Analytical Similarity Assessment in Biosimilar Product Development
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portes grátis
Analytical Similarity Assessment in Biosimilar Product Development
Chow, Shein-Chung
Taylor & Francis Ltd
08/2018
340
Dura
Inglês
9781138307339
15 a 20 dias
445
Descrição não disponível.
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
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Analytical Similarity Assessment;Biosimilar Product;Biosimilar Product Development;Reference Product;BPCI Act;Reference Lots;Fundamental Bioequivalence Assumption;FDA Draft Guidance;Biosimilarity Assessment;Test Lots;Equivalence Test;SUR Model;FDA's Current Thinking;PD Similarity;NMS;Non-inferiority Margin;Vitro Bioequivalence;Ich Q8;Generic Drug Products;Ich Q2R1;Ich Q5C;Similar Biological Medicinal Product;Sample Size Calculation;Simultaneous Confidence Interval;Innovator Biological Product
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
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Analytical Similarity Assessment;Biosimilar Product;Biosimilar Product Development;Reference Product;BPCI Act;Reference Lots;Fundamental Bioequivalence Assumption;FDA Draft Guidance;Biosimilarity Assessment;Test Lots;Equivalence Test;SUR Model;FDA's Current Thinking;PD Similarity;NMS;Non-inferiority Margin;Vitro Bioequivalence;Ich Q8;Generic Drug Products;Ich Q2R1;Ich Q5C;Similar Biological Medicinal Product;Sample Size Calculation;Simultaneous Confidence Interval;Innovator Biological Product
