median Tmax [Study Per­for­mance]

posted by Helmut Homepage – Vienna, Austria, 2019-10-17 08:42  – Posting: # 20699
Views: 830

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.

Cheers,
Helmut Schütz
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