Author:
Edition: 1
Publisher: Wiley-Interscience
Binding: Kindle Edition
ISBN: B00BRY86TA
Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials
"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. Medical books Preclinical Safety Evaluation of Biopharmaceuticals.
—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 Medical books Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based. Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials by Cavagnaro, Joy A. [Hardcover]
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Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials by Cavagnaro, Joy A. [Hardcover]Buy Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials by Joy A. Cavagnaro and Read this Book on Kobo's Free Apps. Discover Kobo's Vast Collection of Ebooks Today - Over 3 Million Titles, Including 2 Million Free Ones!
format hardback language english publication year 22 08 2008 subject engineering technology subject 2 industrial chemistry manufacturing title preclinical safety evaluation of biopharmaceuticals a science based approach to facilitating clinical trials author cavagnaro joy a editor publisher wiley interscience publication date jul 28 2008 pages 1072 binding hardcover edition 1 st dimensions 6 25 wx 9 50 hx 2 00 d isbn 0470108843 subject science chemistry industrial technical description the goaPreclinical Safety Evaluation of Biopharmaceuticals, ISBN-13: 9780470108840, ISBN-10: 0470108843Medical Book Preclinical Safety Evaluation of Biopharmaceuticals
—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
