Microdosing and other phase 0 clinical trials: facilitating translation in Drug Development

Burt, T. and Yoshida, K. and Lappin, G. and Vuong, L. and John, C. and de Wildt, S. N. and 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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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
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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