Application of pharmacokinetics-pharmacodynamics/clinical response modeling and simulation for biologics drug

Liang Zhao1, Elizabeth Y Shang, Chandrahas G Sahajwalla

  • 1Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. liang.zhao@fda.hhs.gov

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Pharmacodynamic Models: Overview01:27

Pharmacodynamic Models: Overview

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Pharmacokinetic–Pharmacodynamic Relationship: Problems01:24

Pharmacokinetic–Pharmacodynamic Relationship: Problems

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Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

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Pharmacodynamic models are essential tools in understanding the relationship between drug concentrations and their effects on biological systems. By characterizing the dynamics of drug action, these models guide dose selection, optimize therapeutic efficacy, and inform the development of new drugs. Two major classes of pharmacodynamic models include direct effect and indirect response models.Direct Effect ModelsDirect effect models describe the immediate relationship between drug concentration...
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