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
Precision-driven Clinical Pharmacology & Translational Medicine
Leverage Certara’s expert clinical pharmacology team and model-informed drug development (MIDD) to predict PK/PD behavior, optimize trial design, and navigate regulatory pathways with confidence, helping you bring safer, effective therapies to patients faster.

