ADMET and DMPK, Vol. 1 No. 4, 2013.
Review article
https://doi.org/10.5599/admet.1.4.10
Estimating the “First in human” dose – a revisit with particular emphasis on oncology drugs
Kin Tam
; Faculty of Health Science, University of Macau, Macau, China
Abstract
The initial dose selection is one of the important steps for any investigative new drug (IND) entering the first clinical study in humans. In this mini review, we will discuss the no observed adverse effect level (NOAEL) and the minimum anticipated biological effect level (MABEL) approaches for the estimation of the first in human (FIH) dose. Particular attention will be placed on the development of the FIH dose for oncology drugs.
Keywords
Initial dose; starting dose; clinical trial; NOAEL; MABEL; cytotoxic; anticancer; combination therapy study
Hrčak ID:
112509
URI
Publication date:
16.12.2013.
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