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Obinoscopy
Junior

Nigeria,
2018-05-15 19:31

Posting: # 18765
Views: 677
 

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

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
Helmut
Hero
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Homepage
Vienna, Austria,
2018-05-15 20:16

@ Obinoscopy
Posting: # 18766
Views: 585
 

 Ethics (?) masquerading as Science

Hi Scopy,

» 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)?

IMHO, the former masquerading as the latter. See this post.

Cheers,
Helmut Schütz
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bebac_fan
Junior

US,
2018-05-15 20:57

@ Obinoscopy
Posting: # 18767
Views: 581
 

 FDA Study Population Requirement for BE Studies: Ethics or Science

Hi Obinoscopy,

Thanks for bringing this up for discussion. We can all think of many examples where PK in intended populations may be different than the general. However, it is hard to think of situations where a physiological state will selectively alter the PK of a test drug.

After thinking for a bit, and quite a bit of stretching, I could come up with gastric pH (e.g. increased in elderly) maybe affecting BA for a pH liable dispersion matrix. Perhaps other formulation dependent things for reduced GI motility. But I think this is in general a "feel good" clause and not scientifically rooted.

Cheers
BF
jag009
Hero

NJ,
2018-05-18 16:28

@ Obinoscopy
Posting: # 18785
Views: 439
 

 FDA Study Population Requirement for BE Studies: Ethics or Science

Hi,

» 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)?

Personally I don't see this "representative population" is enforced since many ANDA (and NDA to a certain extent) studies now being conducted in India (as an example) and the study population is basically Indians. In addition, take Indian studies for example, it's very difficult (if not impossible) to get 50-50 or even 40-60 female to male ratios in a study. I have conducted studies India as well and my M/F ratios are usually 80-20 or 90-10 (sometime no females!).

I believe it's a good idea for the study population to be diverse.

John
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