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.

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.