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Pharmaceutical Book from C.H.I.P.S.

Pharmaceutical Toxicology in Practice
A Guide to Non-Clinical Development
edited by Alberto Lodola

Pharmaceutical Toxicology: A Guide to Non-Clinical Development describes the background to, and conduct of, the principal nonclinical studies that are central to drug development.

The book 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. It also 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.

Contents

  1. Introduction
  2. The Regulatory Environment
  3. Toxicological development: Roles and Responsibilities
  4. Contract Research Organizations
  5. Safety Pharmacology
  6. Formulations, Impurities and Toxicokinetics
  7. General Toxicology
  8. Genetic Toxicology
  9. Developmental and reproductive toxicology
  10. Data analysis, report writing and regulatory documentation
  11. Risk Management

Index

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Pharmaceutical Toxicology in Practice
A Guide to Non-Clinical Development
edited by Alberto Lodola

2011 • 258 pages • $98.95 + shipping
Texas residents please add 6.75 % sales tax

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