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thank you for the invitation to present on the topic of evidence to support pediatric approval through extrapolation focusing my reflections on the pediatric plans hereamp;#39;s my disclosure the views in this presentation are mine and are not the position of johnson and johnson or i have the privilege of being a full-time employee after setting the context i will start with exposure matching followed by the extrapolation of safety matching response the need for exposure response curves extrapolation and controlled trials and then some concluding remarks the extrapolation concept synthesizes what we know and identifies the gaps in knowledge including the degree of certainty or uncertainty about existing knowledge which should be addressed in the extrapolation plan the extrapolation plan must address the data required to establish both the efficacy and safety of the intervention that is the drug or biologic for the indicated pediatric population the categorical approach to the
