Analytical Similarity Assessment in Biosimilar Product Development /

Analytical Similarity Assessment in Biosimilar Product Development /

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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 critica...

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Bibliographic Details
Main Author: Chow, Shein-Chung (Author)
Corporate Author: Taylor and Francis
Format: Electronic eBook
Language:English
Published: Boca Raton, FL : Chapman and Hall/CRC, 2018.
Edition:First edition.
Subjects:
Drug development.
Drug approval.
MEDICAL / Pharmacology.
MEDICAL / Biostatistics.
Electronic books.
Online Access:Click here to view.
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Table of Contents:
  • 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.

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