Impact of Manufacturing Processes on Drug Product Stability and Quality-Reference-Cited by-同舟云学术

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Impact of Manufacturing Processes on Drug Product Stability and Quality

Published:2010-08-05 Issue: Volume: Page:917-940
ISSN:
Container-title:Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
language:
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Author:

Rathore Nitin,Rajan Rahul S.,Freund Erwin

Publisher

John Wiley & Sons, Inc.

Reference61 articles.

1. ICH 2005 ICH Harmonised Tripartite Guideline: Pharmaceutical Development

2. ICH 2007 ICH Harmonised Tripartite Draft Consensus Guideline: Pharmaceutical Development Annex to Q8

3. ICH 2005 ICH Harmonized Tripartite Guideline: Quality Risk Management

4. ICH 2007 ICH Draft Consensus Guideline: Pharmaceutical Quality system

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