PharmPK Discussion - Subjects for BE study

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On 22 Nov 2004 at 21:27:21, vardhini kirthivas (vardhinikirthivas.-at-.yahoo.com) sent the message


Hi all,
Is it a requirement that we need to have both genders in equal
proportion while doing a BE study for a product to be used by both?
Will regulatory authorities accept a BE studies done only in males?
Thanks
Vardhini

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On 23 Nov 2004 at 08:13:55, Nisha K are (nishavenkatesh.-at-.yahoo.co.in) sent the message


Dear Vardhini Kirthivas,
This is what I found, hope it is useful.
Guidance for Industry - Bioavailability and Bioequivalence Studies for
Orally Administered Drug Products - General Considerations
"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."
Regards,
Nisha. K.R.

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On 23 Nov 2004 at 13:54:59, "bollu vvsn prasad" (bolluvasuprasad.-a-.rediffmail.com) sent the message

Dear Vardhini,
  Yes, regulatory authorities will accept if we conduct a study only on
males. NO PROBLEM.
  Regards
  Bollu Prasad
  Research Associate
  Aurobindo Pharma Ltd
  Hyderabad
  INDIA

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On 23 Nov 2004 at 06:58:38, wael aboalrob (waelaboalrob.-at-.yahoo.com) sent the message


dear all,vardini kirthivas
it is not important to have the two genders in the bio-study because
there is no big difference in the metabolic and absorption bathways in
both genders unless there is aknown effect for certain product.

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On 24 Nov 2004 at 04:47:20, "sajjad desai" (drsdesai.at.rediffmail.com) sent the message


  Dear Vardhini
  Good question!!!! Now in this forum so many issues will be raised. But
in my opinion,it is better to include both male and female subjects in
BE studies.
  Dr.Sajjad A.Desai
  MBBSMD(Pharmacology)

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