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Table des matières
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
A propos de l'auteur
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.
Résumé
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 will cover current issues, and recent development in analytical similarity assessment.
