Follow the guidance [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-08-27 10:31 (27 d 23:54 ago) – Posting: # 22549
Views: 398

Hi Suchit,

» As per latest published draft guideline "Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA" […] one sentence is there like The concentration data for the subject who vomited should be reported
»
» Hence it is required to report concentration data of subject who had vomited for the USFDA studies

Correct.

» Valuable suggestions required

Suggestions about what? Simply follow the guidance.

BTW, in my CRO we always analyzed all samples.*
Justification: Although subjects who vomited (IR \(\small{\leq 2\times\widetilde{t_\textrm{max,R}}}\) and MR \(\small{\leq\tau}\)) were excluded from the comparison according to the protocol, their profile was informative. It’s always good to learn something. It turned out that – surprisingly more often than not – the effect was a minor one.



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