Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance, Second Edition

 

Description:

Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect.

These effects often present a hazard-particularly in individuals with compromised or limited organ system functions.

Safety Pharmacology in Pharmaceutical Development

 

Table of Contents:

 

Chapter 1: Safety pharmacology : Background, history, issues, and concerns

Chapter 2: Regulatory requirements : ICH, FDA, EMA, and Japan

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: The immune system

Appendix A: Acronyms

Appendix B: Laboratories conducting safety pharmacology testing