Pharmaceutical toxicology in practice [electronic resource] : a guide for non-clinical development / edited by Alberto Lodola, Jeanne Stadler.
- Hoboken, N.J. : John Wiley & Sons, c2011.
1 online resource (268 p.)
- Drugs -- Toxicity testing.
- Electronic books.
- 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 t
- The regulatory environment / Claudio Bernardi and Marco Brughera
Toxicological development : roles and responsibilities / Franck Chuzel and Bernard Ruty
Contract research organizations / Maurice Cary
Safety pharmacology / Claudio Arrigoni and Valeria Perego
Formulations, impurities and toxicokinetics / Claude Charuel
General toxicology / Alberto Lodola
Genetic toxicology / Peggy Guzzie-Peck, Jennifer Sasaki, and Sandy Weiner
Developmental and reproductive toxicology / Jeanne Stadler
Data analysis, report writing and regulatory documentation / Monique Y. Wells
Risk management / Alberto Lodola.
- Description based upon print version of record.
Includes bibliographical references and index.
- Lodola, Alberto.
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