TY  - BOOK
AU  - Chow,Shein-Chung
ED  - Taylor and Francis.
TI  - Analytical Similarity Assessment in Biosimilar Product Development
SN  - 9780203705131
AV  - RM301.25 
U1  -  615.1/9 
PY  - 2018///
CY  - Boca Raton, FL
PB  - Chapman and Hall/CRC
KW  - Drug development
KW  - Drug approval
KW  - MEDICAL / Pharmacology
KW  - bisacsh
KW  - MEDICAL / Biostatistics
KW  - Electronic books
N1  - Includes bibliographical references and index; Introduction --; Background --; Past Experience for In Vitro Bioequivalence Testing --; Analytical Similarity Assessment --; Scientific Factors and practical issues --; Aim and Scope of the Book --; Regulatory Approval Pathway of Biosimilar Products --; Introduction --; Regulatory requirements --; Analytical Studies for Functional/Structural Characterization --; Global harmonization --; Concluding remarks --; CMC Requirements --; Introduction --; CMC Development --; Manufacturing Process Validation --; Quality Control and Assurance --; Stability Analysis --; Concluding Remarks --; Assay Development and Process Validation --; Introduction --; Regulatory Requirements --; Analytical Method Validation --; Analysis of Validation Data --; Evaluation of Reliability, Repeatability, 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 --; FDAs 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 Sensitivity Index --; Assessment of Sensitivity Index --; Statistical Inference of Extrapolation --; Concluding Remarks --; Case Studies - FDA Submissions --; FDA Abbreviated Licensure Pathway --; Sponsors Strategy for Regulatory Submission --; Avastin Biosimilar Regulatory Submission --; Herceptin Biosimilar Regulatory Submission --; Concluding Remarks --; --Practical and Challenging Issues --; Introduction --; Hypotheses versus Confidence Interval Approach --; Totality-of-the-evidence --; Inconsistencies Between Tired Approaches --; Individual bioequivalence --; Commonly Asked Questions from the Sponsors --; Concluding Remarks --; Recent Development-- --;  Introduction --;  Comparing Means versus Comparing Variances --;  Switching Design --;  Non-Medical Switching --;  FDA guidance on Analytical Similarity Assessment --;  Concluding Remarks; Also available in print format
N2  - 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
UR  - https://www.taylorfrancis.com/books/9780203705131
ER  -