Description
Book SynopsisThis book describes, with references to key source materials,the background to, and conduct of, the principal nonclinical studiesthat 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 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, andrisk management.Further, the book covers the methods of genetic toxicology (assays, genomics, in vivo screening) as a complement to traditional
Trade Review"So, overall, this is a wonderful book for all those who want to learn more about pharmaceutical toxicology and for those who start working in the field." (The British Toxicology Society, 1 May 2011)
"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". (Quote.com, 19 January 2011)
Table of ContentsCONTRIBUTORS. Chapter 1: Introduction (Alberto Lodola and Jeanne Stadler).
Chapter 2: The Regulatory Environment (Claudio Bernardi and Marco Brughera).
Chapter 3: Toxicological development: Roles and Responsibilities (Franck Chuzel and Bernard Ruty).
Chapter 4: Contract Research Organizations (Maurice Cary).
Chapter 5: Safety Pharmacology (Claudio Arrigoni and Valeria Perego).
Chapter 6: Formulations, Impurities and Toxicokinetics (Claude Charuel).
Chapter 7: General Toxicology (Alberto Lodola).
Chapter 8: Genetic Toxicology (Peggy Guzzie-Peck, Jennifer Sasaki and Sandy Weiner).
Chapter 9: Developmental and reproductive toxicology (Jeanne Stadler).
Chapter 10: Data analysis, report writing and regulatory documentation (Monique Y. Wells).
Chapter 11: Risk Management (Alberto Lodola).
INDEX.
