STRATEGIC APPROACHES OF UTILIZING BA/BE STUDIES TO OBTAIN APPROVAL FROM DIFFERENT REGULATORY AGENCIES FOR FIXED DOSE COMBINATION
PRESENTED TO: CRS 2022 by BioPharma Services
PRESENTED BY: J. KWOK, S. LE, J. HE & J. OLDENHOF
PURPOSE
More fixed-dose combinations (FDC) are being developed to improve patients’ adherence, clinical advantages, and affordability. Adapting to the growth of novel and generic FDC development, FDA and EMA are providing regulated frameworks for these products. Despite various published guidelines, some products might not be covered within the guidance. This includes immediate-release (IR) and a modified-release (MR) formulated compounds (IR-MR combo). This review compares basic requirements of a standard novel/ generic FDC and an IR-MR combo application among three major agencies.
This review will focus on clinical trials with PK endpoints. The guidelines from the FDA, EMA and TPD were chosen to review. All guidelines discussing clinic trials with PK endpoints, FDC, comparative bioavailability/bioequivalence (BA/BE) were considered.
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