Bioequivalence and Bioavailability Forum

Dear Auditor (nice nick!),

❝ 1. [...] BA/BE study between 200 mg (test formulation) Vs. 400 mg (RLD)?

You should administer 2 × 200 mg (test) vs. 400 mg (reference). Dose normalization of 200 mg might lead to bioinequivalence even though only a slight deviation of dose linearity is present.

❝ 2. Can we use any US marketed formulation (other then RLD) as a reference

❝   product for pilot BA/BE study?

Why do you want to do that? Does not make any sense, IMHO. You have to use the RLD in the pivotal study anyway. Main reasons of a pilot study are to assess the deviation of test from reference and the variability. Both results from a pilot study with a formulation other than the RLD will be misleading.