Early Drug Development
Strategies and Routes to First-in-Human Trials
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Beschreibung
The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.
Autor*in
Mitchell N. Cayen
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Arzneimittelentwicklung Chemie Chemistry Drug Discovery & Development Medical Science Medizin Pharmacology & Pharmaceutical Medicine Pharmakologie u. Pharmazeutische Medizin Pharmazeutische Chemie Toxicology Toxikologie Wirkstoffforschung u. -entwicklung
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"As such, it may serve both as an introduction for newcomers but also as a reference for the more experienced ... The reader will find valuable advice on how to find the best strategy towards entry into the clinic." (ChemMedChem, 2011)
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