Abstract
Chapters 4 and 5 discuss proof of concept (PoC) and dose-ranging studies respectively and separately.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Box, G. E. P., & Draper, N. R. (1987). Empirical model-building and response surfaces (p. 424). New York: Wiley. ISBN 047180339.
Chang, M., & Chow, S. C. (2006) Power and sample size for dose response studies. In Dose finding in drug development (pp. 220–241). New York: Springer.
Dmitrienko, A., Offen, W., & Westfall, P. (2003). Gatekeeping strategies for clinical trials that do not require all primary effects to be significant. Statistics in Medicine, 22, 2387–2400.
Hamlett, A., Ting, N., Hanumara, C., & Finman, J. S. (2002). Dose spacing in early dose response clinical trial designs. Drug Information Journal, 36(4), 855–864.
Thomas, N., & Ting, N. (2009). Minimum effective dose. In Encyclopedia of clinical trials. Hoboken, NJ: Wiley-Blackwell.
Ting, N. (2009). Practical and statistical considerations in designing an early phase II osteoarthritis clinical trial: A case study. In Communications in statistics—Theory and methods (Vol. 38, # 18, pp. 3282–3296).
Ting, N. (2011). Phase 2 clinical development in treating chronic diseases. Drug Information Journal, 45(4), 431–442.
Wang, X., & Ting, N. (2012). A proof-of-concept clinical trial design combined with dose-ranging exploration. In Biopharmaceutical statistics. wileyonlinelibrary.com. doi:10.1002/pst.1525
Yuan, G., & Ting, N. (2014). First dose ranging clinical trial design—More doses? Or a wider range? In Clinical trial biostatistics and biopharmaceutical applications. Abingdon: Taylor & Francis (to be appeared in 2014).
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
Copyright information
© 2017 Springer Nature Singapore Pte Ltd.
About this chapter
Cite this chapter
Ting, N., Chen, DG., Ho, S., Cappelleri, J.C. (2017). Combining Proof of Concept and Dose-Ranging Trials. In: Phase II Clinical Development of New Drugs. ICSA Book Series in Statistics. Springer, Singapore. https://doi.org/10.1007/978-981-10-4194-5_6
Download citation
DOI: https://doi.org/10.1007/978-981-10-4194-5_6
Published:
Publisher Name: Springer, Singapore
Print ISBN: 978-981-10-4192-1
Online ISBN: 978-981-10-4194-5
eBook Packages: Mathematics and StatisticsMathematics and Statistics (R0)