Design of Clinical Formulations in Early Development
Abstract
Thoughtfully designed early clinical formulations not only meet the needs of the study at hand and inform the development of the commercial product, but can influence the direction of the clinical program as well as provide further guidance to potential backups still in exploratory stages. This chapter focuses on the various types of early clinical formulations, why they are developed, and how the preclinical formulation space helps to guide initial clinical formulation selection. Impacts on clinical program development will be presented through case studies and examples in context of the types of clinical studies being supported: what is the goal of the clinical study, what questions need to be answered, and how will the information be used in subsequent development? Additional factors influencing formulation selection such as patient needs, the practicality of switching between dosage forms, and commercialization potential will be reviewed.