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Submitting a New Drug Application (NDA) for CNS-active drugs comes with unique challenges. In this issue, we dive into the complexities of CNS drug studies, CSA scheduling, the need for additional assessments, critical data reviews, and choosing the right CRO for your program.
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Discover how early clinical cognitive testing and dedicated driving simulation studies can help assess the cognitive functions for safety and efficacy in drug development.
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Industry experts discuss the regulatory environment and challenges for Schedule 1 drug development, including the required preclinical and clinical studies, specialized clinical assessments, and important factors to consider in the formulation and manufacturing of these substances.
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Learn how to identify which cognitive and pharmacodynamic tests are required for novel CNS-active drugs, what populations should be used for testing, and best practices on conducting them during FIH trials.
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