LEADER 00000cam  2200445Mi 4500 
001    1047532528 
003    OCoLC 
005    20200920045018.5 
006    m     o  d         
007    cr cnu|||||||| 
008    180406t19951995nyua    ob    001 0 eng d 
020    9781482273137|q(e-book) 
020    1482273136 
020    |z9780824793364 
035    (OCoLC)1047532528 
035    Taylor & Francis All eBooks 
035    skip4alma 
040    EZ9|beng|erda|epn|cEZ9|dOCLCO|dOCLCF|dOCLCQ|dAU@ 
049    txum 
050  4 RS122.2|b.S738 1995eb 
245 00 Statistical design and analysis in pharmaceutical science 
       :|bvalidation, process controls, and stability /|cedited 
       by Shein-Chung Chow, Jen-pei Liu. 
264  1 New York, New York ;|aBasel [Switzerland] :|bMarcel Dekker,
       Inc.,|c1995. 
264  4 |c©1995 
300    1 online resource (581 pages) :|billustrations. 
336    text|btxt|2rdacontent 
337    computer|bc|2rdamedia 
338    online resource|bcr|2rdacarrier 
490 1  Statistics: Textbooks and Monographs ;|vVolume 143 
504    Includes bibliographical references and index. 
505 0  Cover -- Half Title -- Title Page -- Copyright Page -- 
       Table of Contents -- Preface -- 1: Introduction -- 1.1 
       Background -- 1.2 Regulatory Requirements -- 1.3 
       Pharmaceutical Validation -- 1.4 Quality Assurance -- 1.5 
       Stability Study -- 1.6 Aims and Structure of the Book -- 2
       : Assay Development -- 2.1 Introduction -- 2.2 Calibration
       and Standard Curve -- 2.3 Simple Linear Regression -- 2.4 
       Statistical Methods for Calibration -- 2.5 Weight and 
       Model Selections -- 2.6 Statistical Considerations -- 3: 
       Assay Validation -- 3.1 Introduction -- 3.2 Validation 
       Parameters -- 3.3 Assay Accuracy -- 3.4 Assay Precision --
       3.5 Assay Ruggedness -- 3.6 Statistical Designs -- 3.7 
       Statistical Considerations -- 4: Scaleup Design and 
       Analysis -- 4.1 Introduction -- 4.2 Experimental Designs -
       - 4.3 Scaleup Program and Designs -- 4.4 Scaleup Analysis 
       -- 4.5 Discussion -- 5: USP Tests and Specifications -- 
       5.1 Introduction -- 5.2 Sampling Plan and Acceptance 
       Criteria -- 5.3 Probability of Passing USP Test -- 5.4 
       Acceptance Limits -- 5.5 In-house Specifications -- 5.6 
       Discussion -- 6: Process Validation -- 6.1 Introduction --
       6.2 Process Control and Validation -- 6.3 Basic 
       Considerations -- 6.4 Sampling and Testing Plans -- 6.5 
       Acceptance Limits for Process Validation -- 6.6 Discussion
       -- 7: Quality Assurance -- 7.1 Introduction -- 7.2 Raw 
       Materials Inspection -- 7.3 In-process Controls -- 7.4 
       Release Targets -- 7.5 Examples -- 7.6 Discussion -- 8: 
       Stability Studies -- 8.1 Introduction -- 8.2 Regulatory 
       Requirements -- 8.3 Stability Loss, Overage, and Shelf 
       Life -- 8.4 Short-Term and Long-Term Stability Studies -- 
       8.5 Statistical Considerations -- 8.6 Discussion -- 9: 
       Accelerated Testing -- 9.1 Introduction -- 9.2 Chemical 
       Kinetic Reaction -- 9.3 Statistical Analysis and 
       Prediction -- 9.4 Examinations of Model Assumptions -- 9.5
       Example -- 9.6 Discussion. 
506    Available only to authorized UTEP users. 
588 0  Print version record. 
650  0 Pharmacy|xStatistical methods. 
700 1  Chow, Shein-Chung,|d1955-|eeditor. 
700 1  Liu, Jen-pei,|d1952-|eeditor. 
776 08 |iPrint version:|tStatistical design and analysis in 
       pharmaceutical science :|bvalidation, process controls, 
       and stability /|cedited by Shein-Chung Chow, Jen-pei Liu.
       |dNew York, New York ; Basel, [Switzerland] : Marcel 
       Dekker, Inc., ©1995|hviii, 564 pages|kStatistics, 
       textbooks and monographs ; Volume 143|z9780824793364 
830  0 Statistics, textbooks and monographs ;|vVolume 143. 
856 40 |uhttp://0-www.taylorfrancis.com.lib.utep.edu/books/
       9781315274294|zTo access this resource 
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