Pharmaceutical toxicology in practice : a guide for non-clinical development /

Pharmaceutical toxicology in practice : a guide for non-clinical development /

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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 descripti...

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Bibliographic Details
Other Authors: Lodola, Alberto, Stadler, Jeanne
Format: eBook
Language:English
Published: Hoboken, N.J. : Wiley, [2011]
Series:Wiley online library.
Subjects:
Drug Evaluation, Preclinical > standards.
Drug-Related Side Effects and Adverse Reactions.
Toxicity Tests > standards.
Drugs > Toxicity testing.
Drug Toxicity.
Health.
Medicine.
Pharmacy.
Social Science.
Electronic books.
Online Access:Connect to the full text of this electronic book
Table of Contents:
  • Frontmatter
  • Introduction / Alberto Lodola, Jeanne Stadler
  • The Regulatory Environment / Claudio Bernardi, Marco Brughera
  • Toxicological Development: Roles and Responsibilities / Franck Chuzel, Bernard Ruty
  • Contract Research Organizations / Maurice Cary
  • Safety Pharmacology / Claudio Arrigoni, Valeria Perego
  • Formulations, Impurities, and Toxicokinetics / Claude Charuel
  • General Toxicology / Alberto Lodola
  • Genetic Toxicology / Peggy Guzzie-Peck, Jennifer C Sasaki, Sandy K Weiner
  • Developmental and Reproductive Toxicology / Jeanne Stadler
  • Data Analysis, Report Writing, and Regulatory Documentation / Monique Y Wells
  • Risk Management / Alberto Lodola
  • Index.