Pharmaceutical Toxicology in Practice: A Guide to Non-clinical Development
Author(s): Alberto Lodola (Editor), Jeanne Stadler
Publisher: Wiley
Publication Date: February 2, 2011
Edition: 1st
Language: English
Print length: 280 pages
ISBN-10: 9780470371374
ISBN-13: 9780470371374
Book Description
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.
Editorial Reviews
Review
“So, overall, this is a wonderful book for all those who want to learn more about pharmaceutical toxicology and for those who start working in the field.” (The British Toxicology Society, 1 May 2011)
“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”. (Quote.com, 19 January 2011)
From the Inside Flap
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:
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
Methods of genetic toxicologyassays, 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.
From the Back Cover
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:
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
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.
About the Author
ALBERTO LODOLA is a consulting toxicologist at ToxAdvantage. Prior to this, he spent twenty years at Pfizer, where he became the senior director and head of the toxicology department for the Amboise, France, laboratory. Dr. Lodola has published over forty peer-reviewed papers since 1974.
JEANNE STADLER is an independent consulting toxicologist, following a thirty-four year career at Pfizer R&D, in Amboise, France, coming from the toxicology department and rising to the level of scientific advisor and director. She is the coeditor of one book and the author of forty peer-reviewed papers. Dr. Stadler continues to be a regular speaker and training session leader at professional meetings and at universities.
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