By Teresa I. Lucas, Rafik H. Bishara, and Robert H. Seevers

Published in: Pharmaceutical Technology JULY 2004

Published on: July 1, 2004

This article outlines distribution stability studies designed to generate additional data to complement pre-formulation development and routine International Conference on Harmonization (ICH) Q1A registration studies. If results from routine studies indicate that the product stability profile is very stable, then one may decide that distribution studies are not warranted. If additional distribution stability studies are needed, they can be developed to test the product’s temperature limitations. In the event that a temperature excursion is higher or lower than the recommended storage condition, these data would be examined to evaluate the effect on product quality.

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