Regulatory Query for study repeat [Study As­sess­ment]

posted by jag009  – NJ, 2013-07-28 00:29 (4711 d 19:55 ago) – Posting: # 11079
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Hi Sam,

❝ 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%.


Just want to make sure... You meant fasting study didn't qualify for 80-125% on the 90%CI and the power 100%?

Questions:
  1. Similar to what the other gurus have asked, please provide the numbers to us.
  2. Was there a change in the formulation or process? From pilot batch to scale-up batch... Please check because I have seen a few cases from my previous company (and friend's companies) that the issue was related to the manufacturing process. I work closely with formulators these days (small company) and you will be surprised to hear the things that they educate me on...
  3. Have you checked the PK data in details, both pilot and pivotal. Look for outliers? Don't bother with the post-hoc power business.
  4. Any difference in study population between studies?
  5. Drug has complicated kinetics?
John

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