Bioequivalence and Bioavailability Forum

Hi Joy,

❝ @Priya : I absolutely agree with you. But I think it will be better if we have "general protocol of BE Study" rather than "SOP".

You can have General Protocol of BE study rather than SOP also. Whether SOP or General Protocol of BE study, both should be approved by Ethics Committee before implementation.

❝

❝ @Dr_Dan : Yes, both protocols and informed consents should get approval from Ethic Committee. But how about FDA approval ? Whether both protocols and informed consents (general BE Study and specific BE Studies) should be approved by FDA ? Or FDA only need to approve protocol and informed consent of specific BE Studies ? And if you don’t mind, could you explain the reason.

Usually, Sponsors will not submit either General Protocol or Study Specific Protocol & Informed Consent Documents to FDA before study initiation. As per Recent FDA's Draft Guidance on Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA, only if you are wishing to use variations of FDA recommended study designs or analysis methods (e.g., a sequential design or scaled-average BE), then you need to submit the protocol to FDA for review and their comment before initiation of the study.
For some molecules such as Isotretinoin, FDA request to submit both the protocol and informed consent document to them for their review and approval before initiation of the study.
Hence, for other molecules, no need to submit the protocol and consent document to FDA for their review and approval.

Priya.