Clinical Endpoint Bioequivalence study [Regulatives / Guidelines]

posted by sury – India, 2019-04-09 04:19 (688 d 09:31 ago) – Posting: # 20133
Views: 1,935

» You're referring to the draft guidance on miconazole buccal tablets, right ?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...

yes, i am actually referring to the miconazole buccal tablets drug

» For the statistical analysis the draft guidance refers to another draft guidance, on adapalene + benzoyl peroxyde.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 ?

There is no where in the draft guidance on what data (Untransformed and Log Transformed) to conduct the statistical Analysis.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]

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