Safety Pharmacology In Pharmaceutical Development 2Ed: Approval & Post Marketing Surveillance (Hb) Hardcover

Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance, Second Edition explores the study of pharmacological effects of potential drugs that are unrelated to their intended therapeutic use, which can be hazardous, especially in individuals with impaired organ functions. Drawing on over 30 years of experience, the author provides valuable insights and practical tips for conducting these studies and understanding common pitfalls. The second edition includes up-to-date regulatory requirements from the USFDA, Europe, and Japan. It offers a detailed explanation of the necessary steps to support drug development, focusing on updated testing methods, interpretation, and scientific approaches. The book covers both core and supplemental test procedures and provides an overview of facilities and contract organizations available for conducting studies.