A Best Practice Framework for Applying PBPK Modeling to Pediatric Drug Development

Pediatric PBPK models have broad application in the drug development process and are being used increasingly to optimise and replace clinical studies. However, the approach has yet to become fully integrated in regulatory submissions. Emerging data support an expanded integration of the PBPK model informed approach in regulatory guidances on paediatrics. Best practice standards were … Continued

Juvenile toxicity studies considerations – not just “mini” general tox!

Outlining a pediatric clinical and safety assessment plan for investigational drugs is a required part of drug development due to regulatory legislation. These plans may include juvenile toxicity studies in animals to ensure safe and effective medicines for children. Juvenile toxicity studies are warranted when safety concerns can’t be adequately, ethically, or safely assessed in … Continued

1 of 1
Back to top
Powered by Translations.com GlobalLink OneLink Software