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Book Cover
E-book
Author Chow, Shein-Chung

Title Analytical Similarity Assessment in Biosimilar Product Development
Published Milton : Chapman and Hall/CRC, 2018

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Description 1 online resource (354 pages)
Contents and Reproducibility Concluding remarks Critical Quality Attributes Introduction Identification of CQAs Classification of CQAs Concluding Remarks FDA Tiered Approach for Analytical Assessment Background Stepwise Approach Tier Equivalence Test Other tiered approaches Some Practical Considerations Concluding Remarks Sample Size Requirement Introduction Traditional Approach FDA's Current Thinking and Recommendation Sample Size Requirement Numerical Studies Concluding remarks Multiple References Background Method of Pairwise Comparisons Simultaneous Confidence Interval Reference Product Change Concluding remarks Extrapolation Across Indications Introduction An Example Development of
Cover; Half Title; Title Page; Copyright Page; Table of Contents; Preface; Author; Chapter 1: Introduction; 1.1 Background; 1.2 Past Experience for In Vitro Bioequivalence Testing; 1.2.1 Study Design and Data Collection; Emitted dose uniformity, priming, priming/re-priming, and tail-off profile; Spray pattern; Droplet size distribution; Plume geometry; 1.2.2 Bioequivalence Limit; 1.2.3 Statistical Methods; Non-comparative analysis; Non-profile Analysis; Profile Analysis; 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 Approach1.3.3 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; 1.4.7 Regulator's Current Thinking on Scientific Input; 1.4.8 A Proposed Unified Tiered Approach; 1.4.9 Practical Issues; How Similar is Similar?; Criteria for biosimilarity
Criteria for interchangeabilityBridging studies for assessing biosimilarity; 1.4.10 Remarks; 1.5 Aim and Scope of the Book; Chapter 2: Regulatory Approval Pathway of Biosimilar Products; 2.1 Introduction; 2.2 Regulatory Requirements; 2.2.1 World Health Organization (WHO); 2.2.2 European Union (EU); 2.2.3 North America (United States of America and Canada); 2.2.4 Asian Pacific Region (Japan, South Korea, and China); 2.2.5 Debatable Issues in Regulatory Requirements; 2.3 Analytical Studies for Structural/Functional Characteristics; 2.4 Global Harmonization; 2.5 Conclusion Remarks
Chapter 3: CMC Requirements for Biological Products3.1 Introduction; 3.2 CMC Development; 3.2.1 Fermentation and Purification Process; 3.2.2 Drug Substance and Product Characterization; 3.2.3 Reference Standards and Container Closure System; 3.2.4 Practical Issues; 3.3 Manufacturing Process Validation; 3.3.1 Manufacturing Process; 3.3.2 Process Validation; 3.3.3 Practical Issues; 3.4 Quality Control and Assurance; 3.4.1 General Principles; 3.4.2 Quality by Design; 3.5 Stability Analysis; 3.6 Concluding Remarks; Chapter 4: Analytical Method Validation; 4.1 Introduction
4.2 Regulatory Requirements4.2.1 FDA Guidance on Analytical Procedures and Methods Validation; 4.2.2 ICH Guidance on Assay Validation; 4.2.3 United States Pharmacopeia and National Formulary (USP/NF); 4.3 Analytical Method Validation; 4.3.1 Validation Performance Characteristics; 4.3.2 Study Design; 4.3.3 Choice of Validation Performance Characteristics; 4.3.4 Acceptance Criteria; 4.4 Analysis of Validation Data; 4.4.1 Assessment of Accuracy, Linearity, and Specificity; 4.4.2 The Assessment of Assay Parameters Related to Variability
Summary 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
Notes 4.5 Evaluation of Reliability, Repeatability, and Reproducibility
Print version record
Subject Drug development.
Drug approval.
MEDICAL -- Pharmacology.
MEDICAL -- Biostatistics.
Drug approval
Drug development
Form Electronic book
LC no. 2018030817
ISBN 9781351339469
135133946X
9781351339452
1351339451