Pediatric PBPK models have broad application in the drug development process and are being used increasingly to optimize 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 pediatrics. Best practice standards are … Continued
Tag: pediatric drug development
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
Our speakers will discuss the pediatric oncology regulatory landscape and how modeling and simulation is used in pediatric oncology drug development.