2018 PharmSci 360
SEPARATE FEE AND REGISTRATION REQUIRED.
The gastrointestinal (GI) tract is the most popular and used route of drug product administration due to the convenience for better patient compliance. However, its complex nature poses a great challenge for drug product formulators when developing more complex dosage forms such as those combining two or more drugs. Fix dosed combination (FDC) products are two or more single active ingredients combined in a single dosage form representing a contribution to safety and efficacy compared to the co-administration of the mono-products. A complex drug product, to be dosed through a complex route, requires judicious considerations for formulation development. Additionally, it represents a challenge from a regulatory perspective at the time of demonstrating bioequivalence for generic versions of such drug products.
This short course will offer a comprehensive view of the most influential aspects of the GI physiology on the absorption of drugs and current techniques to help understand the fate of orally ingested complex drug products in the complex environment represented by the GI tract. Through case studies on FDC product development and regulatory issues, this course will provide a great opportunity for attendees to explore avenues for successfully developing FDC products and their generic versions.