Author: Shein-Chung Chow
Edition: 1
Publisher: Chapman and Hall/CRC
Binding: Hardcover
ISBN: 1584889055
Statistical Design and Analysis of Stability Studies (Chapman & Hall/CRC Biostatistics Series)
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. Medical books Statistical Design and Analysis of Stability Studies . 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 Medical books Statistical Design And Analysis Of Stability Studies By Shein-chung Chow Har. Store Search search Title, ISBN and Author Statistical Design and Analysis of Stability Studies by Shein-Chung Chow Estimated delivery 3-12 business days Format Hardcover Condition Brand New The US Food and Drug Administration #039;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
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Store Search search Title, ISBN and Author Statistical Design and Analysis of Stability Studies by Shein-Chung Chow Estimated delivery 3-12 business days Format Hardcover Condition Brand New The US Food and Drug Administration #039;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
Statistical Design and Analysis of Stability Studies , ISBN-13: 9781584889052, ISBN-10: 1584889055
author shein chung chow format hardback language english publication year 18 05 2007 series chapman hall crc biostatistics series subject engineering technology subject 2 industrial chemistry manufacturing title statistical design and analysis of stability studies author chow shein chung author publisher chapman hall publication date may 01 2007 pages 330 binding hardcover edition 1 st dimensions 6 50 wx 9 50 hx 1 00 d isbn 1584889055 subject medical pharmacology description for those in pharm
Pharma Book Syndicate. Paper Back . New. Size-23x15.5cm Contents: Preface About the author Series Introduction Introduction Accelerated Testing Expiration Dating Period Stability Designs Stability Analysis with fixed batches Stability analysis with random batches Stability analysis with a mixed effects model Stability analysis with discrete responses Stability analysis with multiple components Stability analysis with frozen drug products Stability testing for dissolution Current issues and recent developments Appendix A-Guidance for industry Appendix B- SAS Macro files for stab system for stab
Medical Book Statistical Design and Analysis of Stability Studies
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.
