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
Tag: pediatric drug development
Our speakers will discuss the pediatric oncology regulatory landscape and how modeling and simulation is used in pediatric oncology drug development.
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