Pharmacokinetic/pharmacodynamic modeling in drug development.
Annu Rev Pharmacol Toxicol
; 40: 67-95, 2000.
Article
in En
| MEDLINE
| ID: mdl-10836128
ABSTRACT
We propose a framework for considering the role of pharmacokinetic/pharmacodynamic modeling in drug development and an appraisal of its current and potential impact on that activity. After some introduction, definitions, and background information on drug development, we discuss subject-matter models that underlie pharmacokinetic/pharmacodynamic modeling and show how they determine appropriate statistical models. We discuss the broad role modeling can play in drug development, enhancing primarily the "learning" steps, i.e. acquiring the information needed for the label and for planning efficient confirmatory clinical trials. Examples of past applications of modeling to drug development are presented in tabular form, followed by a discussion of some practical issues in application. Modeling will not reach its potential utility until it is manifest as a visible and separate work unit within a drug development program. We suggest that that work unit is the "in numero" study a protocol-driven exercise designed to extract additional information, and/or answer a specific drug-development question, through an integrated model-based (meta-) analysis of existent raw data, often pooled across separate (clinical) studies.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Pharmacology
/
Pharmacokinetics
/
Drug Design
Type of study:
Guideline
/
Risk_factors_studies
Limits:
Animals
/
Humans
Language:
En
Journal:
Annu Rev Pharmacol Toxicol
Year:
2000
Document type:
Article