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Statistical design and analysis in pharmaceutical science : validation, process controls, and stability

Author: Shein-Chung Chow; Jen-pei Liu
Publisher: New York : M. Dekker, ©1995.
Series: Statistics, textbooks and monographs, v. 143.
Edition/Format:   Print book : EnglishView all editions and formats
Summary:

Presents statistical designs and methods of analysis for various stages of pharmaceutical development. This book emphasizes biopharmaceutical applications and demonstrates statistical techniques with  Read more...

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Genre/Form: Statistik
Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Shein-Chung Chow; Jen-pei Liu
ISBN: 0824793366 9780824793364
OCLC Number: 31604915
Notes: Evidence in the book indicates that Shein-Chung Chow and Jen-pei Liu are authors, not editors.
Description: viii, 564 pages : illustrations ; 24 cm.
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.
Series Title: Statistics, textbooks and monographs, v. 143.
Responsibility: edited by Shein-Chung Chow, Jen-pei Liu.
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." . .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." Read more...

 
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