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Back to the forum  Query: 2017-11-24 13:03 UTC (UTC+2h)
 

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

posted by ElMaestro - Denmark, 2017-09-05 06:26  - Posting: # 17777
Views: 819

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

No, I still don't believe much in the usefulness of IVIVCs for OIPs when it comes to picking candidate formulations for the next trial. This is not the same as saying I don't believe in IVIVCs.

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