Major gaps exist in the ability to appropriately design pediatric clinical trials as well as construct suitable dosing guidance in pediatric populations for which drug therapy is warranted. Historically, children have been excluded from clinical trials and therefore data on safety and efficacy of drugs in pediatric populations is often unavailable. As a result, data used to inform dosing in this population is often based on evidence established in other populations such as adults or older children.
This webinar explored strategy options and approaches based on a variety of baseline data to inform clinical trial designs for pediatric populations. This baseline data may include; the physiochemical properties of the active drug and relevant metabolites, in vitro and preclinical experiments defining ADME properties of the drug, data from adult trials in a similar population, and potentially limited pediatric data in a related but not the target pediatric population.
This webinar was presented by Jeff Barrett and Kayla Andrews on the 24th July 2019 at 4:00 pm East African Time (EAT). They provided actual case studies from past trials and modeling and simulation activities as examples with a focus on pharmacometric modeling and simulation approaches to define key protocol elements, principally the dose and duration, sampling scheme and sample size.
A recording of the webinar is now available here
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