Progress in Pharmacometrics Implementation and Regulatory Integration in Africa: A Systematic Review

• Published in: Clinical pharmacology and therapeutics 2024-12, Vol.116 (6), p.1525-1536
• Main Authors: Ndzamba, Bonginkosi S'fiso, Egieyeh, Samuel, Fasinu, Pius
• Format: Article
• Language: English
• Subjects: Africa; Drug Approval - legislation & jurisprudence; Drug Approval - organization & administration; Drug Development - legislation & jurisprudence; Drug Development - methods; Humans
• ISSN: 0009-9236; 1532-6535; 1532-6535
• DOI: 10.1002/cpt.3415

The availability of clinical trial data, advocacy, and increased funding has facilitated the implementation of pharmacometrics in Africa, resulting in the establishment of additional training programs for pharmacometricians. This study conducted a systematic review to evaluate the progress made from the implementation of pharmacometrics in clinical drug development and its adoption into drug approval by regulatory authorities in Africa. We performed a comprehensive literature search using major databases such as PubMed and Google Scholar. The study included articles published until 2024, with no lower cutoff. Articles were excluded if not addressing the research question or of pharmacometrics studies done outside Africa with no collaboration with African researchers (study setting). For the review, a total of 121 articles were included for analysis. Among the reported pharmacometrics approaches, Population pharmacokinetics modeling approaches are the most used (95 (78.5%)). South Africa and Uganda researchers have the most research output in pharmacometrics in Africa (82 (89.1%) and 7 (7.61%), respectively), with the University of Cape Town (South Africa) producing the highest (71 (78.8%)) of all article in Africa. The most studied conditions are TB (43 (35.5%)), HIV (33 (27.3%), TB and HIV (22 (18.2%)), and malaria (12 (9.92%). Pharmacometrics is gaining momentum in Africa, and the progress made since inception will significantly improve the safety and efficacy of therapeutic agents used to treat HIV, TB, and other emerging conditions.