median Tmax [Study Per­for­mance]

posted by Helmut Homepage – Vienna, Austria, 2019-10-17 10:42 (1648 d 06:52 ago) – Posting: # 20699
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Hi mittyri,

❝ […] use the published median Tmax?


Yep – should be given in the SmPC/label. The exclusion should be done by the PI (or a sub-investigator). Sometimes I find statements like “the decision will be done by the pharmacokineticist after discussion with the sponsor” in protocols. Fishy.

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