Reducing the Time to Develop and Manufacture Formulations for First Oral Dose in Humans

Reducing the time to develop and manufacture formulations for first-in-human (FIH) testing is a key part of the product development timeline. This paper discusses approaches to shorten this time, reviewing advantages and disadvantages of various formulation types. A process flowchart is presented to help formulation scientists select an appropriate formulation that can minimize the required resources and rapidly deliver a functional formulation for clinical testing. The required data for each type of formulation and alternatives [e.g., microdosing and chemical-in-capsule-in-bottle (CICICB) approaches] are also discussed.