Module232025

Pediatric Drug Development: Challenges

CMC regulatory considerations for pediatric formulation development challenges associated with the development of pediatric medicinal products, focusing on the

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complex regulatory framework,

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pharmaceutical forms,

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excipient selection,

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palatability,

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and alternative administration strategies.

A summary of the factors impacting pharmacotherapy practice and the development therapeutics aimed at pediatric patients

Quality (CMC) Development Considerations

The Organisation for Professionals in Regulatory Affairs