chapter 1 Safety pharmacology: background, history, issues, and concerns -- chapter 2 Regulatory requirements of ICH, U.S. FDA, EMEA, and Japan MHW -- chapter 3 Principles of screening and study design -- chapter 4 Cardiovascular system -- chapter 5 Central nervous system -- chapter 6 Respiratory system -- chapter 7 Renal function -- chapter 8 The gastrointestinal system -- chapter 9 Safety pharmacology of the immune system -- chapter 10 Integration of evaluations of safety pharmacology endpoints into existing study designs.