CMC Workshop: From Drug Development to Global Supply to Patients

Due to the critical role that dissolution plays in the bioavailability of the drug, in vitro dissolution can serve as a relevant predictor of the in vivo performance of the drug product. This plenary session will discuss relevant factors that should be considered in developing a clinically relevant dissolution method and specifications. The role of dissolution in the development of the appropriate design space will also be illustrated. Establishing the appropriate dissolution specifications will assure that the manufacture of the dosage form is consistent and successful throughout the product’s life cycle and that each dosage unit within a batch will have the same pharmaceutical qualities that correspond to those shown to have an adequate safety and efficacy profile.