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Preclinical Safety Evaluation of Biopharmaceuticals

A Science-Based Approach to Facilitating Clinical Trials

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Éditeur :

Wiley-Interscience


Paru le : 2013-03-07



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Description
"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.
Pages
1072 pages
Collection
n.c
Parution
2013-03-07
Marque
Wiley-Interscience
EAN papier
9780470108840
EAN PDF
9780470292532
Informations sur l'ebook
Nombre pages copiables
0
Nombre pages imprimables
1072
Taille du fichier
7690 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
210,95 €
EAN EPUB
9781118679388
Informations sur l'ebook
Nombre pages copiables
0
Nombre pages imprimables
1072
Taille du fichier
10455 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
210,95 €

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