Pediatric Pharmacology includes the collection of clinical pharmacology data, for example, data with respect to the pharmacokinetic and pharmacodynamics properties of an item relating to dose selection and individualization. This guidance and approach help in obtaining the considerations for conducting studies so that the accurate dosing and information for drugs and biologic products in pediatric populations can be sufficiently characterized, leading to well-designed trials to evaluate safety and effectiveness. Significant advancements have been made in pediatric therapeutics over the last few years to truly benefit from the pharmacological research efforts and translate them into dosing recommendations that are evaluated in an adequately powered randomized clinical trial manner.
