1st Edition

Analytical Similarity Assessment in Biosimilar Product Development

By Shein-Chung Chow Copyright 2019
    354 Pages
    by Chapman & Hall

    354 Pages
    by Chapman & Hall

    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.





    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

    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.