Today, biopredictive performance assays play a key role in the development of peroral drug products. They enable the early prediction of the bioavailability of drugs in animals or humans. Most injectables are developed for smaller patient populations and require a technologically more advanced formulation design. In this area, biopredictive tools are at the infant stage and only few methods are applicable these advanced therapeutics. With more biopharmaceuticals entering the global healthcare market, a growing number of niche busters are developed for the intravenous or subcutaneous route of administration. The talk will showcase recent advances in the development of biopredictive performance assays for intravenous nanomedicines and subcutaneous depot formulations. Current challenges and knowledge gaps will be highlighted.
Matthias G. Wacker, Associate Professor, National University of Singapore