Statistical model for replicate designs Canada [RSABE / ABEL]

posted by d_labes  – Berlin, Germany, 2016-04-05 15:04 (3233 d 09:41 ago) – Posting: # 16165
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Dear pash,

since your mentioned notice demands the use of replicate crossover designs for the evaluation of HVD/HVDP IMHO the answer is given in the guidance document Conduct and Analysis of Comparative Bioavailability Studies.

Section 2.7.4 Statistical Analysis states:
2.7.4.2 Model Fitting

... Higher order models must be analysed with the mixed model approach in order to estimate random effects properly.

...

2.7.4.4 Estimation of Random Effects

A summary of the estimates of inter-subject and intra-subject variances should be presented. For higher order designs estimates of subject by formulation and within formulation variance estimates should be given.


These statements are not compatible with the EMA recommendations.
Thus only the FDA approach (SAS code in Appendix E of the 2001 guidance "Statistical Approaches to Establishing Bioequivalence") is feasible I think.

Regards,

Detlew

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