RESUMO
Quality functions from pharmaceutical sponsor companies aim to increase the use of analytics in their oversight of Good Clinical Practices and Pharmacovigilance activities. To leverage and accelerate progress, several companies decided to establish a collaborative model. The goals of this collaboration span the sharing of knowledge and ideas, the sharing of analytics methods, discussion of talent upskilling and technology adoption strategies, and collaborative discussion on these potential changes with global Health Authorities.
Assuntos
Comportamento Cooperativo , Desenvolvimento de Medicamentos/organização & administração , Indústria Farmacêutica/organização & administração , Difusão de Inovações , Humanos , Modelos Organizacionais , Farmacovigilância , TecnologiaRESUMO
In this article, the use of statistical equivalence testing for providing evidence of process comparability in an accelerated stability study is advocated over the use of a test of differences. The objective of such a study is to demonstrate comparability by showing that the stability profiles under nonrecommended storage conditions of two processes are equivalent. Because it is difficult at accelerated conditions to find a direct link to product specifications, and hence product safety and efficacy, an equivalence acceptance criterion is proposed that is based on the statistical concept of effect size. As with all statistical tests of equivalence, it is important to collect input from appropriate subject-matter experts when defining the acceptance criterion.