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Abstract

The Biopharmaceutics Classification System (BCS) is a key framework for predicting the in vivo performance of oral drugs by assessing solubility, permeability, and dissolution. It aids in formulation development, bioavailability studies, and regulatory decisions on bioequivalence. Advancements in solubility enhancement techniques are crucial for BCS Class II and IV drugs. Permeability and dissolution testing are continuously refined to improve predictive accuracy. The BCS also plays a role in regulatory science, influencing bioequivalence study waivers. Furthermore, it guides drug delivery system selection and emphasizes the importance of gastrointestinal physiology. The BCS framework is evolving with new technologies to enhance its utility in drug development.