This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development. The chapters provide an understanding of the key components of the preclinical phase of drug development with a hands-on description, with core chapters addressing study conduct, types, and reporting. As such, it is a practical guide through toxicology testing and an up-to-date reference on current issues, new developments, and future directions in toxicology. Opening with a practical description of toxicology and its role in the development of pharmaceuticals, the book proceeds to detail international regulations (including the impact of the new REACH standards for chemical safety), interdisciplinary interactions among scientists in drug development, steps in toxicity testing, and risk management. Further, the book covers the methods of genetic toxicology (assays, genomics, in vivo screening) as a complement to "traditional" toxicology in the risk assessment and risk management of pharmaceuticals.
A practical guide and up-to-datereference to toxicology testing
Toxicology is not only an integral part of the identification of drug candidates, structural optimization, and lead candidate selection, but it is a cornerstone of managing attrition in the drug discovery process. This book describes the background to, and conduct of, the principal non-clinical studies that are central to drug development.
Written by two highly experienced toxicologists, Pharmaceutical Toxicology in Practice: A Guide to Non-Clinical Development provides an understanding of the key components of the non-clinical phase of drug development. Taking a hands-on approach, the book's core chapters address conduct, types, and reporting. Opening with a practical description of toxicology and its role in the development of pharmaceuticals, the book details:
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International regulations, including the impact of the new REACH standards for chemical safety
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Interdisciplinary interactions among scientists in drug development
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Steps in toxicity testing and risk management
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Methods of genetic toxicology—assays, genomics, and in vivo screening as a complement to traditional toxicology
By exploring the roles and responsibilities of the interdisciplinary members of a drug development team, Pharmaceutical Toxicology in Practice will help the drug development scientist to understand the toxicological profile of the test compound; the drug discovery scientist to refine the chemical motif of the test compound to optimize efficacy and reduce side effects; and the drug development team to advance the test compound to the clinic and then to the marketplace and the patient.
