Description

Book Synopsis

Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in the review and approval process of regulatory submissions of pharmaceutical products. In addition, statistics in regulatory science are involved with the development of regulatory policy, guidance, and regulatory critical clinical initiatives related research. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are commonly encountered in regulatory science of pharmaceutical research and development including topics related to research activities, review of regulatory submissions, recent critical clinical initiatives, and policy/guidance development in regulatory science.

  • Devoted en

    Table of Contents

    1. Introduction. 2. Totality-of-the-Evidence. 3. Hypotheses Testing Versus Confidence Interval. 4. Endpoint Selection. 5. Non-inferiority Margin. 6. Missing Data. 7. Multiplicity. 8. Sample Size. 9. Reproducible Research. 10. Extrapolation. 11. Consistency Evaluation. 12. Drug Products with Multiple Components. 13. Adaptive Trial Design. 14. Selection Criteria in Adaptive Dose Finding. 15. Generic Drugs and Biosimilars. 16. Precision and Personalized Medicine. 17. Big Data Analytics. 18. Rare Disease Drug Development.

Innovative Statistics in Regulatory Science

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    A Hardback by Shein-Chung Chow

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      Book details

      Publisher Chapman & Hall/CRC
      Published 11 July 2019
      ISBN-13 9780367224769
      978-0367224769
      ISBN-10 0367224763

      Description

      Book Synopsis

      Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in the review and approval process of regulatory submissions of pharmaceutical products. In addition, statistics in regulatory science are involved with the development of regulatory policy, guidance, and regulatory critical clinical initiatives related research. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are commonly encountered in regulatory science of pharmaceutical research and development including topics related to research activities, review of regulatory submissions, recent critical clinical initiatives, and policy/guidance development in regulatory science.

      • Devoted en

        Table of Contents

        1. Introduction. 2. Totality-of-the-Evidence. 3. Hypotheses Testing Versus Confidence Interval. 4. Endpoint Selection. 5. Non-inferiority Margin. 6. Missing Data. 7. Multiplicity. 8. Sample Size. 9. Reproducible Research. 10. Extrapolation. 11. Consistency Evaluation. 12. Drug Products with Multiple Components. 13. Adaptive Trial Design. 14. Selection Criteria in Adaptive Dose Finding. 15. Generic Drugs and Biosimilars. 16. Precision and Personalized Medicine. 17. Big Data Analytics. 18. Rare Disease Drug Development.

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