BCS and IVIVC Based Biowaivers

Biopharmaceutics Classification System (BCS) and In Vitro-In Vivo Correlation (IVIVC) are important concepts in the pharmaceutical industry that can facilitate the approval process for generic drugs, including biowaivers for certain dosage forms. BCS categorizes drugs based on their solubility and permeability characteristics, allowing for predictions about their bioavailability. Drugs falling into BCS Class I and III, which are highly soluble and highly permeable, respectively, are often eligible for biowaivers. IVIVC is a scientific approach that establishes a relationship between in vitro dissolution profiles and in vivo drug absorption, helping to bridge the gap between lab testing and clinical outcomes. The utilization of BCS and IVIVC based biowaivers in drug development can save time and costs, enabling the faster introduction of generic and biosimilar products to the market, ultimately benefiting patients by increasing accessibility to affordable medications.

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