EVOLUÇÃO DA LEGISLAÇÃO E DAS TÉCNICAS ANALÍTICAS APLICADAS A ESTUDOS DE ESTABILIDADE DE INSUMOS E PRODUTOS FARMACÊUTICOS

Stability is an important parameter to evaluate the quality, safety and efficacy of drug substances and pharmaceutical products. The stability studies aim to determine the ability of a formulation to maintain its specifications, in order to establish shelf life and recommended storage conditions. Despite the extensive relevance, until the 1980’s the stability assessment methods complied with technical and scientific principles without the intervention of regulatory acts by health authorities. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human ...