Miranda Claudia, Aceituno Alexis, Fernández Mirna, Mendes Gustavo, Rodríguez Yanina, Llauró Verónica, Cabrera-Pérez Miguel Ángel
Centro de Bioactivos Químicos, Unit of Modeling & Experimental Biopharmaceutics, Universidad Central "Marta Abreu" de Las Villas, 54830 Santa Clara, Cuba.
National Drug Agency Department, Institute of Public Health, 7780050 Santiago, Chile.
Pharmaceutics. 2021 Mar 10;13(3):363. doi: 10.3390/pharmaceutics13030363.
The biopharmaceutical classification system (BCS) is a very important tool to replace the traditional in vivo bioequivalence studies with in vitro dissolution assays during multisource product development. This paper compares the most recent harmonized guideline for biowaivers based on the biopharmaceutics classification system and the BCS regulatory guidelines in Latin America and analyzes the current BCS regulatory requirements and the perspective of the harmonization in the region to develop safe and effective multisource products. Differences and similarities between the official and publicly available BCS guidelines of several Latin American regulatory authorities and the new ICH harmonization guideline were identified and compared. Only Chile, Brazil, Colombia, and Argentina have a more comprehensive BCS guideline, which includes solubility, permeability, and dissolution requirements. Although their regulatory documents have many similarities with the ICH guidelines, there are still major differences in their interpretation and application. This situation is an obstacle to the successful development of safe and effective multisource products in the Latin American region, not only to improve their access to patients at a reasonable cost, but also to develop BCS biowaiver studies that fulfill the quality standards of regulators in developed and emerging markets.
生物药剂学分类系统（BCS）是多源产品开发过程中用体外溶出度试验取代传统体内生物等效性研究的一项非常重要的工具。本文比较了基于生物药剂学分类系统的最新生物豁免协调指南以及拉丁美洲的BCS监管指南，并分析了该地区当前的BCS监管要求以及协调统一以开发安全有效的多源产品的前景。确定并比较了几个拉丁美洲监管当局官方的和公开可用的BCS指南与新的ICH协调指南之间的异同。只有智利、巴西、哥伦比亚和阿根廷有更全面的BCS指南，其中包括溶解度、渗透性和溶出度要求。尽管它们的监管文件与ICH指南有许多相似之处，但在解释和应用方面仍存在重大差异。这种情况阻碍了拉丁美洲地区安全有效的多源产品的成功开发，不仅不利于以合理成本提高患者可及性，也不利于开展符合发达和新兴市场监管机构质量标准的BCS生物豁免研究。
