PRESCRIPTION

Abuse-deterrent drug formulation evaluation

YOUR NEEDS

  • In vitro study assessment of abuse-deterrent drug formulations
  • Independent expert assessment of in vitro data and implications for FDA approval, scheduling and Category 1 labeling
  • Expert interpretation of the FDA 2015 final Guidance to Sponsors for Abuse-Deterrent Opioids and the 2016 draft guidance General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products

OUR SERVICES

  • Provide comprehensive guidance on the in vitro assessment of abuse-deterrent drugs and formulations
  • Design and develop protocols for laboratory assessment of the abuse characteristics of active pharmaceutical ingredients and product formulations
  • Prepare interpretive reports of in vitro data as they relate to scheduling and labeling
  • Support and attend meetings with the FDA to discuss Category 1 labeling
  • Application of our proprietary ALERRT® system to measure the amount of “work” involved in tampering of drug products, including abuse-deterrent formulations
  • ALERRT-related services include but are not limited to the following:
    • Providing comparative analysis of pharmaceuticals, namely, preparation of reports, statistical analysis, studies and ratings comparing abuse-deterrent features of abuse-deterrent formulations and or new chemical entities with abuse-deterrent features with comparator products and similar prototype abuse-deterrent formulations
    • Consulting services in the field of pharmaceuticals, namely, quantitative assessment of drug tamperability and manipulation as it relates to abuse by various routes of drug administration
    • Regulatory compliance consulting services in the field of abuse-deterrent formulations and or new chemical entities with abuse-deterrent features to ensure compliance with government standards concerning labeling, advertising and marketing, risk management and strategic communications, namely, translation of information to regulatory agencies

OUR EXPERTISE

  • Data Management and Statistical Analysis
  • Clinical Pharmacology
  • Regulatory and Health Policy

PinneyAssociates scientists are leaders in in vitro laboratory assessment and tamper testing of abuse-deterrent drugs and formulations. Through our regular engagement with FDA, we have unique insights into the regulatory expectations of abuse-deterrent evaluations.

In collaboration with DrugScan, PinneyAssociates provides a team of scientists with hands-on experience in tamper testing together with a trusted, innovative, state-of-the-art toxicology laboratory.