Cost-effective strategy – An innovative approach assessing the drifting bioavailability of fixed-dose combination formulations
PRESENTED TO: AAPS 2022 by BioPharma Services
PRESENTED BY: T.V. Nguyen, J. KWOK, S. LE, J. HE & J. OLDENHOF
PURPOSE
The development of generic fixed-dose combination (FDC) has seized increasing industry interest due to its advantages in disease management, patient compliance, and market benefits.
In general, the innovator has established the first bridge between FDC and co-administration of mono-components, and the generic sponsor only demonstrates the second bioequivalence (BE) bridge between generic and innovator FDCs. However, these two BE bridges increase the risk of bioavailability drifting from original mono-components to generic FDC and regulatory agencies can require evidence to prove the absence of “drifting” bioavailability.
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