生物学的同等性とバイオアベイラビリティのジャーナル

概要

Medicine Interchangeabilty in Brazil, is it Safe? A Systematic Review for the Last 15 Years about Oral Drugs

Gabriel Silva Lima*, Gustavo Reis Sampaio, Denis de Melo Soares

Objectives: The goal of this study was to review studies about bioequivalence test (BE) for oral drugs interchangeability in Brazil.

Methods: We searched two databases with a strict inclusion process: Conducted in Brazil; humans volunteers; cover the period from 2004 to 2019; be a comparative study between oral formulations; at least one Brazilian formulation under test and published in periodic; Two reviewers independently extracted the data.

Results: 4628 articles screened; 68 articles were included. 67 applying clinical assays and 1 article Chow and Liu methodology. Across studies that evaluated BE by clinical assays 66 demonstrated BE comparing generic or similar to their reference medicine.

Conclusion: These data can be used to inform interventions to change the public’s beliefs about a safe use of generic or similar drugs; and avoiding substitution between copies.