ABSTRACT
CONTENTS 13.1 Background ......................................................................................................................244
13.1.1 Reasons for Drug Failure in Clinical Development/Withdrawal from Market Places ....................................................................................................244
13.2 Origin and Evolution of Safety Pharmacology ..........................................................247 13.2.1 Regulatory Requirements ................................................................................247 13.2.2 Factors Influencing the Approach to Safety Pharmacology ......................250
13.3 Definition and Objectives of Safety Pharmacology Studies ....................................251 13.4 Current Practices ............................................................................................................251
