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Estimating the “First in human” dose – a revisit with particular emphasis on oncology drugs
Kin Tam
2013
Source PublicationADMET & DMPK
ISSN1848-7718
Volume1Issue:4Pages:63-75
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

KeywordInitial Dose Starting Dose Clinical Trial Noael Mabel Cytotoxic Anticancer Combination Therapy Study
DOIhttp://doi.org/10.5599/admet.1.4.10
Language英语
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Document TypeJournal article
CollectionFaculty of Health Sciences
AffiliationFaculty of Health Science, University of Macau, Macau, China
First Author AffilicationUniversity of Macau
Recommended Citation
GB/T 7714
Kin Tam. Estimating the “First in human” dose – a revisit with particular emphasis on oncology drugs[J]. ADMET & DMPK,2013,1(4):63-75.
APA Kin Tam.(2013).Estimating the “First in human” dose – a revisit with particular emphasis on oncology drugs.ADMET & DMPK,1(4),63-75.
MLA Kin Tam."Estimating the “First in human” dose – a revisit with particular emphasis on oncology drugs".ADMET & DMPK 1.4(2013):63-75.
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