Statistical Methods and Approaches to Avoid Stability Failures of Drug Product During Shelf-Life
Author:
Publisher
Springer New York
Link
http://link.springer.com/content/pdf/10.1007/978-1-4939-7686-7_11
Reference15 articles.
1. Kommanaboyina B, Rhodes CT (1999) Trends in stability testing with emphasis on stability during distribution and storage. Drug Dev Ind Pharm 25:857–868
2. FDA (2005) Q1E—Evaluation for stability data Q1E. FDA, US - Published in the Federal Register, 8 June 2004, Vol. 69, No. 110, p. 32010–11
3. Wei GC (1998) Simple methods for determination of the release limits for drug products. J Biopharm Stat 8:103–114
4. Yu LX (2008) Pharmaceutical quality by design: product and process development, understanding, and control. Pharm Res 25(4):781–791
5. Tsae-Yun DL, Chen CW (2007) Overview of stability study designs. J Biopharm Stat 13:337–354
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