Confirmatory reanalysis of incurred bioanalytical samples-Reference-Cited by-同舟云学术

Confirmatory reanalysis of incurred bioanalytical samples

Published:2007-09 Issue:3 Volume:9 Page:E336-E343
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Rocci Mario L.,Devanarayan Viswanath,Haughey David B.,Jardieu Paula

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1208/aapsj0903040.pdf

Reference14 articles.

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2. Shah VP. The history of bioanalytical method validation and regulation: evolution of a guidance document on bioanalytical methods validation. AAPS J. 2007; 9: E43-E47.

3. Viswanathan CT, Bansal S, Booth B, et al. Workshop/conference report—quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 2007; 9: E30-E42.

4. Findlay JWA, Smith WC, Lee JW, et al. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J Pharm Biomed Anal. 2000; 21: 1249–1273.

5. FDA/CDER. Guidance for the Industry: Bioanalytical Method Validation. Rockville, MD: US Department of Health and Human Services FDA (CDER) and (CVM); May 2001.

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