The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price contract to Institutes for Behavior Resources, Inc. for preclinical validation of behavioral economic methods for abuse potential assessment. The primary objective is to assist the government with validating behavioral economic demand curve analysis for abuse potential assessment. The contractor will establish a quantitative framework for comparing the relative abuse potential of novel compounds against known drugs of abuse. The contractor will conduct a multi-site validation to confirm the robustness and reproducibility of the methodology. Key tasks include:
• Validating behavioral economic demand curve analysis for abuse potential assessment
• Establishing a quantitative framework for comparing the relative abuse potential of novel compounds
• Conducting a multi-site validation to confirm the robustness and reproducibility of the methodology
• Collecting data for a positive control and a test drug
• Utilizing the same animal cohorts for standard Dose-Effect curves and Behavioral Economic (BE) Demand Curves
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