PRESCRIPTION

CNS-Active Drug Products

In vitro evaluation for abuse potential and deterrence

YOUR NEEDS

  • In vitro evaluation of a CNS-active drug product’s relative abuse potential or abuse-deterrence
  • Independent expert assessment of in vitro data and implications for FDA approval and abuse-deterrent labeling (when applicable)
  • Development and regulatory strategy grounded in expert interpretation of FDA guidance documents
  • Assistance in selection of an independent laboratory for execution of in vitro evaluations

OUR SERVICES

  • Provide expert regulatory support and comprehensive guidance on in vitro abuse potential and abuse-deterrent evaluations
  • Advise on claims related to abuse potential and abuse deterrence
  • Prepare gap analyses on existing in vitro data
  • Design and develop protocols for in vitro abuse potential and abuse-deterrent evaluations
  • During early drug product development, design and develop protocols for abuse-deterrent formulation selection
  • Evaluate in vitro data as they are generated and provide recommendations regarding the need for potential additional studies or study modifications
  • Prepare interpretive reports of in vitro data in support of FDA approval and abuse-deterrent labeling
  • Support independent laboratory selection for in vitro evaluations
  • Support and attend meetings with the FDA to discuss drug product approval
  • Application of our proprietary ALERRT® system to measure the amount of “work” involved in the tampering of abuse-deterrent drug products

PinneyAssociates scientists are leaders in in vitro abuse potential and abuse-deterrent evaluations. Through our regular engagement with FDA, we have unique insights into the regulatory expectations of such evaluations and how to maximize these studies to support potential claims.

In collaboration with NMS Labs, PinneyAssociates provides a team of chemists and forensic scientists expert in understanding drug abuse behaviors and hands-on experience with in vitro evaluations of CNS-active drug products.