Valerii Fedorov
Overview
Explore the profile of Valerii Fedorov including associated specialties, affiliations and a list of published articles.
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9
Citations
145
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Recent Articles
1.
Marchenko O, Fedorov V, Lee J, Nolan C, Pinheiro J
Ther Innov Regul Sci
. 2017 Jul;
48(1):20-30.
PMID: 28670507
In this paper, we describe developments in adaptive design methodology and discuss implementation strategies and operational challenges in early phase adaptive clinical trials. The BATTLE trial - the first completed,...
2.
Fedorov V, Wu Y, Zhang R
Stat Med
. 2011 Dec;
31(3):217-34.
PMID: 22162014
In dose-finding clinical studies, it is common that multiple endpoints are of interest. For instance, in phase I/II studies, efficacy and toxicity are often the primary endpoints, which are observed...
3.
Fedorov V, Mannino F, Zhang R
Pharm Stat
. 2008 Apr;
8(1):50-61.
PMID: 18389492
Dichotomization is the transformation of a continuous outcome (response) to a binary outcome. This approach, while somewhat common, is harmful from the viewpoint of statistical estimation and hypothesis testing. We...
4.
Fedorov V, Leonov S
J Biopharm Stat
. 2007 Sep;
17(5):919-41.
PMID: 17885874
In pharmacokinetic (PK) studies, including bioavailability assessment, various population PK measures, such as area under the curve (AUC), maximal concentration (C(max)) and time to maximal concentration (T(max)) are estimated. In...
5.
Dragalin V, Fedorov V
Stat Med
. 2005 Oct;
25(16):2701-19.
PMID: 16252268
We propose a correlated beta-binomial model for the binary response in multi-centre trials. The likelihood function in this case has a closed-form and we avoid multivariate numerical integrations in determining...
6.
Fedorov V, Jones B
Stat Methods Med Res
. 2005 Jun;
14(3):205-48.
PMID: 15969302
The analysis of data collected in multicentre trials offers challenges because the data from the individual centres must be combined in some way to give an overall evaluation of the...
7.
Fedorov V, Jones B, Jones M, Zhigljavsky A
J Biopharm Stat
. 2004 Dec;
14(4):1037-63.
PMID: 15587979
The three fixed effects estimators of a treatment,difference are compared under conditions of random enrollment in a multicenter clinical trial. These comparisons are performed by assuming five different enrollment schemes....
8.
Dragalin V, Fedorov V, Patterson S, Jones B
Stat Med
. 2003 Mar;
22(6):913-30.
PMID: 12627409
In this paper we propose a methodology for evaluating the bioequivalence of two formulations of a drug that encompasses not only average bioequivalence (ABE), but also the more recently introduced...
9.
Dragalin V, Fedorov V, Cheuvart B
Stat Med
. 2002 Mar;
21(6):877-93.
PMID: 11870823
In a vaccine safety trial, the primary interest is to demonstrate that the vaccine is sufficiently safe, rejecting the null hypothesis that the relative risk of an adverse event attributable...