Full 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.
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
