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RegisterClarity required [Regulatives / Guidelines]
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]
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]
Complete thread:
- Clarity requiredsuchit_bhavsar 2021-08-27 05:02 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Follow the guidance Helmut 2021-08-27 10:31
Ing. Helmut Schütz