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1

Simulation Practices For Adaptive Trial Designs In Drug And Device Development

Mayer, C., Perevoskaya, I., Leonov, S., Dragalin, V., Pritchett, Y., Bedding, A., Hartford, A., Fardipour, P., Cicconetti, G.

Journal:

Statistics in Biopharmaceutical Research

Year:

2019

Language:

english

File:

PDF, 477 KB

english, 2019

2

Aligning Treatment Policy Estimands and Estimators—A Simulation Study in Alzheimer’s Disease

Polverejan, Elena, Dragalin, Vladimir

Journal:

Statistics in Biopharmaceutical Research

Year:

2019

Language:

english

File:

PDF, 2.25 MB

english, 2019

3

Statistical approaches to establishing vaccine safety

Vladimir Dragalin, Valerii Fedorov, Brigitte Cheuvart

Journal:

Statistics in Medicine

Year:

2002

Language:

english

File:

PDF, 134 KB

english, 2002

4

Kullback–Leibler divergence for evaluating bioequivalence

Vladimir Dragalin, Valerii Fedorov, Scott Patterson, Byron Jones

Journal:

Statistics in Medicine

Year:

2003

Language:

english

File:

PDF, 165 KB

english, 2003

5

Adaptive Designs in Clinical Drug Development—An Executive Summary of the PhRMA Working Group

Gallo, Paul, Chuang-Stein, Christy, Dragalin, Vladimir, Gaydos, Brenda, Krams, Michael, Pinheiro, José

Journal:

Journal of Biopharmaceutical Statistics

Year:

2006

Language:

english

File:

PDF, 118 KB

english, 2006

6

Multistage Designs for Vaccine Safety Studies

Dragalin, V., Fedorov, V.

Journal:

Journal of Biopharmaceutical Statistics

Year:

2006

Language:

english

File:

PDF, 824 KB

english, 2006

7

Confidence intervals for confirmatory adaptive two-stage designs with treatment selection

Bebu, Ionut, Dragalin, Vladimir, Luta, George

Journal:

Biometrical Journal

Year:

2013

Language:

english

File:

PDF, 513 KB

english, 2013

8

ANDREI ANDREEVICH MARKOV (on his seventieth birthday)

Dragalin, A G, Nagornyi, N M, Petri, N V, Shanin, N A

Journal:

Russian Mathematical Surveys

Year:

1974

Language:

english

File:

PDF, 368 KB

english, 1974

9

Twenty-five years of confirmatory adaptive designs: opportunities and pitfalls

Bauer, Peter, Bretz, Frank, Dragalin, Vladimir, König, Franz, Wassmer, Gernot

Journal:

Statistics in Medicine

Year:

2016

Language:

english

File:

PDF, 348 KB

english, 2016

10

On Problems of the Evolution of Logic

Bocharov, V. A., Voishvillo, E. K., Dragalin, A. G., Smirnov, V. A.

Journal:

Russian Studies in Philosophy

Year:

1980

Language:

english

File:

PDF, 1.19 MB

english, 1980

11

Adaptive Seamless Phase II/III Designs—Background, Operational Aspects, and Examples

Maca, Jeff, Bhattacharya, Suman, Dragalin, Vladimir, Gallo, Paul, Krams, Michael

Journal:

Drug Information Journal

Year:

2006

Language:

english

File:

PDF, 1.42 MB

english, 2006

12

Adaptive designs for drug combination informed by longitudinal model for the response

Mielke, Tobias, Dragalin, Vladimir

Journal:

Statistical Papers

Year:

2019

Language:

english

File:

PDF, 564 KB

english, 2019

13

The Total Least Squares Method in Individual Bioequivalence Evaluation

Vladimir Dragalin, Valerii Fedorov

Journal:

Biometrical Journal

Year:

2001

Language:

english

File:

PDF, 348 KB

english, 2001

14

Likelihood inference for a two-stage design with treatment selection

Ionut Bebu, George Luta, Vladimir Dragalin

Journal:

Biometrical Journal

Year:

2010

Language:

english

File:

PDF, 144 KB

english, 2010

15

Adaptive Dc-optimal designs for dose finding based on a continuous efficacy endpoint

S. Krishna Padmanabhan, Vladimir Dragalin

Journal:

Biometrical Journal

Year:

2010

Language:

english

File:

PDF, 355 KB

english, 2010

16

Convenient Synthesis of Drimenol and Its Oxidation with Selenium Dioxide.

K. I. Kuchkova, A. N. Aricu, I. P. Dragalin, P. F. Vlad

Journal:

Year:

2005

File:

PDF, 16 KB

2005

17

Steroidal saponins of Yucca filamentosa: Yuccoside C and protoyuccoside C

Ivan P. Dragalin, Pavel K. Kintia

Journal:

Year:

1975

Language:

english

File:

PDF, 367 KB

english, 1975

18

Adaptive designs for dose-finding based on efficacy–toxicity response

Vladimir Dragalin, Valerii Fedorov

Journal:

Journal of Statistical Planning and Inference

Year:

2006

Language:

english

File:

PDF, 934 KB

english, 2006

19

Adaptive designs for selecting drug combinations based on efficacy–toxicity response

Vladimir Dragalin, Valerii Fedorov, Yuehui Wu

Journal:

Journal of Statistical Planning and Inference

Year:

2008

Language:

english

File:

PDF, 975 KB

english, 2008

20

A Bayesian dose-finding procedure applied to a seamless phase I/II trial in rheumatoid arthritis

Anne Whitehead, Helene Thygesen, Vladimir Dragalin, John Whitehead

Journal:

Year:

2011

Language:

english

File:

PDF, 121 KB

english, 2011

21

Implementation of an adaptive group sequential design in a bioequivalence study

Nibedita Bandyopadhyay, Vladimir Dragalin

Journal:

Pharmaceutical Statistics

Year:

2007

Language:

english

File:

PDF, 177 KB

english, 2007

22

Design of multi-centre trials with binary response

Vladimir Dragalin, Valerii Fedorov

Journal:

Statistics in Medicine

Year:

2006

Language:

english

File:

PDF, 176 KB

english, 2006

23

Two-stage design for dose-finding that accounts for both efficacy and safety

Vladimir Dragalin, Valerii V. Fedorov, Yuehui Wu

Journal:

Statistics in Medicine

Year:

2008

Language:

english

File:

PDF, 502 KB

english, 2008

24

Explicit algebraic models for constructive and classical theories with non-standard elements

Albert G. Dragalin

Journal:

Year:

1995

Language:

english

File:

PDF, 1.50 MB

english, 1995

25

A simple and effective scanning rule for a multi-channel system

Vladimir Dragalin

Journal:

Year:

1996

Language:

english

File:

PDF, 628 KB

english, 1996

26

Synthesis of Drim-9(11)-en-8α- and -8β-ols from Drimenol

K. I. Kuchkova, A. N. Aryku, I. P. Dragalin, P. F. Vlad

Journal:

Chemistry of Natural Compounds

Year:

2005

Language:

english

File:

PDF, 41 KB

english, 2005

27

Convenient synthesis of drimenol and its oxidation with selenium dioxide

K. I. Kuchkova, A. N. Aricu, I. P. Dragalin, P. F. Vlad

Journal:

Russian Chemical Bulletin

Year:

2004

Language:

english

File:

PDF, 277 KB

english, 2004

28

Beshornin and beshornoside, steroidal saponins of Beshorneria yuccoides

Pavel K. Kintia, Valentin A. Bobeyko, Ivan P. Dragalin, Stepan A. Shvets

Journal:

Year:

1982

Language:

english

File:

PDF, 287 KB

english, 1982

29

A discussion on ‘Detection of intrusions in information systems by sequential change-point methods’ by Tartakovsky, Rozovskii, Blažek, and Kim

Vladimir Dragalin

Journal:

Statistical Methodology

Year:

2006

Language:

english

File:

PDF, 159 KB

english, 2006

30

Membrane photocatalytic destruction of benzothiazoles in an aqueous medium

O. V. Kovaleva, G. G. Duka, V. V. Kovalev, M. V. Ivanov, I. P. Dragalin

Journal:

Journal of Water Chemistry and Technology

Year:

2009

Language:

english

File:

PDF, 1.13 MB

english, 2009

31

Steroid saponins III. Glycosides A and B from Yucca filamentosa

P. K. Kintya, I. P. Dragalin, V. Ya. Chirva

Journal:

Chemistry of Natural Compounds

Year:

1972

Language:

english

File:

PDF, 181 KB

english, 1972

32

Methods of analyzing cucurbitacins in cucumbers

N. E. Mashchenko, P. K. Kintya, I. P. Dragalin, G. V. Lazur'evskii, T. V. Demakova, L. I. Guseva

Journal:

Chemistry of Natural Compounds

Year:

1976

Language:

english

File:

PDF, 172 KB

english, 1976

33

The structure of yuccoside E from Yucca filamentosa

I. P. Dragalin, A. P. Gulya, V. V. Krokhmalyuk, P. K. Kintya

Journal:

Chemistry of Natural Compounds

Year:

1975

Language:

english

File:

PDF, 257 KB

english, 1975

34

Chemical characteristics of protoyuccoside E. IX

I. P. Dragalin, P. K. Kintya

Journal:

Chemistry of Natural Compounds

Year:

1975

Language:

english

File:

PDF, 144 KB

english, 1975

35

Multihypothesis sequential probability ratio tests. II. Accurate asymptotic expansions for the expected sample size

Dragalin, V.P., Tartakovsky, A.G., Veeravalli, V.V.

Journal:

IEEE Transactions on Information Theory

Year:

2000

Language:

english

File:

PDF, 656 KB

english, 2000

36

A bivariate Bayesian dose-finding procedure applied to a seamless phase I/II trial in rheumatoid arthritis

Helene Thygesen, Vladimir Dragalin, Anne Whitehead, John Whitehead

Journal:

Pharmaceutical Statistics

Year:

2012

Language:

english

File:

PDF, 310 KB

english, 2012

37

Asymptotic Solution of the Kiefer–Weiss Problem for Processes with Independent Increments

Dragalin, V. P., Novikov, A. A.

Journal:

Theory of Probability & Its Applications

Year:

1988

Language:

english

File:

PDF, 872 KB

english, 1988

38

An introduction to adaptive designs and adaptation in CNS trials

Vladimir Dragalin

Journal:

European Neuropsychopharmacology

Year:

2011

Language:

english

File:

PDF, 170 KB

english, 2011

39

Crossing Boundaries: Statistical Essays in Honor of Jack Hall || Bias of Estimates of Secondary Parameters in Linear-Boundary Sequential Tests

Vladimir Dragalin, Benjamin Yakir and W. J. Hall

Journal:

IMS Lecture Notes--Monograph Series

Year:

2003

Language:

english

File:

PDF, 1.12 MB

english, 2003

40

Inference for Change Point and Post Change Means after a CUSUM Testby Yanhong Wu

Review by: Vladimir Dragalin

Journal:

Journal of the American Statistical Association

Year:

2006

Language:

english

File:

PDF, 278 KB

english, 2006

41

Asymptotic design of symmetric triangular tests for the drift of brownian motion

Huang, Peng, Dragalin, Vladimir, Hall, W.J

Journal:

Sequential Analysis

Year:

2000

Language:

english

File:

PDF, 1.09 MB

english, 2000

42

Adaptive Approaches in Clinical Drug Development

Dr Michael Krams,Amarnath Sharma,Vlad Dragalin…

Journal:

Pharmaceutical Medicine

Year:

2009

Language:

english

File:

PDF, 147 KB

english, 2009

43

A Bayesian Dose-Finding Design Adapting to Efficacy and Tolerability Response

Padmanabhan, S. Krishna, Berry, Scott, Dragalin, Vladimir, Krams, Michael

Journal:

Journal of Biopharmaceutical Statistics

Year:

2012

Language:

english

File:

PDF, 554 KB

english, 2012

44

Adaptive Clinical Trials: Overview of Phase III Designs and Challenges

Maca, J., Dragalin, V., Gallo, P.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2014

Language:

english

File:

PDF, 310 KB

english, 2014

45

Sequential Methods in Multi-Arm Clinical Trials

Dragalin, Vladimir

Journal:

Sequential Analysis

Year:

2010

Language:

english

File:

PDF, 163 KB

english, 2010

46

Adaptive Designs in Clinical Drug Development: Opportunities, Challenges, and Scope Reflections Following PhRMA's November 2006 Workshop

Krams, Michael, Burman, Carl-Fredrik, Dragalin, Vladimir, Gaydos, Brenda, Grieve, Andrew P., Pinheiro, Jose, Maurer, Willi

Journal:

Journal of Biopharmaceutical Statistics

Year:

2007

Language:

english

File:

PDF, 66 KB

english, 2007

47

Guest Editorial—Statistical Issues in Adaptive Design Methods in Clinical Trials

Dragalin, Vladimir

Journal:

Journal of Biopharmaceutical Statistics

Year:

2007

Language:

english

File:

PDF, 34 KB

english, 2007

48

Adaptive Designs for Dose-Finding Studies Based on Sigmoid E max Model

Dragalin, Vladimir, Hsuan, Francis, Padmanabhan, S. Krishna

Journal:

Journal of Biopharmaceutical Statistics

Year:

2007

Language:

english

File:

PDF, 1.71 MB

english, 2007

49

A Simulation Study to Compare New Adaptive Dose–Ranging Designs

Dragalin, Vladimir, Bornkamp, Björn, Bretz, Frank, Miller, Frank, Padmanabhan, S. Krishna, Patel, Nitin, Perevozskaya, Inna, Pinheiro, José, Smith, Jonathan R.

Journal:

Statistics in Biopharmaceutical Research

Year:

2010

Language:

english

File:

PDF, 16.52 MB

english, 2010

50

Data Monitoring in Adaptive Dose-Ranging Trials

Gallo, Paul, Fardipour, Parvin, Dragalin, Vladimir, Krams, Michael, Littman, Gary S., Bretz, Frank

Journal:

Statistics in Biopharmaceutical Research

Year:

2010

Language:

english

File:

PDF, 137 KB

english, 2010