Regulatory Considerations for Implementation of the QbD Paradigm for Biologics: Laying the Foundation for Product and Process Lifecycle Management-Reference-Cited by-同舟云学术

Regulatory Considerations for Implementation of the QbD Paradigm for Biologics: Laying the Foundation for Product and Process Lifecycle Management

Published:2015 Issue: Volume: Page:693-705
ISSN:2210-7371
Container-title:Quality by Design for Biopharmaceutical Drug Product Development
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Author:

Krummen Lynne

Publisher

Springer New York

Link

http://link.springer.com/content/pdf/10.1007/978-1-4939-2316-8_28

Reference5 articles.

1. CMC Biotech Working Group (2009) A-Mab case study. Via CASSS website: http://www.casss.org/associations/9165/files/A-Mab_Case_Study_Version_2-1.pdf . Accessed 16 Feb 2014

2. CMC Strategy Forum (2010) QbD for Biologics, Learning from the Product Development and Realization (A–MAb) Case Study and the FDA OBP Pilot Program, based on Proceedings of 2010, 23rd CMC Strategy Forum

3. ICH Q8(R2)(2009a). Pharmaceutical Development. Fed Reg 71(98):29344–29345

4. ICH Q9(2006). Quality Risk Management. Fed Reg 71(106):32105–32106

5. ICH Q10(2009b). Pharmaceutical Quality System. ICH Q10: Pharmaceutical Quality Systems. Fed Reg 74(66):15990–15991

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