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

• Άλλοι συγγραφείς: Lodola, Alberto, Stadler, Jeanne
• Μορφή: Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Hoboken, N.J. : Wiley, [2011]
• Θέματα: Drugs > Toxicity testing.; Drug Evaluation, Preclinical > standards.; Drug Toxicity.; Toxicity Tests > standards.; Health.; Pharmacy.; Social Science.; Medicine.; MEDICAL > Pharmacology.; 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. 

 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.