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E-BOOK
Title Statistical design and analysis in pharmaceutical science : validation, process controls, and stability / edited by Shein-Chung Chow, Jen-pei Liu.
Imprint New York, New York ; Basel [Switzerland] : Marcel Dekker, Inc., 1995.
©1995

Copies/Volumes

LOCATION CALL # STATUS
 Internet  Electronic Book    AVAILABLE
Description 1 online resource (581 pages) : illustrations.
Series Statistics: Textbooks and Monographs ; Volume 143
Statistics, textbooks and monographs ; Volume 143.
Bibliog. Includes bibliographical references and index.
Note Available only to authorized UTEP users.
Print version record.
Subject Pharmacy -- Statistical methods.
Contents 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.
Other Author Chow, Shein-Chung, 1955- editor.
Liu, Jen-pei, 1952- editor.
Other Title Print version: Statistical design and analysis in pharmaceutical science : validation, process controls, and stability / edited by Shein-Chung Chow, Jen-pei Liu. New York, New York ; Basel, [Switzerland] : Marcel Dekker, Inc., ©1995 viii, 564 pages Statistics, textbooks and monographs ; Volume 143 9780824793364