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Publication: Clinical Pharmacology & Therapeutics

Abstract

This paper reviews how decades of scientific and technological advances have transformed clinical pharmacology and drug development. It demonstrates how early discoveries (some nearly 80 years old) have evolved into modern modeling, simulation, and data-driven approaches that now inform dose selection, formulation design, and risk-benefit assessment. The review categorizes innovations as established, in progress, or emerging, highlighting how these have shaped and will continue to shape the partnership between the pharmaceutical industry and regulatory agencies in delivering safer and more effective therapies.

Author(s): Lawrence J Lesko, Piet H van der Graaf

Published: September 24, 2025

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