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

"The authors discuss approaches to delivering formulations for first-time-in- human 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."