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Pharmacokinetic/pharmacodynamic modeling in drug development
1Department of Laboratory Medicine, University of California San Francisco 94143, USA. lbs@c255.ucsf.edu
Annual Review of Pharmacology and Toxicology
|June 3, 2000
Summary
Pharmacokinetic/pharmacodynamic (PK/PD) modeling enhances drug development by improving learning phases and planning clinical trials. Integrating modeling as a distinct work unit, like "in numero" studies, maximizes its utility.
Area of Science:
- Pharmacology
- Drug Development
- Biostatistics
Background:
- Drug development is a complex, lengthy process.
- Pharmacokinetic/pharmacodynamic (PK/PD) modeling offers potential benefits.
- Current applications and impact of PK/PD modeling require appraisal.
Purpose of the Study:
- Propose a framework for PK/PD modeling in drug development.
- Appraise the current and potential impact of PK/PD modeling.
- Identify strategies to maximize the utility of PK/PD modeling.
Main Methods:
- Review of PK/PD modeling principles and underlying subject-matter models.
- Discussion of PK/PD modeling's role in enhancing drug development learning phases.
- Analysis of past applications and practical issues in PK/PD modeling.
Main Results:
- PK/PD modeling can significantly enhance information acquisition for drug labeling.
- Modeling aids in planning more efficient confirmatory clinical trials.
- Current integration of modeling is often insufficient to realize its full potential.
Conclusions:
- PK/PD modeling is crucial for optimizing drug development.
- Establishing modeling as a distinct work unit, such as "in numero" studies, is essential.
- "In numero" studies, through integrated model-based analysis, can extract additional information and answer key development questions.