Clinical Endpoint Bioequivalence study [Regulatives / Guidelines]

posted by Ohlbe – France, 2019-04-08 13:18 (694 d 16:32 ago) – Posting: # 20131
Views: 2,058

Dear Sury,

» I have recently got an bioequivalence study with clinical endpoints for some drug
» In OGD it states that
» “To establish bioequivalence, the 90% confidence interval of the test/reference ratio of the mean should be contained within [0.80, 1.25], using the per protocol (PP) population.”

For BE with PK endpoint, yes. Not with clinical endpoint.

» The scores of the clinical endpoint shall be as follows [...]

You're referring to the draft guidance on miconazole buccal tablets, right ? Would be easier for us if you could say so straight away and link the guidance...

» For the above, do we need to convert the grading (0,1,2,3) to log transformed data and conduct the statistical analysis?
» As the above states that 20% difference is accepted, then in normal bioequivalence case (if untransformed data), it should be 80.00-120.00?

For the statistical analysis the draft guidance refers to another draft guidance, on adapalene + benzoyl peroxyde. Did you read it ? Did you see anywhere a mention of log-transformation ? And why are you changing acceptance limits of -0.20 to +0.20 into 80.00 - 120.00 ?


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