Integrated PK/PD and Drug Metabolism Approaches in Drug Development and Evaluation

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25

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articles

Integrated PK/PD and Drug Metabolism Approaches in Drug Development and Evaluation

72.1K

views

25

authors

20

articles

Editorial

18 August 2026

Editorial: Integrated PK/PD and drug metabolism approaches in drug development and evaluation

Fenglei Huang

,

Yurong Lai

,

André Dallmann

and

Xinning Yang

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Pharmacokinetics (PK) and pharmacodynamics (PD) are essential in drug development, providing critical insights into the absorption, distribution, metabolism, and excretion (ADME) of drugs, as well as their pharmacological effects. Drug metabolism, a key component of PK, significantly influences a drug's efficacy, safety, and potential for drug-drug interactions (DDIs)—an increasingly important consideration in the context of polypharmacy.Recent advancements in modeling, simulation, and in vitro/in vivo methodologies have enabled the integration of PK/PD and drug metabolism data across the entire drug development process. This integrated approach supports the optimization of dosing regimens, early identification of safety risks like DDIs, and more effective translation of preclinical data to clinical outcomes. Regulatory agencies increasingly rely on model-informed drug development (MIDD), highlighting the importance of these integrated approaches in guiding decisions throughout the drug development lifecycle.Integrating PK/PD and drug metabolism is crucial for streamlining drug development, optimizing clinical trials, and improving regulatory outcomes. This special research topic aims to present innovative research that explores how PK/PD and drug metabolism integration can enhance drug discovery and evaluation from preclinical models to clinical trials. By featuring advanced methodologies, case studies, and translational research, the Research Topic will provide valuable insights for pharmaceutical scientists, clinicians, and regulatory experts. Dr. Yurong Lai is affiliated with Gilead Sciences and Dr. Fenglei Huang is affiliated with Boehringer Ingelheim. All other Topic Editors declare no Conflicts of Interest

Pharmacokinetics (PK) and pharmacodynamics (PD) are essential in drug development, providing critical insights into the absorption, distribution, metabolism, and excretion (ADME) of drugs, as well as their pharmacological effects. Drug metabolism, a key component of PK, significantly influences a drug's efficacy, safety, and potential for drug-drug interactions (DDIs)—an increasingly important consideration in the context of polypharmacy.Recent advancements in modeling, simulation, and in vitro/in vivo methodologies have enabled the integration of PK/PD and drug metabolism data across the entire drug development process. This integrated approach supports the optimization of dosing regimens, early identification of safety risks like DDIs, and more effective translation of preclinical data to clinical outcomes. Regulatory agencies increasingly rely on model-informed drug development (MIDD), highlighting the importance of these integrated approaches in guiding decisions throughout the drug development lifecycle.Integrating PK/PD and drug metabolism is crucial for streamlining drug development, optimizing clinical trials, and improving regulatory outcomes. This special research topic aims to present innovative research that explores how PK/PD and drug metabolism integration can enhance drug discovery and evaluation from preclinical models to clinical trials. By featuring advanced methodologies, case studies, and translational research, the Research Topic will provide valuable insights for pharmaceutical scientists, clinicians, and regulatory experts. Dr. Yurong Lai is affiliated with Gilead Sciences and Dr. Fenglei Huang is affiliated with Boehringer Ingelheim. All other Topic Editors declare no Conflicts of Interest

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Frontiers in Pharmacology

Drug Metabolism and Transport

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