Bioisenção em Foco – RDC N.O 749 E Fluorescência No Ultravioleta-Visível

Abstract

A drug can take up to decades from the moment of its conception until it is administered to humans. After a period of twenty years, the duration of a patent, generics of the reference drug can be produced. For this, many studies are necessary, which also require time and investment, which are called relative bioavailability/bioequivalence studies. In September 2022, the Collegiate Board of the National Health Surveillance Agency (Anvisa) of the Ministry of Health published RDC, No 749. This resolution brings criteria for the exemption of relative bioavailability/bioequivalence studies, which makes it possible to reduce the time (and cost) of producing a generic product, while maintaining the same scientific rules. The norm applies to specific situations, for example: aqueous solutions for oral use, aqueous ophthalmic solutions, aqueous and oil solutions for parenteral use, oral inhaled drugs administered via nebulizers, among others. For such studies, called biowaiver, the ultraviolet-visible (UV-Vis) fluorescence technique, combined with chemometrics, is a powerful tool. Thus, in this work we present a synopsis of these tools and, at the same time, an approach on a fluorescence UV-Vis equipment that adds chemometrics, and that even makes it possible to carry out investigations of formulations in aqueous solutions effectively and efficiently.