Pediatric Drug Development: Overcoming Practical and Ethical Concerns with Trial Simulator

Acetaminophen is an effective antipyretic and analgesic agent that has been widely used in oral administration for adult and pediatric patients, although this route is highly impacted by first pass metabolism in the liver. An intravenous (IV) formulation of acetaminophen was developed and
approved in approximately 80 countries, but not in the United States.

A biopharmaceutical company specializing in pharmaceuticals for use in the hospital setting sought FDA marketing approval for an IV-administered treatment for acute pain and fever in pediatric patients.

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