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.
Authors
- Steven E. Kern (ORCID: https://orcid.org/0000-0002-2849-0836)
Institutions
- Bellevue College (US)
- Bellevue Hospital Center (US)
- Intellectual Ventures (United States) (US)
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
- 0.00