Advancing Pharmacoequity in Low‐ and Middle‐Income Countries via Model Informed Drug Development

Across low- and middle-income countries (LMICs) inequities in access to safe, effective medicines persist due to limited regulatory capacity, inadequate financing, and insufficient local data. Regulatory authorities are engaging with model-informed drug development (MIDD), but uneven technical readiness and resource gaps limit uptake. Physiologically based and population pharmacokinetic modeling can strengthen regulatory review and optimize dosing. When aligned with global harmonization initiatives, these tools can support evidence-based decisions and advance pharmacoequity by ensuring context-appropriate therapies reach patients.

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Publication Details

Journal
Clinical and Translational Science
Published
2026-04-27
DOI
https://doi.org/10.1111/cts.70571
Primary Topic
Pharmaceutical Economics and Policy
Type
article
Field-Weighted Citation Impact
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article

Advancing Pharmacoequity in Low‐ and Middle‐Income Countries via Model Informed Drug Development

Thaddeus H. Grasela, Ian S. Haworth, Catriona John Waitt, Sandra Cvijić et al.
Clinical and Translational Science
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article

Advancing Pharmacoequity in Low‐ and Middle‐Income Countries via Model Informed Drug Development

Thaddeus H. Grasela, Ian S. Haworth, Catriona John Waitt, Sandra Cvijić, Francis Williams Ojara, Henry Enzama
article en

Abstract

Across low- and middle-income countries (LMICs) inequities in access to safe, effective medicines persist due to limited regulatory capacity, inadequate financing, and insufficient local data. Regulatory authorities are engaging with model-informed drug development (MIDD), but uneven technical readiness and resource gaps limit uptake. Physiologically based and population pharmacokinetic modeling can strengthen regulatory review and optimize dosing. When aligned with global harmonization initiatives, these tools can support evidence-based decisions and advance pharmacoequity by ensuring context-appropriate therapies reach patients.

Clinical and Translational ScienceVol. 19(5)
University of Southern California (US), Gulu University (UG), University of Liverpool (GB), University of Belgrade (RS), Liverpool Women's Hospital (GB), Infectious Diseases Institute (UG), Calspan-University of Buffalo Research Center (US), Makerere University (UG)
Openalex Percentile: Top 4%
Pharmaceutical Economics and Policy
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