Lisa Murray

Record numbers of patent expirations, unprecedented expansion of the global generics market, and mounting pressure from government and customers for low-cost drugs, contribute to the need for reliable, economical, and expeditious test systems for supporting BCS-based biowaivers. And yet, this pathway remains underutilized by the generic industry. This session will review progress which has been made in BCS permeability classification techniques, including identification of increasingly accurate internal standards and optimized pH conditions. Current limitations will also be explored, including passive transport requirements and solubility conditions. Opportunities for applying updated science and ultimately expanding the utility of BCS biowaivers will be discussed.