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Statistical Design and Analysis of Stability Studies
ISBN-13:
9781584889069
Veröffentl:
2007
Einband:
PDF
Seiten:
349
Autor:
Shein-Chung Chow
Serie:
Chapman & Hall/CRC Biostatistics Series
eBook Typ:
PDF
eBook Format:
PDF
Kopierschutz:
Adobe DRM [Hard-DRM]
Sprache:
Englisch
Beschreibung:
The US Food and Drug Administration''s Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how sta
The US Food and Drug Administration''s Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how sta