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Innovative Statistics in Regulatory Science / Shein-Chung Chow.
- Format:
- Book
- Author/Creator:
- Chow, Shein-Chung, 1955- author.
- Series:
- Chapman & Hall/CRC biostatistics series.
- Chapman and Hall/CRC Biostatistics Series
- Language:
- English
- Subjects (All):
- Research--Statistical methods.
- Research.
- Physical Description:
- 1 online resource (553 pages).
- Edition:
- First edition.
- Place of Publication:
- Boca Raton, FL : CRC Press, [2020]
- Summary:
- "The proposed book will focus on practical issues in pharmaceutical/clinical research and development from both regulatory and scientific perspectives. The book will outline and clarify those issues that have been commonly misused in the subject area of regulatory science"-- Provided by publisher.
- Contents:
- Totality-of-the-evidence
- Hypotheses testing versus confidence interval
- Endpoint selection
- Non-inferiority margin
- Missing data
- Multiplicity
- Sample size
- Reproducible research
- Extrapolation
- Consistency evaluation
- Drug products with multiple components
- Adaptive trial design
- Selection criteria in adaptive dose finding
- Generic drugs and biosimilars
- Precision and personalized medicine
- Big data analytics
- Rare disease drug development.
- Notes:
- Includes bibliographical references and index.
- Description based on print version record.
- ISBN:
- 1-000-71081-5
- 1-000-71003-3
- 0-429-27506-4
- 9780429275067
- OCLC:
- 1130379655
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