Critical Update: Generic Abuse Deterrent Opioids and the Final FDA Guidance

Featured speakers include:

  • Chris Altomare, (Director, Clinical Development & Pharmaceutical Services, DRUGSCAN)
  • Dr. Edward Cone (Principal Scientist, Drug Delivery and Abuse-Deterrent Drug Products, PinneyAssociates)
  • Dr. Beatrice Setnik (VP Medical & Scientific Affairs, INC Research)
  • Topics covered: During this webinar abuse-deterrent testing experts from DRUGSCAN, Pinney Associates and INC Research will discuss and dissect the recently released final FDA guidance “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products” and what it means to both generic and innovator ADF developers.

Untangling methods to tamper with opioid formulations: Perspectives from the benchtop to the real world

Featured speakers include:
Christopher Altomare, B.S. Director, Pharmaceutical Services
Greg Gironda, VP Business Development

Topics covered: This webinar features interviews with recreational and dependent prescription opioid abusers offering a rare look into the manipulation techniques abusers use to prepare opioid tablets for routes of administration that provide a more powerful euphoria, such as intravenous or intranasal. The webinar also discusses the laboratory experiments DRUGSCAN scientists conduct to evaluate the properties of abuse-deterrent formulations that are designed to resist these manipulation techniques

DRUGSCAN In Vitro Mastication Studies for Abuse-Deterrent Formulations

Featured speakers include:
Eric Kinzler, PhD, Study Director
Christopher Altomare, B.S. Director, Pharmaceutical Services

Topics covered: Eric Kinzler and Chris Altomare of DRUGSCAN discuss designing in vitro mastication studies for abuse-deterrent formulations.

Webinar on Best Practices and the FDA’s Abuse-Deterrent Guidance for Innovator and Generic Opioids

Featured speakers include:
Daniel Leach, B.Sc (Hons), Director of Pharmaceutical Services DRUGSCAN, Inc.
Edward Cone, Ph.D., Principal Scientist, Drug Delivery and Abuse-Deterrent Drug Products, PinneyAssociates.
Beatrice Setnik, Ph.D., Vice President of Clinical Pharmacology Early Phase, INC Research.

Topics covered: Describe the similarities and differences between the FDA’s innovator and generic guidance for abuse-deterrent opioids and their target audiences
Review best practices for conducting studies to evaluate abuse resistance and abuse potential.