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avinash ★ India, 2014-02-04 06:45 (4526 d 10:51 ago) Posting: # 12332 Views: 3,155 |
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Dear Members, In 2013 White Paper on recent issues in bioanalysis: there was a topic of Incurred sample stability (ISS). The same was not discussed in the draft guidance on Bioanalytical Method Validation released in September 2013 by FDA. Is ISS a regulatory requirement for bioequivalence studies? If yes please guide me how to perform ISS? (Like minimum number of samples required, selection criteria of the samples and acceptance criteria) Thanks & regards, Avinash Jain |
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Ohlbe ★★★ France, 2014-02-04 10:17 (4526 d 07:19 ago) @ avinash Posting: # 12333 Views: 2,410 |
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Dear Avinash, ❝ Is ISS a regulatory requirement for bioequivalence studies? No, not in the EU or USA, nor anywhere else AFAIK. Discussions on ISS are currently only limited to industry, and regulators did not get involved yet. ISS could be of value in the case of potentially unstable metabolites. But there is currently no clear recommendation or consensus on when to do it, how, and acceptance criteria. — Regards Ohlbe |
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avinash ★ India, 2014-02-04 10:44 (4526 d 06:52 ago) @ Ohlbe Posting: # 12334 Views: 2,416 |
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Dear Ohlbe, Thanks for clarification. Best regards, Avinash Jain |
Ing. Helmut Schütz