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 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, and risk management. Further, the book covers the methods of genetic toxicology (assays, genomics, in vivo screening) as a complement to "traditional" toxicology in the risk assessment and risk management of pharmaceuticals.
ALBERTO LODOLA is a consulting toxicologist at ToxAdvantage. Prior to this, he spent twenty years at Pfizer, where he became the senior director and head of the toxicology department for the Amboise, France, laboratory. Dr. Lodola has published over forty peer-reviewed papers since 1974. JEANNE STADLER is an independent consulting toxicologist, following a thirty-four year career at Pfizer R&D, in Amboise, France, coming from the toxicology department and rising to the level of scientific advisor and director. She is the coeditor of one book and the author of forty peer-reviewed papers. Dr. Stadler continues to be a regular speaker and training session leader at professional meetings and at universities.
CONTRIBUTORS. 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.