Series Introduction Regulatory agencies require that any drug (parent or major metabolite) that penetrates the brain and has CNS activity, regardless of its therapeutic indication, be assessed for that drug’s abuse potential. In this series on Assessing Potential Drug Abuse, we are sharing how the team designs and setup accurate and valid nonclinical …
When to assess a drug’s potential for abuse: series introduction
Drug abuse and potential drug abuse are critical issues for today’s pharmaceutical industry and the health of patients. Understanding the latest FDA regulatory requirements, different study types, relevant timelines and logistics can be challenging. Conducted at a critical stage of drug development, the assessment for drug abuse potential is complex …