Frequent Queries from FDA: Gender Imbalance [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2022-11-14 17:01 (25 d 07:44 ago) – Posting: # 23364
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Dear krish85!

The query is not new!

❝ Now a days, CROs are receiving frequent queries from FDA (after publishing guidance Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA Aug 2021) like as below.


The recruitment is voluntary and many a times recruitment of female subjects are challenging. In the protocol- generally it is not written that how much percentage of male/female will be dosed. As the number of subjects are sufficient to have appropriate power, the clinical phase can be initiated. I believe unless it is not mentioned in protocol that you are going to dose 50:50 ratio, you are complying. If any sponsor wants this, they shall mention in protocol.

On the other front, CRO do not have to have their own data for justification. The SBOA's data or EMA's scientific justification data or even research article can be provided for support purpose mentioning no gender effect on PK is observed.

Regards,
Divyen Shah

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