Analytical similarity assessment in biosimilar product development. (2018)
- Record Type:
- Book
- Title:
- Analytical similarity assessment in biosimilar product development. (2018)
- Main Title:
- Analytical similarity assessment in biosimilar product development
- Further Information:
- Note: Shein-Chung Chow.
- Authors:
- Chow, Shein-Chung, 1955-
- 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 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 Sensitivity Index Assessment of Sensitivity Index Statistical Inference of Extrapolation Concluding Remarks Case Studies -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 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 Sensitivity Index Assessment of Sensitivity Index Statistical Inference of Extrapolation Concluding Remarks Case Studies - FDA Submissions FDA Abbreviated Licensure Pathway Sponsor’s 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 … (more)
- Edition:
- 1st
- Publisher Details:
- Boca Raton : Chapman & Hall/CRC
- Publication Date:
- 2018
- Extent:
- 1 online resource
- Subjects:
- 615.19
Pharmaceutical biotechnology
Drugs -- Generic substitution
Biological products
Drugs -- Analysis -- Standards - Languages:
- English
- ISBNs:
- 9781351339452
9781351339469
9781351339445
9780203705131 - Related ISBNs:
- 9781138307339
- Notes:
- Note: Description based on CIP data; resource not viewed.
- Access Rights:
- Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
- Access Usage:
- Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.
- View Content:
- Available online (eLD content is only available in our Reading Rooms) ↗
- Physical Locations:
- British Library HMNTS - ELD.DS.327308
- Ingest File:
- 01_267.xml