Written Question·Department of Health and Social Care·UIN 25099

Drugs: Gender

Tabled: 20 January 2025
Answered: 24 January 2025

Question

Graeme Downie

LabourDunfermline and Dollar

To ask the Secretary of State for Health and Social Care, what testing requirements are in place in the approval process to identify the different impacts of medicines on men and women.

Answer

Karin Smyth
As part of the approval process for new drugs, the impact of sex, on men versus women, is assessed on pharmacokinetics, or exposure, pharmacodynamics, and overall efficacy and safety. The data is assessed in terms of whether any dose adjustments are warra...

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