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RegisterInterpretation 'after the conduct of the study' ref:Guideline of BABE CDSCO [Regulatives / Guidelines]
Dear All,
Can anyone give the interpretation of following clause as per CDSCO 'Guideline for Bioavailability & Bio equivalence Studies'.
Section 8: Retention of BA/BE samples
All samples of Test and reference drug products used in bioavailability / bioequivalence study should be retained for a period of three years after conduct of the study or one year after the expiry of the drug.
Specifically, what should be "after conduct of the study"?
whether should be after sign off the final CSR?
or after last study specific data collected?
or after last dosing of last period?
or anything else?
Regards.
Ravi.
Can anyone give the interpretation of following clause as per CDSCO 'Guideline for Bioavailability & Bio equivalence Studies'.
Section 8: Retention of BA/BE samples
All samples of Test and reference drug products used in bioavailability / bioequivalence study should be retained for a period of three years after conduct of the study or one year after the expiry of the drug.
Specifically, what should be "after conduct of the study"?
whether should be after sign off the final CSR?
or after last study specific data collected?
or after last dosing of last period?
or anything else?
Regards.
Ravi.
Complete thread:
- Interpretation 'after the conduct of the study' ref:Guideline of BABE CDSCOravi.shah206 2016-12-02 07:22
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Interpretation 'after the conduct of the study' ref:Guideline of BABE CDSCO ElMaestro 2016-12-02 10:35
Ing. Helmut Schütz