Margaret Gamalo

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Extent of safety database in pediatric drug development: types of assessment, analytical precision, and pathway for extrapolation through on-target effects

Feb 26, 2023 | tandfonline.com | Robert Nelson |Margaret Gamalo

ABSTRACTPediatric patients should have access to medicines that have been appropriately evaluated for safety and efficacy through revised labelling. Given this goal, the adequacy of the pediatric clinical development plan and resulting safety database are critical factors to inform a favorable benefit-risk assessment for the intended use of the medicinal product.

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