Reporting guidelines for population pharmacokinetic analyses.

ABSTRACT: The purpose of this work was to develop a consolidated set of guiding principles for reporting of population pharmacokinetic (PK) analyses based on input from a survey of practitioners as well as discussions between industry, consulting and regulatory scientists. The survey found that identification of population covariate effects on drug exposure and support for dose selection (where population PK frequently serves as preparatory analysis to exposure-response modeling) are the main areas of influence for population PK analysis. The proposed guidelines consider two main purposes of population PK reports (1) to present key analysis findings and their impact on drug development decisions, and (2) as documentation of the analysis methods for the dual purpose of enabling review of the analysis

SUBMITTER: Dykstra K 

PROVIDER: S-EPMC4432104 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature