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Library | Item Barcode | Call Number | Material Type | Item Category 1 | Status |
|---|---|---|---|---|---|
Searching... | 32050000000683 | RS380 .C45 2014 | Open Access Book | Book | Searching... |
Searching... | 30000010342162 | RS380 C46 2014 | Open Access Book | Book | Searching... |
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Summary
Summary
As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products. But scientific challenges remain due to the complexity of both the manufacturing process and the structures of biosimilar products.
Written by a top biostatistics researcher, Biosimilars: Design and Analysis of Follow-on Biologics is the first book entirely devoted to the statistical design and analysis of biosimilarity and interchangeability of biosimilar products. It includes comparability tests of important quality attributes at critical stages of the manufacturing processes of biologic products.
Connecting the pharmaceutical/biotechnology industry, government regulatory agencies, and academia, this state-of-the-art book focuses on the scientific factors and practical issues related to the design and analysis of biosimilar studies. It covers most of the statistical questions encountered in various study designs at different stages of research and development of biological products.
Author Notes
Shein-Chung Chow is a professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. Dr. Chow is also a professor of clinical sciences at Duke-National University of Singapore Graduate Medical School. He is the editor-in-chief of the Journal of Biopharmaceutical Statistics and editor-in-chief of the Chapman & Hall/CRC Biostatistics Series. He has authored or co-authored over 230 papers and 22 books, including Adaptive Design Methods in Clinical Trials, Second Edition, Handbook of Adaptive Designs in Pharmaceutical and Clinical Development, and Controversial Statistical Issues in Clinical Trials. A fellow of the ASA and member of the ISI, Dr. Chow has received the ASA Chapter Service Recognition Award, the DIA Outstanding Service Award, and the ICSA Extraordinary Achievement Award.
Table of Contents
| Introduction |
| Background |
| Fundamental Differences |
| Regulatory Requirements |
| Biosimilarity |
| Interchangeability of Biological Drug Products |
| Scientific Factors |
| Aim and Scope of the Book |
| Bioequivalence Experience for Small-Molecule Drug Products |
| Background |
| Process for Bioequivalence Assessment |
| Issue of Drug Interchangeability |
| Highly Variable Drugs |
| Practical Issues |
| Frequently Asked Questions |
| Regulatory Requirements for Assessing Follow-On Biologics |
| Background |
| Definitions and Interpretations of Biosimilar Products |
| Regulatory Requirements |
| Review of the FDA Draft Guidances |
| Global Harmonization |
| Criteria for Similarity |
| Introduction |
| Criteria for Bioequivalence |
| Similarity Factor for Dissolution Profile Comparison |
| Measures of Consistency |
| Comparison of Moment-Based and Probability-Based Criteria |
| Alternative Criteria |
| Statistical Methods for Assessing Average Biosimilarity |
| Introduction |
| Classic Methods for Assessing Biosimilarity |
| Bayesian Methods |
| Wilcoxon-Mann-Whitney Two One-Sided Tests Procedure |
| Three-Arm Parallel Design |
| General Approach for Assessing Biosimilarity |
| Background |
| Reproducibility Probability |
| Development of the Biosimilarity Index |
| Relationship of the Biosimilarity Criterion versus Variability |
| Biosimilarity Index Based on the Bayesian Approach |
| Consistency Approach |
| Non-Inferiority versus Equivalence/Similarity |
| Background |
| Testing for Equality |
| Testing for Noninferiority |
| Testing for Superiority |
| Testing for Equivalence |
| Relationship among Testing for Noninferiority, Superiority, and Equivalence |
| Determination of the Noninferiority Margin |
| Sample Size Requirement When There Is a Switch in Hypothesis Testing |
| Statistical Test for Biosimilarity in Variability |
| Introduction |
| Pitman-Morgan's Adjusted Test for Comparing Variabilities |
| F-Type Test under Parallel Design |
| Non-Parametrics Methods |
| Alternative Methods |
| Sample Size for Comparing Variabilities |
| Introduction |
| Comparing Intra-Subject Variability |
| Comparing Inter-Subject Variability |
| Comparing Total Variability |
| Comparing Intra-Subject CVs |
| Impact of Variability on Biosimilarity Limits for Assessing Follow-On Biologics |
| Introduction |
| Relationship between Variability and Biosimilarity Limits |
| Scaled Biosimilarity Margins |
| Simulations |
| Discussions |
| Drug Interchangeability |
| Introduction |
| Population and Individual Bioequivalence |
| Interchangeability for Biosimilar Products |
| Study Designs for Interchangeability |
| Statistical Methods |
| Issues on Immunogenicity Studies |
| Introduction |
| Regulatory Requirements |
| Assay Development/Validation |
| Design for Immunogenicity Studies |
| Sample Size for Immunogenicity Studies |
| CMC Requirements for Biological Products |
| Introduction |
| CMC Development |
| Product Characterization and Specification |
| Manufacture and Process Validation |
| Quality Control/Assurance |
| Reference Standards, Container Closure System, and Stability |
| Test for Comparability in Manufacturing Process |
| Introduction |
| Biologic Manufacturing Process |
| Consistency Index |
| Test for Comparability |
| Other Comparability Tests |
| Stability Analysis of Biosimilar Products |
| Introduction |
| Regulatory Stability Guidelines on Biologicals |
| Stability Indicating Profile and Expiration Dating Period |
| Stability Designs |
| Statistical Analysis |
| Assessing Biosimilarity Using Biomarker Data |
| Introduction |
| Assessment of Biosimilarity |
| Statistical Test for Biosimilarity Using Biomarker Data |
| Numerical Study |
| Current Issues in Biosimilar Studies |
| Introduction |
| Scientific Factors |
| Current Issues |
| References |
| Index |
