Burt, T., Yoshida, K., Lappin, G. , Vuong, L., John, C., de Wildt, S. N., Sugiyama, Y. and Rowland, M. (2016) Microdosing and other phase 0 clinical trials: facilitating translation in Drug Development. Clinical and Translational Science, 9 (2). pp. 74-88. ISSN 1752-8054
Full content URL: http://dx.doi.org/10.1111/cts.12390
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27962 Burt_et_al-2016-Clinical_and_Translational_Science.pdf - Whole Document Available under License Creative Commons Attribution 4.0 International. 532kB |
| Item Type: | Article |
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| Item Status: | Live Archive |
Abstract
Increasing costs of drug development and ethical concernsabout the risks of exposing humans and animals to novelchemical entities favor limited exposure clinical trials suchas microdosing and other phase 0 trials. An increasing bodyof research supports the validity of extrapolation from thelimited drug exposure of phase 0 approaches to the full,therapeutic exposure. An increasing number of applicationsand design options demonstrate the versatility and exibilitythese approaches offer to drug developers.
| Keywords: | Pharmacy, Drug development, NotOAChecked |
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| Subjects: | B Subjects allied to Medicine > B200 Pharmacology, Toxicology and Pharmacy |
| Divisions: | College of Science > School of Pharmacy |
| ID Code: | 27962 |
| Deposited On: | 01 Aug 2017 13:08 |
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