Pharmaceutical Toxicology

Covering areas of drug toxicity which address the major issues including registration requirements of new drugs and pharmacovigilance, this book provides an overview of the methodology and requirements of pre-clinical safety assessment of new medicines. It discusses mechanisms by which drugs cause toxic effects in living organisms. 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 the BSc, MSc and PhD level, 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. Gerard J Mulder is Director of Research, Leiden Amsterdam Center for Drug Research, Leiden University, The Netherlands. Lennart Dencker is Professor and Chairman of Toxicology and Dean of the Faculty of Pharmacy, Uppsala University, Sweden. The "ULLA" series is a new and innovative series of introductory textbooks for postgraduate students in the pharmaceutical sciences. This new series is produced by the ULLA Consortium (European University Consortium for Advanced Pharmaceutical Education and Research). The Consortium is a European academic collaboration in research and teaching of the pharmaceutical sciences that is constantly growing and expanding. Before a drug substance can be tested in man, a set of toxicology studies must be carried out in animals and in vitro to ensure, as far as possible, safety for the test subjects. Toxicity studies involve assessment of acute, repeated dose and chronic toxicities, evaluation of potential effects on vital organs, reproductive and developmental toxicity studies, and carcinogenicity studies. This book covers a limited number of areas of drug toxicity which address the major issues including registration requirements of new drugs and pharmacovigilance. It also provides an overview of the methodology and requirements of pre-clinical safety assessment of new medicines. Mechanisms by which drugs cause toxic effects in living organisms, and problems in the toxicity of specific agents are covered, as are regulatory issues, pharmacovigilence, and clinical toxicology. There is no other textbook at this level dedicated to pharmaceutical toxicology, and this new title in the "ULLA" series fills a definite gap in the market.