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ravi.shah206 ☆ India, 2016-12-02 08:22 (3496 d 15:56 ago) Posting: # 16823 Views: 3,766 |
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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. |
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ElMaestro ★★★ Denmark, 2016-12-02 11:35 (3496 d 12:43 ago) @ ravi.shah206 Posting: # 16825 Views: 3,106 |
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Hi Ravi, ❝ 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? I think it means by intention that it counts as three years after the SR was signed off, because it is more conservative/allows the longer retention period and thus is in extreme situations the solution that provides the best protection. I don't see any reason to assume anything else, but I am interested to hear other people's opinion. Note, ICH E6 §4.2.2 actually has a wording which could suggest regulators make a distinction between "conduct" and "complete" and §5.22 somehow suggests that the SR is issued after the trial is "complete", so in that sense I am sure a lawyer would find pleasure in arguing arguing that the trial conduct is done some point before issuance of the SR. I am not convinced such argumentation would change any regulatory practice though. Freeze your samples for 3 years after the last SR signatuer, add a little safety buffer to that time frame and sleep well. — Pass or fail! ElMaestro |
Ing. Helmut Schütz