Fundamentals of population pharmacokinetic modelling: validation methods.

Abstract:

:Population pharmacokinetic modelling is widely used within the field of clinical pharmacology as it helps to define the sources and correlates of pharmacokinetic variability in target patient populations and their impact upon drug disposition; and population pharmacokinetic modelling provides an estimation of drug pharmacokinetic parameters. This method's defined outcome aims to understand how participants in population pharmacokinetic studies are representative of the population as opposed to the healthy volunteers or highly selected patients in traditional pharmacokinetic studies. This review focuses on the fundamentals of population pharmacokinetic modelling and how the results are evaluated and validated. This review defines the common aspects of population pharmacokinetic modelling through a discussion of the literature describing the techniques and placing them in the appropriate context. The concept of validation, as applied to population pharmacokinetic models, is explored focusing on the lack of consensus regarding both terminology and the concept of validation itself. Population pharmacokinetic modelling is a powerful approach where pharmacokinetic variability can be identified in a target patient population receiving a pharmacological agent. Given the lack of consensus on the best approaches in model building and validation, sound fundamentals are required to ensure the selected methodology is suitable for the particular data type and/or patient population. There is a need to further standardize and establish the best approaches in modelling so that any model created can be systematically evaluated and the results relied upon.

journal_name

Clin Pharmacokinet

authors

Sherwin CM,Kiang TK,Spigarelli MG,Ensom MH

doi

10.1007/BF03261932

subject

Has Abstract

pub_date

2012-09-01 00:00:00

pages

573-90

issue

9

eissn

0312-5963

issn

1179-1926

journal_volume

51

pub_type

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