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

This book gives you the details you need to effectively design, implement, and evaluate the results of preclinical toxicology studies of biopharmaceuticals. It also covers the practices of preclinical safety evaluation, including animal testing and toxicity screening, for biotechnology drugs and addresses regulations in the U.S.

"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 productionDiscusses the principles of ICH S6 and their implementation in the U.S., Europe, and JapanCovers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticalsAddresses 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 biopharmaceuticalsCovers 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.