Drug Safety Evaluation presents an all-inclusive, practical guidefor those who are responsible for ensuring the safety of drugs andbiologics for patients, for health care providers, for thoseinvolved in the manufacture of medicinal products, and for allthose who need to understand how the safety of these products isevaluated.
Individual chapters address specific approaches to evaluatinghazards, including problems that are encountered and theirsolutions. Author Shayne Gad draws upon over twenty years ofexperience in toxicology, drug development, and risk assessment,explaining the scientific and philosophical bases for evaluatingspecific concerns (carcinogenicity, development toxicity, etc.) toprovide both understanding and guidance for approaching newproblems. Containing information specifically relevant to thepharmaceutical and biotechnology industries, Drug Safety Evaluationcovers a wide variety of topics, including:
* Acute toxicity testing in pharmaceutical safety evaluation
* Genotoxicity
* Safety assessment of inhalant drugs
* Immunotoxicology in pharmaceutical development
* Large animal studies
* Evaluation of human tolerance and safety in clinicaltrials
Drug Safety Evaluation provides a road map for safety assessment asan integral part of the development of new drugs and therapeutics.
Shayne Cox Gad
Arzneimittel Arzneimittelnebenwirkung Chemie Chemistry Drug Discovery & Development Medical Science Medizin Pharmacology & Pharmaceutical Medicine Pharmakologie Pharmakologie u. Pharmazeutische Medizin Wirkstoffforschung u. -entwicklung
"For toxicologic pathologists, this book is the most useful as areference book in a departmental library." (VeterinaryPathology, November 2004)
"Gad brings...25 years of experience...to this practicalguide..." (SciTech Book News, Vol. 26, No. 2, June 2002)
"...offers an accumulation of facts and knowledge of a highlyspecialized and intense industry from an individual who has beensuccessful in innovations and quality assurance...." (Veterinaryand Human Toxicology, Vol. 45, No. 1, February 2003)
"...it is a substantial book and accordingly should beconsidered a definitive reference work in this branch oftoxicology." (Journal of Applied Toxicology, March-April2003)
"...a definitive guide for those in the pharmaceutical industrywho need to know how their products are evaluated and approved."(Business Horizons, January-February 2003)
"This book provides excellent treatise on drug safetyevaluation...an excellent guide and reference..."(Pharmaceutical Research, Vol. 20, No. 6, June 2003)
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