subject inclusion criteria in PK and stat and BE conclusion [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2017-09-05 08:26 (1043 d 02:22 ago) – Posting: # 17777
Views: 6,151

Hi Ramesh,

EU: Include those who provide both a Test and Reference period.
US: Include those who provide data.

Descriptive PK: Done on all data as much as possible.

I have a feeling you may have asked about something else, though?

I could be wrong, but...

Best regards,

"Pass or fail" (D. Potvin et al., 2008)

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