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What African Patients, Clinicians, and Regulators Can Gain from Pharmacometrics: Forecasts for the Future in a New
1Global Health Labs, Bellevue, Washington, USA.
Abstract:
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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