What African Patients, Clinicians, and Regulators Can Gain from Pharmacometrics: Forecasts for the Future in a New Era in Health

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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Publication Details

Journal
Clinical Pharmacology & Therapeutics
Published
2025-12-17
DOI
https://doi.org/10.1002/cpt.70167
Primary Topic
Statistical Methods in Clinical Trials
Type
article
Field-Weighted Citation Impact
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article

What African Patients, Clinicians, and Regulators Can Gain from Pharmacometrics: Forecasts for the Future in a New Era in Health

Steven E. Kern
Clinical Pharmacology & Therapeutics
Statistical Methods in Clinical Trials
article

What African Patients, Clinicians, and Regulators Can Gain from Pharmacometrics: Forecasts for the Future in a New Era in Health

Steven E. Kern
article en

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.

Clinical Pharmacology & Therapeutics
Bellevue College (US), Bellevue Hospital Center (US), Intellectual Ventures (United States) (US)
Openalex Percentile: Top 63%
Statistical Methods in Clinical Trials
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What African Patients, Clinicians, and Regulators Can Gain from Pharmacometrics: Forecasts for the Future in a New Era in Health — Steven E. Kern · Clinical Pharmacology & Therapeutics (2025) | TGRS Research Map | TGRS