PEDIATRIC DRUG DEVELOPMENT
What dose should I recommend to be used with pediatric patients?
I can support your pediatric drug development. When it is reasonable to assume that children have similar disease progression and response to intervention compared to adults, it may be acceptable to extrapolate exposure from adults to pediatrics. I can help you to investigate the most appropriate dose in pediatrics by developing a model that describes the size, maturation, and organ function influences. This type of model can be used to predict the exposure in pediatrics patients and to justify a dose recommendation.