One fail and one success, should it be accepted? [Regulatives / Guidelines]

posted by WhiteCoatWriter – India, 2019-07-23 14:18 (543 d 09:28 ago) – Posting: # 20438
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Most of us come across such situations where we have a study that has not been bio equivalent because of one subject and after all the investigations there has been no reason to exclude the subject and thereby accept the fate of the study and repeat the study with the same formulation. However, in your case, if the formulation batch remains the same, I guess you can proceed with the ANDA application while you must however be ready with a strong justification for why you chose a fully replicated design and describe in detail about it (from what I assume is a case of a highly variable drug).

Thanks and Regards
Dr Anonymous

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