Preclinical Safety Evaluation of Biopharmaceuticals (PDF)

"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.