Preclinical Safety Evaluation of Biopharmaceuticals

Beschreibung

"The goal is to provide a comprehensive reference book for thepreclinicaldiscovery and development scientist whoseresponsibilities span target identification, lead candidateselection, pharmacokinetics, pharmacology, and toxicology, and forregulatory scientists whose responsibilities include the evaluationof novel therapies." --From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictivevalue, lessen the time and cost of launching newbiopharmaceuticals, and speed potentially lifesaving drugs tomarket. This guide covers topics ranging from lead candidateselection to establishing proof of concept and toxicity testing tothe selection of the first human doses. With chapters contributedby experts in their specific areas, Preclinical SafetyEvaluation of Biopharmaceuticals: A Science-Based Approach toFacilitating Clinical Trials: * Includes an overview of biopharmaceuticals with information onregulation and methods of production * Discusses the principles of ICH S6 and their implementation inthe U.S., Europe, and Japan * Covers current practices in preclinical development andincludes a comparison of safety assessments for small moleculeswith those for biopharmaceuticals * Addresses all aspects of the preclinical evaluation process,including: the selection of relevant species; safety/toxicityendpoints; specific considerations based upon class; and practicalconsiderations in the design, implementation, and analysis ofbiopharmaceuticals * Covers transitioning from preclinical development to clinicaltrials This is a hands-on, straightforward reference for professionalsinvolved in preclinical drug development, including scientists,toxicologists, project managers, consultants, and regulatorypersonnel.

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Joy A. Cavagnaro

Themen in »Preclinical Safety Evaluation of Biopharmaceuticals«

Biopharmazie Biotechnologie Chemie Chemistry Drug Discovery & Development Medical Science Medizin Pharmacology & Pharmaceutical Medicine Pharmakologie u. Pharmazeutische Medizin Toxicology Toxikologie Wirkstoffforschung u. -entwicklung

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"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)
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