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The increasing role of toxicology in early decision making processes

19 April 2011 | By Eckhard von Keutz, Senior Vice President, Head Global Early Development, Bayer HealthCare

Clinical development costs are rising at an alarming rate. There is a decreasing success rate for new drug candidate approval and the duration of development is increasing. In other words, industry is spending more and getting less from current drug development efforts. In 2010, 21 new drugs were approved in…

Toxicology and Pharmaceutical Industry Advanced Training (PIAT)

19 August 2010 | By Brian Lockwood, Director of PIAT, School of Pharmacy & Pharmaceutical Sciences, University of Manchester

Toxicology is the study of the harmful interactions between chemicals and biological systems. Man, as well as other animals and plants, is increasingly exposed to a huge variety of chemicals. These range from metals to large complex organic molecules, all of which are potentially toxic. A toxicologist must understand pathology,…

Applying systems biology and computer simulations to predicting idiosyncratic DILI

19 August 2010 | By David Cook, Associate Director, Global Safety Assessment, AstraZeneca

Idiosyncratic drug-induced liver injury (DILI) is a rare adverse drug reaction which accounts for a significant amount of patient suffering, including death. Currently, idiosyncratic DILI is unpredictable and as a result arises late in the drug development process or even post-marketing. The prediction of idiosyncratic DILI based on preclinical or…

Neurotoxicity in preclinical studies

3 December 2008 | By

Neurotoxicology is not a discipline that can expect to be popular in pharmaceutical circles. It is a not unreasonable prejudice amongst people working in drug development that even a suggestion that a candidate drug might be neurotoxic is enough to halt development, or at the least to stimulate a highly…

In vitro toxicity screening as pre-selection tool

19 June 2008 | By

Drug discovery relies on massive screening of compound libraries with in vitro cell-based target assays. These pharmacological screens have been well accepted. For in vitro toxicological screening, this privilege has only been obtained for the Ames, chromosomal aberration and eye irritation tests. At the moment, a number of cellular assays…

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