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Dear All,
Need your expert suggestions.
If product monograph or other literature states that, there is no
gender related effects on efficacy and safety of product.
can we go for Bioequivalence Study only in Healthy male and not in
females.
Or is it must to include female subjects though there is no known
gender effect.
Because US guidelines states that, If the drug product is intended
for use in both sexes, the sponsor should attempt to include similar
proportions of males and females in the study.
Thanks
Minal Deokar
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Dear Minal,
The US guidances include recommendations. It is fine if you conduct
this study on healthy males only. Moreover, a huge amount of BE
studies have been performed solely on healthy, adult, human males
even if the drugs were indicated on both males and females.
You can go ahead with your study keeping in mind your facility has
all the systems and SOP's in place. All the best!
Dr. Gagandeep Singh
Head, Clinical Research
BioArc (Alembic Ltd) India
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