The role of adverse events and related safety data in the pre-market evaluation of drug abuse potential.

@article{Mansbach2010TheRO,
  title={The role of adverse events and related safety data in the pre-market evaluation of drug abuse potential.},
  author={Robert S. Mansbach and Kerri Alexandra Schoedel and Jeffrey P Kittrelle and Edward M. Sellers},
  journal={Drug and alcohol dependence},
  year={2010},
  volume={112 3},
  pages={173-7}
}
The scientific and regulatory assessment of abuse and dependence potential of drugs involves a multi-layered evaluation of its properties related to chemistry, formulation, pharmacology, animal behavior and clinical response. In addition to the primary laboratory-based assessment in experienced drug users, data are also reviewed from studies in healthy volunteers and in the patient population. Much of the emphasis in these latter studies is placed on adverse events that are reported by the… CONTINUE READING