Pharmaceutical Toxicology in Practice: A Guide to Non-clinical DevelopmentISBN: 978-0-470-37137-4
Hardcover
280 pages
February 2011
|
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.