Subjects to be considered in partial replicate BE study [RSABE / ABEL]

posted by d_labes  – Berlin, Germany, 2015-01-08 10:03 (3682 d 04:54 ago) – Posting: # 14246
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Dear Cher,

❝ One more query,why a subject with two periods, each with reference, will not be included in the pharmacokinetic analysis for SWR?


I didn't not recommend this. I only pointed you to the problem in your cited rules.

I myself would include all subjects with at least 2 periods, regardless which formulation was applied, into PK and statistical analysis.

The rest is done automatically: Subjects with Reference only will not contribute to the BE decision but to the sWR estimation, subjects with Test and only one Reference will contribute to the BE decision but not to the sWR estimation.

Regards,

Detlew

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