Repeats [Study As­sess­ment]

posted by sam – India, 2013-07-27 13:18 (4714 d 02:11 ago) – Posting: # 11069
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Thanks for your esteemed reply. The PE of my pilot study was 90% and based on that the sample size of 54 was considered and including the dropout and withdrawn the final sample size of 64 was considered. But in the pivotal study the PE comes out to be 79% with power of 100% which shows that our sample size is very correct but there is some problem may be with study conduct or formulation. We have one more justification that the Pivotal PE of the Fed study is same as that of the Pilot which we carried out and Fed study meets the BE criteria.
On the basis of above reasons we wanted to re-conduct the same fasting study again but worried the regulatory will accept the same justification if the proposed study meets the BE limit.
Since this is our premier molecule we don’t want to miss this opportunity so need your expert views.

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