ANVISA and replicate designs [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2016-05-11 09:47 (1757 d 16:08 ago) – Posting: # 16291
Views: 9,647

(edited by d_labes on 2016-05-11 11:40)

Dear All (especially our Brazilian colleges),

is there any more specific information what type of statistical evaluation ANVISA demands for replicate crossover designs?

I have only found the Resolution - RE n. 898, of May 29, 2003 which states in Section 3.2 Data analysis: "A variance analysis (ANOVA) must be used in the pharmacokinetic parameters ASC and Cmax using generalized linear models. Appropriate statistical models according to the design chosen in the study must be employed."

Only the case of classical 2x2x2 crossover is then exemplified in the next sentences.

Is the same ANOVA model demanded for replicate designs (like the EMA recommendation)?
Or is a mixed model approach the better choice (like Proc Mixed SAS code of the FDA)?
Is an analysis via intra-subject contrasts acceptable or recommended (like FDA's progesterone guidance)?



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