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

posted by d_labes  – Berlin, Germany, 2015-01-07 15:45 (3682 d 21:25 ago) – Posting: # 14236
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Dear Cher,

❝ 1. The selection of subjects who complete at least two periods with at least one test and one reference treatment of the study will be included in the pharmacokinetic and statistical analysis.

❝ 2. The Selection of subjects who completes at least two periods with at least one test and one reference treatment of the subject will be considered for Bioequivalence

❝ 3. The subjects who complete minimum of two periods with two references in the study will be included in the statistical analysis to estimate within-subject variability of the reference product (SWR).


IMHO point 1 and point 3 are contradictory.
Since according to 1. a subject with two periods, each with reference, will not be included in the pharmacokinetic analysis it can't be included in the statistical analysis (of whatever) since no PK metrics are available.

Regards,

Detlew

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