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In Silico Drug Degradation Assessment in Early Phase Development

pdf fileAli MA; Hemingway R; Ott MA;

In this poster presented by Ash Ali, the authors describe an in silico approach to predicting forced drug degradation of an API. There is increasing interest in stability or forced degradation studies that lead to the identification of degradation products (and pathways) of an active pharmaceutical ingredient (API). Stability assessment is crucial as API impurities can appear due to its chemical breakdown. The FDA and ICH guidelines require performance of stability testing which include long-term (12 months) and accelerated (6 months) investigations with further studies on degradation products. This latter aspect overlaps with the ICH M7 guideline (risk posed by mutagenic degradants).

Poster presented by Ash Ali at the 2016 Academic Drug Discovery Meeting, Cambridge, UK; 22nd - 23rd March 2016.


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