Combination Products Regulatory Challenges and Successful Product Development
Fr. 303.00
inkl. gesetzl. MwSt.,
Beschreibung
Produktdetails
Einband
Gebundene Ausgabe
Erscheinungsdatum
01.03.2009
Abbildungen
schwarz-weiss Illustrationen, Tabellen, schwarz-weiss
Verlag
Taylor and FrancisSeitenzahl
264
Maße (L/B/H)
23.9/16.3/2.2 cm
Gewicht
549 g
Sprache
Englisch
ISBN
978-1-4200-6446-9
The field of combination product development is so new that very few publications, including FDA documents, are available. This text provides an overview of the process from start to finish, complete with relevant definitions, and then shows how to establish a design and development plan. It provides an overview of FDA and other regulatory expectations and covers resource requirements, manufacturing, pitfalls, post-launch compliance requirements, and agency audits and challenges. The book presents practical guidelines on how to develop combination products successfully and how to implement these products into the market successfully and in a timely manner.
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