Regulatory Query for study repeat [Study As­sess­ment]

posted by sam – India, 2013-07-27 09:50 (4712 d 12:58 ago) – Posting: # 11067
Views: 27,161

Dear Sir,

Recently we have carried two pilot studies (Fasting and Fed) for a molecule and based on the pilot study data we have calculated the sample size and time point for the Pivotal study. Fortunately the data for the Fed study ratio is totally replica of the Pilot Fed study and our Fed study data qualify the BE criteria of 80-125% with 100 % power. But unfortunately our fasting study ratio unexpectedly lower than the Pilot Fasting study and the study does qualify the 80-125% and the power 100%. So based on the above fact we cannot file the molecule for regulatory approval. Since the Fasting pivotal data has unexpected outcome. So we wanted to repeat the whole study in other CRO from the beginning because of the unexpected ratio in the Pivotal study. In that case kindly suggest if there will be any regulatory hurdles if we repeat the whole study in other CRO or regulatory will easily accept the data of the second study if it qualifies the BE criteria.
Hope for your positive reply.


Regards

Sam

Edit: Category changed. [Helmut]

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