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Back to the forum  Query: 2017-11-24 14:03 CET (UTC+1h)
 

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

posted by ElMaestro - Denmark, 2017-09-05 10:16  - Posting: # 17781
Views: 815

Hi Ramesh,

» US

Then all variance components come from a mixed model that has been fit using REML. Any subject who has an R or T value or any quantity of both contributes (let's leave 'outliers' and aberrant values out for the purpose of this discussion).

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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