Stability Studies Needed to Define the Handling and Transport Conditions of Sensitive Pharmaceutical or Biotechnological Products-Reference-Cited by-同舟云学术

Stability Studies Needed to Define the Handling and Transport Conditions of Sensitive Pharmaceutical or Biotechnological Products

Published:2011-09-27 Issue:4 Volume:12 Page:1264-1275
ISSN:1530-9932
Container-title:AAPS PharmSciTech
language:en
Short-container-title:AAPS PharmSciTech

Author:

Ammann Claude

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics

Link

http://link.springer.com/content/pdf/10.1208/s12249-011-9684-0.pdf

Reference19 articles.

1. Stability testing of new drug substances and products—Q1A (R2). (ICH), International Conference on Harmonization. Originally published 1994, revised 2003.

2. Stability testing: photostability testing of new drug substances and products—Q1B. (ICH), International Conference on Harmonization. 6 November 1996.

3. Stability testing for new dosage forms—Q1C. (ICH), International Conference on Harmonization. 6 November 1996.

4. Bracketing and matrixing designs for stability testing of new drug substances and products—Q1D. (ICH), International Conference on Harmonization. 7 February 2002.

5. Evaluation for stability data—Q1E. (ICH), International Conference on Harmonization. 6 February 2003.

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