Bioequivalence and Bioavailability Forum

❝ Fed study also should be conducted as per the revised recommendation of abiraterone.

❝ Please share your thougts on that.

• The reference listed drug (RLD) labeling indicates that abiraterone acetate tablets must be taken on an empty stomach. However, due to the complex food effects associated with abiraterone acetate tablets, FDA recommends applicants conduct a BE study under fed conditions.