Five Takeaways from the University of Maryland CERSI Pediatric Conference
Surprising takeaways from the recent University of Maryland CERSI workshop, Shaping the Future of Pediatric Formulation Development.
Explore expert perspectives, scientific advances, and practical strategies to help develop medicines that patients are willing to take.
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Surprising takeaways from the recent University of Maryland CERSI workshop, Shaping the Future of Pediatric Formulation Development.
Regulations in the EU and US require the development of pediatric dosage forms of every new drug. Pediatric Investigation Plans (for EMA) and Pediatric Study Plans (for FDA) should be submitted early in development, but frequently are filed late and lack specificity. A savvy applicant should take a proactive approach by proposing scientific, stage-gate study plans to fulfill regulatory requirements while mitigating technical and economic risks.
By: Jeff Worthington – Senopsys President and Founder Regulations in the United States and European Union are incentivizing (via pediatric exclusivity) and requiring the development of pediatric medicine. These regulations are designed to ensure that every new drug will be evaluated for use in pediatric patients and studied in this population when appropriate. A key
By: David Tisi – Senopsys Technical Director What is Flavor? We can trace the origins of many dosage forms and pharmaceutical technologies back to the food industry – and today we consider it a rich source for approaches, tools and methods that pharmaceutical scientists can adapt to develop palatable drug products. How do we define