(1993; 36 pages)
8.2. Guidelines on stability testing of pharmaceutical products containing established drug substances
In response to the Committees earlier request (2), the draft WHO guidelines on stability testing were reviewed. It was emphasized that these guidelines should be consistent with those in course of preparation within the ICH programme with respect to all technical definitions and other related issues. The focus of the WHO guidelines, however, would be on providing advice on the stability testing of formulations containing established drug substances intended for use in the more extreme climatic conditions frequently encountered in many developing countries.