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

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.