Best Practices for Drug Substance Stress and Stability Studies During Early-Stage Development Part II—Conducting Abbreviated Long-Term and Accelerated Stability Testing on the First Clinical Drug Substance Batch to Confirm and Adjust the Drug Substance Retest Period/Powder for Oral Solution Shelf Life-Reference-Cited by-同舟云学术

Best Practices for Drug Substance Stress and Stability Studies During Early-Stage Development Part II—Conducting Abbreviated Long-Term and Accelerated Stability Testing on the First Clinical Drug Substance Batch to Confirm and Adjust the Drug Substance Retest Period/Powder for Oral Solution Shelf Life

Published:2013-01-24 Issue:1 Volume:8 Page:56-65
ISSN:1872-5120
Container-title:Journal of Pharmaceutical Innovation
language:en
Short-container-title:J Pharm Innov

Author:

Li Q. Chan,Cohen K.,Tougas T.,Qiu F.,Li J.,McCaffrey J.,Purdue T.,Song Jinhua J.,Swanek F.,Abelaira S.

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1007/s12247-013-9147-0.pdf

Reference18 articles.

1. Li QC, Qiu F, Cohen K, Tougas T, Li J, McCaffrey J, Purdue T, Song J, Swanek F, Abelaira S. Recommended best practices for drug substance stress and stability studies to support drug development from preclinical to phase II clinical trials, part I—conducting drug substance solid stress to support phase Ia clinical trials. J Pharm Innov (JPI). 2012;7(Issue 3):214–24.

2. International Conference on Harmonisation Guidance (ICH) Q1A (R2): Stability testing of new drug substances and products, February 2003.

3. International Conference on Harmonisation Guidance (ICH) Q1B: Stability testing: photostability testing of new drug substances and products, November 1996.

4. International Conference on Harmonisation Guidance (ICH) Q1D: Bracketing and matrixing designs for stability testing of new drug substances and products, February 2002.

5. International Conference on Harmonisation Guidance (ICH) Q1E: Stability data, February 2003.

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