Biowaivers for Fixed-Dose Combination (FDC) Drug Products
Fixed-dose combination (FDC) drug products present unique challenges in biowaiver assessments, as they involve multiple active pharmaceutical ingredients (APIs) with different physicochemical properties and release characteristics. Regulatory guidelines (USFDA, EMA, WHO) provide biowaiver provisions, but their applicability depends on several factors, such as API solubility, permeability, formulation type, and release mechanisms. Key Considerations for Biowaivers…