A Critical Assessment of the ICH Guideline on Photostability Testing of New Drug Substances and Products (Q1B): Recommendation for Revision

Author:

Baertschi Steven W.,Alsante Karen M.,Tønnesen Hanne H.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference19 articles.

1. Photostability testing of new drug substances and products;Fed Reg,1997

2. The questions most frequently asked;Tønnesen,2004

3. The International Conference on Harmanization Photostability Guideline. A discussion of experimental conditions;Tønnesen,2007

4. Photochemical degradation of components in drug formulations;Tønnesen;Pharm Technol Eur,1993

5. Unexpected photochemistry in pharmaceutical products: A review on the role of diluents, excipients, and product components in promoting pharmaceutical photochemistry;Templeton,2007

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