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

posted by ElMaestro  – Belgium?, 2017-09-05 08:26  – Posting: # 17777
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Hi Ramesh,

Statistics:
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,
ElMaestro

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