Preclinical Safety Evaluation of Biopharmaceuticals (eBook)

A Science-Based Approach to Facilitating Clinical Trials

Joy A. Cavagnaro (Herausgeber)

eBook Download: EPUB

2013 | 1. Auflage
1064 Seiten
John Wiley & Sons (Verlag)
978-1-118-67938-8 (ISBN)

Infos

"The goal is to provide a comprehensive reference book for the
preclinicaldiscovery and development scientist whose
responsibilities span target identification, lead candidate
selection, pharmacokinetics, pharmacology, and toxicology, and for
regulatory scientists whose responsibilities include the evaluation
of novel therapies."

--From the Afterword by Anthony D. Dayan

Proper preclinical safety evaluation can improve the predictive
value, lessen the time and cost of launching new
biopharmaceuticals, and speed potentially lifesaving drugs to
market. This guide covers topics ranging from lead candidate
selection to establishing proof of concept and toxicity testing to
the selection of the first human doses. With chapters contributed
by experts in their specific areas, Preclinical Safety
Evaluation of Biopharmaceuticals: A Science-Based Approach to
Facilitating Clinical Trials:

* Includes an overview of biopharmaceuticals with information on
regulation and methods of production

* Discusses the principles of ICH S6 and their implementation in
the U.S., Europe, and Japan

* Covers current practices in preclinical development and
includes a comparison of safety assessments for small molecules
with those for biopharmaceuticals

* Addresses all aspects of the preclinical evaluation process,
including: the selection of relevant species; safety/toxicity
endpoints; specific considerations based upon class; and practical
considerations in the design, implementation, and analysis of
biopharmaceuticals

* Covers transitioning from preclinical development to clinical
trials

This is a hands-on, straightforward reference for professionals
involved in preclinical drug development, including scientists,
toxicologists, project managers, consultants, and regulatory
personnel.

Autor

Joy A. Cavagnaro, PhD, is the President of Access BIO, a consultancy specializing in science-based regulatory strategies and product development services. She has over twenty-five years of experience in biotech spanning academia, the CRO and biotech industries, and government. During her tenure at the FDA, Dr. Cavagnaro served as rapporteur for ICH S6. She is founder and past chair of the BIO Preclinical Safety Expert Group (BioSafe) and was the U.S. BIO Representative to the 2006 ABPI/BIA Early Stage Clinical Trials Taskforce.Dr. Cavagnaro is currently North American Chair of the Drug Information Association-Biotech SIAC and Chair of the Clinical and Regulatory Affairs Committee of the American Society of Gene Therapy. She serves on a number of scientific advisory boards and lectures internationally in the area of preclinical development of novel therapies.

Rezensionen

"For scientists who are intimately involved with biopharmaceutical development, a copy of the book for their personal library is mandatory. Those who may not be intimately involved in biopharmaceutical development but may have an interest in the progress of a biotherapeutic agent will find this book a valuable resource and a reminder for the need of evaluating the safety of biotherapeutics by looking at each biopharmaceutical on a case-by-case approach." (International Journal of Toxicology, March/April 2009)

Produkt-Details

• Erscheint lt. Verlag: 7.3.2013
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
• Themenwelt: Naturwissenschaften ► Chemie
• Themenwelt: Technik
• Schlagworte: Biopharmazie • Biotechnologie • Chemie • Chemistry • Drug Discovery & Development • Medical Science • Medizin • Pharmacology & Pharmaceutical Medicine • Pharmakologie u. Pharmazeutische Medizin • Toxicology • Toxikologie • Wirkstoffforschung u. -entwicklung
• ISBN-10: 1-118-67938-5 / 1118679385
• ISBN-13: 978-1-118-67938-8 / 9781118679388