FDA Study Population Requirement for BE Studies: Ethics or Science [Regulatives / Guidelines]

posted by Obinoscopy  – USA, 2018-05-15 17:31 (888 d 09:41 ago) – Posting: # 18765
Views: 2,106

Hi Guys,

Was going through the USFDA Guidance Document on Bioequivalence titled Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations (March 2003) which states that:

"...in vivo BE studies be conducted in individuals representative of the general population, taking into account age, sex, and race. We recommend that if the drug product is intended for use in both sexes, the sponsor attempt to include similar proportions of males and females in the study. If the drug product is to be used predominantly in the elderly, we also recommend that the sponsor attempt to include as many subjects of 60 years of age or older as possible."

For IND and NDAs, I can understand the need for representative population. But for ANDA submissions for the registration of generics, I wonder why there is need for the use of representative population. Is it based on the need for equity (ethics) or for soundness of data (science)?

Or could it be that I misinterpreted the document.

Regards,

Scopy

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