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RegisterGender effect on metformin and sitagliptin [Regulatives / Guidelines]
Dear All,
As per updated guidelines
If a drug product is intended for use in both sexes, the applicant should include similar proportions of males and females in the study or provide a justification supporting the use of a single-sex population.
for metformin and Sitagliptin we have enrolled only male subjects so please provide the justification on the same of gender effect. with references.
Your quick response will much helpful
Thanks in advance.
As per updated guidelines
If a drug product is intended for use in both sexes, the applicant should include similar proportions of males and females in the study or provide a justification supporting the use of a single-sex population.
for metformin and Sitagliptin we have enrolled only male subjects so please provide the justification on the same of gender effect. with references.
Your quick response will much helpful
Thanks in advance.
Complete thread:
- Gender effect on metformin and sitagliptinkhageswara Rao 2022-03-01 07:26 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Gender effect on metformin and sitagliptin dshah 2022-03-01 13:01
- Gender effect on metformin and sitagliptin khageswara Rao 2022-03-03 05:54
- Gender effect on metformin and sitagliptin dshah 2022-03-01 13:01
Ing. Helmut Schütz