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The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The FDA reviews the IND application for safety to assure that research subjects will not be subjected to unreasonable risk. If the application is approved, the candidate drug usually enters a Phase 1 clinical trial.

Klappentext

The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The FDA reviews the IND application for safety to assure that research subjects will not be subjected to unreasonable risk. If the application is approved, the candidate drug usually enters a Phase 1 clinical trial.

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Weitere Informationen

Allgemeine Informationen
- GTIN 09786130238131
- Editor Frederic P. Miller, Agnes F. Vandome, John McBrewster
- Sprache Englisch
- Genre Psychologie
- Größe H220mm x B150mm x T4mm
- Jahr 2009
- EAN 9786130238131
- Format Fachbuch
- ISBN 978-613-0-23813-1
- Titel Investigational New Drug
- Untertitel Food and Drug Administration (United States), Pharmaceutical industry, Commerce Clause, Clinical trial, New Drug Application, Expanded access, FDA Fast Track Development Program
- Gewicht 118g
- Herausgeber Alphascript Publishing
- Anzahl Seiten 68

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