Fed-fasted BE studies using different polymorphs [Regulatives / Guidelines]

posted by london12 – 2009-08-25 16:21 (5145 d 13:56 ago) – Posting: # 4110
Views: 3,137

Dear all

Hope you can help me out. I am planning to repeat a fasted bioequivalence study for a particular product. Previously two studies have been performed using crystalline API, one fed study and one fasted. The fed study passed but the fasted study passed in that sense that it was within protocol-defined wider criteria. The wider criteria was not accepted by some authorities and therefore the fasted study will be repeated. I have available tablet batches manufactured using different source of API, ie amorphous material. What is your opinion regarding conducting fed and fasted studies for the same product using different forms of active? Dissolution profiles are similar in all cases but there was a minor change in the target coating amount (the coating is critical).

Best regards

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