Current challenges for FDA-regulated bioanalytical laboratories for human (BA/BE) studies. Part I: defining the appropriate compliance standards – application of the principles of FDA GLP and FDA GMP to bioanalytical laboratories-Reference-Cited by-同舟云学术

Current challenges for FDA-regulated bioanalytical laboratories for human (BA/BE) studies. Part I: defining the appropriate compliance standards – application of the principles of FDA GLP and FDA GMP to bioanalytical laboratories

Published:2007 Issue:1 Volume:11 Page:3-15
ISSN:1087-8378
Container-title:The Quality Assurance Journal
language:en
Short-container-title:Qual. Assur. J.

Author:

Ocampo Arlene,Lum Steven,Chow Frank

Publisher

Wiley

Subject

Pharmacology, Toxicology and Pharmaceutics (miscellaneous),Medicine (miscellaneous)

Reference15 articles.

1. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Veterinary Medicine. Guidance for Industry: Bioanalytical Method Validation. May 2001.

2. Drug Importation Act, 9 Stat. 237 (26 June 1848).

3. Pure Food and Drugs Act, 34 Stat. 768 (30 June 1906).

4. Federal Food, Drug and Cosmetic (FDC) Act, United States Code (U.S.C.) Title 21, Chapter 9 (25 June 1938).

5. Kefauver-Harris Amendments, Public Law 87-781; 76 Stat. 788-89 (10 October 1962).

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