Product Homogeneity Assessment During Validation of Biopharmaceutical Drug Product Manufacturing Processes-Reference-Cited by-同舟云学术

Product Homogeneity Assessment During Validation of Biopharmaceutical Drug Product Manufacturing Processes

Published:2015 Issue: Volume: Page:649-659
ISSN:2210-7371
Container-title:Quality by Design for Biopharmaceutical Drug Product Development
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Author:

Doymaz Fuat,Ye Frank,Burdick Richard K.

Publisher

Springer New York

Link

http://link.springer.com/content/pdf/10.1007/978-1-4939-2316-8_26

Reference7 articles.

1. Agalloco J, Carleton FJ (2008) Validation of pharmaceutical processes, 3rd edn. Informa Healthcare, London

2. Burdick RK, Sidor L (2013) Establishment of an equivalence acceptance criterion for accelerated stability studies. J Biopharm Stat 23(4):730–743

3. Chambers D, Kelly G, Limentani G, Lister A, Lung KR, Warner E (2005) Analytical method equivalency: an acceptable analytical practice. Pharm Technol 29, 64–80

4. FDA—Guidance for Industry (2011) General Principles and Practices, U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), Current Good Manufacturing Practices (CGMP), Revision 1

5. FDA—Guidance for Industry (2001) Statistical Approaches to Establishing Bioequivalence, U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), BP

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