7 February 2023 - Commenters on the US FDA draft guidance outlining principles for in vivo or in vitro bioequivalence studies for investigational new drugs, new drug applications, abbreviated new drug applications indicated that they want the agency to elaborate on new topic areas introduced in the guidance.

The draft guidance, which replaces a 2001 guidance for industry published under the same name, added new information on how to assess bioequivalence in narrow therapeutic index drugs and highly variable drugs, anticipate missing data and intercurrent events and using adaptive trial design to “help applicants plan and analyse their bioequivalence studies with the goal of minimising the number of assessment cycles necessary for approval.”

Read Regulatory Affairs Professional Society article