Regulatory acceptance pre-mature discontinuation of study [Study Per­for­mance]

posted by Helmut Homepage – Vienna, Austria, 2022-06-21 15:12 (10 d 10:33 ago) – Posting: # 23072
Views: 213

Hi Vaibhav

» » which assumptions (CV, T/R-ratio) and target power lead to the sample size?
»
» T/R ratio- 95%
» Power ≥ 80%
» CV%- 25%

Here I can’t follow you. Why did you try to recruit 40 subjects in order to have 36 eligible? If your assumptions were reasonable, 28 would have been enough (80.7% power). If you stop with 31 now, power will be with 84.6% higher than expected. I’m confused.

» One statement they mentioned in protocol “Additional subjects may be randomized in case of excessive drop outs, to get at least 36 subjects with complete pharmacokinetic assessment if required”

Such a phrase is not uncommon.

» Development of Abbreviated New Drug Applications During the COVID-19 Pandemic mentions April 2021. Updated on September 8, 2021.
» “It may be acceptable to utilize a different batch of unexpired reference product to complete a BE study, so long as the prospective applicant provides adequate scientific justifications for the use of different batches of reference product in the BE studies. A prospective applicant that intends to use a different batch of reference product for such purposes may submit additional inquiries with specific proposals or alternative proposals to demonstrate BE for the development program via the controlled correspondence pathway or, if applicable, via the pre-ANDA meeting request pathway”

THX, I’ve forgotten that one. If it will cost you 10 million bucks (why on earth?), go ahead but after initiating a Controlled Correspondence with the OGD.

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