Preformulation characterization of new chemical entities (NCE) can be critical in the selection of the most appropriate drug substance form and formulations to be used in non-clinical and First in Human (FIH) clinical studies. Formulation design should take into account the characteristics of the Active Pharmaceutical Ingredient (e.g. solubility, stability, bioavailability), the intended dosage route and purpose of the study and be appropriate for the stage of development. The goal of preformulation is to establish the physical, chemical, and mechanical properties of a drug substance that provide a roadmap to formulate the molecule into a fit-for-purpose product. The purpose of early FIH clinical studies is often to establish as quickly as possible the safety and oral bioavailability (efficacy assessment may also be possible) of the NCE and suitable formulations can range from simple API (in a bottle or capsule), through to more traditional formulations such as solutions, suspensions, and powder filled capsules or tablets. This panel discussion will provide an in-depth review of preformulation and formulation development, and discuss key considerations and challenges in accelerating drug development from preclinical research to FIH studies.
In this webinar you will learn about:
• State-of-the-art preformulation characterization techniques
• How these techniques can be used to optimize drug substance characteristics that can influence success criteria such as stability, manufacturability (processing and scale-up) and clinical performance
• Factors to consider in the design of formulations for non-clinical and early clinical studies including the information gained from preformulation characterization studies