How Does the In Vivo Biliary Elimination of Drugs Change with Age? Evidence from In Vitro and Clinical Data Using a Systems Pharmacology Approach

Information on the developmental changes in biliary excretion (BE) of drugs is sparse. The aims of this study were to collate literature data on the pharmacokinetics of biliary excretion of drugs used in pediatrics and to apply a physiologically-based pharmacokinetic (PBPK) model to predict their systemic clearance (CL) with a view to elucidating age-related changes […]

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Recent Advances in Development and Application of Physiologically-based Pharmacokinetic (PBPK) Models: A Transition from Academic Curiosity to Regulatory Acceptance

There is a renewed surge of interest in applications of physiologically-based pharmacokinetic (PBPK) models by the pharmaceutical industry and regulatory agencies. Developing PBPK models within a systems pharmacology context allows separation of the parameters pertaining to the animal or human body (the system) from that of the drug and the study design which is essential to develop […]

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Cutting Edge Modeling and Simulation Solutions for Drug Development Drug development has become more complex and multi-layered. New combination therapies require more precise and individualized analyses, new approaches such as “basket studies” evaluate potential disease targets through a new lens, safety issues are more challenging, and comparative effectiveness plays an increasingly important role in “go/no […]

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About Our Consulting Services

Why Partner with our Drug Development, Regulatory, and Clinical Pharmacology Experts? Committed to scientific, regulatory, and commercial advancement, Certara creates impactful solutions facing the biopharm industry today—speed and cost. The largest and most comprehensive provider of strategic drug development, modeling and simulation, and regulatory science services, Certara partners with you to optimize drug development and […]

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