Clinical Endpoint Bioequivalence study [Regulatives / Guidelines]

posted by sury – India, 2019-04-09 06:19 (598 d 10:10 ago) – Posting: # 20133
Views: 1,798

» You're referring to the draft guidance on miconazole buccal tablets, right ?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» For the statistical analysis the draft guidance refers to another draft guidance, on adapalene + benzoyl peroxyde.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There is no where in the draft guidance on what data (Untransformed and Log Transformed) to conduct the statistical Analysis.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]

Complete thread:

Activity
 Admin contact
21,214 posts in 4,427 threads, 1,481 registered users;
online 13 (0 registered, 13 guests [including 11 identified bots]).
Forum time: Friday 15:30 CET (Europe/Vienna)

Biostatistician. One who has neither the intellect for mathematics
nor the commitment for medicine but likes to dabble in both.    Stephen Senn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5