Development and approval of combination products : a regulatory perspective /

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A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufa.

Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Siegel, Evan B.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken, N.J. : Wiley, ©2008.
Temas:
United States. > Food and Drug Administration.
United States > Food and Drug Administration
United States. > Food and Drug Administration
Drug approval > United States.
Biological products > United States.
Medical instruments and apparatus > United States.
Médicaments > Autorisation de mise sur le marché > États-Unis.
Produits biologiques > États-Unis.
Médecine > Appareils et instruments > États-Unis.
HEALTH & FITNESS > Safety.
Biological products
Drug approval
Medical instruments and apparatus
United States
Acceso en línea:Texto completo
Descripción
Sumario:A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufa.
Descripción Física:1 online resource (xii, 215 pages) : illustrations
Bibliografía:Includes bibliographical references and index.
ISBN:9780470371190
0470371196
9780470371077
0470371072
128138190X
9781281381903
0470050942
9780470050941
9786611381905
6611381902

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