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Cayen, Mitchell N.

Early Drug Development: Strategies and Routes to First-in-Human Trials

Cayen, Mitchell N. - Early Drug Development: Strategies and Routes to First-in-Human Trials, e-bok

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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.

Nyckelord: successful; intensive; drug; highly; odds; effort; candidate; resource; process; selection; high; clinical; demands; cost; nonclinical; rate; attrition; critical; stages; guides; role; entity; chemical; book; continuum; new; disciplines, Pharmacology & Pharmaceutical Medicine, Toxicology, Pharmacology & Pharmaceutical Medicine, Toxicology

Utgivare
Utgivare
John Wiley and Sons, Inc.
Utgivningsår
2010
Språk
en
Utgåva
1
Sidantal
624 sidor
Kategori
Hälsa, skönhet, mode
Format
E-bok
eISBN (ePUB)
9781118035207
Tryckt ISBN
9780470170861

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