Lodola / Stadler Pharmaceutical Toxicology in Practice

A Guide to Non-clinical Development
1. Auflage 2011
ISBN: 978-0-470-92272-9
Verlag: John Wiley & Sons
Format: EPUB
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 304 Seiten, E-Book

This book describes, with references to key sourcematerials, the background to, and conduct of, the principalnonclinical studies that are central to drug development. Thechapters provide an understanding of the key components of thepreclinical 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 anup-to-date reference on current issues, new developments, andfuture directions in toxicology. Opening with a practicaldescription of toxicology and its role in the development ofpharmaceuticals, the book proceeds to detail internationalregulations (including the impact of the new REACH standards forchemical safety), interdisciplinary interactions amongscientists in drug development, steps in toxicity testing,and risk management. Further, the book covers the methodsof genetic toxicology (assays, genomics, in vivo screening) as acomplement to "traditional" toxicology in the riskassessment and risk management of pharmaceuticals.

Autoren/Hrsg.

Lodola, Alberto

Stadler, Jeanne

Inhaltsverzeichnis

CONTRIBUTORS.
Chapter 1: Introduction (Alberto Lodola and JeanneStadler).
Chapter 2: The Regulatory Environment (Claudio Bernardi andMarco Brughera).
Chapter 3: Toxicological development: Roles and Responsibilities(Franck Chuzel and Bernard Ruty).
Chapter 4: Contract Research Organizations (MauriceCary).
Chapter 5: Safety Pharmacology (Claudio Arrigoni and ValeriaPerego).
Chapter 6: Formulations, Impurities and Toxicokinetics(Claude Charuel).
Chapter 7: General Toxicology (Alberto Lodola).
Chapter 8: Genetic Toxicology (Peggy Guzzie-Peck, JenniferSasaki and Sandy Weiner).
Chapter 9: Developmental and reproductive toxicology (JeanneStadler).
Chapter 10: Data analysis, report writing and regulatorydocumentation (Monique Y. Wells).
Chapter 11: Risk Management (Alberto Lodola).
INDEX.

Über Autor(innen)

ALBERTO LODOLA is a consulting toxicologist at ToxAdvantage.Prior to this, he spent twenty years at Pfizer, where he became thesenior director and head of the toxicology department for theAmboise, France, laboratory. Dr. Lodola has published over fortypeer-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 thelevel of scientific advisor and director. She is the coeditor ofone book and the author of forty peer-reviewed papers. Dr. Stadlercontinues to be a regular speaker and training session leader atprofessional meetings and at universities.