Clarity required [Regulatives / Guidelines]

posted by suchit_bhavsar – India, 2021-08-27 07:02 (529 d 10:11 ago) – Posting: # 22548
Views: 1,510

Dear All,

Hello to every one.

As per latest published draft guideline "Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA", under heading Data deletion because of vomiting, 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

Valuable suggestions required

Regards,
Suchit Bhavsar

Edit: Guidance linked. [Helmut]

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