Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance

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. This volume covers safety pharmacology from the regulatory requirements down to the studies that must be done to justify them. Using the authors more than 30 years of direct experience, the book incorporates tricks and practical insights for making studies work and understanding why they fail.