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Early Drug Development: Bringing a Preclinical Candidate to the Clinic, 2 Volume Set by Editor: Fabrizio Giordanetto, Series Editor: Raimund Mannhold, Series Editor: Helmut Buschmann (Aachen, Germany), Series Editor: Jörg Holenz (Laboratorios Dr. Esteve, Barcelona, Spain)

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

by Editor: Fabrizio Giordanetto , Series Editor: Raimund Mannhold , Series Editor: Helmut Buschmann (Aachen, Germany), Series Editor: Jörg Holenz (Laboratorios Dr. Esteve, Barcelona, Spain)
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Hardcover: Hardcover
  • ISBN13: 9783527341498
  • Binding: Hardcover
  • Subject: N/A
  • Publisher: Wiley
  • Publisher Imprint: Wiley-VCH
  • Publication Date:
  • Pages: 816
  • Original Price: USD 362.95
  • Language: English
  • Edition: N/A
  • Item Weight: 1860 grams
  • BISAC Subject(s): Biotechnology

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.

Fabrizio Giordanetto graduated in Medicinal Chemistry (Genoa, Italy) followed by his Ph.D. (London, UK) while working for the chemistry unit of Pharmacia - Pfizer (Italy). After positions at AstraZeneca (Sweden) as Principal Scientist and Project Leader and at Taros (Germany) as Head of Medicinal Chemistry, he has recently joined DE Shaw Research LLC (New York, USA) where he leads medicinal chemistry activities and drug discovery projects. During his career, he worked on several drug discovery programs resulting in multiple clinical candidates spanning oncology, CNS, inflammation, metabolic and cardiovascular indications and >100 international patents, peer-reviewed publications and book chapters.

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