Login

Cavagnaro, Joy A.

Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials

Cavagnaro, Joy A. - Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials, ebook

184,50€

Ebook, ePUB with Adobe DRM
ISBN: 9781118679388
DRM Restrictions

Printing30 pages with an additional page accrued every day, capped at 30 pages
Copy to clipboard5 excerpts

"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.

Author(s)
Publisher
John Wiley and Sons, Inc.
Publication year
2008
Language
en
Edition
1
Page amount
800 pages
Category
Technology, Energy, Traffic
Format
Ebook
eISBN (ePUB)
9781118679388
Printed ISBN
9780470108840

Similar titles