Pharmaceutical Toxicology in Practice (PDF)
A Guide to Non-clinical Development
(Sprache: Englisch)
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...
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...
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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.
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.
Inhaltsverzeichnis zu „Pharmaceutical Toxicology in Practice (PDF)“
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.
Autoren-Porträt
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.
Bibliographische Angaben
- 2011, 1. Auflage, 280 Seiten, Englisch
- Herausgegeben: Alberto Lodola, Jeanne Stadler
- Verlag: John Wiley & Sons
- ISBN-10: 0470909900
- ISBN-13: 9780470909904
- Erscheinungsdatum: 10.03.2011
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