Less than 10% of the analgesics in clinical trials make it past phase II studies. There are many reasons for this, including the inability of animal models to predict efficacy in humans and the placebo response with analgesic trials. This presentation will cover the preclinical models used to study analgesics and the process of human studies ranging from phase I to postmarketing trials. Methods used to predict analgesic signals in phase I trials will be discussed, along with analgesic development challenges such as dealing with the placebo response and regulatory issues.
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