PRESCRIPTION

CNS-Active Drug Products

In vitro abuse potential and deterrence evaluation

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

OUR EXPERTISE

  • Clinical Pharmacology
  • Regulatory Strategy
  • Analytical Chemistry
  • Forensic Toxicology

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.