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Medicine levels in pregnancy reports
We received a grant from the Bill and Melinda Gate Foundation (BMGF) in 2019 to explore and validate a pregnancy mathematical modelling technique known as “physiologically based pharmacokinetic (PBPK) modelling for its potential to be used to predict medicines blood levels in pregnant women.
This data will be used to support benefit-risk decision in clinical practice but also aid in the delivery of clinical trials with pregnant patients.
With input from UK clinical experts, we have identified over 200 medicines commonly used in pregnancy, and we have collected available pharmacokinetic data on over 100 medicines so far. This data is being used to qualify and validate PBPK models and give a good assessment of their potential to replace clinical data or inform clinical trial design.
Further information on this project is available on the MHRA MedRegs Blog.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SPCs) and scientific reports (PARs).