As of July 2017, America’s opioid crisis has been declared a state of emergency. In order to help combat prescription opioid drug misuse and abuse, pharmaceutical drug companies are developing and commercializing drug products that have abuse- deterrent features. The FDA issued guidance in April 2015 for new drug applications (NDAs), and suggested guidance in March 2016 for generic abbreviated new drug applications (ANDAs) to aid in the formal evaluation of the abuse-deterrent nature of drug products. A crucial test for drug products that are abused intravenously are syringeability studies. Because most syringeability studies are performed exclusively in-vitro due to the hazardous nature of abuse-deterrent formulation excipients, accurate experimental design is crucial and carefully reviewed by the FDA.
This webinar will:
- Provide an overview of Category One abuse-deterrent testing
- Focus on the experimental design of syringeability studies for abuse-deterrent formulations
- Explain important factors in study design that can influence syringeability study results
- Provide insight into other related laboratory experiments that evaluate real-world intravenous abuse techniques