Theory of drug development

DOI10.1201/B15521MaRDI QIDQ2864531zbMATH OpenOpenAlexFDO

Authors Eric B. Holmgren

Publication date 25 November 2013

Published in Chapman \& Hall CRC Biostatistics Series (Search for Journal in Brave)

Full work available at URL https://doi.org/10.1201/b15521

zbMATH Keywords

efficient drug developmentquantitative frameworktheory of evidence

Mathematics Subject Classification ID

Applications of statistics to biology and medical sciences; meta analysis (62P10) Research exposition (monographs, survey articles) pertaining to biology (92-02) Biochemistry, molecular biology (92C40) Medical applications (general) (92C50)

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(6)

• A multistate model for early decision-making in oncology
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• A prospective combination of phase II and phase III in drug development
• Optimal sample size allocation and go/no-go decision rules for phase II/III programs where several phase III trials are performed
• The estimated and theoretical assurances and the probabilities of launching a phase III trial
• Statistical Issues in Drug Development

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