V. Dragalin

发表

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

F. Hsuan, V. Dragalin, S. K. Padmanabhan, 2007, Journal of biopharmaceutical statistics.

Optimal Design of Experiments for Delayed Responses in Clinical Trials

V. Dragalin, 2013 .

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

M. Krams, W. Maurer, J. Pinheiro, 2007, Journal of biopharmaceutical statistics.

Adaptive Penalized D-Optimal Designs for Dose Finding Based on Continuous Efficacy and Toxicity

F. Hsuan, V. Dragalin, S. K. Padmanabhan, 2010 .

Sequential Methods in Multi-Arm Clinical Trials

V. Dragalin, 2010 .

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

V. Fedorov, V. Dragalin, 2006 .

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

M. Krams, J. Pinheiro, P. Gallo, 2006, Journal of biopharmaceutical statistics.

Rejoinder

M. Krams, J. Pinheiro, P. Gallo, 2006 .

Design of multi‐centre trials with binary response

V. Fedorov, V. Dragalin, 2006, Statistics in medicine.

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

Valerii V. Fedorov, Vladimir Dragalin, Yuehui Wu, 2008 .

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

Vladimir Dragalin, Yuehui Wu, V. Fedorov, 2008, Statistics in medicine.

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

I. Bebu, V. Dragalin, G. Luta, 2013, Biometrical journal. Biometrische Zeitschrift.

Likelihood inference for a two‐stage design with treatment selection

Vladimir Dragalin, Ionut Bebu, George Luta, 2010, Biometrical journal. Biometrische Zeitschrift.

Multistage Designs for Vaccine Safety Studies

V. Fedorov, V. Dragalin, 2006, Journal of biopharmaceutical statistics.

II. Simulation and Retrospective Assessment of Performance of the Proposed FDA metric and the Kullback-Leibler Divergence in Individual Bioequivalence Assessment

V. Fedorov, B. Jones, V. Dragalin, 2001 .

Simulation Practices for Adaptive Trial Designs in Drug and Device Development

S. Leonov, A. Hartford, V. Dragalin, 2019, Statistics in Biopharmaceutical Research.

An introduction to adaptive designs and adaptation in CNS trials

V. Dragalin, 2011, European Neuropsychopharmacology.

Viewpoints on the FDA Draft Adaptive Designs Guidance from the PhRMA Working Group

M. Krams, J. Pinheiro, P. Gallo, 2010, Journal of biopharmaceutical statistics.

Oral Clonidine in Postmenopausal Patients with Breast Cancer Experiencing Tamoxifen-Induced Hot Flashes: A University of Rochester Cancer Center Community Clinical Oncology Program Study

P. Flynn, K. Pandya, V. Dragalin, 2000, Annals of Internal Medicine.

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

V. Dragalin, E. Polverejan, 2020 .

Variables influencing penicillin treatment outcome in streptococcal tonsillopharyngitis.

M. Pichichero, V. Dragalin, A. Francis, 1999, Archives of pediatrics & adolescent medicine.

An optimal sequential selection procedure

V. Dragalin, 1995 .

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

A. Whitehead, J. Whitehead, H. Thygesen, 2012, Pharmaceutical statistics.

How Adaptive Trial Designs can Increase Efficiency in Psychiatric Drug Development: A Case Study.

M. Krams, S. Preskorn, Amarnath Sharma, 2011, Innovations in clinical neuroscience.

A Simulation Study to Compare New Adaptive Dose–Ranging Designs

Frank Bretz, Joshua R. Smith, José Pinheiro, 2010 .

Authors' response to comments

Frank Bretz, Gernot Wassmer, Peter Bauer, 2016, Statistics in medicine.

Adaptive Designs: Terminology and Classification

Vladimir Dragalin, V. Dragalin, 2006 .

Considerations and Optimization of Adaptive Trial Design in Clinical Development Programs

Michael Krams, Vladimir Dragalin, M. Krams, 2014 .

Views on Emerging Issues Pertaining to Data Monitoring Committees for Adaptive Trials

Christy Chuang-Stein, Vladimir Dragalin, Paul Gallo, 2013, Therapeutic innovation & regulatory science.

Adaptive and Model-Based Dose-Ranging Trials: Quantitative Evaluation and Recommendations. White Paper of the PhRMA Working Group on Adaptive Dose-Ranging Studies

Frank Bretz, Joshua R. Smith, Chyi-Hung Hsu, 2010 .

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

Jeff Maca, Suman Bhattacharya, Michael Krams, 2006 .

Data Monitoring in Adaptive Dose-Ranging Trials

Frank Bretz, Paul Gallo, Michael Krams, 2010 .

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

Frank Bretz, Gernot Wassmer, Peter Bauer, 2015, Statistics in medicine.

A Case Study for Adaptive Trial Design Consideration and Implementation

Michael Krams, Vladimir Dragalin, M. Krams, 2014 .

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

Vladimir Dragalin, Michael Krams, Scott Berry, 2012, Journal of biopharmaceutical statistics.

Discussion on “Likelihood Ratio Identities and Their Applications to Sequential Analysis” by Tze L. Lai

V. Dragalin, 2004 .

Adaptive Clinical Trials: Overview of Phase III Designs and Challenges

Vladimir Dragalin, Paul Gallo, Jeff Maca, 2014, Therapeutic innovation & regulatory science.

Designing Issues in Confirmatory Adaptive Population Enrichment Trials

Gernot Wassmer, G. Wassmer, V. Dragalin, 2015, Journal of biopharmaceutical statistics.

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

S Krishna Padmanabhan, Vladimir Dragalin, V. Dragalin, 2010, Biometrical journal. Biometrische Zeitschrift.

Kullback–Leibler divergence for evaluating bioequivalence

Byron Jones, Vladimir Dragalin, Valerii Fedorov, 2003, Statistics in medicine.

Statistical approaches to establishing vaccine safety

V. Fedorov, V. Dragalin, B. Cheuvart, 2002, Statistics in medicine.

Multihypothesis sequential probability ratio tests - Part I: Asymptotic optimality

Venugopal V. Veeravalli, Alexander G. Tartakovsky, Vladimir P. Dragalin, 1999, IEEE Trans. Inf. Theory.

Multihypothesis sequential probability ratio tests - Part II: Accurate asymptotic expansions for the expected sample size

Venugopal V. Veeravalli, Alexander G. Tartakovsky, Vladimir P. Dragalin, 2000, IEEE Trans. Inf. Theory.

The Total Least Squares Method in Individual Bioequivalence Evaluation

V. Fedorov, V. Dragalin, 2001 .