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Theory of drug development / Eric B. Holmgren.
- Format:
- Book
- Author/Creator:
- Holmgren, Eric B., 1959- author.
- Series:
- Chapman & Hall/CRC biostatistics series (Unnumbered)
- Chapman & Hall/CRC biostatistics series
- Language:
- English
- Subjects (All):
- Drugs--Design.
- Drugs.
- Drug development.
- Pharmaceutical industry.
- Physical Description:
- 1 online resource (xvi, 245 pages) : illustrations.
- Place of Publication:
- Boca Raton : CRC Press, Taylor & Francis Group, [2014]
- Language Note:
- English
- Summary:
- Theory of Drug Development presents a formal quantitative framework for understanding drug development that goes beyond simply describing the properties of the statistics in individual studies. It examines the drug development process from the perspectives of drug companies and regulatory agencies.By quantifying various ideas underlying drug development, the book shows how to systematically address problems, such as:Sizing a phase 2 trial and choosing the range of p-values that will trigger a follow-up phase 3 trialDeciding whether a dr
- Contents:
- section I. A theory of evaluating drugs
- section II. A theory of evidence in drug development
- section III. Additional topics.
- Notes:
- "A CHAPMAN & HALL BOOK."
- Includes bibliographical references.
- Description based on print version record.
- ISBN:
- 9781040192641
- 1040192645
- 9780429086809
- 0429086806
- 9781466507463
- 1466507462
- OCLC:
- 861536611
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