PBPK’s Pivotal Role in Modern Drug Development: Busting Common Myths and Misconceptions
Physiologically-based pharmacokinetic modeling and simulation (PBPK M&S) is a mechanistic modeling approach, actively encouraged by regulators, increasingly leveraged by biopharmaceutical companies, and used by key academics to optimize drug discovery and development by integrating preexisting knowledge to synthesize new insights. Hence, PBPK is used to inform key research and development (R&D) decisions relating to clinical trial design, first-in-human (FIH) dosing, formulation design, treating special populations, and predictions of the likelihood of drug-drug interactions (DDIs).1 Although early applications of PBPK were limited to risk assessment of environmental chemicals and animal/human toxicology, technological advances have transformed PBPK into a systems biology “superhero” in the modern drug development toolbox. PBPK—A Systems Biology Approach to Drug Development PBPK falls under the systems biology umbrella that applies a nonlinear, integrative, quantitative, and holistic approach using biology, computational modeling, engineering, bioinformatics, and other sciences to understand the complexity of biological systems. The development and evolution of “omics” technologies, eg, genomics, proteomics, transcriptomics, metabolomics, and others—the underlying building blocks of systems biology research—has led to better understanding of how diseases result from perturbations of biological networks. These learnings have advanced the field of systems biology, and notably with PBPK.
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