Lifecycle Management of Biotherapeutic Dosage Forms-Reference-Cited by-同舟云学术

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Lifecycle Management of Biotherapeutic Dosage Forms

Published:2018 Issue: Volume: Page:561-578
ISSN:2210-7371
Container-title:Challenges in Protein Product Development
language:
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Author:

Warne Nicholas,Balthazor Bryan,Parr William

Publisher

Springer International Publishing

Link

http://link.springer.com/content/pdf/10.1007/978-3-319-90603-4_25

Reference20 articles.

1. ICH Harmonised Tripartite Guideline—Pharmaceutical Development Q8(R2); Step 4 Version August 2009.

2. Guidance for Industry—Q9 Quality Risk management; United States FDA June 2006 ICH.

3. Guidance for Industry—Q10 Pharmaceutical Quality System; United States FDA April 2009 ICH.

4. ICH Harmonised Tripartite Guideline—Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Q11; Step 4 Version 01 May 2012.

5. Clinical Development Success Rates 2006–2015—BIO, Biomedtracker, Amplion (2016).

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