Author : Anonim
Publisher : Unknown
Page : 95 pages
File Size : 52,9 Mb
Release : 1989
Category : Drugs
ISBN : OCLC:19473402
FDA IRB Information Sheets
Anonim
Fda Irb Information Sheets
Fda Irb Information Sheets Book in PDF, ePub and Kindle version is available to download in english. Read online anytime anywhere directly from your device. Click on the download button below to get a free pdf file of Fda Irb Information Sheets book. This book definitely worth reading, it is an incredibly well-written.
IRB Information Sheet
United States. Food and Drug Administration
Author : United States. Food and Drug Administration
Publisher : Unknown
Page : 84 pages
File Size : 47,7 Mb
Release : 1984
Category : Electronic
ISBN : MINN:319510029207547
IRB Information Sheet by United States. Food and Drug Administration Pdf
Information Sheets
Anonim
Author : Anonim
Publisher : Unknown
Page : 124 pages
File Size : 53,8 Mb
Release : 1998
Category : Drugs
ISBN : MINN:31951P00838559K
Information Sheets by Anonim Pdf
Current Issues in Human Subject Protection
United States. Food and Drug Administration
Author : United States. Food and Drug Administration
Publisher : Unknown
Page : 288 pages
File Size : 55,6 Mb
Release : 1996
Category : Clinical trials
ISBN : MINN:31951D02465636D
Current Issues in Human Subject Protection by United States. Food and Drug Administration Pdf
Oversight of NIH and FDA
United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources
Author : United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources
Publisher : Unknown
Page : 232 pages
File Size : 50,5 Mb
Release : 1997
Category : Medical
ISBN : PURD:32754067873269
Oversight of NIH and FDA by United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources Pdf
105-1 Hearing: Oversight of NIH and FDA: Bioethics and The Adequacy of Informed Consent, May 8, 1997
Anonim
Author : Anonim
Publisher : Unknown
Page : 236 pages
File Size : 42,6 Mb
Release : 1998
Category : Electronic
ISBN : MINN:31951P00547350U
105-1 Hearing: Oversight of NIH and FDA: Bioethics and The Adequacy of Informed Consent, May 8, 1997 by Anonim Pdf
105-2 Hearing: Clinical Trail Subjects: Adequate FDA Protections?, April 22, 1998
Anonim
Author : Anonim
Publisher : Unknown
Page : 236 pages
File Size : 52,7 Mb
Release : 1998
Category : Electronic
ISBN : MINN:31951P008411535
105-2 Hearing: Clinical Trail Subjects: Adequate FDA Protections?, April 22, 1998 by Anonim Pdf
Clinical Evaluation of Medical Devices
Karen M. Becker,John J. Whyte
Author : Karen M. Becker,John J. Whyte
Publisher : Springer Science & Business Media
Page : 360 pages
File Size : 44,5 Mb
Release : 2007-11-05
Category : Technology & Engineering
ISBN : 9781597450041
Clinical Evaluation of Medical Devices by Karen M. Becker,John J. Whyte Pdf
The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs.
Institutional Review Board
Elizabeth A. Bankert,Robert J. Amdur
Author : Elizabeth A. Bankert,Robert J. Amdur
Publisher : Jones & Bartlett Learning
Page : 568 pages
File Size : 42,9 Mb
Release : 2006
Category : Institutional review boards (Medicine)
ISBN : 0763730491
Institutional Review Board by Elizabeth A. Bankert,Robert J. Amdur Pdf
This comprehensive reference covers three separate areas related to IRBs: administration, daily management; and ethical issues. This instructional manual provides IRB members and administrators with the information they need to run an efficient and effective system of protecting human research subjects, while remaining in compliance with federal research regulations. The text includes case studies, sample forms, and sample policy documents. The updated Second Edition includes seven new chapters: IRB Closure of Study Files, Internet Research, Research in Public Schools, Phase I Clinical Trials in Healthy Volunteers, Vulnerability in Research, Balancing the Risks and Potential Benefits,and HIPAA.
Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics
Carmen Medina
Author : Carmen Medina
Publisher : CRC Press
Page : 604 pages
File Size : 51,6 Mb
Release : 2003-12-09
Category : Medical
ISBN : 9780824758745
Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics by Carmen Medina Pdf
This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.
Investigational Device Exemptions Manual
Center for Devices and Radiological Health (U.S.). Division of Small Manufacturers Assistance
Author : Center for Devices and Radiological Health (U.S.). Division of Small Manufacturers Assistance
Publisher : Unknown
Page : 220 pages
File Size : 47,8 Mb
Release : 1996
Category : Government publications
ISBN : UOM:39015038600071
Investigational Device Exemptions Manual by Center for Devices and Radiological Health (U.S.). Division of Small Manufacturers Assistance Pdf
Investigational Device Exemptions Manual
Anonim
Author : Anonim
Publisher : Unknown
Page : 220 pages
File Size : 52,6 Mb
Release : 1996
Category : Medical instruments and apparatus
ISBN : MINN:30000005032085
Investigational Device Exemptions Manual by Anonim Pdf
FDA Drug Bulletin
Anonim
Author : Anonim
Publisher : Unknown
Page : 14 pages
File Size : 49,6 Mb
Release : 1984
Category : Drugs
ISBN : MINN:30000010715484
FDA Drug Bulletin by Anonim Pdf
Design and Analysis of Clinical Trials
Shein-Chung Chow,Jen-Pei Liu
Author : Shein-Chung Chow,Jen-Pei Liu
Publisher : John Wiley & Sons
Page : 754 pages
File Size : 55,6 Mb
Release : 2008-12-04
Category : Mathematics
ISBN : 9780471473299
Design and Analysis of Clinical Trials by Shein-Chung Chow,Jen-Pei Liu Pdf
Praise for the First Edition of Design and Analysis of Clinical Trials "An excellent book, providing a discussion of the clinical trial process from designing the study through analyzing the data, and to regulatory requirement . . . could easily be used as a classroom text to understand the process in the new drug development area." –Statistical Methods in Medicine A complete and balanced presentation now revised, updated, and expanded As the field of research possibilities expands, the need for a working understanding of how to carry out clinical trials only increases. New developments in the theory and practice of clinical research include a growing body of literature on the subject, new technologies and methodologies, and new guidelines from the International Conference on Harmonization (ICH). Design and Analysis of Clinical Trials, Second Edition provides both a comprehensive, unified presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. This unique resource bridges the gap between clinical and statistical disciplines, covering both fields in a lucid and accessible manner. Thoroughly updated from its first edition, the Second Edition of Design and Analysis of Clinical Trials features new topics such as: Clinical trials and regulations, especially those of the ICH Clinical significance, reproducibility, and generalizability Goals of clinical trials and target population New study designs and trial types Sample size determination on equivalence and noninferiority trials, as well as comparing variabilities Also, three entirely new chapters cover: Designs for cancer clinical trials Preparation and implementation of a clinical protocol Data management of a clinical trial Written with the practitioner in mind, the presentation assumes only a minimal mathematical and statistical background for its reader. Instead, the writing emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references-280 of them new to the Second Edition-to the literature. Design and Analysis of Clinical Trials, Second Edition will benefit academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students in these areas by serving as a useful, thorough reference source for clinical research.
The Medical Staff Services Handbook
Cindy A. Gassiot,Vicki L. Searcy,Christina W. Giles
Author : Cindy A. Gassiot,Vicki L. Searcy,Christina W. Giles
Publisher : Jones & Bartlett Publishers
Page : 522 pages
File Size : 41,8 Mb
Release : 2010-05-02
Category : Medical
ISBN : 9781449658908
The Medical Staff Services Handbook by Cindy A. Gassiot,Vicki L. Searcy,Christina W. Giles Pdf
The Medical Staff Services Handbook, Second Edition, is a complete reference and explores all functions performed in a medical staff services department. It contains practical advice on problems in credentialing and privileging as well as organizing the medical staff services department and supporting medical staff meetings. There is new information on the ongoing professional practice evaluation process and the focused professional practice evaluation process (new Joint Commission requirements). All chapters have been updated with current information. The book also contains chapters on credentialing in managed care organizations, credentials verification organizations and health system shared credentialing services. There is extensive information about various health care accreditation programs as well as information on hospital functions such as the institutional review board, cancer programs, and accredited continuing medical education programs. The Medical Staff Services Handbook, Second Edition also contains helpful information about technology and its applications in the medical staff services department. The law chapter points out areas that can lead to serious legal problems and methods to avoid these. This text can be used as a training tool for new employees; as a resource for areas that the medical staff services professional may not work with on a regular basis; to assist with standardizing processes in the medical staff services department; and as a tool for leadership training for physician leaders. The Medical Staff Services Handbook, Second Edition is not just an introductory text – it goes beyond the basics. It is a comprehensive review of all information needed to prepare for the NAMSS certification examinations. Including chapter quizzes, PowerPoints and an accompanying CD ROM with dozens of useful forms and policies, this text is the most comprehensive educational resource for all functions performed in the medical staff services department. It is a useful reference for those who are studying to sit for the certification examinations sponsored by the National Association Medical Staff Services.