Development of Stability Indicating Methods-Reference-Cited by-同舟云学术

Development of Stability Indicating Methods

Published:2009 Issue: Volume: Page:139-161
ISSN:
Container-title:Handbook of Stability Testing in Pharmaceutical Development
language:
Short-container-title:

Author:

Aubry Anne-Françoise,Tattersall Peter,Ruan Joan

Publisher

Springer New York

Link

http://link.springer.com/content/pdf/10.1007/978-0-387-85627-8_7.pdf

Reference52 articles.

1. Smela M J (2005) Regulatory considerations for stability indicating analytical methods in drug substance and drug product testing. Am Pharm Rev 8:51–54.

2. ICH Q5 (1996) Stability testing of biotechnological/biological products.

3. ICH Q1A (2003) Stability testing of new drug substances and products.

4. ICH Q1E (2003) Evaluation of stability data.

5. ICH Q3A (R) (2003) Impurities in new drug substances.

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