Reference? [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2016-04-09 16:24 (3233 d 12:39 ago) – Posting: # 16175
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Hi pash,

❝ For HVD drugs recently Canada regulatory has published a notice proposing to adopt an average bioequivalence approach to HVDP with expanding limits based on the within-subject variability of the reference product.


Do you have a reference? I only know the archived notice Detlew mentioned. The FDA’s model sometimes fails to converge for data of the partial replicate design. Either use one of the full replicates designs (RTRT|TRTR or RTR|TRT) instead or change the random section where the structure of the variance-covariance matrix is specified from FA0(2) to FA0(1).

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