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Estimating the “First in human” dose – a revisit with particular emphases in oncology drugs
Tam, K. Y.
2013-09-01
Source PublicationADMET & DMPK
ISSN1848-7718
Pages63-75
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
DOI10.5599/admet.1.4.10
Language英語English
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Document TypeJournal article
CollectionDEPARTMENT OF PHARMACEUTICAL SCIENCES
Faculty of Health Sciences
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GB/T 7714
Tam, K. Y.. Estimating the “First in human” dose – a revisit with particular emphases in oncology drugs[J]. ADMET & DMPK, 2013, 63-75.
APA Tam, K. Y..(2013). Estimating the “First in human” dose – a revisit with particular emphases in oncology drugs. ADMET & DMPK, 63-75.
MLA Tam, K. Y.."Estimating the “First in human” dose – a revisit with particular emphases in oncology drugs".ADMET & DMPK (2013):63-75.
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