Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance

ISBN-13: 9780367381455 / Angielski / Miękka / 2019 / 213 str.

Shayne C. Gad

Opis

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 author’s more than 30 years of direct experience, the book incorporates tricks and practical insights for making studies work and understanding why they fail.

Spis treści

Safety Pharmacology: Background, History, Issues, and Concerns. Regulatory Requirements: ICH, FDA, EMA, and Japan. Principles of Screening and Study Design. Cardiovascular System. Central Nervous System. Respiratory System. Renal Function. The Gastrointestinal System. The Immune System.

O autorze

Shayne Cox Gad is Principal at Gad Consulting Services in Cary, North Carolina. He has over 33 years experience as a toxicologist, statistical consultant, manager, and consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries.