Early Drug Development, 2 Volume Set: Bringing a Preclinical Candidate to the Clinic

Early Drug Development, 2 Volume Set:Bringing a Preclinical Candidate to the Clinic (Methods & Principles in Medicinal Chemistry) 1st Edition

by: Fabrizio Giordanetto (Editor), Raimund Mannhold (Series Editor), Helmut Buschmann (Series Editor), Jörg Holenz (Series Editor)

Publisher: Wiley-VCH; 1st edition (December 10, 2018)

Language: English

Print Length: 816 pages

ISBN-10: 3527341498

ISBN-13: 9783527341498

Book Description

This one-stop reference systematically covers key aspects in early drug development that are directly relevant to the discovery phase and are required for first-in-human studies.
Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues.
After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order:the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources.
Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials.

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