Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and Stability
Author:   Shein-Chung Chow ,  Jen-pei Liu ,  Jen-pei Liu (National Taiwan University, Taipei, Taiwan)
Publisher:   Taylor & Francis Inc
Volume:   v. 143
ISBN:  

9780824793364


Pages:   580
Publication Date:   22 February 1995
Format:   Hardback
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

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Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and Stability


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Full Product Details

Author:   Shein-Chung Chow ,  Jen-pei Liu ,  Jen-pei Liu (National Taiwan University, Taipei, Taiwan)
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Volume:   v. 143
Dimensions:   Width: 15.20cm , Height: 3.10cm , Length: 22.90cm
Weight:   1.230kg
ISBN:  

9780824793364


ISBN 10:   0824793366
Pages:   580
Publication Date:   22 February 1995
Audience:   College/higher education ,  Professional and scholarly ,  Postgraduate, Research & Scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

Table of Contents

Assay development; assay validation; scaleup design and analysis; USP tests and specifications; process validation; quality assurance; stability studies; accelerated testing; design for long-term stability studies; stability analysis with fixed batches; stability analysis with random batches. Appendices: statistical tables; SAS programs; regulations. references.

Reviews

""". . .comprehensive. . ..a useful reference for practitioners as well as a good source for statisticians wishing to understand some of the key issues in these aspects of drug development. "" ---Publication of the International Statistical Institute "". . .Particularly appealing in this book are the extensive explanations of technical concepts, beginning with a fine overview. . .and continuing as concepts such as assay validation, process validation, quality assurance, and stability studies are introduced subsequently. "" ---Technometrics"


. . .comprehensive. . ..a useful reference for practitioners as well as a good source for statisticians wishing to understand some of the key issues in these aspects of drug development. ---Publication of the International Statistical Institute . . .Particularly appealing in this book are the extensive explanations of technical concepts, beginning with a fine overview. . .and continuing as concepts such as assay validation, process validation, quality assurance, and stability studies are introduced subsequently. ---Technometrics


Author Information

Chow, Shein-Chung; Liu, Jen-pei

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