Dr. Flavian Ștefan Rădulescu
Center for Drug Sciences, UMF Carol Davila Bucharest
Romania
2024 Presentation
The Topical drug Classification System (TCS) was proposed by Dr.Vinod P.Shah as a simple, reliable and science-based framework adapted to the complexity of topical semisolid drug products.
It relies on the in-depth comparative evaluation of the qualitative and quantitative composition, microstructure and in vitro performance of a test formulation and a reference product.
The presentation will include the evolution of the classification concept, its relationship with the draft guidance documents issued by the regulatory authorities and the central role of the in vitro release tests.
2022 Presentation
The in vitro release test (IVRT) has been proposed initially for the evaluation of the impact of controlled changes in composition and manufacturing process (scale-up and post approval changes). Gradually, the role of IVRT has been extended by publication of product specific draft guidances (US Food and Drug Administration). It is part of the aggregate weight of evidence approach and it has an assumed ability to reflect in aggregate the influence of several physical and chemical properties. The 2108 Draft guidance on quality and equivalence of topical products published by European Medicine Agency mentions IVRT as required to support the new concept of Extended Pharmaceutical Equivalence. The significance of comparison of in vitro performance depends on adequate understanding of the compared products, characterization of the degree of similarity / differences and evaluation of their impact on the in vivo outcome. The presentation will focus on current applications and trends in IVRT.
About the speaker:
Dr. Flavian Rădulescu is associate professor at the Faculty of Pharmacy, University of Medicine and Pharmacy Carol Davila Bucharest, Department of Biopharmaceutics.
Currently, he is head of the Department Drug Industry and Pharmaceutical Biotechnologies and one of the coordinators of the Center for Drug Sciences, a laboratory dedicated to the development of in vitro methodologies and their use in the screening of drug and drug products.
The Center is based on the collaboration of the Romanian Academy, Section of Medical Sciences, and the University.