Analytical Similarity Assessment in Biosimilar Product Development / (Record no. 70301)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 04702nam a2200469Ii 4500 |
| 001 - CONTROL NUMBER | |
| control field | 9780203705131 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20220531132302.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS | |
| fixed length control field | m o d |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 181112s2018 fluab ob 001 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780203705131 |
| -- | (e-book : PDF) |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)1049800753 |
| 040 ## - Cataloging Source | |
| -- | FlBoTFG |
| -- | FlBoTFG |
| -- | rda |
| 041 1# - | |
| -- | eng |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RM301.25 |
| 072 #7 - | |
| -- | MAT |
| -- | 029000 |
| -- | bisacsh |
| 072 #7 - | |
| -- | MED |
| -- | 071000 |
| -- | bisacsh |
| 072 #7 - | |
| -- | MED |
| -- | 090000 |
| -- | bisacsh |
| 072 #7 - | |
| -- | MBNS |
| -- | bicscc |
| 082 04 - | |
| -- | 615.1/9 |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Chow, Shein-Chung, |
| Relator term | author. |
| 245 10 - TITLE STATEMENT | |
| Title | Analytical Similarity Assessment in Biosimilar Product Development / |
| Statement of responsibility, etc. | by Shein-Chung Chow. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | First edition. |
| 264 #1 - | |
| -- | Boca Raton, FL : |
| -- | Chapman and Hall/CRC, |
| -- | 2018. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource (354 pages) : |
| Other physical details | 70 illustrations, text file, PDF |
| 336 ## - | |
| -- | text |
| -- | rdacontent |
| 337 ## - | |
| -- | computer |
| -- | rdamedia |
| 338 ## - | |
| -- | online resource |
| -- | rdacarrier |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE | |
| Bibliography, etc | Includes bibliographical references and index. |
| 505 00 - | |
| -- | 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. |
| 520 3# - | |
| -- | 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. |
| 530 ## - | |
| -- | Also available in print format. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drug development. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drug approval. |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL / Pharmacology. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL / Biostatistics. |
| Source of heading or term | bisacsh |
| 655 #0 - | |
| -- | Electronic books. |
| 710 2# - ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | Taylor and Francis. |
| 776 08 - | |
| -- | Print version: |
| -- | 9781138307339 |
| 856 40 - | |
| -- | https://www.taylorfrancis.com/books/9780203705131 |
| -- | Click here to view. |
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