Reducing the time to develop and manufacture formulations forfirst oral dose in humans

The authors discuss approaches to delivering formulations for first-time-inhuman dosing. The advantages and disadvantages of various formulation types and a work-process flow chart are 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 data needs for each type of formulation and alternatives such as microdosing and chemical in capsule in bottle-type approaches are also discussed.