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RegisterDon’t include tmax [NCA / SHAM]
Dear Helmut,
Thanks for your reply on tmax.
In one study, we have drawn samples up to 96.00 hrs post dose. we have stated only Cmax and AUC(0 to t) as primary parameters for bioequivalence in our protocol. We have, mentioned AUC(0 to inf) as secondary parameter. Sponsor wants AUC also to be tested for BE criteria. Our statistician says, if we include tmax points for some subjects, it is passing. Shall we submit the AUC(0 to inf) data, (including tmax)?
Thanks for your reply on tmax.
In one study, we have drawn samples up to 96.00 hrs post dose. we have stated only Cmax and AUC(0 to t) as primary parameters for bioequivalence in our protocol. We have, mentioned AUC(0 to inf) as secondary parameter. Sponsor wants AUC also to be tested for BE criteria. Our statistician says, if we include tmax points for some subjects, it is passing. Shall we submit the AUC(0 to inf) data, (including tmax)?
Complete thread:
- Selection of points for Elimination rate constant ryraman2661 2023-12-23 08:41
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- Don’t include tmax Helmut 2023-12-23 11:46
Ing. Helmut Schütz