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if the predefined PK parameters in BE study included AUC(0-t) i.e. truncated and the practical results of t1/2 was lower than planned in protocol and allowed the calculation of AUC0-t and AUC0-inf instead, is it possible to predefine this criteria in protocols (to use AUC-inf instead of AUC 0-t in such cases) or to issue protocol deviation from the stated PK parameters?
Thanks in advance
if the predefined PK parameters in BE study included AUC(0-t) i.e. truncated and the practical results of t1/2 was lower than planned in protocol and allowed the calculation of AUC0-t and AUC0-inf instead, is it possible to predefine this criteria in protocols (to use AUC-inf instead of AUC 0-t in such cases) or to issue protocol deviation from the stated PK parameters?
Thanks in advance
Complete thread:
- PK parametersLoky do 2022-05-11 15:45 [PK / PD]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- PK parameters dshah 2022-05-12 11:42
- predefine in the Protocol whenever possible mittyri 2022-05-14 22:21
Ing. Helmut Schütz