Gender effect on metformin and sitagliptin [Regulatives / Guidelines]

posted by khageswara Rao – India, 2022-03-01 08:26 (279 d 13:41 ago) – Posting: # 22816
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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.

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