving surface and lubricating fluid.

Wang, Shao

1991-02-01

241

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

242

Highly sensitive fluorescence detection of avidin/streptavidin with an optical interference mirror slide.  

PubMed

This paper presents highly sensitive fluorescence detections of avidin and streptavidin using an optical interference mirror (OIM) slide consisting of a plane mirror covered with an optical interference layer. Compared with a common glass slide, the OIM slide can enhance the fluorescence from a dye by more than 100-fold. We fabricated an OIM slide by depositing an optical interference layer of Al(2)O(3) on an Ag mirror. To enhance the fluorescence maximally, the optimal thickness of the Al(2)O(3) layer was estimated from optical interference theory. For detections of protein, avidin/streptavidin labeled with fluorescein, Cy3, and Cy5 were detected with biotin immobilized on an OIM slide with the optimal Al(2)O(3) thickness. We achieved a sensitivity improvement of more than 50-fold, comparing with a glass slide. Such a high degree of improvement would be a significant contribution to further progress in biomedical research and medical diagnostics. PMID:23059989

Yasuda, Mitsuru; Akimoto, Takuo

2012-01-01

243

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.

244

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

245

FDA'S food ingredient approval process: Safety assurance based on scientific assessment.  

PubMed

Fifty years ago, the Food and Drug Administration (FDA) began implementing new provisions of the Federal Food, Drug, and Cosmetic Act aimed at assuring the safety of new food additives before they enter the marketplace. Today, the agency's procedures for premarket evaluation of food additive safety have evolved into a scientifically rigorous, sound and dependable system whose objective and independent evaluations by FDA scientists assure that new food additives are safe for their intended uses before they arrive on the consumer's plate. Although controversy often surrounds food additives in the popular media and culture, and science-based challenges to FDA's decisions do arise, the agency's original safety judgments successfully withstand these challenges time and again. This article reviews the basic components of the FDA's decision-making process for evaluating the safety of new food additives, and identifies characteristics of this process that are central to assuring that FDA's decisions are marked by scientific rigor and high integrity, and can continue to be relied on by consumers. PMID:18983884

Rulis, Alan M; Levitt, Joseph A

2009-02-01

246

The Sliding of Ptfe on Ptfe.  

National Technical Information Service (NTIS)

In sliding tests, a weighted sled with PTFE runners was pulled over a PTFE track. The sliding velocity was measured as a function of tangential load and ambient temperature for two normal loads. The results have led to treating the sliding phenomenon as a...

R. P. Steijn

1964-01-01

247

A novel low chattering sliding mode controller  

Microsoft Academic Search

The purpose of this paper is to design a high performance sliding mode controller through the use of a new switching function. This method uses the idea of boundary layer sliding mode while taking the boundary layer width as a function of the angle between the state trajectory and the sliding surface which we call approach angle. By incorporating the

M. R. Rafimanzelat; M. J. Yazdanpanah

2004-01-01

248

Linear Classification of Dairy Cattle. 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 principles of the linear classification of dairy cattle. Included in the guide are narrations for use with 63 slides, which illustrate the following areas that are considered in the linear classification system: stature, strength,…

Sipiorski, James; Spike, Peter

249

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.

250

Mannheim Type Slide Rule with Leather Sleeve  

USGS Multimedia Gallery

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

2009-07-22

251

Stop the Summer Reading Slide  

ERIC Educational Resources Information Center

When teachers wave goodbye to their students as they head off for summer vacation, they might just be bidding farewell to some of their hard-won gains in reading skills. The "summer slide" is well-documented by research: Unless students read regularly during the break, they fall behind about three months in their reading achievement. This article…

Lundstrom, Meg

2005-01-01

252

Linear Motor With Air Slide  

NASA Technical Reports Server (NTRS)

Improved linear actuator comprises air slide and linear electric motor. Unit exhibits low friction, low backlash, and more nearly even acceleration. Used in machinery in which positions, velocities, and accelerations must be carefully controlled and/or vibrations must be suppressed.

Johnson, Bruce G.; Gerver, Michael J.; Hawkey, Timothy J.; Fenn, Ralph C.

1993-01-01

253

Electrically assisted drop sliding on inclined planes  

NASA Astrophysics Data System (ADS)

We demonstrate that electrowetting using alternating current (ac) voltage can be used to overcome pinning of small drops due to omnipresent heterogeneities on solid surfaces. By balancing contact angle hysteresis with gravity on inclined planes, we find that the critical electrowetting number for mobilizing drops is consistent with the voltage-dependent reduction in contact angle hysteresis in ac electrowetting. Moreover, the terminal velocity of sliding drops under ac electrowetting is found to increase linearly with the electrowetting number. Based on this effect, we present a prototype of a wiper-free windscreen.

't Mannetje, D. J. C. M.; Murade, C. U.; van den Ende, D.; Mugele, F.

2011-01-01

254

The FDA's role in medical device clinical studies of human subjects  

NASA Astrophysics Data System (ADS)

This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

Saviola, James

2005-03-01

255

The FDA Review Process for Cardiac Medical Devices in Children: A Review for the Clinician  

PubMed Central

Pediatric medical devices play a vital role in the treatment of children with cardiovascular disease. Most cardiac medical devices used in children today are used off-label where the risk-benefit of devices has not been well characterized. Pediatric medical devices face a variety of challenges to FDA approval related in large part to the small target population, heterogeneity of the patient population and ethical considerations of device testing in children. While relatively few cardiac devices have received FDA approval in children, the number of devices navigating the approval process successfully is growing. Most pediatric device approvals are being granted through the humanitarian device exemption (HDE) pathway, which is designed for rare diseases making it suitable for devices treating congenital heart disease. This review summarizes the FDA review process for pediatric medical devices as it continues to evolve in response to the unique challenges of understanding device performance in the pediatric population.

Almond, Christopher S.

2012-01-01

256

Price, Performance, and the FDA Approval Process: The Example of Home HIV Testing  

PubMed Central

The Food and Drug Administration (FDA) is considering approval of an over-the-counter, rapid HIV test for home use. To support its decision, the FDA seeks evidence of the test’s performance. It has asked the manufacturer to conduct field studies of the test’s sensitivity and specificity when employed by untrained users. In this paper, we argue that additional information should be sought to evaluate the prevalence of undetected HIV in the end-user population. Our analytic framework produces the elementary but counterintuitive finding that the performance of the home HIV test – measured in terms of its ability to correctly detect the presence and absence of HIV infection among the people who purchase it – depends critically on the manufacturer’s retail price. This finding has profound implications for the FDA’s approval process.

Paltiel, A. David; Pollack, Harold A.

2010-01-01

257

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

258

Optoelectronic hit/miss transform for screening cervical smear slides  

NASA Astrophysics Data System (ADS)

An optoelectronic morphological processor for detecting regions of interest (abnormal cells) on a cervical smear slide using the hit/miss transform is presented. Computer simulation of the algorithm tested on 184 Pap-smear images provided 95% detection and 5% false alarm. An optoelectronic implementation of the hit/miss transform is presented, along with preliminary experimental results.

Narayanswamy, R.; Turner, R. M.; McKnight, D. J.; Johnson, K. M.; Sharpe, J. P.

1995-06-01

259

Separation of aromatics\\/aliphatics with crosslinked 6FDA-based copolyimides  

Microsoft Academic Search

For the separation of benzene\\/cyclohexane mixtures the pervaporation properties of different crosslinked 4,4?-hexafluoro-isopropylidene dianhydrid (6FDA) based copolyimide membranes have been investigated. The copolyimides were obtained by polycondensation of the 6FDA with various diamines. In order to obtain high permeability as well as high selectivity a combination of the diamines 2,3,5,6 tetramethyl-1, 4-phenylene diamine (4MPD), 4,4?hexafluoro-isopropylidene dianiline (6FpDA) and 3,5-diaminobenzoic acid

Jizhong Ren; Claudia Staudt-Bickel; Rüdiger N. Lichtenthaler

2001-01-01

260

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

261

We really need to talk: adapting FDA processes to rapid change.  

PubMed

The rapidly evolving realm of modern commerce strains traditional regulatory paradigms. This paper traces the historical evolution of FDA crisis-response regulation and provides examples of ways in which the definitions and procedures resulting from that past continue to be challenged by new products as market entrants, some in good faith and others not, take actions that create disconnects between actual product and marketing controls and those that consumers might expect. The paper then explores some of the techniques used by other federal agencies that have faced similar challenges in environments characterized by rapid innovation, and draws from this analysis suggestions for improvement of the FDA's warning letter system. PMID:24552079

Lykken, Sara

2013-01-01

262

FDA working to ensure the safety of medical devices used in the pediatric population.  

PubMed

Special initiatives exist in FDA's Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research to ensure the safety and effectiveness of medical products used in the vulnerable pediatric population. This article focuses on the special programs, projects, and special studies implemented by CDRH to ensure this safety and effectiveness in devices used in pediatric patients throughout the devices' total product life-cycles. Pediatricians play a major role in keeping medical devices safe for use in children by reporting device problems to FDA. PMID:23116531

Flack, Marilyn Neder; Gross, Thomas P; Reid, Joy Samuels; Mills, Thalia T; Francis, Jacqueline

2012-12-01

263

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

264

Formation of cylindrical sliding-wear debris on silicon in humid conditions and elevated temperatures  

Microsoft Academic Search

The present study investigates the mechanics of roll formation between sliding bodies at elevated temperatures and humid conditions. Silicon is used as the model material for reciprocating linear sliding tests. The evolution of tribological rolls initially involves the rapid oxidation of silicon wear debris by water, the deformation of SiO2 particles into platelets, and then the compaction of these particles

Elmer S. Zonoria; Steven Danyluk; Michael J. McNallan

1995-01-01

265

Formation of Cylindrical Sliding-Wear Debris on Silicon in Humid Conditions and Elevated Temperatures  

Microsoft Academic Search

The present study investigates the mechanics of roll formation between sliding bodies at elevated temperatures and humid conditions. Silicon is used as the model material for reciprocating linear sliding tests. The evolution of tribological rolls initially involves the rapid oxidation of silicon wear debris by water, the deformation of SiO2 particles into platelets, and then the compaction of these particles

Elmer S. Zanoria; Steven Danyluk; Michael J. Mcnallan

1995-01-01

266

A robust active queue management scheme based on global sliding mode control  

Microsoft Academic Search

For the problem of transmission control protocol (TCP) network congestion control, on the basis of global sliding mode control, an active queue management (AQM) scheme adaptive to the change of dynamic network flow is presented. The proposed scheme can eliminate the reaching phase from conventional sliding mode control, and guarantee the system robustness during the whole control process. At the

Hongwei Wang; Georgi M. Dimirovski; Yuanwei Jing; Zhaona Chen

2008-01-01

267

A Novel Sliding Mode Observer with Adaptive Feedback Gain for PMSM Sensorless Vector Control  

Microsoft Academic Search

A novel sliding mode observer (SMO) with adaptive feedback gain is presented for sensorless vector control of permanent magnet synchronous machines (PMSM). The rotor position angle is estimated based on the equivalent control in the sliding mode observer. By selecting adaptive feedback gain, the equivalent control has the same constant magnitude as rotor flux over full speed range. Compared to

S. Chi; Z. Zhang; L. Xu

2007-01-01

268

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

269

On robust control of uncertain chaotic systems: a sliding-mode synthesis via chaotic optimization  

Microsoft Academic Search

This paper presents a novel Lyapunov-based control approach which utilizes a Lyapunov function of the nominal plant for robust tracking control of general multi-input uncertain nonlinear systems. The difficulty of constructing a control Lyapunov function is alleviated by means of predefining an optimal sliding mode. The conventional schemes for constructing sliding modes of nonlinear systems stipulate that the system of

Zhao Lu; Leang-San Shieh; Guanrong Chen

2003-01-01

270

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

Microsoft Academic Search

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

Onder Efe

271

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

Microsoft Academic Search

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

M. O. Efe

2007-01-01

272

PWM in three-phase switching converters-sliding mode solution  

Microsoft Academic Search

In this paper, the selection of the switching logic for PWM three phase switching converters (inverters and rectifiers) is presented. The approach is based on the deliberate introduction of the sliding mode motion in the control system. It is shown that the selection of the PWM pattern is a direct result of the sliding mode existence in the closed-loop system.

Nadira Sabanovic-Behlilovic; Asif Sabanovic; Tamotsu Ninomiya

1994-01-01

273

Full discrete sliding mode controller for three phase PWM rectifier based on load current estimation  

Microsoft Academic Search

This paper presents a novel full discrete sliding mode controller for voltage-sourced three phase rectifier to improve its dynamic response under the load and dc link voltage variation. Using the concept of power balance in three phase rectifier, the sliding mode controller for dc link voltage regulation is derived. Also, in order to avoid the additional load current sensor, a

Jin Ye; Xu Yang; Haizhong Ye; Xiang Hao

2010-01-01

274

A sliding wear tester for overhead wires and current collectors in light rail systems  

Microsoft Academic Search

This paper presents the dedicated experimental equipment developed for a study of the tribological behaviour of current collectors sliding against overhead contact wires under various conditions. A unique wear tester that replicates the operating conditions of actual pantographs in railway power collection systems was developed. The sliding element moves over the wire in a controlled horizontal motion at homogeneous velocity,

Da Hai He; Rafael Manory; Harry Sinkis

2000-01-01

275

Sliding wear of PP\\/UHMWPE blends: effect of blend composition  

Microsoft Academic Search

In the present investigation, a wear resistant polymer, ultra high molecular weight polyethylene (UHMWPE) was melt blended with isotactic polypropylene (PP) in different proportions. Sliding wear tests were conducted by using Cameron Plint pin-on-disc apparatus. Polymer samples in the form of the pin were tested against EN-24 steel disc at different pressures and sliding speeds. The wear volume of PP

S. A. R Hashmi; Somit Neogi; Anuradha Pandey; Navin Chand

2001-01-01

276

HMM-based sliding video text recognition for Turkish broadcast news  

Microsoft Academic Search

In this paper, we develop an HMM-based sliding video text recognizer and present our results on Turkish broadcast news for the hearing impaired. We use well known speech recognition techniques to model and recognize sliding video text characters using a minimal amount of labeled data. Baseline system without any language modeling gives a word error rate of 2.2% on 138

Temucin Som; Dogan Can; Murat Saraclar

2009-01-01

277

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...

278

Asymptotic uniqueness of the sliding state for charge-density waves  

Microsoft Academic Search

Analytic results are presented for the dynamic behavior of sliding charge-density waves (CDW's) and related extended nonlinear systems with randomness. It is shown that, in the limit of long times, a sliding configuration approaches a unique solution. In CDW models, the velocity of this asymptotic solution is periodic in time. These results explain previous numerical observations, simplify further analysis and

A. Alan Middleton

1992-01-01

279

Dielectrophoretic Segregation of Different Human Cell Types on Microscope Slides  

PubMed Central

A new method for preparing cells for microscopic examination is presented in which cell mixtures are fractionated by dielectrophoretic forces and simultaneously collected into characteristic zones on slides. The method traps cells directly from the suspending medium onto the slide, reducing cell loss. Furthermore, it exploits differences in the dielectric properties of the cells, which sensitively reflect their morphology. Because different cell types are trapped in characteristic zones on the slide, the technique represents an advance over existing methods for slide preparation, such as centrifugation and smears where cells are randomly distributed. In particular, the new method should aid in the detection of rare and anomalous cell subpopulations that might otherwise go unnoticed against a high background of normal cells. As well as being suitable for traditional microscopic examination and automated slide scanning approaches, it is compatible with histochemical and immunochemical techniques, as well as emerging molecular and proteomic methods. This paper describes the rationale and design of this so-called electrosmear instrumentation and shows experimental results that verify the theory and applicability of the method with model cell lines and normal peripheral blood subpopulations.

Das, Chandra M.; Becker, Frederick; Vernon, Suzanne; Noshari, Jamileh; Joyce, Celine; Gascoyne, Peter R. C.

2005-01-01

280

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

281

High current density, cryogenically cooled sliding electrical joint development  

SciTech Connect

In the past two years, conceptual designs for fusion energy research devices have focussed on compact, high magnetic field configurations. The concept of sliding electrical joints in the large magnets allows a number of technical advantages including enhanced mechanical integrity, remote maintainability, and reduced project cost. The rationale for sliding electrical joints is presented. The conceptual configuration for this generation of experimental devices is highlghted by an approx. 20 T toroidal field magnet with a flat top conductor current of approx. 300 kA and a sliding electrical joint with a gross current density of approx. 0.6 kA/cm/sup 2/. A numerical model was used to map the conductor current distribution as a function of time and position in the conductor. A series of electrical joint arrangements were produced against the system code envelope constraints for a specific version of the Ignition Studies Project (ISP) which is designated as 1025.

Murray, H.

1986-09-01

282

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

283

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

284

Paleo Slide Set: Heinrich Events  

NSDL National Science Digital Library

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

285

Base-Two Slide Rule  

NSDL National Science Digital Library

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

286

Exploration of the Humboldt Slide using Anisotropy of Magnetic Susceptibility - Comparison with the Gaviota Slide  

NASA Astrophysics Data System (ADS)

The origin of the "so-called" Humboldt Slide has raised much controversy. Some researchers argue that it is a slide deposit, while others interpret the deposit as a depositional feature mantling an old slide scar formed by down-slope gravity flows. We adapted the standard paleomagnetic tool of Anisotropy of Magnetic Susceptibility \\(AMS\\) in order to detect minor post-depositional deformation \\(i.e., "crypto-slumps"\\) in sedimentary successions and applied it to the Humboldt Slide controversy. Crypto-slumps are slumps that are not easily observed in outcrop or core samples. Undeformed sediments show a typical oblate fabric while even slightly deformed sediments develop a triaxial fabric. Based on examining cores from the center and top of the Humboldt Slide structure, we find no evidence for deformation. The cores from the top are in an area that is clearly free from drape and thus we can be sure that we are sampling the structure seen in chirp seismics. We recently sampled a known slide for comparison to the Humboldt Slide. We used 5 gravity cores from the USGS V1-81-SC cruise which sampled the Gaviota Slide. The Gaviota Slide in on the northern slope of the Santa Barbara Basin and is just to the west of the much larger Golita Slide. The AMS measurements from the Gaviota Slide show a clearly deformed fabric that we expect from a slide. From these analyses we found that the fabric is dominantly oblate for the Humboldt Slide while the Gaviota Slide is predominantly triaxial. Based on these results, we re-emphasize our conclusion that the Humboldt Slide is not a slide. We now know that the ridges and swales of the Humboldt Slide appear to have grown as sediment waves on an old slide scar and our chirp seismics show thickening on the upslope side of these structures and continuous reflectors across regions where others have mapped normal faults.

Schwehr, K.; Driscoll, N.; Tauxe, L.; Lee, H. J.

2003-12-01

287

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

288

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

289

Identifying, Understanding, and Communicating Medical Device Use Errors: Observations from an FDA Pilot Program  

Microsoft Academic Search

The U.S. Food and Drug Administration (FDA) attempts to identify and understand new risks associated with medical device use; communicate information and recommendations to device users; help manage known risks by providing strategies to facilitate safe use; guide manufacturers to improve design, labeling, and training to address known risks; and guide users to make smart decisions about the acquisition and

Marilyn Flack; Terrie Reed; Jay Crowley; Susan Gardner

290

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

291

21 CFR 516.34 - FDA recognition of exclusive marketing rights.  

Code of Federal Regulations, 2010 CFR

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

2009-04-01

292

21 CFR 516.34 - FDA recognition of exclusive marketing rights.  

Code of Federal Regulations, 2010 CFR

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

2010-04-01

293

MSC-based product characterization for clinical trials: an FDA perspective.  

PubMed

Proposals submitted to the FDA for MSC-based products are undergoing a rapid expansion that is characterized by increased variability in donor and tissue sources, manufacturing processes, proposed functional mechanisms, and characterization methods. Here we discuss the diversity in MSC-based clinical trial product proposals and highlight potential challenges for clinical translation. PMID:24506881

Mendicino, Michael; Bailey, Alexander M; Wonnacott, Keith; Puri, Raj K; Bauer, Steven R

2014-02-01

294

NCI and FDA Announce Joint Program to Streamline Cancer Drug Development: Questions and Answers  

Cancer.gov

The National Cancer Institute (NCI) and the Food and Drug Administration (FDA) have established this collaboration (which is being formalized through an interagency agreement) to enhance the efficiency of clinical research and the scientific evaluation of new cancer medications and diagnostics.

295

Quantitative analysis on the characteristics of targets with FDA approved drugs.  

PubMed

Accumulated knowledge of genomic information, systems biology, and disease mechanisms provide an unprecedented opportunity to elucidate the genetic basis of diseases, and to discover new and novel therapeutic targets from the wealth of genomic data. With hundreds to a few thousand potential targets available in the human genome alone, target selection and validation has become a critical component of drug discovery process. The explorations on quantitative characteristics of the currently explored targets (those without any marketed drug) and successful targets (targeted by at least one marketed drug) could help discern simple rules for selecting a putative successful target. Here we use integrative in silico (computational) approaches to quantitatively analyze the characteristics of 133 targets with FDA approved drugs and 3120 human disease genes (therapeutic targets) not targeted by FDA approved drugs. This is the first attempt to comparatively analyze targets with FDA approved drugs and targets with no FDA approved drug or no drugs available for them. Our results show that proteins with 5 or fewer number of homologs outside their own family, proteins with single-exon gene architecture and proteins interacting with more than 3 partners are more likely to be targetable. These quantitative characteristics could serve as criteria to search for promising targetable disease genes. PMID:18167532

Sakharkar, Meena K; Li, Peng; Zhong, Zhaowei; Sakharkar, Kishore R

2008-01-01

296

Trocar-associated injuries and fatalities: An analysis of 1399 reports to the FDA  

Microsoft Academic Search

Laparoscopic trocars, medical devices used to gain access into the abdominal cavity, are the most common device named in malpractice injury claims associated with laparoscopic procedures. As part of its ongoing adverse event reporting program, the U.S. Food and Drug Administration (FDA) requires manufacturers and user facilities to file a report whenever a device was or may have been a

Janie Fuller; Binita S. Ashar; Julia Carey-Corrado

2005-01-01

297

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

Microsoft Academic Search

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

Kip Canfield; Michele Ritondo; Richard Sponaugle

1998-01-01

298

NCI, FDA Announce Two New Initiatives As Part of Strategic Partnership  

Cancer.gov

At a Friends of Cancer Research meeting, National Cancer Institute (NCI) Director Andrew C. von Eschenbach, M.D., and Food and Drug Administration (FDA) Commissioner Mark McClellan, M.D., Ph.D, announced two new collaborative initiatives to facilitate the development and use of better cancer treatments.

299

The rosiglitazone decision process at FDA and EMA. What should we learn?  

PubMed

In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone, while the FDA decided to restrict the use of rosiglitazone. These actions were taken approximately 10 years after the introduction of rosiglitazone, because rosiglitazone might be associated with an increased risk of ischemic heart disease. It is often stated that the first signs of an increased risk of ischemic heart disease were noticed in 2004, however already in 2001 the FDA concluded, based on data available to the EMA at the time of initial approval, that rosiglitazone should not be used in combination with insulin, because this combination therapy was associated with an increased risk of cardiac failure and ischemic heart disease. Remarkably, in 2007, when the evidence against this combination therapy had increased, the EMA made a decision that encouraged the use of insulin in combination with rosiglitazone, while the FDA tried to restrict this combination therapy. Despite the publication of several studies, including a large randomized controlled study, the cardiovascular risk of rosiglitazone still has not been definitively established. The weight given to the benefits and the risks seems mainly a subjective decision. To prevent new cases like rosiglitazone, more attention should be given to evaluation of study protocols of safety trials prior to their starts. This paper gives a critical overview of the decision making process at the FDA and the EMA on the basis of public available information. PMID:22751189

Pouwels, Koen B; van Grootheest, Kees

2012-01-01

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

Fatalities Reported to FDA Following Blood Collection and Transfusion. Annual Summary for Fiscal Year 2010.  

National Technical Information Service (NTIS)

As previously mentioned in the annual summary of fatalities reported to the FDA in Fiscal Years (FY) 2005 through FY2009, the blood supply is safer today than at any time in history. Due to advances in donor screening, improved testing, automated data sys...

2010-01-01

302

FDA-regulated validation in clinical and nonclinical environments (Regulatory Affairs)  

Microsoft Academic Search

The Food and Drug Administration (FDA) governs the activities of medical and pharmaceutical research and healthcare organizations through regulations including, but not limited to, good laboratory practices (GLPs), current good manufacturing practices (CGMPs), good clinical practices (GCPs), and electronic records and electronic signatures (ERESs). These good practices and ERESs cite various requirements that comprise \\

C. Curts

2007-01-01

303

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

Federal Register 2010, 2011, 2012, 2013

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

2011-08-30

304

A Summary of Adverse Reactions Reported to FDA. Volume I. Drug to Adverse Reaction. Volume II. Adverse Reaction to Drug.  

National Technical Information Service (NTIS)

This summary reflects cases of adverse drug reactions reported to FDA which have an occurrence of two or more relative relationships of probable or definite for the period covered by the report. These reports were received through the FDA Voluntary Report...

1980-01-01

305

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.

2014-04-01

306

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

307

Laser Transformation Hardening of Precision V-Slide Way.  

National Technical Information Service (NTIS)

The paper presents the results of the study of the application of laser transformation hardening (LTH) on the precision slide ways and some specimens of 20, 45, GCr15, 18Cr2Ni4WA or other steels by 1KW transverse CO2 laser. It is concluded that (1) the LT...

G. Zhang Q. Yang Y. Wu

1986-01-01

308

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

309

Friction and abrasive wear of UHWMPE sliding on ice  

Microsoft Academic Search

The authors present an experimental approach of abrasion resistance of material currently used in ski: ultra high molecular weight polyethylene (UHMWPE) is used as the main element of ski sole: cross country skiing, speed skiing, alpine skiing, ….The aim of this work is to characterise abrasive wear and tribological performance of ski sole when one slides on ice in different

S. Ducret; H. Zahouani; A. Midol; P. Lanteri; T. G. Mathia

2005-01-01

310

Dynamic positioning systems: An experimental analysis of sliding mode control  

Microsoft Academic Search

Vessel dynamic positioning (DP) systems are based on conventional PID-type controllers and an extended Kalman filter. However, they present a difficult tuning procedure, and the closed-loop performance varies with environmental or loading conditions since the dynamics of the vessel are eminently nonlinear. Gain scheduling is normally used to address the nonlinearity of the system. To overcome these problems, a sliding

E. A. Tannuri; A. C. Agostinho; H. M. Morishita; L. Moratelli Jr

2010-01-01

311

Sliding mode control of interior permanent magnet synchronous motors  

Microsoft Academic Search

The paper presents a digital control system of speed for an interior permanent magnet synchronous motor (IPMSM), based on the sliding mode control of the electromagnetic torque. The torque controller was designed taking into consideration a model of the machine in the rotating reference frame attached to the stator flux. The feedback signals are determined by using the measured values

M. Cernat; Vasile Comnac; Maria Cotorogea; Peter Korondi; Sergy Ryvkin; R.-M. Cernat

2000-01-01

312

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...

313

IMPACT OF FDA DRUG RISK COMMUNICATIONS ON HEALTH CARE UTILIZATION AND HEALTH BEHAVIORS: A SYSTEMATIC REVIEW  

PubMed Central

Objective To review literature on the impact of FDA drug risk communications on medication utilization, health care services use, and health outcomes. Data Sources The authors searched MEDLINE and the Web of Science for manuscripts published between January 1990 and November 2010 that included terms related to drug utilization, the FDA, and advisories or warnings. We manually searched bibliographies and works citing selected articles and consulted with experts to guide study selection. Study Selection Studies were included if they involved an empirical analysis evaluating the impact of an FDA risk communication. Data Extraction We extracted the drug(s) analyzed, relevant FDA communication(s), data source, analytical method, and main outcome(s) assessed. Results Of the 1432 records screened, 49 studies were included. These studies covered sixteen medicines or therapeutic classes; one-third examined communications regarding antidepressants. Most used medical or pharmacy claims and few rigorously examined patient-provider communication, decision-making or risk perceptions. Advisories recommending increased clinical or laboratory monitoring generally led to decreased drug use, but only transient and modestly increased monitoring. Communications targeting specific subpopulations often spilled over to other groups. Repeated or sequential advisories tended to have larger but delayed effects and decreased incident more than prevalent use. Drug-specific warnings were associated with particularly large decreases in utilization, though the magnitude of substitution within therapeutic classes varied across clinical contexts. Conclusions While some FDA drug risk communications had immediate, strong impacts, many had either delayed or no impact on health care utilization or health behaviors. These data demonstrate the complexity of using risk communication to improve the quality and safety of prescription drug use, and suggest the importance of continued assessments of the effect of future advisories and label changes. Identifying factors that are associated with rapid and sustained responses to risk communications will be important for informing future risk communication efforts.

Dusetzina, Stacie B.; Higashi, Ashley S.; Dorsey, E. Ray; Conti, Rena; Huskamp, Haiden A.; Zhu, Shu; Garfield, Craig F.; Alexander, G. Caleb

2012-01-01

314

FDA moves to permit oral contraceptive prescriptions without initial pelvic exam.  

PubMed

The Planned Parenthood Federation of America (PPFA) submitted recommendations to the US Food and Drug Administration's (FDA) Fertility and Maternal Health Drugs Advisory Committee. The PPFA wanted the FDA to remove requirements for a pelvic examination and blood tests before an oral contraceptive (OC) is prescribed. Two representatives of the Family Planning Council of Southeastern Pennsylvania told the FDA advisory committee about the evaluation results of its Smart Start program. 23% of teenagers wanting to use OCs opted to delay the pelvic examination, and 40% opted to delay the blood tests. 83% of these same teenagers were already sexually active. 69% returned for pelvic exams at 3 months. Increased education and counseling over several sessions probably explained why more study participants used condoms and fewer of them became pregnant during the 6-month study. Physicians from the American College of Obstetricians and Gynecologists and the American Fertility Society also attended the committee hearing and supported PPFA's recommendations. The National Women's Health Network wanted to delay the discussion until the committee could also address the sale of OCs over-the-counter. The statements convinced the committee to allow physicians to defer to full physical examination as long as there are no contraindications. This May 20, 1993 approval emphasized the need for physicians to continue taking a complete medical history and conducting other tests that may uncover contraindications (e.g. pregnancy and blood pressure). FDA staff now must write the exact language needed for the OC labeling change to be approved by the FDA commissioner. PMID:12286460

1993-05-28

315

The US approach to biosimilars: the long-awaited FDA approval pathway.  

PubMed

In the US, the Biologics Price Competition and Innovation Act (BPCI Act, 2009) provided the pathway to create an abbreviated licensure procedure for biologic products that are demonstrated to be biosimilar to or interchangeable with a Food and Drug Administration (FDA) licensed biologic product. In February 2012, the FDA issued three guidelines that list the requirements for biosimilar registration. The topics covered include scientific and quality considerations to demonstrate biosimilarity to a reference product and a guidance that clarifies the BPCI Act implementation. The sponsor application for the biosimilar approval must contain biosimilarity information based on data derived from analytical, animal, and clinical studies. Clinical studies should include an assessment of immunogenicity, pharmacokinetics, pharmacodynamics, and address one or more indications licensed for the reference product. To demonstrate biosimilarity the applicant is allowed to use comparative animal or clinical data with a non-US-licensed product. According to these guidelines, the FDA will consider different aspects when evaluating biosimilarity, such as product formulation, complexity, and stability which will have a risk-based approach and will depend on the degree of knowledge of the product characteristics, as well as clinical experience with the reference one. The FDA intends to use a risk-based and facts-focused approach for review of applications of biosimilars, although it faces several challenges. Once a biologic medicine has been demonstrated to be biosimilar to the reference product, an abridged development program for the biosimilar medicine can be carried out in a similar way to that established by the European Medicines Agency (EMA). In addition, FDA legislation goes a step further than the EMA, offering the possibility to adopt full interchangeability for biosimilars. PMID:23030677

Calvo, Begoña; Zuñiga, Leyre

2012-12-01

316

Recommendations from the iSBTc-SITC/FDA/NCI Workshop on Immunotherapy Biomarkers  

PubMed Central

Purpose To facilitate development of innovative immunotherapy approaches, especially for treatment concepts exploiting the potential benefits of personalized therapy, there is a need to develop and validate tools to identify patients who can benefit from immunotherapy. Despite substantial effort, we do not yet know which parameters of anti-tumor immunity to measure and which assays are optimal for those measurements. Experimental Design The iSBTc-SITC, FDA and NCI partnered to address these issues for immunotherapy of cancer. Here, we review the major challenges, give examples of approaches and solutions and present our recommendations. Results and Conclusions While specific immune parameters and assays are not yet validated, we recommend following standardized (accurate, precise and reproducible) protocols and use of functional assays for the primary immunologic readouts of a trial; consideration of central laboratories for immune monitoring of large, multi-institutional trials; and standardized testing of several phenotypic and functional potential potency assays specific to any cellular product. When reporting results, the full QA/QC performed, selected examples of truly representative raw data and assay performance characteristics should be included. Lastly, to promote broader analysis of multiple aspects of immunity, and gather data on variability, we recommend that in addition to cells and serum, that RNA and DNA samples be banked (under standardized conditions) for later testing. We also recommend that sufficient blood be drawn to allow for planned testing of the primary hypothesis being addressed in the trial, and that additional baseline and post-treatment blood is banked for testing novel hypotheses (or generating new hypotheses) that arise in the field.

Butterfield, Lisa H.; Palucka, A. Karolina; Britten, Cedrik M.; Dhodapkar, Madhav V.; Hakansson, Leif; Janetzki, Sylvia; Kawakami, Yutaka; Kleen, Thomas-Oliver; Lee, Peter P.; Maccalli, Cristina; Maecker, Holden T.; Maino, Vernon C.; Maio, Michele; Malyguine, Anatoli; Masucci, Giuseppe; Pawelec, Graham; Potter, Douglas M.; Rivoltini, Licia; Salazar, Lupe G.; Schendel, Dolores J.; Slingluff, Craig L.; Song, Wenru; Stroncek, David F.; Tahara, Hideaki; Thurin, Magdalena; Trinchieri, Giorgio; van Der Burg, Sjoerd H.; Whiteside, Theresa L.; Wigginton, Jon M.; Marincola, Francesco; Khleif, Samir; Fox, Bernard A.; Disis, Mary L.

2011-01-01

317

Archive: FDA/CFSAN International Affairs November 18, 2009  

NSDL National Science Digital Library

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

Moss, Julie

1900-01-01

318

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

319

An illustration of sliding contact at any constant speed on highly elastic half-spaces  

NASA Astrophysics Data System (ADS)

A rigid smooth indentor slides at a constant speed on a compressible isotropic neo-Hookean half-space that is subjected to pre-stress aligned with the surface and sliding direction. A dynamic steady-sliding situation of plane strain is treated as the superposition of contact-triggered infinitesimal deformations superposed upon finite deformations due to pre-stress. The neo-Hookean material behaves for small strains as a linear elastic solid with Poisson's ratio 1 : 4. Exact solutions are presented for both deformations and, for a range of acceptable pre-stress values, the infinitesimal component exhibits the typical non-isotropy induced by pre-stress, and several critical speeds. In view of the unilateral constraints of contact, these speeds serve to define the sliding speed ranges for which physically acceptable solutions arise. A Rayleigh speed is the upper bound for subsonic sliding, and transonic sliding can occur only at a single speed. For the generic parabolic indentor, contact zone traction continuity is lost at the zone leading edge for trans- and supersonic sliding. For pre-stress levels that fall outside the acceptable range, either a negative Poisson effect occurs, or a Rayleigh speed does not exist and the unilateral constraints cannot be satisfied for any subsonic sliding speed.

Brock, L. M.; Georgiadis, H. G.

2001-12-01

320

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

321

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

322

CSU-FDA Collaborative Radiological Health Laboratory annual report 1979  

SciTech Connect

Highlights of findings by the Collaborative Radiological Health Laboratory (CRHL) on lifetime hazards associated with prenatal and early postnatal exposure to discrete doses of gamma radiation are presented in this volume. The CRHL study is designed to provide information that will facilitate the evaluation of risks to human beings from medical exposure during early development. It is a life span study using beagles exposed at one of several specific times in early development. The CRHL program is multidisciplinary in nature and involves evaluation of a variety of diseases of potential concern for human health. Problems of growth and development, reproductive capacity, degenerative diseases, and aging are among those addressed. Separate abstracts of 20 studies have been prepared for inclusion in the Energy Data Base. (RJC)

Not Available

1981-01-01

323

The Gebra Slide: a submarine slide on the Trinity Peninsula Margin, Antarctica  

Microsoft Academic Search

A large submarine slide – the Gebra Slide – has been discovered on the continental margin of Trinity Peninsula, Central Bransfield Basin, Antarctic Peninsula. The slide scar is clearly expressed in the bathymetry and is cut into the toe of the glacial-period slope-prograding strata on the lower continental slope. Seismic data give evidence of an associated debris-flow deposit embedded in

Y Imbo; M De Batist; M Canals; M. J Prieto; J Baraza

2003-01-01

324

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

PubMed Central

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

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

2013-01-01

325

A proposal for financing postmarketing drug safety studies by augmenting FDA user fees.  

PubMed

I propose to raise funds for postapproval studies of long-term drug safety by augmenting the existing "user-fee" system. Fees would be raised by an amount deemed optimal for revenue collection, and the U.S. Food and Drug Administration (FDA) would direct the incremental funds to a combination of randomized controlled trials, epidemiological studies, and postmarketing surveillance. User-fee augmentation is an achievable, incremental reform that would subsidize information that is now undersupplied in the U.S. health care system; spread the burden of funding postmarketing safety studies among pharmaceutical sponsors; and help restore public, scientific, and professional confidence in the FDA and its user-fee system. PMID:16234281

Carpenter, Daniel

2005-01-01

326

Killing with kindness: why the FDA need not certify drugs used for execution safe and effective.  

PubMed

In 1977, Texas and Oklahoma became the first states to legalize administration of the death penalty by lethal injection; by late 1985, 14 other states had followed suit. Opponents of the death penalty petitioned the Food and Drug Administration in 1980 to declare drugs specified for use in executions as "not approved," and to prevent their use for that purpose. When the FDA denied their request, the petitioners took legal action against the agency, eventually arguing their case before the U.S. Supreme Court, which ruled against them in Heckler v. Chaney (1985). Annas discusses the Court's action, which dealt only with the judicial reviewability under federal statute of the FDA's decision not to exercise its authority over the use of drugs in interstate commerce. He notes that, by dealing only with procedural issues, the Court avoided ruling on the death penalty itself. PMID:4025665

Annas, G J

1985-09-01

327

A continuing black hole? The FDA boxed warning: an appeal to improve its clinical utility.  

PubMed

The boxed warning is increasingly utilized by the Food and Drug Administration (FDA) as a clinical warning to prescribers of dangerous adverse drug reactions. As these warnings have expanded, we feel the utility and application of boxed warnings are becoming more nebulous. The use of drugs following issuance of a boxed warning has been variable. Droperidol sales decreased 10-fold in the year following the warning, yet there has been essentially no change in the methadone usage over a similar time period after its boxed warning. Including more information, such as estimation of incidence for the adverse drug reaction, would be more clinically useful to the prescriber. Reasonable standards using supplemental databases outside of the FDA (such as national poison center data) could be helpful in developing an integrated and balanced approach to boxed warnings. PMID:21591886

Matlock, Aaron; Allan, Nicholas; Wills, Brandon; Kang, Christopher; Leikin, Jerrold B

2011-07-01

328

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

PubMed

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

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

2005-12-01

329

The Temperature Dependence of Macroscopic Sliding Friction  

NASA Astrophysics Data System (ADS)

We present measurements of the static and kinetic coefficients of friction of gold-plated copper on gold-plated copper and sapphire on sapphire as a function of temperature from 10K to 400K. The measurements were done by sliding a block down a controllable incline plane and using high-speed video to extract the acceleration. The large size of our optical cryostat allowed linear motion of 7.5 cm over which to measure the acceleration. Surfaces were baked under high vacuum at 400K, and data was taken as they cooled. Preliminary results indicate that the coefficient of friction for gold plated copper surfaces change by 10 percent from room temperature to 10K.

Burton, J. C.; Taborek, P.; Rutledge, J. E.

2006-03-01

330

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.; Carter, J. D.

2012-07-25

331

Implantable Cardioverter-Defibrillator FDA Safety Advisories: Impact on Patient Mortality and Morbidity  

PubMed Central

Background A significant proportion of implantable cardioverter-defibrillators (ICDs) have been subject to FDA advisories. The impact of device advisories on mortality or patient care is poorly understood. Although estimated risks of ICD generators under advisory are low, dependency on ICD therapies to prevent sudden death justifies assessment of long-term mortality. Objective To test association of FDA advisory status with long-term mortality. Methods The study was a retrospective, single-center review of clinical outcomes, including device malfunctions, in patients from implantation to either explant or death. Patients with ICDs first implanted at Cleveland Clinic between 8/96-5/04 who became subject to FDA advisories on ICD generators were identified. Mortality was determined using the Social Security Death Index. Results In 1644 consecutive patients receiving first ICD implants, 704 (43%) became subject to an FDA advisory, of which 172 (10.5%) were Class I and 532 (32.3%) were Class II. ICDs were explanted before advisory notifications in 14.0% of Class I and 10.1% of Class II advisories. Among ICDs under advisory, 28 (4.0%) advisory related and 15 non-advisory related malfunctions were documented. Over a median follow-up of 70 months, 814 patients died. Kaplan-Meier 5-year survival was 65.6% overall, and 64.2%, 61.1%, and 69.3% in patients with no, Class I, and Class II advisories, respectively, p=0.17. Conclusions ICD advisories impacted 43% of patients. Advisory-related malfunctions affected 4% within the combined Advisory group. Based on a conservative management strategy ICDs under advisory were not associated with increased mortality over a background of significant disease-related mortality.

Sengupta, Jay; Kendig, Arthur C.; Goormastic, Marlene; Hwang, Eui-Seock; Ching, Elizabeth A.; Chung, Roy; Lindsay, Bruce D.; Tchou, Patrick J.; Wilkoff, Bruce L.; Niebauer, Mark J.; Martin, David O.; Varma, Niraj; Wazni, Oussama; Saliba, Walid; Kanj, Mohamed; Bhargava, Mandeep; Dresing, Thomas; Taigen, Tyler; Ingelmo, Christopher; Bassiouny, Mohamed; Cronin, Edmond M.; Wilsmore, Bradley; Rickard, John; Chung, Mina K.

2012-01-01

332

Olefin\\/paraffin gas separations with 6FDA-based polyimide membranes  

Microsoft Academic Search

Pure gas permeation and sorption experiments were carried out for the gases ethylene, ethane, propylene and propane using polyimides based on 4,4?-(hexafluoroisopropylidene) diphthalic anhydride (6FDA). Composite membranes and free films were used. Experiments were performed at 308K and feed pressures up to 17atm for ethylene and ethane and 9atm for propylene and propane. Mixed gas permeation experiments were carried out

Claudia Staudt-Bickel; William J Koros

2000-01-01

333

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.

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

2010-05-01

334

3D finite element modeling of sliding wear  

NASA Astrophysics Data System (ADS)

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

Buentello Hernandez, Rodolfo G.

335

Risk Assessment for Submarine Slope Stability: Preliminary Studies and Numerical Modeling of Hydroplaning of Submarine Slides.  

National Technical Information Service (NTIS)

Submarine landslides present an important risk to offshore structures and related facilities. Although submarine slides have many similarities to their subaerial counterparts, there are important differences. As part of previous OTRC research sponsored by...

H. Hu S. G. Wright

2004-01-01

336

XPS Analysis of 440C Steel Surfaces Lubricated with Perfluoropolyethers under Sliding Conditions in High Vacuum.  

National Technical Information Service (NTIS)

This work presents the results of the X-Ray Photoelectron Spectroscopy (XPS) analysis of AISI 440C ball surfaces lubricated with perfluoropolyether (PFPE) oils after friction experiments under sliding conditions at high load in air and vacuum environments...

P. Herrera-fierro M. Masuko W. R. Jones S. V. Pepper

1994-01-01

337

The Development and Validation of a Nonverbal Measure of Self-Esteem: The Sliding Person Test.  

ERIC Educational Resources Information Center

Validity evidence from several studies for a nonverbal measure of self-esteem, the Sliding Person Test (SPERT), is presented. Results of the studies indicate the utility of the measure for elementary through college students. (JKS)

Karmos, Ann H.

1979-01-01

338

Management of a TIFS System: Organizing Tests with Instructional Feedback on Slides.  

ERIC Educational Resources Information Center

Presents three components of the tests with instructional feedback on slides system (TIFS), the needs of the three, background on the production of the test item reference card, and the advantage of the system for both instructor and student. (MER)

Brown, F. Dale; Mitchell, Thomas O.

1980-01-01

339

The impact of Wyeth v. Levine on FDA regulation of prescription drugs.  

PubMed

In Wyeth v. Levine, decided in March, 2009, the United States Supreme Court concluded that the plaintiff's failure to warn claim against the makers of the drug Phenergan was not impliedly preempted by the Food, Drug and Cosmetic Act. In doing so, the Court rejected the argument of the U.S. Food and Drug Administration (FDA) that tort claims of this nature stand as an obstacle to federal regulatory objectives. This Article evaluates the Court's opinion in Wyeth and examines that decision's impact on subsequent litigation in the area of prescription drug labeling. The Article first discusses the preemption doctrine and its application to state law tort claims against product manufacturers. It then reviews the history of implied preemption of tort claims against manufacturers of FDA-approved prescription drugs prior to Wyeth and then discusses the Wyeth decisions in the Vermont Supreme Court and the United States Supreme Court. Finally, the Article evaluates some of the prescription drug preemption cases that have been decided in the lower federal courts since Wyeth and suggests that these courts are now reluctant to preempt failure to warn claims unless a manufacturer affirmatively seeks permission from FDA to change a drug's labeling. PMID:24475542

Ausness, Richard C

2010-01-01

340

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

341

Food and Drug Administration (FDA) drug approval end points for chronic cutaneous ulcer studies.  

PubMed

The rising costs of caring for chronic cutaneous ulcers (CCUs) and recent appreciation of the mortality of CCUs have led to consideration of the reasons for the failure to have new drug therapies. No new chemical entities to heal CCUs have been approved by the Food and Drug Administration (FDA) in over a decade, in part due to an inability to reach the FDA accepted end point of "complete wound closure." The frequent failure to reach the complete closure end point brings forward the question of the relevance of other healing end points such as improved quality of life, or partial healing. Because CCUs carry a prognosis and mortality rate worse than many cancers, it is reasonable to compare the FDA trial end points for cancer drug approval with those for CCUs. And the difference is quite striking. While there is only one end point for CCUs, there are five surrogate and three direct end points for cancers. In contrast to cancer, surrogate end points and partial healing are not acceptable for therapies aimed at CCUs. For example, making tumors smaller is an acceptable end point, but making CCUs smaller is not and improvement in the signs and symptoms of cancer is an acceptable end point for cancers but not CCUs. As CCUs carry a prognosis and mortality rate worse than many cancers, we believe a reconsideration of end points for CCUs is highly warranted. PMID:23126458

Eaglstein, William H; Kirsner, Robert S; Robson, Martin C

2012-01-01

342

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.

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

343

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.

Christian, Wolfgang; Belloni, Mario

2006-01-11

344

Cost functional minimizing sliding mode control design  

Microsoft Academic Search

In this paper, a three-step method is proposed to design a sliding mode control strategy, that provides optimal system dynamics with respect to a given cost functional. The method is based on methods of constrained continuous dynamic optimization. It allows a systematic control unit design and therefore reduces the time to find an appropriate sliding mode control law. The proposed

Christian Fischer; Heide Brandtstadter; Vadim Utkin; Martin Buss

2006-01-01

345

Ladder Slide Out - First Order Analysis  

Microsoft Academic Search

One of the more important collapse modes for straight, combination, and extension ladders is base slide out; the top of the ladder slides down the support wall as the base slips away from it. Various fundamental models have been used to study this behavior. This paper revisits the analytical solutions associated with these models and describes their implications for the

Ralph L. Barnett; Dolores Gildin; S. Carl Uzgiris; Dennis B. Brickman; Kenneth L. d'Entremont; Michael A. Dilich; Christopher W. Ferrone; Suzanne A. Glowiak; John M. Goebelbecker; Crispin Hales; Gary M. Hutter; Brian D. King; Dror Kopernik; Woodrow Nelson; Peter J. Poczynok; R. Kevin; Harry R. Smith; William G. Switalski; Andrew H. Tudor; James R. Wingfield; Lucinda Fuller; Betty Bellows; Marna Forbes; Maureen Gilligan; Jan A. King; Norene Kramer; Florence Lasky; Neil Miller; Jackie Schwartz; Peter Warner; Glenn Werner; Mary A. Misiewicz; Christina Timmins; Lynn Wallace-Mills; Thomas E. Zabinski; Paula L. Barnett; Robert Kaplan; Bill Brown; Mario Visocnik; Charles Sinkovits; Patrick M. Brinckerhoff; John P. Bederka; Jr. Richard Gullickson; Diane K. Moshman; James T. O'Donnell; William D. Sheridan; Audrone M. Stake; Shelley Hamilton; Jeffery W. Abendshien; Leslie A. Savage; James T. Semrau; Theodore Liber

1996-01-01

346

Sliding Induced Crystallization of Metallic Glass.  

National Technical Information Service (NTIS)

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 amorphou...

K. Miyoshi D. H. Buckley

1983-01-01

347

A Sliding Mode Control with Optimized Sliding Surface for Aircraft Pitch Axis Control System  

NASA Astrophysics Data System (ADS)

A sliding mode controller with an optimized sliding surface is proposed for an aircraft control system. The quadratic type of performance index for minimizing the angle of attack and the angular rate of the aircraft in the longitudinal motion is used to design the sliding surface. For optimization of the sliding surface, a Hamilton-Jacobi-Bellman (HJB) equation is formulated and it is solved through a numerical algorithm using a Generalized HJB (GHJB) equation and the Galerkin spectral method. The solution of this equation denotes a nonlinear sliding surface, on which the trajectory of the system approximately satisfies the optimality condition. Numerical simulation is performed for a nonlinear aircraft model with an optimized sliding surface and a simple linear sliding surface. The simulation result demonstrates that the proposed controller can be effectively applied to the longitudinal maneuver of an aircraft.

Lee, Sangchul; Kim, Kwangjin; Kim, Youdan

348

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

349

Sliding Down an Inclined Plane Model  

NSDL National Science Digital Library

The Sliding Down an Inclined Plane model displays an object sliding down on an incline plane. The object can be a box, a sphere, or a car. When the object reaches the bottom of the incline, it can be set to bounce (elastic collision) or stick (inelastic collision). The incline angle and the object's initial position can be changed by dragging. Auxiliary windows show position and velocity data as the object slides. The Sliding Down an Inclined Plane model was developed using the Easy Java Simulations (Ejs) modeling tool. It is distributed as a ready-to-run (compiled) Java archive. Double clicking the ejs_mech_newton_SlidingOnInclinedPlane.jar file will run the program if Java is installed.

Christian, Wolfgang

2011-06-08

350

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.

351

Review of the Annual Reporting Process for Investigational New Drugs Regulated by the FDA's Center for Biologics Evaluation and Research.  

National Technical Information Service (NTIS)

The Food and Drug Administrations (FDA) Center for Biologics Evaluation and Research (CBER) is responsible for overseeing-biological products that sponsors develop under investigational new drug applications (INDs). As of September 30, 1997, CBER was over...

1998-01-01

352

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

...interviews; Statistical, scientific, and forensic analyses; Interim and final FDA reports...experts asked to perform statistical, forensic, or other analyses; the relevant...Scientist and Deputy Commissioner for Science and Public Health, the Agency's...

2012-08-28

353

FDA Quarterly Data Extract from the Adverse Event Reporting System (FAERS). (Raw Data File on CD-ROM).  

National Technical Information Service (NTIS)

This product is an extract from the FDA Adverse Event Reporting System (FAERS). FAERS is a computerized database for the spontaneous reporting of adverse events and medication errors involving human drugs and therapeutic biological products. FAERS began o...

2012-01-01

354

Efficacy of FDA-Approved Hemostatic Drugs to Improve Survival and Reduce Bleeding in Rat Models of Uncontrolled Hemorrhage.  

National Technical Information Service (NTIS)

Several FDA-approved intravenous drugs are used to reduce surgical bleeding. This series of studies tested whether these drugs (aprotinin, desmopressin, tranexamic acid, e-aminocaproic acid) could reduce bleeding due to traumatic injuries in two models of...

K. L. Ryan D. S. Cortez E. J. Dick A. Pusateri

2005-01-01

355

Slides: Communicating with Today's Generation  

NSDL National Science Digital Library

These webinar slides are from the webinar that was recorded 12/12/08. They have been turned into a PDF file. Are your classroom lectures designed to teach the new breed of student? One raised on a steady diet of video games, electronic gadgets and the Internet. Confused by the right use of Wikis, Blogs, IM and Podcasts for the classroom? Ever wonder how to communicate with the ever connected but seamingly isolated new generation of students? Then this webinar is for you. Based on the hot selling book "Gadgets, Games and Gizmos for Learning." Dr. Karl M. Kapp will explain how and why the incoming "gamer generation" requires major changes in instructional delivery methods and techniques. He will also explain steps and tips for reaching this new generation through the use of their own "New Media."

2010-07-21

356

Digital storage of glass slides for quality assurance in histopathology and cytopathology.  

PubMed

Proficiency testing programmes for measuring screening skills in pathology are mainly conducted using conventional glass microscope slides. However, the availability of robotic microscopes allows an entire conventional slide to be digitized. Our experiments have shown that, using a widely available robotized microscope and a PC, the image of a single field may be acquired in 2 s on average, including stage movements, autofocus and storage. Digitizing an entire slide, a fully automated procedure, takes up to 8 h. If the image of each field is compressed at an appropriate quality level (a compression ratio of, say, 35:1) it requires about 40 kByte to be stored, resulting in a total storage requirement of about 600 MByte per slide. Thus one CD-ROM can be used to store one virtual slide, as well as a self-installing program to provide a microscope simulator facility. This allows pathologists to examine the virtual case from their computer in a similar manner to looking at a glass slide on a conventional microscope. This permits a new, computer-based approach to proficiency testing in histopathology and cytopathology. Use of virtual slides should encourage the diffusion of national quality assurance programmes, which at present suffer from certain organizational and logistical limitations. PMID:12097174

Demichelis, Francesca; Della Mea, Vincenzo; Forti, Stefano; Dalla Palma, Paolo; Beltrami, Carlo Alberto

2002-01-01

357

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

NASA Astrophysics Data System (ADS)

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

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

2014-01-01

358

XPS analysis of 440C steel surfaces lubricated with perfluoropolyethers under sliding conditions in high vacuum  

SciTech Connect

This work presents the results of the X-Ray Photoelectron Spectroscopy (XPS) analysis of AISI 440C ball surfaces lubricated with perfluoropolyether (PFPE) oils after friction experiments under sliding conditions at high load in air and vacuum environments. The PFPE lubricants tested were Demnum S100, Fomblin Z-25, and Krytox 143AB. It was found that all the PFPE lubricants were degraded by sliding contact causing the formation of inorganic fluorides on the metallic surfaces and a layer of organic decomposition products. KRYTOX 143AB was the least reactive of the three lubricants tested. It was also found that metal fluoride formed at off-scar areas. This suggests the formation of reactive species, such as COF2 or R[sub f]COF, during sliding experiments, which can diffuse through the lubricant film and react with the metallic surfaces away from the contact region. Comparison of reference specimens before sliding with those that had undergone the sliding tests showed that the amount of non-degraded PFPE remaining on the surface of the balls after the sliding experiments was greater than that of the balls without sliding.

Herrera-Fierro, P.; Masuko, M.; Jones, W.R. Jr.; Pepper, S.V.

1994-04-01

359

XPS analysis of 440C steel surfaces lubricated with perfluoropolyethers under sliding conditions in high vacuum  

NASA Technical Reports Server (NTRS)

This work presents the results of the X-Ray Photoelectron Spectroscopy (XPS) analysis of AISI 440C ball surfaces lubricated with perfluoropolyether (PFPE) oils after friction experiments under sliding conditions at high load in air and vacuum environments. The PFPE lubricants tested were Demnum S100, Fomblin Z-25, and Krytox 143AB. It was found that all the PFPE lubricants were degraded by sliding contact causing the formation of inorganic fluorides on the metallic surfaces and a layer of organic decomposition products. KRYTOX 143AB was the least reactive of the three lubricants tested. It was also found that metal fluoride formed at off-scar areas. This suggests the formation of reactive species, such as COF2 or R(sub f)COF, during sliding experiments, which can diffuse through the lubricant film and react with the metallic surfaces away from the contact region. Comparison of reference specimens before sliding with those that had undergone the sliding tests showed that the amount of non-degraded PFPE remaining on the surface of the balls after the sliding experiments was greater than that of the balls without sliding.

Herrera-Fierro, Pilar; Masuko, Masabumi; Jones, William R., Jr.; Pepper, Stephen V.

1994-01-01

360

Whole slide imaging for educational purposes.  

PubMed

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

361

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.

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

2012-01-01

362

An updated nuclear criticality slide rule  

SciTech Connect

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

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

1998-04-01

363

Slide tracheoplasty in infant with congenital tracheal stenosis and tracheomalacia after esophageal atresia with tracheoesophageal fistula repair  

Microsoft Academic Search

Slide tracheoplasty can be applied successfully to all types of long segment congenital tracheal stenosis. In case of short segment tracheal stenosis, direct resection and anastomosis is often preferred. We report a case illustrating a new side benefit of the slide tracheoplasty in a patient presenting a relatively short hypoplastic tracheal segment coexisting with tracheomalacia after EA with TEF repair.

Emmanuel Le Bret; François Roubertie; Gilles Roger; Anne Sigal-Cinqualbre; Mathieu Coblence; Emre Belli; Noureddine Gharbi; Régine Roussin; Eréa Noel Garabédian; Alain Serraf

2009-01-01

364

Slide tracheoplasty in infant with congenital tracheal stenosis and tracheomalacia after esophageal atresia with tracheoesophageal fistula repair.  

PubMed

Slide tracheoplasty can be applied successfully to all types of long segment congenital tracheal stenosis. In case of short segment tracheal stenosis, direct resection and anastomosis is often preferred. We report a case illustrating a new side benefit of the slide tracheoplasty in a patient presenting a relatively short hypoplastic tracheal segment coexisting with tracheomalacia after EA with TEF repair. PMID:19573645

Le Bret, Emmanuel; Roubertie, François; Roger, Gilles; Sigal-Cinqualbre, Anne; Coblence, Mathieu; Belli, Emre; Gharbi, Noureddine; Roussin, Régine; Garabédian, Eréa Noel; Serraf, Alain

2009-07-01

365

Sliding mode control design of current fed full bridge DC to DC converter for fuel cell applications  

Microsoft Academic Search

Since a fuel cell system has a low voltage output, it requires a boost DC\\/DC converter for the most of vehicle and stationary power applications. In this paper, a robust sliding mode controller for the current fed full bridge DC\\/DC converter for PEM fuel cell systems is presented. The details of the sliding mode controller for the converter are derived

Woonki Na; Hoon Lee

2011-01-01

366

The friction and wear of Kevlar 49 sliding against aluminium at low velocity under high contact pressures  

Microsoft Academic Search

The friction and wear behaviour of Kevlar 49 sliding against aluminium under large contact pressures at low sliding velocities was examined. Kevlar 49 on aluminium friction is measured using yarns on capstans, and compared with literature results for Kevlar 49 on itself. A modified version of Howell's equation is presented in terms of stresses, ?=a??, to allow finite element modelling

I. F Brown; C. J Burgoyne

1999-01-01

367

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

Microsoft Academic Search

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

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

1995-01-01

368

Gela submarine slide: gigantic basin-wide event in the Plio-Quaternary foredeep of Sicily  

SciTech Connect

The Gela basin is a Pliocene-Quaternary foredeep basin located at the front of the Maghrebian fold-thrust belt of Sicily, filled with 2,500 m-thick shallowing-upward marine sediments. An important contribution to the basin fill comes from a huge, basin-wide submarine slide which extends for 3,500 km/sup 2/ and thickens as much as 450 m; the estimated sediment volume involved in the slide is close to 1,000 km/sup 3/. The authors investigation used more than 3,000 km of multichannel and single-channel seismic reflection profiles. The slide depositional geometries and facies relationships have been reconstructed from seismic interpretation to provide insight into transport and emplacement mechanisms. Apparently, the slide was not simply deposited via mass transfer from the slope into the basin. Indeed, the bulk of the slide is composed of basin sediments plastically deformed under the gravitational force driven by the correspondent slope sediments. Such a deformation occurred above an extremely effective decollement surface which controlled the slide distribution throughout the basin. More localized decollement planes are, however, present within the slide body and contributed to its complex deformation. The slide can thus be considered the result of a generalized gravitational collapse which affected the sediments lying above a peculiar decollement horizon. A general uplift characterized the late Quaternary evolution of the area, and volcanic activity was quite widespread and documented in the historical record. A punctuated episode of energy release (volcanic related ), superimposed to the uplift trend, may have triggered the slide in conjunction with potentially easy detachment of a decollement.

Argnani, A.; Trincardi, F.

1988-08-01

369

Hemifield slide from traumatic optic chiasmopathy.  

PubMed

A 56-year-old man suffered a high velocity linear acceleration closed head injury, resulting in skull fractures including bone dehiscence at the planum sphenoidale and tuberculum sellae. After regaining consciousness, he reported blurry vision and episodic diplopia. Visual field testing showed a bitemporal hemianopia. Ocular motility testing uncovered no misalignment. Brain MRI revealed post-traumatic encephalomalacia within the optic chiasm, resulting in the visual field defect and subsequent hemifield slide. Normally, cerebral processing of overlap between the visual fields prevents hemifield slide, which is caused by episodic loss of visual field overlap with subsequent slipping or sliding apart of images. PMID:24613428

Pula, John H; Fischer, Matthew; Kattah, Jorge C

2014-08-01

370

The Earth surface slide movement at Soledad  

NASA Astrophysics Data System (ADS)

The Earth surface slide movement at Soledad is a mountain-slide type of movement. Estimations of the thickness of the layer which is moving range between 10 and 100 m. There is no proof that the movement is water induced, but it could be influenced by the water household. The slope of the slide area is H: D = 1: 2. The height difference in the moving area studied, according to this paper, is 1 km. The actual rate of movement is about 12 cm/yr.

Moreno, A.

1986-11-01

371

Laser transformation hardening of precision V-slide way  

Microsoft Academic Search

The results of the study of the application of laser transformation hardening (LTH) on the precision slide ways and some specimens of 20, 45, GCr15, 18Cr2Ni4WA, or other steels by a 1KW transverse CO2 laser are presented. It is concluded that the LTH can meet all the requirements, such as the case hardness, case depth, distortion allowance, wear resistance, and

G. Zhang; Q. Yang; Y. Wu

1986-01-01

372

Control Using Sliding Mode of Two Phase Stepper Motor  

Microsoft Academic Search

This paper presents a proposition of sliding mode position controller of stepper motor - two phase are commonly used in low-cost open-loop positioning control systems. However, acceleration and deceleration are limited and operating open-loop can cause the loss of steps and stalling of the motor. To overcome these inherent problems, a low-cost minor closed-loop position control system (SMC) was developed

Yousfi Khemissi; Abdulwahab Amrani

2010-01-01

373

Experimental study of casing wear under impact-sliding conditions  

Microsoft Academic Search

Theoretical analysis and field monitoring show that lateral vibration has very important effect on casing wear in deep & ultra-deep\\u000a well drilling. The wear mechanism of casing under impact-sliding work conditions has been investigated and many experiments\\u000a have been completed with a newly developed full-scale casing wear test machine. Test results present that adhesion wear, contact\\u000a fatigue, and grinding abrasion

Shengli Chu; Laibin Zhang; Jianchun Fan; Wenpei Zheng; Huiyuan Yu

2009-01-01

374

Surface gouging by hypervelocity sliding contact between metallic materials  

Microsoft Academic Search

Surface gouging due to hypervelocity sliding contact has been observed for many years above certain threshold velocities in hypervelocity gun barrels and on the rails of rocket-propelled sleds. To aid in understanding the environment of the gouging event, some order-of-magnitude calculations of pertinent temperatures, pressures, energies, times, distances are presented. The calculations of the gouging environment, together with a review

L. M. Barker; T. G. Trucano; J. W. Munford

1987-01-01

375

SERIOUS LAND SLIDE ASSESSMENT USING ALOS SENSORS DATA FUSION TECHNIQUES  

Microsoft Academic Search

In this paper, we presented a technique to assess land slide damage using ALOS sensors data fusion techniques. Firstly, land cover change is investigated to detect a landslide damaged area with a time series of multi-spectral imagery of AVNIR-2 at a 7.2-magnitude Iwate-Miyagi-Nairiku earthquake in June 14, 2008. Then triplet PRISM images are used to derive digital surface models (DSMs)

Yusuke Matsumura; Wataru Takeuchi; Haruo Sawada

2008-01-01

376

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

377

Adaptive Sliding-Mode Tracking Control Laws Applied to Fault-Tolerant Flight Control Systems  

Microsoft Academic Search

An adaptive sliding mode controller is presented for fault-tolerant flight control system against the loss-of-effectiveness actuator faults. This proposed scheme employs the robustness of adaptive sliding mode control to accommodate the faults effect on the system without the fault detection and isolation mechanism. The adaptive rules are derived from the Lyapunov stability theorem, and the closed-loop system stability is guaranteed.

Zhi-Jun Yang; Xiao-Hui Qi; Gan-Lin Shan

2009-01-01

378

Sliding-Mode Control for a Single-Phase AC\\/AC Quantum Resonant Converter  

Microsoft Academic Search

This paper presents a sliding-mode control for a single-phase AC\\/AC quantum resonant converter. The closed-loop system improves regulation, sensitivity to disturbances, and transient response. The design of the closed-loop system is based on the sliding-mode control theory, and it is carried out with the help of an averaged large-signal model of the resonant converter. Simulation and experimental results are reported

Luis GarcÍa Garcia de Vicuna; Miguel Castilla; Jaume Miret; JosÉ Matas; Josep M. Guerrero

2009-01-01

379

Sliding wear behaviour of ZrN and (Zr, 12 wt% Hf)N coatings  

Microsoft Academic Search

In the present study, the sliding wear resistances of ZrN and (Zr, 12wt% Hf)N coatings deposited on a hardened AISI D2 tool steel by arc-physical vapor deposition (PVD) technique were examined by a ball-on-disc wear tester. Alloying of ZrN coating with 12wt% Hf did not change the hardness significantly, but achieved an improvement on adhesion strength and dry sliding wear

Erdem Atar; E. Sabri Kayali; Huseyin Cimenoglu

2006-01-01

380

Short-time spectral analysis with the conventional and sliding CZT  

Microsoft Academic Search

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

1978-01-01

381

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

382

Color standardization in whole slide imaging using a color calibration slide  

PubMed Central

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

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

2014-01-01

383

Large-scale combining signals from both biomedical literature and the FDA Adverse Event Reporting System (FAERS) to improve post-marketing drug safety signal detection  

PubMed Central

Background Independent data sources can be used to augment post-marketing drug safety signal detection. The vast amount of publicly available biomedical literature contains rich side effect information for drugs at all clinical stages. In this study, we present a large-scale signal boosting approach that combines over 4 million records in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and over 21 million biomedical articles. Results The datasets are comprised of 4,285,097 records from FAERS and 21,354,075 MEDLINE articles. We first extracted all drug-side effect (SE) pairs from FAERS. Our study implemented a total of seven signal ranking algorithms. We then compared these different ranking algorithms before and after they were boosted with signals from MEDLINE sentences or abstracts. Finally, we manually curated all drug-cardiovascular (CV) pairs that appeared in both data sources and investigated whether our approach can detect many true signals that have not been included in FDA drug labels. We extracted a total of 2,787,797 drug-SE pairs from FAERS with a low initial precision of 0.025. The ranking algorithm combined signals from both FAERS and MEDLINE, significantly improving the precision from 0.025 to 0.371 for top-ranked pairs, representing a 13.8 fold elevation in precision. We showed by manual curation that drug-SE pairs that appeared in both data sources were highly enriched with true signals, many of which have not yet been included in FDA drug labels. Conclusions We have developed an efficient and effective drug safety signal ranking and strengthening approach We demonstrate that large-scale combining information from FAERS and biomedical literature can significantly contribute to drug safety surveillance.

2014-01-01

384

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.

2013-01-01

385

The NeuroStar TMS device: conducting the FDA approved protocol for treatment of depression.  

PubMed

The Neuronetics NeuroStar Transcranial Magnetic Stimulation (TMS) System is a class II medical device that produces brief duration, pulsed magnetic fields. These rapidly alternating fields induce electrical currents within localized, targeted regions of the cortex which are associated with various physiological and functional brain changes. In 2007, O'Reardon et al., utilizing the NeuroStar device, published the results of an industry-sponsored, multisite, randomized, sham-stimulation controlled clinical trial in which 301 patients with major depression, who had previously failed to respond to at least one adequate antidepressant treatment trial, underwent either active or sham TMS over the left dorsolateral prefrontal cortex (DLPFC). The patients, who were medication-free at the time of the study, received TMS five times per week over 4-6 weeks. The results demonstrated that a sub-population of patients (those who were relatively less resistant to medication, having failed not more than two good pharmacologic trials) showed a statistically significant improvement on the Montgomery-Asberg Depression Scale (MADRS), the Hamilton Depression Rating Scale (HAMD), and various other outcome measures. In October 2008, supported by these and other similar results, Neuronetics obtained the first and only Food and Drug Administration (FDA) approval for the clinical treatment of a specific form of medication-refractory depression using a TMS Therapy device (FDA approval K061053). In this paper, we will explore the specified FDA approved NeuroStar depression treatment protocol (to be administered only under prescription and by a licensed medical profession in either an in- or outpatient setting). PMID:21189465

Horvath, Jared C; Mathews, John; Demitrack, Mark A; Pascual-Leone, Alvaro

2010-01-01

386

Timing of thienopyridine loading and outcomes in the TRITON trial: the FDA Prasugrel Action Package outlook.  

PubMed

TRial to assess Improvement in Therapeutic Outcomes by optimizing platelet inhibitioN with prasugrel Thrombolysis In Myocardial Infarction 38 (TRITON-TIMI 38) was a Phase 3, randomized, double blind, parallel-group, multinational head-to-head study of prasugrel vs. clopidogrel both on top of aspirin. The primary end point was the rate of cardiovascular death, nonfatal myocardial infarction (MI), or stroke, and was reached in 12.1% of patients treated with clopidogrel and in 9.9% of patients randomized to prasugrel, suggesting impressive vascular outcome benefit of prasugrel over clopidogrel. However, this overoptimistic interpretation of the trial results was challenged by the Food and Drug Administration (FDA) Secondary Review, which revealed several shortcomings with TRITON design and data interpretation including the front-loaded nature of prasugrel benefit. Recently, following approval with black box warning, the FDA posted the complete documentation set (Action Package), revealing additional information including the timing of loading in TRITON, and how it affects vascular outcomes. The detailed FDA communications revealed highly significant correlation of the loading dose delay and primary efficacy outcomes favoring prasugrel. Indeed, when patients in TRITON were loaded early, or pretreated, the benefit of prasugrel was nonexistent. However, the longer it takes during or especially after PCI to load with thienopyridine, the more prasugrel benefit occurs. Considering that pretreatment with clopidogrel was disallowed; that three quarters of patients in TRITON were loaded during or after intervention; and that prasugrel was used at the 60-mg loading dose, which is over three times more potent than 300 mg clopidogrel, the claim of superiority of prasugrel over clopidogrel is not valid due to inappropriate use of clopidogrel. PMID:21421187

Serebruany, Victor L

2011-01-01

387

A robust second order sliding mode controller for Buck converter  

Microsoft Academic Search

A robust second order sliding mode control is used for Buck converter. After building the model of Buck circuit, the Twisting Algorithm is designed, which is based on relative degree of sliding mode control. The second order sliding mode not only reserves advantages of traditional sliding mode: robustness, but also eliminates the chattering problem. By comparing PID control with second

Huangfu Yigeng; Ma Ruiqing; Xie En; Abdellatif Miraoui

2010-01-01

388

FDA advisory committees meet January 26 on Salk HIV-1 immunogen.  

PubMed

Two advisory committees of the Food and Drug Administration (FDA) will meet to consider future trials of the HIV-1 immunogen developed by Dr. Jonas Salk. The Immune Response Corporation has already conducted several studies of the immunogen, and has found improvement in various immunological and other blood tests, and no adverse effects. However, the studies have not been large enough to show conclusively that the treatment has clinical benefit in delaying disease progression. The new, larger trials are intended to demonstrate a delay in disease progression and validate the use of blood-test markers of disease progression for studying an immune-based treatment. PMID:11362184

1995-01-01

389

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

390

Making Complex Mathematics Learnable By All (slides)  

NSDL National Science Digital Library

This set of slides in pdf format accompanies an archived webinar in which Deborah Loewenberg Ball discusses the work of teaching mathematics. The webinar is cataloged separately: Making Ambitious Mathematics Learnable By All.

Ball, Deborah L.

2010-04-14

391

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

392

Roentgenologic Diagnosis of Sliding Esophageal Hiatus Hernia.  

National Technical Information Service (NTIS)

On the basis of the study of 210 cases of sliding esophageal hiatus hernia (SEHH) and normal esophagogastric regions in 40 subjects, 4 roentgenologic diagnostic features have been suggested: supraphrenic hernial sac, the gastric mucosa appears supradiaphr...

C. Xingrong

1980-01-01

393

Sliding Down an Incline Plane Model  

NSDL National Science Digital Library

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

Franciscouembre

2010-04-16

394

Foam-filled cushions for sliding trays  

NASA Technical Reports Server (NTRS)

Polytetrafluoroethylene tube filled with polyurethane foam forms low friction sliding surface that cushions vibrations and absorbs manufacturing tolerances and misalignment. Possible uses include packaging of components for shipping and seals for doors in lockers, cars, and refrigerators.

Nahin, S. B.; Robb, P. H.

1980-01-01

395

Long-term subglacial sliding patterns based on a sliding law with cavitation  

NASA Astrophysics Data System (ADS)

In ice-sheet models and glacial landscape evolution models, subglacial sliding rates are often related to basal shear stress by a power-law. However, the power-law relationship implies that the subglacial bed can provide unlimited levels of basal drag as sliding rates increases, which is recognized as an inadequate assumption, particularly when the effects of subglacial cavities are considered (Schoof 2005). We have implemented a glacial sliding law suggested by Schoof (2005) in a depth-integrated higher-order ice-sheet model (Egholm et al. 2011) and coupled this to a model for glacial hydrology. The sliding law includes an upper bound to the basal drag and depends on the effects of longitudinal and transverse stress components for obtaining force balance along the glacier bed. Computational experiments indicate that high annually averaged sliding rates concentrate along valley sides when basal melt-water pressures are relatively low, whereas fast sliding spreads to the valley bottoms when melt-water pressure increases. We couple equations for glacial sliding to a model for subglacial bedrock erosion and test the implications of the sliding law for long-term glacial landscape evolution. References Schoof, C. The effect of cavitation on glacier sliding. Proc. R. Soc. A , 461, 609-627 (2005). Egholm et al. Modeling the flow of glaciers in steep terrains: The integrated second-order shallow ice approximation (iSOSIA). Journal of Geophysical Research, 116, F02012 (2011).

Vej Ugelvig, Sofie; Lundbek Egholm, David

2013-04-01

396

An FDA bioinformatics tool for microbial genomics research on molecular characterization of bacterial foodborne pathogens using microarrays  

PubMed Central

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 a genomics tool, ArrayTrackTM, which provides extensive functionalities to manage, analyze, and interpret genomic data for mammalian species. ArrayTrackTM has been widely adopted by the research community and used for pharmacogenomics data review in the FDA’s Voluntary Genomics Data Submission program. Results ArrayTrackTM has been extended to manage and analyze genomics data from bacterial pathogens of human, animal, and food origin. It was populated with bioinformatics data from public databases such as NCBI, Swiss-Prot, KEGG Pathway, and Gene Ontology to facilitate pathogen detection and characterization. ArrayTrackTM’s data processing and visualization tools were enhanced with analysis capabilities designed specifically for microbial genomics including flag-based hierarchical clustering analysis (HCA), flag concordance heat maps, and mixed scatter plots. These specific functionalities were evaluated on data generated from a custom Affymetrix array (FDA-ECSG) previously developed within the FDA. The FDA-ECSG array represents 32 complete genomes of Escherichia coli and Shigella. The new functions were also used to analyze microarray data focusing on antimicrobial resistance genes from Salmonella isolates in a poultry production environment using a universal antimicrobial resistance microarray developed by the United States Department of Agriculture (USDA). Conclusion The application of ArrayTrackTM to different microarray platforms demonstrates its utility in microbial genomics research, and thus will improve the capabilities of the FDA to rapidly identify foodborne bacteria and their genetic traits (e.g., antimicrobial resistance, virulence, etc.) during outbreak investigations. ArrayTrackTM is free to use and available to public, private, and academic researchers at http://www.fda.gov/ArrayTrack.

2010-01-01

397

Metal gouging at low relative sliding velocities  

Microsoft Academic Search

Surface gouging by metals in high-velocity sliding contact has been observed for more than thirty years in engineering applications involving rocket sleds, two-stage gas guns and electromagnetic railguns. The onset of gouging is usually observed to occur at sliding velocities in excess of 1000 m s?1. Previous investigations of the phenomenon have indicated that the gouging onset velocity is proportional

K. R. Tarcza; W. F. Weldon

1997-01-01

398

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.

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

2010-01-01

399

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

400

A Sliding Mode Control for Four-Wire Shunt Active Filter  

NASA Astrophysics Data System (ADS)

The present paper deals with the sliding mode control of a three-phase four-wire shunt active filter SAF, to improve phase-current waveform, neutral current mitigation and reactive power compensation in electric power distribution system. The sliding mode is formulated using elementary differential geometry, then the control vector is deduced from the sliding surface accessibility using the Lyapunov stability. The algorithm used to establish the current references for the sliding mode controller is based on the instantaneous real and imaginary power theory for four-wire system. It will be seen that this method permits to synthesis the control vector with simple manner, and finally, the obtained simulation results confirm that the above objectives are satisfied.

Hamoudi, Farid; Chaghi, Aziz; Adli, Mouloud; Amimeur, Hocine

2011-09-01

401

Deformable Image Registration of Sliding Organs Using Anisotropic Diffusive Regularization.  

PubMed

Traditional deformable image registration imposes a uniform smoothness constraint on the deformation field. This is not appropriate when registering images visualizing organs that slide relative to each other, and therefore leads to registration inaccuracies. In this paper, we present a deformation field regularization term that is based on anisotropic diffusion and accommodates the deformation field discontinuities that are expected when considering sliding motion. The registration algorithm was assessed first using artificial images of geometric objects. In a second validation, monomodal chest images depicting both respiratory and cardiac motion were generated using an anatomically-realistic software phantom and then registered. Registration accuracy was assessed based on the distances between corresponding segmented organ surfaces. Compared to an established diffusive regularization approach, the anisotropic diffusive regularization gave deformation fields that represented more plausible image correspondences, while giving rise to similar transformed moving images and comparable registration accuracy. PMID:21785755

Pace, Danielle F; Enquobahrie, Andinet; Yang, Hua; Aylward, Stephen R; Niethammer, Marc

2011-03-30

402

The giant submarine alika debris slide, Mauna Loa, Hawaii.  

USGS Publications Warehouse

A 4000-km2 area of submarine slump and slide deposits along the W flank of Mauna Loa volcano has been mapped with GLORIA side-scan sonar images, seismic reflection profiles, and new bathymetry. The youngest deposits are 2 debris avalanche lobes that travelled from their breakaway area near the present shoreline as much as 100 km into the Hawaiian Deep at water depths of 4800 m. The 2 lobes partly overlap and together are designated the Alika slide. They were derived from the same source area and probably formed in rapid succession. Slumping on Mauna Loa has been most intense adjacent to the large arcuate bend in its SW rift zone, as the rift zone migrated westward away from the growing Kilauea volcano. Slumping events were probably triggered by seismic activity accompanying dike injection along the rift zone. Such massive slumps, landslides and distal submarine turbidity flows appear to be widespread on the flanks of Hawaiian volcanoes.-from Authors

Lipman, P. W.; Normark, W. R.; Moore, J. G.; Wilson, J. B.; Gutmacher, C. E.

1988-01-01

403

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

404

Compact, Automated Centrifugal Slide-Staining System  

NASA Technical Reports Server (NTRS)

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

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

2004-01-01

405

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

NASA Astrophysics Data System (ADS)

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

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

2008-01-01

406

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

407

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.

Administration., United S.

1997-01-01

408

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

409

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

PubMed

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

410

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

PubMed Central

Background: The BP oil spill of 2010 resulted in contamination of one of the most productive fisheries in the United States by polycyclic 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 [levels of concern (LOCs)] of PAH contaminants in Gulf Coast seafood. Objectives: We evaluated the degree to which the FDA’s risk criteria adequately protect vulnerable Gulf Coast populations from cancer risk associated with PAHs in seafood. Discussion: The FDA LOCs significantly underestimate risk from seafood contaminants among sensitive Gulf Coast populations by failing to a) account for the increased vulnerability of the developing fetus and child; b) use appropriate seafood consumption rates; c) include all relevant health end points; and d) incorporate health-protective estimates of exposure duration and acceptable risk. For benzo[a]pyrene and naphthalene, revised LOCs are between two and four orders of magnitude below the level set by the FDA. Comparison of measured levels of PAHs in Gulf seafood with the revised LOCs revealed that up to 53% of Gulf shrimp samples were above LOCs for pregnant women who are high-end seafood consumers. Conclusions: FDA risk assessment methods should be updated to better reflect current risk assessment practices and to protect vulnerable populations such as pregnant women and children.

Wong, Karen K.; Solomon, Gina M.

2011-01-01

411

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

412

Safety overview of FDA-approved medications for the treatment of the motor symptoms of Parkinson's disease.  

PubMed

Introduction: Parkinson's disease (PD) is among the most common of the neurodegenerative disorders. Treatment is primarily focused on correcting neurotransmitter imbalances. Several classes of medication are available for this purpose. Areas covered: A Medline search was performed to gather information about the safety of the medications approved for the treatment of the motor symptoms of PD. This was supplemented with additional articles obtained from online sources and information provided by the FDA and the manufacturers. The focus of this review is the side-effect and safety profiles of carbidopa/levodopa, dopamine agonists, selective monoamine oxidase inhibitors, catechol-o-methyltransferase inhibitors, anticholinergics and amantadine. Expert opinion: Though serious side-effects may occur, as a group, the medications used for the treatment of PD motor symptoms tend to produce side-effects that are mild to moderate in nature, and that primarily reflect the focus on dopaminergic therapies. Care plans for Parkinson's patients should be approached based on the needs of the individual as disease presentation, lifestyle, level of disability, concurrent disease states and the presence of non-motor symptoms make each case unique. Patients and caregivers must have realistic expectations about the use of PD medications. PMID:24962891

Faulkner, Michele A

2014-08-01

413

Design and Simulation of Guidance Law with Angular Constraint Based on Non-singular Terminal Sliding Mode  

NASA Astrophysics Data System (ADS)

According to the characteristics of the guided bomb, a guidance law with angular constraint and robustness is always needed. The paper proposed a guidance law based on non-singular terminal sliding mode (NTSM). In the non-singular Terminal sliding mode control, the tracking error on the sliding surface can converge to zero in a finite time, so a nonlinear term was introduced into the design of the terminal guidance law to substitute the traditional linear sliding mode. In addition, considering the measurement error and the external interference as disturbance with known boundary and making an adaptive estimation to extremes in real time, a non-singular terminal sliding mode guidance law was presented. Controlled by TSMG, the rate of the line-of-sight (LOS) angle between bomb and target can converge quickly, and high guidance precision of bomb in large range airspace of flight condition can be obtained. The simulation results confirm the efficiency and availability of the guidance law.

MengXiuyun, SongQiaozhen

414

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

NASA Astrophysics Data System (ADS)

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

Lo, Chia-Ming

2014-05-01

415

Terminal sliding mode fuzzy control based on multiple sliding surfaces for nonlinear ship autopilot systems  

NASA Astrophysics Data System (ADS)

A terminal sliding mode fuzzy control based on multiple sliding surfaces was proposed for ship course tracking steering, which takes account of rudder characteristics and parameter uncertainty. In order to solve the problem, the controller was designed by employing the universal approximation property of fuzzy logic system, the advantage of Nussbaum function, and using multiple sliding mode control algorithm based on the recursive technique. In the last step of designing, a nonsingular terminal sliding mode was utilized to drive the last state of the system to converge in a finite period of time, and high-order sliding mode control law was designed to eliminate the chattering and make the system robust. The simulation results showed that the controller designed here could track a desired course fast and accurately. It also exhibited strong robustness peculiarly to system, and had better adaptive ability than traditional PID control algorithms.

Yuan, Lei; Wu, Han-Song

2010-12-01

416

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

417

A Theoretical Development on Lubrication Mechanism at Thrust Slide-Bearing of Scroll Compressors  

NASA Astrophysics Data System (ADS)

This study presents a theoretical development of excellent lubrication at the thrust slide-bearing of scroll compressors, caused by a wedge formation due to elastic deformation of the thrust plate at its periphery. In theoretical calculations, the average Reynolds equation by Patir & Cheng for rough sliding surfaces of the thrust slide-bearing was applied to analyze the fluid lubrication, while the solid contact theory by Greenwood & Williamson was applied to analyze the plastic and elastic contacts between the orbiting and fixed thrust plates. With the FEM-calculated wedge angle between the sliding surfaces, the oil film pressure, the solid contact force, the fluid frictional force and the solid shearing drag force were calculated to determine the resultant friction coefficient at the thrust slide-bearing. As a result, it was shown that the theoretical results have a good agreement with the lubrication test results, thus unveiling the essential contents of excellent fluid lubrication at the thrust slide-bearing, caused by the wedge formation due to large thrust loads.

Oku, Tatsuya; Ishii, Noriaki; Anami, Keiko; Sawai, Kiyoshi; Morimoto, Takashi; Hiwata, Akira

418

Introducing Recent NASA Discoveries into the Astro 101 Classroom with Modular Slide Sets  

NASA Astrophysics Data System (ADS)

This paper summarizes the special interest group discussion about slides sets for use by Astronomy 101 instructors. The NASA Science Mission Directorate Astrophysics Education and Public Outreach Forum is coordinating the development of a pilot series of slide sets to help Astronomy 101 instructors incorporate new discoveries in their classrooms. The “Astro 101 slide sets” are presentations of 5–7 slides 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 (discoveries not yet in their textbooks) into the broader context of the course. With their modular design and non-technical language, the slide sets may also serve audiences beyond Astronomy 101 instruction and are adaptable to different needs. An example on exoplanets was highlighted in this session. In this paper, we outline the community feedback, which falls into the broad categories of content, format, uses, relevant topics, and future adaptations.

Meinke, B.; Schultz, G.; Bianchi, L.; Blair, W. P.; Len, P. M.

2014-07-01

419

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

PubMed Central

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

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

2014-01-01

420

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

421

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

PubMed Central

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

2011-01-01

422

The FDA's risk/benefit calculus in the approvals of Qsymia and Belviq: treating an obesity epidemic while avoiding another fen-phen.  

PubMed

As obesity rates continue to rise in the United States, both physicians and patients have demanded more safe and effective drug treatment options. However, following the fen-phen/Redux and sibutramine failures, the FDA has been hesitant to approve any anti-obesity drugs, despite the magnitude of the epidemic. Some have argued that these public embarrassments have led the FDA to overestimate the risks and underestimate the benefits when deciding whether to approve new anti-obesity drugs. On June 27, 2012, the FDA approved Belviq for chronic weight management, making it the first anti-obesity drug approved by the FDA in thirteen years. Less than one month later, the FDA approved Qsymia for the treatment of obesity. Both drugs had been denied FDA approval less than two years earlier. In this paper, I will first review the obesity crisis and discuss the high-profile market withdrawals of fenfluramine, dexfenfluramine, and sibutramine. Second, I will explain the FDA's drug approval process with a focus on the FDA's risk/benefit calculus. Third, I will compare the FDA's risk/benefit analysis for Qsymia and Belviq in 2010 with the agency's risk/benefit analysis in 2012 to determine what caused the agency to grant approval in 2012 while denying it in 2010. Finally, I will analyze what these drug approvals may mean for the future of other anti-obesity drugs. PMID:24772687

Azebu, Lauren M

2014-01-01

423

Enumerating bacterial cells on bioadhesive coated slides.  

PubMed

Quantifying bacterial abundance and biomass is fundamental to many microbiological studies. Directly counting via epifluorescence microscopy has become the method of choice, especially for environmental samples, and conventional techniques require filtration of cells onto black polycarbonate membrane filters. We investigated the utility of instead capturing stained bacterial suspensions on bioadhesive slides, performing tests using pure cultures of bacteria, mixtures of cultured bacteria, and environmental samples from five habitat types. When compared to the standard filtration and flow cytometric approaches, bioadhesive slides were found to be an accurate and precise platform for rapid enumeration of bacteria. Total bacterial counts made using the three methods were positively correlated for acridine orange and Live/Dead® (L/D) staining (0.81?r?0.95, all p?0.002). All platforms had similar precision, though counts obtained using bioadhesive slides were significantly higher than those made with polycarbonate filters and flow cytometry. The specific bioadhesive slides we used resulted in substantial cell mortality for certain pure cultures and river water samples, limiting their use for L/D determination. Cell enumeration using bioadhesive slides is particularly effective because it is highly precise at a wide range of cell concentrations, allows observation of cells that are not readily discernible on filters, reduces the number of steps and processing materials associated with sample analysis, and increases throughput. PMID:21893107

Franklin, Rima B; Campbell, Alaina H; Higgins, Colleen B; Barker, M Kensey; Brown, Bonnie L

2011-11-01

424

Mössbauer Spectroscopic Characterization of Iron Species in Sliding Mud  

NASA Astrophysics Data System (ADS)

Chemical states of Fe in the sliding mud and host rocks of landslide Kitayama and Tsuchikura were determined by 57Fe Mössbauer spectroscopy. The composition of Fe species in the sliding mud is different from that in the debris and bedrock. The sliding muds contain more Fe(II); specifically the existence of pyrite indicates a stronger reducing condition in the sliding plane. Total Fe also varied along with Fe speciation. These data show that the sliding mud is formed under reducing condition. Iron speciation might be a useful means to estimate sliding mud generation and landslide progressing.

Zheng, Guodong; Lang, Y. H.; Matsuo, M.; Takano, B.; Kuno, A.; Tsushima, H.

2002-06-01

425

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

426

An analysis of the FDA Food Safety Modernization Act: protection for consumers and boon for business.  

PubMed

This article analyzes components of the FDA Food Safety Modernization Act, which was prompted by incidents of food contamination, exploring the history of its passage and explaining its significance, as well as its limitations. As the first time in 70 years that food law has been changed substantially, this new law represents only an initial but significant step in the direction of improving food safety. With bipartisan support from both Congress and the President, this legislation embodies a mandate that food safety is at this moment becoming a priority. As a result, the time is ripe for a reassessment of other areas of food laws--particularly genetically modified foods and the use of milk and meat from cloned animals and their progeny--which are allowed under current U.S. law with no labeling, preapprovals, or post-market monitoring. These areas warrant special regulation consistent with the new proactive policy towards securing the safety of the food supply. PMID:24505853

Strauss, Debra M

2011-01-01

427

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

NASA Astrophysics Data System (ADS)

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

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

2012-02-01

428

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

429

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.

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

2014-01-01

430

FDA's risk evaluation and mitigation strategies (REMS): effective and efficient safety tools or process poltergeist?  

PubMed

Implementation of REMS began in March 2008 and by mid-2011 close to 200 New Molecular Entities (NMEs) and New Drug Applications (NDAs) (i.e., NMEs plus new doses and formulations of drugs) approved by FDA were required to have a REMS. As the REMS program expands, there has been an increasing chorus of stakeholders who have expressed a range of concerns and criticisms about the program's impact on the health care system. Yet, these impacts still remain underexplored by academic study. The authors conducted a series of qualitative interviews with individuals representing the experiences and opinions of five stakeholder groups involved in various aspects of REMS programs. The groups were comprised of representatives of biopharmaceutical companies, payers, health care providers (HCPs), pharmacists, and patient advocacy organizations. Questions were organized around the following themes: REMS implementation and administration; REMS components (i.e., medication guides, communication plans, and elements to assure safe use); effects on patient access and delivery of care; program outcomes; and, issues specific to each stakeholder group. What was most surprising was not that respondent groups with such divergent perspectives and diverse roles within the REMS program disagreed on certain points, but rather that they agreed on so many points. There was general agreement that the program is burdensome and not an improvement over previous risk management programs. Respondents also concurred almost unanimously that the patient information is weighted much too heavily on the risk end of the risk/benefit scale. Similarly, there was general concern from all the responder groups about uncompensated time and resources expended by HCPs and pharmacists. While some positive aspects were noted, these tended to be viewed as opportunities for improvement rather than actual benefits of the REMS program as currently implemented. As PDUFA V draws ever nearer, it's clear that FDA is attempting to address the program's shortcomings but it is clear that more needs to be done. PMID:24505829

Wilson, Andrew; Milne, Christopher-Paul

2011-01-01

431

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

432

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

433

[Sliding motility and biofilm formation in mycobacteria].  

PubMed

Using as a model Mycobacterium smegmatis, a non-motile microorganism, we have studied for the first time in mycobacteria the phenomenon known as sliding motility, as well as the process of biofilm formation. A screen of random transposon mutants was performed in order to identify the genes required for mycobacterial sliding over the surface of motility plates. The genetic analysis described here has been published recently. The genes required for sliding and for biofilm formation (mps and tmtpC) are involved in the biosynthesis of the glycopeptidolipids (GPLs) and their transport to the mycobacterial capsule. Based on our results, we suggest a model for the role of the GPLs in both phenomena. PMID:11899706

Recht, J; Martínez, A; Torello, S; Kolter, R

2001-01-01

434

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

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

2014-02-01

435

Comparison of two different deposition methods of 3-aminopropyltriethoxysilane on glass slides and their application in the ThinPrep cytologic test.  

PubMed

In this work, two different deposition methods of 3-aminopropyltriethoxysilane (APTES) on glass slides were compared in order to study the adhesion effect of cervical exfoliated cells on smear slides. Glass slides were modified by vapor-phase deposition (V-D) and liquid-phase deposition (L-D), respectively. The topographic images and amine density of the modified slides were investigated by using atomic force microscopy, UV-vis spectroscopy and X-ray photoelectron spectroscopy. The numbers of cells adhered on the slides functionalized by V-D and L-D were counted and compared under the microscope. The data showed significant differences between the two methods (t-test: P < 0.05). The results presented here have made it theoretically possible to produce amine slides by V-D method for the ThinPrep cytologic test. PMID:22334278

Xiang, Sen; Xing, Gaowa; Xue, Wei; Lu, Chao; Lin, Jin-Ming

2012-04-01

436

Liquid crystal studies of sliding vapour bubbles  

NASA Astrophysics Data System (ADS)

The paper discusses localized measurements that may be used to validate individual sub-models in mechanistic models of nucleate boiling on inclined surfaces with sliding bubbles. A previous study of wall temperature variations near isolated sliding bubbles by Kenning et al. (Multiphase Sci Technol 14:75-94, 2002), employing liquid crystal thermography, has been expanded in range and compared with recent studies by Qiu and Dhir (Exp Therm Fluid Sci 26:605-616, 2002) and Bayazit et al. (J Heat Transfer 125:503-509, 2003). The implications for modelling nucleate boiling are discussed.

Kenning, D. B. R.; Bustnes, O.-E.

2009-05-01

437

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.

438

Measurement of Temperature Due to Sliding in Vacua.  

National Technical Information Service (NTIS)

An apparatus is designed and built for the measurement of temperatures due to friction near the interface of two sliding objects. The sliding specimen is electromagnetically suspended and rotated in the suspended position. The only elements in contact wit...

J. D. Vasilakis F. F. Ling

1968-01-01

439

Slide Set - Unit 7 - 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 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

441

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

442

Friction in Low Speed Lubricated Rolling and Sliding Contacts.  

National Technical Information Service (NTIS)

A four-disc machine was built for friction measurements at low speed lubricated rolling and sliding contacts. The most important parameters influencing friction in these conditions turned out to be the sliding speed, the lubricant and its additive content...

K. Holmberg

1984-01-01

443

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

444

Slide Set - Unit 5 - 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 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

446

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

447

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

448

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

449

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

450

‘Off-label’ drug use: an FDA regulatory term, not a negative implication of its medical use  

Microsoft Academic Search

As physicians continue to prescribe more and more drugs, plaintiff's attorneys in the wake of tort reform are attempting to carve out or create informed consent cases based on the Food and Drug Administration's (FDA) labeling requirements and the doctors' communications with their patients as it relates to those requirements. The theory of tort litigation revolves around whether the doctor

W A Meadows; B D Hollowell

2008-01-01

451

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

452

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

Federal Register 2010, 2011, 2012, 2013

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

2011-07-14

453

Median approval times for class III medical devices have been well above statutory deadlines set for FDA and CMS.  

PubMed

The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) play key roles in making safe and effective medical devices available to the public. Since 1997 Congress has passed "modernization" laws that specify statutory deadlines for these agencies to review manufacturers' applications for premarket approval--the process by which the FDA evaluates the safety and effectiveness of class III medical devices, those that pose the highest risk--and applications for national coverage by Medicare. We questioned whether these reforms shortened approval time at the FDA and CMS. We searched publicly available databases for information for the period from January 1, 1995, through December 31, 2008, and calculated median time to approval. After initially declining, the FDA median approval time increased after 2002 and nearly reached the 1997 prereform levels by the end of the study period. In contrast, the CMS median approval time decreased steadily over the period. Neither agency consistently met the statutory deadline of 180 days for approval of premarket applications or national coverage. Congress should consider the underlying causes for these delays in the development of future modernization legislation. PMID:23048112

Zinn, Annette M; Allen, John C; Hacker, Carl S

2012-10-01

454

Mössbauer Spectroscopic Characterization of Iron Species in Sliding Mud  

Microsoft Academic Search

Chemical states of Fe in the sliding mud and host rocks of landslide Kitayama and Tsuchikura were determined by 57Fe Mssbauer spectroscopy. The composition of Fe species in the sliding mud is different from that in the debris and bedrock.\\u000a The sliding muds contain more Fe(II); specifically the existence of pyrite indicates a stronger reducing condition in the\\u000a sliding plane.

Guodong Zheng; Y. H. Lang; M. Matsuo; B. Takano; A. Kuno; H. Tsushima

2002-01-01

455

Experimental investigation of DVR with sliding mode control  

Microsoft Academic Search

Voltage sags and swells are vital power quality problems and the dynamic voltage restorer (DVR) is known as an effective device to mitigate voltage sags and swells. The paper deals with the sliding mode control of single phase DVR for voltage sag\\/swell correction. A sliding mode controller is designed and developed for a single phase DVR. Using sliding mode control

Rammohan Rao Errabelli; Y. Y. Kolhatkar; S. P. Das

2006-01-01

456

AQM algorithm based on Kelly's scheme using sliding mode control  

Microsoft Academic Search

This paper deals with the congestion control problem for queues in TCP\\/IP networks. In order to improve the congestion control performance for queues, based on the utility optimization source model proposed by Kelly, the linear and terminal sliding active queue management (AQM) algorithms are designed. Especially in the terminal sliding AQM algorithm, a special nonlinear terminal sliding surface is proposed

Nannan Zhang; Georigi M. Dimirovski; Yuanwei Jing; Siying Zhang

2009-01-01

457

Shear strength estimation for Åknes sliding area in western Norway  

Microsoft Academic Search

This paper deals with the unstable rock-slope at Åknes sliding area, located in the county of Møre and Romsdal in western part of Norway. The sliding body has a complex geometry with several sliding planes at different levels, involving unfilled joints, gouge material\\/brecciated material as well as bridges of intact rock. Stability of the rock slope strongly depends on the

Guro Grøneng; Bjørn Nilsen; Rolf Sandven

2009-01-01

458

Slide Rule for Predicting Shelf Life of Cod.  

National Technical Information Service (NTIS)

The article describes the slide rule for predicting shelf life of cod and the manner in which the slide rule operates for this and other fish and fish products. The slide rule should be useful to anyone concerned with distribution and handling of fresh fi...

L. J. Ronsivalli R. J. Learson S. E. Charm

1973-01-01

459

Detection of tissue folds in whole slide images  

Microsoft Academic Search

In whole slide imaging (WSI) the quality of scanned images is an interplay between the hardware specifications of the scanning device and the condition of the tissue slide itself. Tissue artifacts such as folds and bubbles have been known to affect the efficiency of a whole slide scanning system in selecting the focus points wherein the presence of the said

Pinky A. Bautista; Yukako Yagi

2009-01-01

460

Quasi sliding mode controller for single phase PFC boost converter  

Microsoft Academic Search

In this paper, a quasi sliding mode controller is proposed to control single phase PFC boost converter. The outer voltage loop is PI control and the sliding mode control is used in the inner current loop. The designed quasi sliding mode controller has advantages such as robustness when there are large variations in line voltage and output load. Moreover, the

Yanping Jiao; Fang Lin Luo

2010-01-01

461

45 CFR 98.42 - Sliding fee scales.  

Code of Federal Regulations, 2013 CFR

...Requirements § 98.42 Sliding fee scales. (a) Lead Agencies shall...revise, by rule, a sliding fee scale(s) that provides for cost...services. (b) A sliding fee scale(s) shall be based on income...family and may be based on other factors as appropriate. (c)...

2013-10-01

462

Sliding Electrical Contacts for Ultrahigh Vacuum.  

National Technical Information Service (NTIS)

A new sliding contact material was developed that is a composite of silver, copper, and molybdenum disulfide and it is produced by powder metallurgy techniques. Tests at 10 to the -9th power Torr demonstrate that this material can operate at current densi...

F. J. Clauss

1965-01-01

463

Impact Driver With Integral Sliding Hammer  

NASA Technical Reports Server (NTRS)

Tool combines impact driver with sliding dead-blow hammer. Used for any purpose for which ordinary impact driver used; tightening fasteners or driving starter holes for drill. Tool protects user from accidental injury and surrounding equipment from damage that might occur from ordinary arm-wielded hammer. Especially useful in underwater work.

Wallace, Bilby J.

1987-01-01

464

Metallic Contact and Friction between Sliding Surfaces  

Microsoft Academic Search

A new device has been developed and used to study metallic contact and friction between sliding, lubricated surfaces. The system consists basically of a fixed metal ball loaded against a rotating cylinder. The extent of metallic contact is determined by measuring both the instantaneous and average electrical resistance between the two surfaces. Friction between the ball and cylinder is recorded

M. J. Furey

1961-01-01

465

Creating Computer Slide Shows the Easy Way.  

ERIC Educational Resources Information Center

Explains how to create slide shows via computer using common software programs such as ClarisWorks. Highlights include identifying the audience, organizing the information, becoming familiar with technical specifications of the equipment, the use of text, style consistency, the use of graphics, and the use of color. (LRW)

Anderson, Mary Alice

1996-01-01

466

Ceramic wear in indentation and sliding contact  

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.

1985-01-01

467

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

468

Tectonic controlled submarine slidings and dewatering structures  

Microsoft Academic Search

Geologic structures associated with mass movements processes such as slumping, sliding, and creeping can be the key to understanding the tectonic or geologic constraints in the time they were formed. Because they are sensitively reflected by the paleo-topography which must be associated with active tectonics. It must be very useful if the direction of paleo-slope instability is known easily in

Y. Yamamoto; T. Hirono; M. Takahashi

2003-01-01

469

Martas precision slides: branding in international markets  

Microsoft Academic Search

Purpose – The case focuses on Martas Precision Slides, a late entrant in the growing furniture fitting market in Taiwan. The company is led by an ambitious and aggressive management team which has helped in achieving phenomenal growth to date. The company management however is now at a crossroads with regard to entering new international markets and has to make

Paurav Shukla; Steve Hogan

2009-01-01

470

Metal surface gouging by hypervelocity sliding contact  

Microsoft Academic Search

Surface gouging due to hypervelocity sliding contact occurs above certain threshold velocities in hypervelocity gun barrels and on the rails of rocket-propelled sleds. A theory for the mechanism of gouging damage is tested by computer simulation of the dynamic gouge initiation and growth phases. In addition to agreeing with the observations, parameter variations indicated design concepts which result in gouge-mitigating

L. M. Barker; T. G. Trucano; J. W. Munford

1987-01-01

471

Sliding, Insulating Window Panel Reduces Heat Loss.  

ERIC Educational Resources Information Center

A new sliding insulated panel reduces window heat loss up to 86 percent, and infiltration 60-90 percent, paying for itself in 3-9 years. This article discusses the panel's use and testing in the upper Midwest, reporting both technical characteristics and users' reactions. (MCG)

School Business Affairs, 1984

1984-01-01

472

Color Microfiche as a Replacement for Slides.  

National Technical Information Service (NTIS)

This is the summary of a larger paper describing the evolution of a mediated elementary accounting course at the University of Wisconsin-Stout. The course was initially developed as a 25 slide-tape lesson course which included 950 visuals and approximatel...

P. Schwarz

1976-01-01

473

A Slide Scanner Input for Paramatrix.  

National Technical Information Service (NTIS)

A special purpose flying-spot slide scanner was designed to provide an efficient and flexible means for transmitting an input pattern to Paramatrix, a pattern processing computer. The light spot of a CRT is positioned by the 'horizontal' and 'vertical' ou...

L. D. Ryan

1967-01-01

474

Slide/Sound Projects in History Classes  

ERIC Educational Resources Information Center

At the College of St. Thomas, the initiation of a sound/slide project requirement in the introductory history course solved several chronic problems. Student interest, traditionally low, picked up dramatically. In addition, the meager supply of adequate courseware was supplemented, for the project resulted in some excellent productions which have…

Fitzharris, Joseph

1973-01-01

475

Sliding drops on an inclined plane  

Microsoft Academic Search

An evolution equation for the film thickness was derived recently combining diffuse interface theory and long-wave approximation (Phys. Rev. E 62 (2000) 2480). Based on results for the structure formation in a thin liquid film on a horizontal plane, we study one-dimensional periodic drop profiles sliding down an inclined plane. The analysis of the dependence of their amplitude, velocity, advancing

Uwe Thiele; Kai Neuffer; Michael Bestehorn; Yves Pomeau; Manuel G. Velarde

2002-01-01

476

Gas bearings. [fluid lubrication theory of sliding contact surfaces  

NASA Technical Reports Server (NTRS)

The present work deals with the fundamentals of gas lubrication theory, which forms the foundation of all analytical design tools for gas bearings. Most of the hard lessons learned in the past are outlined with reference to dry contact, debris ingestion, sliding speed, and chemical stability of lubricant. The mathematical theory of gas lubrication is described for scaling rules in thin-film viscous flow, momentum conservation, mass conservation, energy conservation, isothermal gas bearing theory, coupling effects, and global bearing characteristics. Particular attention is given to the governing differential equations for common bearing configurations. Also discussed are representative solutions of self-acting gas bearings, externally pressurized bearings, and time-dependent effects.

Pan, C. H. T.

1980-01-01

477

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

478

A Survey of the FDA's AERS Database Regarding Muscle and Tendon Adverse Events Linked to the Statin Drug Class  

PubMed Central

Background Cholesterol management drugs known as statins are widely used and often well tolerated; however, a variety of muscle-related side effects can arise. These adverse events (AEs) can have serious impact, and form a significant barrier to therapy adherence. Surveillance of post-marketing AEs is of vital importance to understand real-world AEs and reporting differences between individual statin drugs. We conducted a review of post-approval muscle and tendon AE reports in association with statin use, to assess differences within the drug class. Methods We analyzed all case reports from the FDA AE Reporting System (AERS) database linking muscle-related AEs to statin use (07/01/2005–03/31/2011). Drugs examined were: atorvastatin, simvastatin, lovastatin, pravastatin, rosuvastatin, and fluvastatin. Results Relative risk rates for rosuvastatin were consistently higher than other statins. Atorvastatin and simvastatin showed intermediate risks, while pravastatin and lovastatin appeared to have the lowest risk rates. Relative risk of muscle-related AEs, therefore, approximately tracked with per milligram LDL-lowering potency, with fluvastatin an apparent exception. Incorporating all muscle categories, rates for atorvastatin, simvastatin, pravastatin, and lovastatin were, respectively, 55%, 26%, 17%, and 7.5% as high, as rosuvastatin, approximately tracking per milligram potency (Rosuvastatin>Atorvastatin>Simvastatin>Pravastatin?Lovastatin) and comporting with findings of other studies. Relative potency, therefore, appears to be a fundamental predictor of muscle-related AE risk, with fluvastatin, the least potent statin, an apparent exception (risk 74% vs rosuvastatin). Interpretation AE reporting rates differed strikingly for drugs within the statin class, with relative reporting aligning substantially with potency. The data presented in this report offer important reference points for the selection of statins for cholesterol management in general and, especially, for the rechallenge of patients who have experienced muscle-related AEs (for whom agents of lower expected potency should be preferred).

Hoffman, Keith B.; Kraus, Christina; Dimbil, Mo; Golomb, Beatrice A.

2012-01-01

479

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

480

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

481

Investigating drug repositioning opportunities in FDA drug labels through topic modeling  

PubMed Central

Background Drug repositioning offers an opportunity to revitalize the slowing drug discovery pipeline by finding new uses for currently existing drugs. Our hypothesis is that drugs sharing similar side effect profiles are likely to be effective for the same disease, and thus repositioning opportunities can be identified by finding drug pairs with similar side effects documented in U.S. Food and Drug Administration (FDA) approved drug labels. The safety information in the drug labels is usually obtained in the clinical trial and augmented with the observations in the post-market use of the drug. Therefore, our drug repositioning approach can take the advantage of more comprehensive safety information comparing with conventional de novo approach. Method A probabilistic topic model was constructed based on the terms in the Medical Dictionary for Regulatory Activities (MedDRA) that appeared in the Boxed Warning, Warnings and Precautions, and Adverse Reactions sections of the labels of 870 drugs. Fifty-two unique topics, each containing a set of terms, were identified by using topic modeling. The resulting probabilistic topic associations were used to measure the distance (similarity) between drugs. The success of the proposed model was evaluated by comparing a drug and its nearest neighbor (i.e., a drug pair) for common indications found in the Indications and Usage Section of the drug labels. Results Given a drug with more than three indications, the model yielded a 75% recall, meaning 75% of drug pairs shared one or more common indications. This is significantly higher than the 22% recall rate achieved by random selection. Additionally, the recall rate grows rapidly as the number of drug indications increases and reaches 84% for drugs with 11 indications. The analysis also demonstrated that 65 drugs with a Boxed Warning, which indicates significant risk of serious and possibly life-threatening adverse effects, might be replaced with safer alternatives that do not have a Boxed Warning. In addition, we identified two therapeutic groups of drugs (Musculo-skeletal system and Anti-infective for systemic use) where over 80% of the drugs have a potential replacement with high significance. Conclusion Topic modeling can be a powerful tool for the identification of repositioning opportunities by examining the adverse event terms in FDA approved drug labels. The proposed framework not only suggests drugs that can be repurposed, but also provides insight into the safety of repositioned drugs.

2012-01-01

482

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

483

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

PubMed Central

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

Bautista, Pinky A.; Yagi, Yukako

2010-01-01

484

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.

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.