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The numerous controls and processes in place to ensure a medication is safe, effective, and manufactured with the utmost efficiency make drug development extremely complicated. The challenges of drug development can increase if a manufacturer assumes an existing formulation for an adult can also be used for a child. Pediatric drug development requires a formulation designed to fit the specific needs of that patient population. Not considering these requirements early enough could add significant delays and costs to the development process.
Author: Kaspar van den Dries, Ph.D., Senior Director Formulation Sciences, Solid Dosage Forms and Softgels, Patheon, by Thermo Fisher Scientific