Current challenges for FDA-regulated bioanalytical laboratories performing human BA/BE studies; Part III: selected discussion topics in bioanalytical LC/MS/MS method validation-Reference-Cited by-同舟云学术

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Current challenges for FDA-regulated bioanalytical laboratories performing human BA/BE studies; Part III: selected discussion topics in bioanalytical LC/MS/MS method validation

Published:2009-01 Issue:1 Volume:12 Page:22-30
ISSN:1087-8378
Container-title:The Quality Assurance Journal
language:en
Short-container-title:Qual. Assur. J.

Author:

Chow Frank,Ocampo Arlene,Vogel Paul,Lum Steven,Tran Nhan

Publisher

Wiley

Subject

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

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/qaj.436/fullpdf

Reference16 articles.

1. Food and Drug Administration 2006

2. US Department of Health and Human Services 2001

3. Analytical methods validation: Bioavailability, bioequivalency, and pharmacokinetics studies;Shah;J Pharm Sci,1992

4. Bioanalytical method validation: A revisit with a decade of progress;Shah;Pharm Res,2000

5. Strategy for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC-MS/MS;Matuszewski;Anal Chem,2003

Cited by 2 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Incurred sample reanalysis at GSK: what have we learned?;Bioanalysis;2018-11-01

2. Regulatory Inspection Trends and Findings of Bioanalytical Laboratories;Handbook of LC-MS Bioanalysis;2013-08-30

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