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
Recenzii
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