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. Introduction / Alberto Lodola and Jeanne Stadler.
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 C. Sasaki, and Sandy K. Weiner.
Developmental and reproductive toxicology / Jeanne Stadler.
Data analysis, report writing, and regulatory documentation / Monique Y. Wells.
Risk management / Alberto Lodola. 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.