Clarity required [Regulatives / Guidelines]
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
Edit: Guidance linked. [Helmut]