The Importance of Formulation Development in Successful Drug Development
Formulation development is a critical part of any drug development program. Once a sponsor selects a new chemical entity (NCE) or 505(b)(2) drug candidate for first-in-human Phase 1 clinic study or a Phase 2 efficacy study, the focus must be on selecting a strong formulation development team to complete a successful investigational new drug (IND) application. Many critical decisions are made […]