Abuse Liability Assessment and Risk Assessment for a New Formulation of a Stimulant Pharmaceutical

A medium-sized pharmaceutical company was conducting due diligence on a stimulant in early stages of development which is an analog of a currently marketed product. Pinney Associates recommended a series of studies related to abuse liability and risk assessment that will be required prior to registration and scheduling. The proposed timing and potential study sites were based upon the perceived needs of regulators in making decisions regarding the scheduling and risk management requirements for novel compounds.