Bioequivalence and Bioavailability Forum

Dear all

According to ANVISA's resolution - RE n. 898, of May 29, 2003, For highly variable drug products, replicated crossover design shall be adopted following Bataam design or Williams design.

However, anybody could clarify whether these two methods allow widening of confidence interval for PK parameters based on the observed intra-individual variability of the reference product.

Otherwise, Kindly advice whether ANVISA would allow SABE design based on USFDA or EMEA methods for highly variable drug products.


Thanks