Current challenges for FDA-regulated bioanalytical laboratories for human (BA/BE) studies, Part II: recent FDA Inspection trends for bioanalytical laboratories using LC/MS/MS methods and FDA Inspection readiness preparation-Reference-Cited by-同舟云学术

Current challenges for FDA-regulated bioanalytical laboratories for human (BA/BE) studies, Part II: recent FDA Inspection trends for bioanalytical laboratories using LC/MS/MS methods and FDA Inspection readiness preparation

Published:2007-06 Issue:2 Volume:11 Page:111-122
ISSN:1087-8378
Container-title:The Quality Assurance Journal
language:en
Short-container-title:Qual. Assur. J.

Author:

Chow Frank,Lum Steven,Ocampo Arlene,Vogel Paul

Publisher

Wiley

Subject

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

Reference17 articles.

1. LC/MS applications in drug development

2. Bioanalytical method validation: a risk-based approach?

3. Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies

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

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