Combination products regulatory challenges and successful product developement için kapak resmi
Başlık:
Combination products regulatory challenges and successful product developement
Yazar:
Gopalaswamy, Smita.
ISBN:
9781420064513
Yayın Bilgileri:
Boca Raton, Fla. : Taylor & Francis, 2008.
Fiziksel Tanımlama:
xvi, 241 p. : ill.
İçerik:
Overview and definitions of combination products -- Ensuring successful development -- Overview of FDA and other regulatory agency expectations -- Resource requirements -- Manufacturing of combination products -- Challenges and pitfalls to avoid with combination products -- Post launch compliance requirements -- Agency audits and challenges.
Tüzel Kişi Konu Girişi:
United States. Food and Drug Administration.
Konu Terimleri:
Drugs -- Standards -- United States.

Medical instruments and apparatus -- Standards -- United States.

Biological products -- Standards -- United States.
Yazar Ek Girişi:
Gopalaswamy, Venky.
Elektronik Erişim:
Distributed by publisher. Purchase or institutional license may be required for access.
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