Introduction

Drug development programs rely increasingly on pharmacometric analysis to support decision-making and submissions to regulatory agencies.1,2 To ensure high quality analysis, organizations must apply state-of-the-art science and implement a comprehensive infrastructure of procedures, workflows, and informatics capable of efficiently organizing, processing, maintaining, and communicating the volume of data and results generated by pharmacometric departments over the duration of a development program.3,4 KIWI is a novel platform designed to meet these challenges.

Population Approach Group in Europe (PAGE), Alicante, Spain, June 2014

By Sebastien Bihorel, David Fox, Luann Phillips, Jill Fiedler-Kelly, Andrew Rokitka, Cynthia Walawander, Thaddeus H. Grasela