PK parameters [PK / PD]

posted by Loky do – Egypt, 2022-05-11 17:45 (739 d 17:09 ago) – Posting: # 22971
Views: 1,736

Dears

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

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