Safety sciences of drugs
Mulder, Gerard J; Dencker, Lennart
Edited by Gerard J Mulder - Director of Research and Lennart Dencker - Professor and Chairman of Toxicology; Dean, Faculty of Pharmacy at Uppsala University
Toxicology studies are carried out on all drug substances to ensure safety. This book provides an overview of the methodology and requirements of pre-clinical safety assessments of new medicines. With the focus on medicinal drugs - the most important safety issues of drugs are covered, including registration requirements of new drugs and pharmacovigilance.
After a general introduction and a number of chapters on basic toxicological principles, organ toxicity of drugs is illustrated by chapters on toxicity in the liver, in the kidney, in the respiratory system and in the immune system.
This is an introductory text for students at BSc, MSc and PhD levels,and will be an excellent companion to pharmacology textbooks, combining a broad treatment of the issues relevant for assessing the safety/efficacy balance of a new drug with information on the toxicological knowledge base and methodology.
1. General Toxicology
2. Drug Metabolism: Inactivation and Bioactivation of Xenobioptics
3. Molecular and Cellular Mechanisms of Toxicity
6. Carcinogenicity of Drugs
7. Liver Toxicity
8. Kidney Toxicity
9. Toxicology in the Respiratory System
11. Clinical Toxicology
12. Safety Assessment of Pharmaceuticals: Regulatory Aspects
'...this is a great little book...the text is aimed primarily at new PHD students in the pharmaceutical and related sciences but could equally well serve taught postgraduate students on toxicology, clinical pharmacology, drug development and safety or similar courses. The book 'does exactly what it says on the tin' and will definitely whet the appetite of enthusiastic young researched for toxicology.'
Heather M Wallace, Summer 2007 issue of the British Toxicology Society Newsletter
01-Nov-06, Irish Pharmacy Journal
'The text is well written, concise and easy to understand with informative and helpful illustrations, figures and tables...it serves as an excellent companion to pharmacology textbooks, dealing with the issues relevant for assessing the safety of new drugs...a good starting point for the novice toxicologist, ambitious undergraduate student or graduate students working in the pharmaceutical sciences.'
Irish Pharmacy Journal, November 2006, p418
ISBN 978 0 85369 593 6
Published Jun 2006
234 x 156mm (280pp)