Females in Bioequivalence studies [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2022-03-08 20:09 (79 d 20:35 ago) – Posting: # 22827
Views: 425

Dear Loky do:
As per EMA- Subjects could belong to either sex; however, the risk to women of childbearing potential should be considered. Subjects should preferably be non-smokers and without a history of alcohol or drug abuse. Phenotyping and/or genotyping of subjects may be considered for safety or pharmacokinetic reasons.
However considering the current trend as per FDA, 0.5:0.5 ratio for male:female might be recommended. If no gender effect is reported, then only male/female subjects can be included.

Contraception recommendation:
a. Female of child bearing potential practicing an acceptable method of birth control for at least 30 days from date of last dose of study drug the duration of the study as judged by the investigator(s), non hormonal intrauterine device (IUD), abstinence or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam, or
b. Postmenopausal for at least 01 year, if less than 1 year, then following acceptable contraceptive measures as mentioned above or
c. Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).

Regards,
Divyen Shah

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