Method Transfer, Partial Validation, and Cross Validation: Recommendations for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team-Reference-Cited by-同舟云学术

Method Transfer, Partial Validation, and Cross Validation: Recommendations for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

Published:2014-09-05 Issue:6 Volume:16 Page:1143-1148
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Briggs R. J.,Nicholson R.,Vazvaei F.,Busch J.,Mabuchi M.,Mahesh K. S.,Brudny-Kloeppel M.,Weng N.,Galvinas P. A. R.,Duchene P.,Hu Pei,Abbott R. W.

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1208/s12248-014-9650-3.pdf

Reference13 articles.

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2. van Amsterdam P, Lausecker B, Luedtke S, et al. Towards harmonized regulations for bioanalysis: moving forward! Bioanalysis. 2010;2(4):689–91.

3. van Amsterdam P, Arnold M, Bansal S, et al. Building the Global Bioanalysis Consortium—working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation. Bioanalysis. 2010;2(11):1801–3.

4. European Medicines Agency—guideline on the validation of bioanalytical methods Doc. Ref: EMEA/CHMP/EWP/192217/2009.

5. 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); 2001.

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