Pharmaceutical Toxicology in Practice: A Guide to Non–clinical Development

A practical guide and up–to–datereference to toxicology testing
Toxicology is not only an integral part of the identification of drug candidates, structural optimization, and lead candidate selection, but it is a cornerstone of managing attrition in the drug discovery process. This book describes the background to, and conduct of, the principal non–clinical studies that are central to drug development.
Written by two highly experienced toxicologists, Pharmaceutical Toxicology in Practice: A Guide to Non–Clinical Development provides an understanding of the key components of the non–clinical phase of drug development. Taking a hands–on approach, the book′s core chapters address conduct, types, and reporting. Opening with a practical description of toxicology and its role in the development of pharmaceuticals, the book details:
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
Methods of genetic toxicology—assays, genomics, and in vivo screening as a complement to traditional toxicology
By exploring the roles and responsibilities of the interdisciplinary members of a drug development team, Pharmaceutical Toxicology in Practice will help the drug development scientist to understand the toxicological profile of the test compound; the drug discovery scientist to refine the chemical motif of the test compound to optimize efficacy and reduce side effects; and the drug development team to advance the test compound to the clinic and then to the marketplace and the patient.

Spis treści:
Chapter 1: Introduction (Alberto Lodola and Jeanne Stadler).
Chapter 2: The Regulatory Environment (Claudio Bernardi and Marco Brughera).
Chapter 3: Toxicological development: Ro les 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).

Nota biograficzna:

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.

Okładka tylna:

A practical guide and up–to–datereference to toxicology testing
Toxicology is not only an integral part of the identification of drug candidates, structural optimization, and lead candidate selection, but it is a cornerstone of managing attrition in the drug discovery process. This book describes the background to, and conduct of, the principal non–clinical studies that are central to drug development.
Written by two highly experienced toxicologists, Phar maceutical Toxicology in Practice: A Guide to Non–Clinical Development provides an understanding of the key components of the non–clinical phase of drug development. Taking a hands–on approach, the book′s core chapters address conduct, types, and reporting. Opening with a practical description of toxicology and its role in the development of pharmaceuticals, the book details:
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
Methods of genetic toxicology—assays, genomics, and in vivo screening as a complement to traditional toxicology
By exploring the roles and responsibilities of the interdisciplinary members of a drug development team, Pharmaceutical Toxicology in Practice will help the drug development scientist to understand the toxicological profile of the test compound; the drug discovery scientist to refine the chemical motif of the test compound to optimize efficacy and reduce side effects; and the drug development team to advance the test compound to the clinic and then to the marketplace and the patient.