Exposure-Response Modeling

Contents

Symbol Description xv

Preface xvii

1 Introduction 1

1.1 Multifaceted exposure–response relationships . . . . . . . . . 1

1.2 Practica l scenarios in ER modeling . . . . . . . . . . . . . . 2

1.2.1 Moxifloxacin exposure and QT pr olongation . . . . . 2

1.2.2 Theophylline . . . . . . . . . . . . . . . . . . . . . . . 6

1.2.3 Argatroban and activated partial thromboplastin time 6

1.3 Models and modeling in exposure–re sponse analysis . . . . . 9

1.4 Model-based decision-making and drug development . . . . . 12

1.5 Drug regulator y guidance for analysis of exposure–response re-

lationship . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 ...