Pharmaceutical Toxicology in Practice – A Guide for Non–clinical Development

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.