Statistical Design and Analysis of Stability Studies - Couverture rigide

Livre 13 sur 151: Chapman & Hall/CRC Biostatistics

Chow, Shein-Chung

 
9781584889052: Statistical Design and Analysis of Stability Studies
Couverture rigide
ISBN 10 : 1584889055 ISBN 13 : 9781584889052
Editeur : Chapman & Hall/CRC, 2007

Synopsis

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 stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies.

After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies.

To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

À propos de l?auteur

Shein-Chung Chow

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
Chapman & Hall/CRC
Date d'édition
2007
Langue
anglais
ISBN 10 
1584889055
ISBN 13 
9781584889052
Reliure
Relié
Numéro d'édition
1
Nombre de pages
331
Coordonnées du fabricant
non disponible
Personne responsable
non disponible

Autres éditions populaires du même titre

9780367577681: Statistical Design and Analysis of Stability Studies

Edition présentée

ISBN 10 :  0367577682 ISBN 13 :  9780367577681
Editeur : Routledge, 2020
Couverture souple