Policy of Multisource Drug Products in Latin America: Opportunities and Challenges on the Application of Bioequivalence In Vitro Assays.
Claudia Miranda-Pérez de AlejoAlexis Aceituno ÁlvarezGustavo Mendes Lima SantosMirna Fernández CerveraHelgi Jung-CookMiguel Ángel Cabrera-PérezPublished in: Therapeutic innovation & regulatory science (2020)
The study shows that the region is in a position to improve access to safe and effective medicines at a reasonable cost by applying BCS-based biowaiver guidance.