PharmPK Discussion - Bioequivalence studies for oral contraceptives

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On 3 Dec 2003 at 12:57:45, Gilberto De Nucci (denucci.at.dglnet.com.br) sent the message


Dear all

I would like to perform some bioequivalence studies for oral
contraceptives. Is there any major reason for not performing in healthy
male volunteers?

Many thanks

Gilberto De Nucci
Cartesius Analytical Unit
Sao Paulo - Brazil

Thanks,

Gilberto

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On 3 Dec 2003 at 09:07:12, "Vuong Trieu" (vtrieu.-a-.AmericanBioScience.com) sent the message


The following message was posted to: PharmPK

BE experiments are to be performed in healthy volunteer as the primary
endpoints are PK and not PD.

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On 3 Dec 2003 at 15:46:57, "FEDERICO EZEQUIEL LERNER" (flerner.aaa.intramed.net) sent the message


The following message was posted to: PharmPK

Dear Gilberto,

Depending on the dose, some formulations contains higher dose that are
unacceptable for male administration,

Federico

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