Safety Pharmacology in Pharmaceutical Development (2nd Ed.) Approval and Post Marketing Surveillance, Second Edition
Auteur : Gad Shayne C.
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: Approval and Post Marketing Surveillance, Second Edition 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.
The second edition includes current regulations, including USFDA and those from Europe and Japan. Presenting a clear description of what is needed and why for supporting drug development, the book focuses on updated test methods, interpretation, and science. It covers the core and supplemental batteries of test procedures and how to do them and provides an overview of available facilities and contract organizations for performing studies.
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.
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.
Date de parution : 09-2019
15.6x23.4 cm
Date de parution : 05-2012
Ouvrage de 197 p.
15.6x23.4 cm
Thèmes de Safety Pharmacology in Pharmaceutical Development :
Mots-clés :
Safety Pharmacology; Ich S7A; Safety Pharmacology Studies; Fob; Test Article; Ich S7B; Locomotor Activity; TdP Risk; Safety Pharmacology Evaluations; Ph Ar; Qt Interval Prolongation; 51Cr EDTA; Plasma Concentration; Class Ii MHC; Single Nephron GFR; Qt Prolongation; Non-antiarrhythmic Drugs; Qt Interval; Maximal Expiratory; Test Substance; Total Respiratory System; CNS Safety; Maximal Expiratory Flow Volume Curve; Te Ch; Ventricular Repolarization