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Back to the forum  2018-06-22 18:47 CEST (UTC+2h)

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

posted by ElMaestro - Denmark, 2017-09-05 08:26  - Posting: # 17777
Views: 2,176

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?

if (3) 4

Best regards,
ElMaestro

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