Analytical Similarity Assessment in Biosimilar Product Development  book cover
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Analytical Similarity Assessment in Biosimilar Product Development





ISBN 9781138307339
Published August 1, 2018 by Chapman and Hall/CRC
354 Pages

 
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Book Description

This book focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It covers concepts such as the tiered approach for assessment of similarity of critical quality attributes in the manufacturing process of biosimilar products, models/methods like the statistical model for classification of critical quality attributes, equivalence tests for critical quality attributes in Tier 1 and the corresponding sample size requirements, current issues, and recent developments in analytical similarity assessment.





Table of Contents

1.1 Background 1.2 Past Experience for In Vitro Bioequivalence Testing 1.2.1 Study Design and Data Collection 1.2.2 Bioequivalence Limit 1.2.3 Statistical Methods 1.2.4 Sample Size Requirement 1.3 Analytical Similarity Assessment 1.3.1 Tier 1 Equivalence Test 1.3.2 Tier 2 Quality Range Approach 1.3.3 Tier 3 Raw Data and Graphical Comparison 1.4 Scientific Factors and Practical Issues 1.4.1 Fundamental Similarity Assumption 1.4.2 Primary Assumptions for Tiered Approach 1.4.3 Fixed Approach for Margin Selection 1.4.4 Inconsistent Test Results between Tiered Approaches 1.4.5 Sample Size Requirement 1.4.6 Relationship between Similarity Limit and Variability

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Author(s)

Biography



Author



Shein-Chung Chow, Ph.D, is currently an Associate Director at Office of



Biostatistics, Center for Drug Evaluation and Research, United States Food



and Drug Administration (FDA). Prior to joining FDA, Dr. Chow was a



Professor at Duke University School of Medicine, Durham, NC. He was



also a special government employee (SGE) appointed by the FDA as an



Advisory Committee member and statistical advisor to the FDA. Prior to



that, Dr. Chow also held various positions in the pharmaceutical industry



such as Vice President at Millennium, Cambridge, MA, Executive Director at



Covance, Princeton, NJ, and Director and Department Head at Bristol-Myers



Squibb, Plainsboro, NJ. Dr. Chow is the Editor-in-Chief of the Journal of



Biopharmaceutical Statistics and the Editor-in-Chief of the Biostatistics Book Series



at Chapman and Hall/CRC Press, Taylor & Francis Group. He was elected



Fellow of the American Statistical Association and an elected member of the



ISI (International Statistical Institute). Dr. Chow is the author or co-author of



over 300 methodology papers and 29 books including Designs and Analysis



of Bioavailability and Bioequivalence Studies, Sample Size Calculations in Clinical



Research, Adaptive Design Methods in Clinical Trials, Translational Medicine,



Design and Analysis of Clinical Trials, and Quantitative Methods for Traditional



Chinese Medicine Development.