Executive summary This guideline defines key elements necessary for the validation of bioanalytical methods. The guideline focuses on the validation of the bioanalytical methods generating quantitative concentration data used for pharmacokinetic and toxicokinetic parameter determinations.
Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Validation Draft Guidance For Industry; Part 11; Validation
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) Draft Guideline Bioanalytical method validation
FSIS Guidance for Test Kit Manufacturers, Laboratories: Evaluating the Performance of Pathogen Test Kit Methods Compliance Guidelines: Conducting Validation Studies for Pathogen Detection Methods
As of May 3, 2010 FSIS Fact Sheet: Validation The draft guidance material on validation has caused a fair amount of concern. We believe that it will help everyone if we put to rest some of the misconceptions about the Agency's expectations.
Guidance for Industry Bioanalytical Method Validation U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM) May 2001 BP
GHTF/SG3/N99-10:2004 (Edition 2) FINAL DOCUMENT Title: Quality Management Systems - Process Validation Guidance Authoring Group: SG3 Endorsed by: The Global Harmonization Task Force Date: Edition 2 - January 2004 Taisuke Hojo, GHTF Chair The ...
Reliability Engineering and System Safety 91 (2006) 1331-1357 Calibration, validation, and sensitivity analysis: What'swhat T.G. Trucano a, , L.P. Swiler a, T. Igusa b, W.L. Oberkampf c, M. Pilch c a Optimization and Uncertainty Estimation Department, Sandia National Laboratories, P.O. Box 5800 ...
Working document QAS/03.055/Rev.2 RESTRICTED WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTE SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES (GMP): VALIDATION © World Health Organization 2005 All rights reserved.
This document is an official policy statement of the Society for Industrial and Organizational Psychology (Division 14 of the American Psychological Association) and was approved as policy of the American Psychological Association (APA) by the APACouncil of Representatives in August 2003.