ADMET & DMPK
Estimating the “First in human” dose – a revisit with particular emphasis on oncology drugs
Yazarlar: Kin Tam
Cilt 1 , Sayı 4 , 2013 , Sayfalar 63-75
Konular:-
DOI:10.5599/admet.1.4.10
Anahtar Kelimeler:Initial dose,Starting dose,Clinical trial,NOAEL,MABEL,Cytotoxic,Anticancer,Combination therapy study
Özet: 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.
ATIFLAR
Atıf Yapan Eserler
KAYNAK GÖSTER
BibTex
KOPYALA
@article{2013, title={Estimating the “First in human” dose – a revisit with particular emphasis on oncology drugs}, volume={1}, number={63–75}, publisher={ADMET & DMPK}, author={Kin Tam}, year={2013} }
APA
KOPYALA
Kin Tam. (2013). Estimating the “First in human” dose – a revisit with particular emphasis on oncology drugs (Vol. 1). Vol. 1. ADMET & DMPK.
MLA
KOPYALA
Kin Tam. Estimating the “First in Human” Dose – a Revisit with Particular Emphasis on Oncology Drugs. no. 63–75, ADMET & DMPK, 2013.