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When studying about phase I design, some questions emerged.
When we are developing a fixed combination of two known drugs (of course with established PK data
for each single entity), is there any possibility the gender difference might be different from each
Drug A: no gender difference
Drug B: plasma concentration is 2 times higher in female, but no difference in efficacy
Drug (A+B): let say it is under development and no PK interaction is expected but no robust clinical
evidence. Dose of each component is not higher than those already on market.
So if one is making a new combination of A+B, is gender difference study need to be incorporated in
Ph 1 PK study of new combination? From regulatory perspective, Is there any requirement regarding
this issue from major authority like FDA or EMA?
Because using male only will be beneficial (because the combination of two drugs is new) so we can
expect lower variation in PK result, but we can not assess gender difference. But if one also
includes female, higher number of subjects will be needed.
I am looking forward to hearing from you guys.
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