Free Whitepaper: "Human Abuse Liability Studies."

In January 2010, the FDA published draft guidance for the pharmaceutical industry entitled “Assessment of Abuse Potential of Drugs.” The FDA issued this guidance to aid pharmaceutical companies and research organizations in the development of drugs with potential for abuse. In this document, the FDA details its position on abuse liability by examining the Controlled Substances Act’s drug classification schedule and the process of submitting an abuse potential assessment.

This whitepaper will: 

• Summarize the FDA's draft guidance
• Explain what's involved in conducting and submitting an abuse potential assessment 
• Define and explain abuse liability and the abuse potential of a drug 
• Provide a historical synopsis of drugs with abuse liability 
• Review the Controlled Substances Act, as well as the steps involved in determining a drug's abuse potential 
• Discuss the final steps required, including a post-market experience, to submit an abuse potential assessment to the Food and Drug Administration. 

This whitepaper was written by (and offered with permission from) Clinilabs, a New York Pharma Forum member. Clinilabs is a full service contract research organization that specializes in early-phase pharmaceutical studies. 

Please complete the form on the right to receive the download link to this whitepaper.