By Dr. San Kiang, J-Star Research / Porton
The business goal of most CMC development is to reach FIH as fast as possible. However, before IND or Phase 1, safe use of the new drug candidate is of major concern. On the clinical side, the bio-pharmaceutical goal is to enable maximum exposure of animals to the drug during tox studies so that the dose ranges during FIH can be determined. Most new drug candidates nowadays have poor solubility. In this session we will review various technologies and approaches to improve solubilities. The inherent risks and implications for further development associated with each approach will also be discussed.