Trust, but Verify: Translating Dosing Evidence to Understudied Populations in Low‐ and Middle‐Income Countries

Drug dosing recommendations derived from healthy volunteers and selected preregistration populations may not translate reliably to physiologically distinct or understudied groups, particularly in low- and middle-income countries. Using a metformin-dolutegravir drug interaction study and colistin pharmacokinetic study from South Africa, we illustrate how body composition and disease severity, respectively, can alter dosing assumptions. Drug development and post-registration programs should include explicit translation plans using target-population data to confirm, refine, or revise dosing recommendations in understudied target populations.