Pharmacometrics enhances regulatory decision-making in Africa, suggesting improved drug development outcomes for patients.
With the growth of African national regulatory agencies into a Pan‐African entity called the African Medicines Agency (AMA), an opportunity exists for using the best regulatory science methods available. AI‐supported model‐informed drug development could be the backbone to support regulatory decision‐making efforts. The pharmacometrics community can play a pivotal role in advancing this state‐of‐the‐art opportunity. But, to do this successfully, pharmacometricians must gain the trust of African regulators, clinicians, and patients in using model‐based methods.
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Steven E. Kern (2025) studied this question.
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