Statistics in regulatory science. (2019)

• Record Type: Book
• Further Information: Note: Shein-Chung Chow.
• Authors: Chow, Shein-Chung, 1955-
• Contents: Preface 1. Introduction ; Introduction; Key Statistical Concepts; Complex Innovative Designs; Practical, Challenging, and Controversial Issues; Aim and Scope of the Book 2. Totality-of-the-Evidence; Introduction; Substantial Evidence; Totality-of-the-evidence; Practical and Challenging Issues; Development of Index for Totality-of-the-Evidence; Concluding Remarks 3. Hypotheses Testing Versus Confidence Interval ; Introduction; Hypotheses Testing; Confidence Interval Approach; Two One-sided Tests Procedure and Confidence Interval Approach; A Comparison; Sample Size Requirement; Concluding Remarks; Appendix of Chapter 3 4. Endpoint Selection ; Introduction; Clinical Strategy for Endpoint Selection; Translations Among Clinical Endpoints; Comparison of Different Clinical Strategies; A Numerical Study; Development of Therapeutic Index Function; Concluding Remarks 5. Non-inferiority Margin ; Introduction; Non-inferiority Versus Equivalence; Non-inferiority Hypotheses; Methods for Selection of Non-inferiority Margin; Strategy for Margin Selection; Concluding Remarks 6. Missing Data ; Introduction; Missing Data Imputation; Marginal/Conditional Imputation for Contingency; Test for Independence; Recent Development; Concluding Remarks 7. Multiplicity ; General Concepts; Regulatory Perspective and Controversial Issues; Statistical Methods for Multiplicity Adjustment; Gate-keeping Procedures; Concluding Remarks 8. Sample Size; Introduction; Traditional Sample Size Calculation; Selection of Study Endpoints; Multiple-Stage Adaptive Designs; Adjustment with Protocol Amendments; Multi-Regional Clinical Trials; Current Issues; Concluding Remarks 9. Reproducible Research ; Introduction; The Concept of Reproducibility Probability; The Estimated Power Approach; Alternative Methods for Evaluation of Reproducibility Probability; Applications; Future Perspectives 10. Extrapolation ; Introduction; Shift in Target Patient Population; Assessment of Sensitivity Index; Statistical Inference; An Example; Concluding Remarks; Appendix of Chapter 10 11. Consistency Evaluation ; Introduction; Issues in Multi-regional Clinical Trials; Statistical Methods; Simulation Study; An Example; Other Considerations/Discussions; Concluding Remarks 12. Drug Products with Multiple Components ; Introduction; Fundamental Differences; Basic Considerations; TCM Drug Development; Challenging Issues; Recent Development; Concluding Remarks 13. Adaptive Trial Design ; Introduction; What Is Adaptive Design; Regulatory/Statistical Perspectives; Impact, Challenges, and Obstacles; Some Examples; Strategies for Clinical Development; Concluding Remarks 14. Selection Criteria in Adaptive Dose Finding ; Introduction; Criteria for Dose Selection; Practical Implementation and Example; Clinical Trial Simulations; Concluding Remarks 15. Generic Drugs and Biosimilars ; Introduction; Fundamental Differences; Quantitative Evaluation of Generic Drugs; Quantitative Evaluation of Biosimilars; General Approach for Assessment of Bioequivalence/Biosimilarity; Scientific Factors and Practical Issues; Concluding Remarks 16. Precision and Personalized Medicine; Introduction; The Concept of Precision Medicine; Design and Analysis of Precision Medicine; Alternative Enrichment Designs; Concluding Remarks 17. Big Data Analytics ; Introduction; Basic Considerations; Types of Big Data Analytics; Bias of Big Data Analytics; Statistical Methods for Estimation of ∆ and μP - μN Concluding Remarks 18. Rare Disease Drug Development ; Introduction; Basic Considerations; Innovative Trial Designs; Statistical Methods for Data Analysis; Evaluation of Rare Disease Clinical Trials; Some Proposals for Regulatory Consideration; Concluding Remarks References Subject Index
• Edition: 1st
• Publisher Details: Boca Raton : Chapman & Hall/CRC
• Publication Date: 2019
• Extent: 1 online resource
• Subjects: 615.1900727; Drug development -- Statistical methods
• Languages: English
• ISBNs: 9781000710816; 9781000710038; 9781000710427; 9780429275067
• Related ISBNs: 9780367224769
• Notes: Note: Description based on CIP data; resource not viewed.
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