The EMA describes extrapolation as extending information and conclusions available from studies in one or more subgroups of the patient population (source population(s)), or in related conditions or with related medicinal products, in order to make inferences for another subgroup of the population (target population), or condition or product, thus reducing the amount of, or general need for, additional evidence generation (types of studies, design modifications, number of patients required) needed to reach conclusions.
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Extrapolation of efficacy and Safety in medicine development
Published by IRDiRC
Research and Drug DevelopmentRegulatory AffairsClinical DevelopmentClinical Trial DesignTarget PopulationStudy DesignExtrapolation of Efficacy and SafetyAdaptative Pathways