Metodologias de análise de bioequivalência entre varfarina de referência e genérica: comparativo entre agências reguladoras

Abstract

As drug regulators are controlled by the production and marketing of drugs. For a quality of a genetic medicine to be met, bioequivalence tests must be performed. These were the reference results and the test of a not very significant series of bioavailability. Line limits are regulated by regulators, as well as the conditions for testing to be performed. Warfarin, a narrow therapeutic index (NTI) drug, should be more stringent to be considered bioequivalent, considering risks that may occur to the patient, such as bleeding that can lead to death due to its narrow therapeutic window, which makes it a BIT drug. ANVISA, the Brazilian regulatory manufacturer, determines bioequivalence between 95% and 105% for NTI drugs; the US Food and Drug Administration (FDA) is more permissive, with limits of 80% and 125%, but with the payment of statistics for a warfarin, inducing a7 new update. A European Medicines Agency (EMA) uses a similar analysis to the FDA, and acceptance limits between 90% and 111.11% for NTI drugs. Some studies point to the FDA, and others also point out tests that will be performed with a warfarin to assess its bioavailability, involving in vitro tests and even pharmacogenetics.