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I was reviewing a protocol and hung upon the following criteria
" Female subjects must be surgically sterile or practicing adequate
non-hormonal contraception for at least 3 months prior to and for the
duration of the study " I heard counter point for this kind of
exclusion criteria, one CRO indicated that in BE studies it is OK to
include female subjects taking steroidal contraceptives, can someone
advise me what is the industry practice in US and elsewhere in terms of
generic or OTC drug development practice.
Thank you very much
Prasad
Prasad NV Tata, M.Pharm., Ph.D., FCP
Manager-Pharmacokinetics
Mallinckrodt, Inc.
675 McDonnell Blvd.
Saint Louis, MO 63134
Tel: (314) 654-5325
Fax: (314) 654-9325
e-mail: prasad.tata.at.tycohealthcare.com
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Dear Mr.prasad,
The usual procedure followed in recruiting female subjects is they
should remain abstinent or use double-barrier contraception (partner
using condom and female volunteer using diaphragm, contraceptive
sponge, spermicide, or IUD.
With Regards,
V.Radhakrishna
Radhakrishna
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