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  • 1
    Online Resource
    Online Resource
    Weinheim, Germany :Wiley-VCH Verlag GmbH & Co.,
    UID:
    almafu_9959327024302883
    Format: 1 online resource
    ISBN: 9783527801756 , 3527801758 , 9783527801763 , 3527801766
    Series Statement: Methods and principles in medicinal chemistry ; v. 73
    Content: 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.
    Language: English
    Keywords: Electronic books. ; Electronic books. ; Electronic books.
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