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Více informací o knize Guidebook for Drug Regulatory Submissions

• Parametry knihy
• Anotace
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Anotace knihy

The high-stakes process of submitting drug documents and applications for regulatory review can be intimidating, particularly for the inexperienced regulatory professional charged with preparing a major regulatory submission. This book provides regulatory professionals with the key tools necessary to submit major documents to the United States Food and Drug Administration. The book consists of thirteen chapters, including an introductory and conclusion chapter and 11 units, each consisting of an introductory essay, submission checklist, evaluation checklist giving guidance on FDA criteria, and copies of relevant FDA documents.

Parametry knihy

Zařazení knihy Knihy v angličtině Medicine Other branches of medicine

• Plný název: Guidebook for Drug Regulatory Submissions
• Autor: Sandy Weinberg
• Jazyk: Angličtina
• Vazba: Pevná
• Počet stran: 392
• EAN: 9780470371381
• ISBN: 0470371382
• ID: 04882923
• Nakladatelství: John Wiley & Sons Inc
• Hmotnost: 752 g
• Rozměry: 242 × 165 × 27 mm
• Datum vydání: 03. April 2009

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