Early Drug Development (eBook)

Strategies and Routes to First-in-Human Trials

Mitchell N. Cayen (Herausgeber)

eBook Download: PDF | EPUB

2010 | 1. Auflage
654 Seiten
John Wiley & Sons (Verlag)
978-0-470-61317-7 (ISBN)

Infos

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

MITCHELL N. CAYEN, PhD, is Principal of Cayen Pharmaceutical Consulting, LLC, a firm that advises pharmaceutical companies in nonclinical and clinical drug develop-ment, with specific focus on candidate drug selection, discovery, drug metabolism and pharmacokinetics, drug development strategies, and regulatory submissions. Previously, he was senior director of drug metabolism and pharmacokinetics at Schering-Plough Research Institute.

Rezensionen

"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)

Produkt-Details

• Erscheint lt. Verlag: 25.2.2011
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie ► Gesundheitsfachberufe
• Themenwelt: Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
• Themenwelt: Naturwissenschaften ► Chemie
• Schlagworte: Arzneimittelentwicklung • Chemie • Chemistry • Drug Discovery & Development • Medical Science • Medizin • Pharmacology & Pharmaceutical Medicine • Pharmakologie u. Pharmazeutische Medizin • Pharmazeutische Chemie • Toxicology • Toxikologie • Wirkstoffforschung u. -entwicklung
• ISBN-10: 0-470-61317-3 / 0470613173
• ISBN-13: 978-0-470-61317-7 / 9780470613177