Publications by authors named "Sandeep Menon"

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Combination MCP-Mod for two-drug combination dose-ranging studies.
Yifan Zhou, Abigail Sloan, Sandeep Menon, Ling Wang

J Biopharm Stat· March 2025

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Master protocols and other innovative trial designs in inflammation and immunology to expedite clinical drug development.
Elena Peeva, Anindita Banerjee, Christopher Banfield, Koshika Soma, Jared Christensen, Sandeep Menon

Drug Discov Today· May 2024

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Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Intravenous Infusions of PF-07304814 (Lufotrelvir) in Participants Hospitalized With COVID-19.
Philip Robinson, Sima S Toussi, Sudeepta Aggarwal, Arthur Bergman, Tong Zhu, Sandeep Menon

Open Forum Infect Dis· August 2023

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Innovative Randomized Phase I Study and Dosing Regimen Selection to Accelerate and Inform Pivotal COVID-19 Trial of Nirmatrelvir.
Ravi Shankar P Singh, Sima S Toussi, Frances Hackman, Phylinda L Chan, Rohit Rao, Sandeep Menon

Clin Pharmacol Ther· July 2022

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Achieving end-to-end success in the clinic: Pfizer's learnings on R&D productivity.
Kathy Fernando, Sandeep Menon, Kathrin Jansen, Prakash Naik, Gianluca Nucci

Drug Discov Today· March 2022

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Advancing cancer drug development through precision medicine and innovative designs.
Weidong Zhang, Jing Wang, Sandeep Menon

J Biopharm Stat· July 2019

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Clinical dose-response for a broad set of biological products: A model-based meta-analysis.
Joseph Wu, Anindita Banerjee, Bo Jin, Sandeep M Menon, Steven W Martin

Stat Methods Med Res· September 2018

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Biomarker informed add-arm design for unimodal response.
Jing Wang, Mark Chang, Sandeep Menon

J Biopharm Stat· November 2017

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Ethical Considerations in Adaptive Design Clinical Trials.
Thomas Laage, John W Loewy, Sandeep Menon, Eva R Miller, Erik Pulkstenis

Ther Innov Regul Sci· March 2017

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Safety and Efficacy of SBI-087, a Subcutaneous Agent for B Cell Depletion, in Patients with Active Rheumatoid Arthritis: Results from a Phase II Randomized, Double-blind, Placebo-controlled Study.
Nemanja Damjanov, Malgorzata Tlustochowicz, Jacob Aelion, Maria Greenwald, Annette Diehl, Sandeep Menon

J Rheumatol· December 2016

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Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of SBI-087, a CD20-Directed B-cell Depleting Agent: Phase 1 Dose Escalating Studies in Patients With Either Mild Rheumatoid Arthritis or Systemic Lupus.
Stanley Cohen, Megan Clowse, Patricia Pardo, Indranil Bhattacharya, Sandeep Menon

Clin Ther· June 2016

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An Adaptive Staggered Dose Design for a Normal Endpoint.
Joseph Wu, Sandeep Menon, Mark Chang

J Biopharm Stat· April 2016

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Inference of equivalence for the ratio of two normal means with unspecified variances.
Siyan Xu, Steven Ye Hua, Ronald Menton, Kerry Barker, Sandeep Menon

J Biopharm Stat· June 2015

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Covariate effect on constancy assumption in noninferiority clinical trials.
Siyan Xu, Kerry Barker, Sandeep Menon, Ralph B D'Agostino

J Biopharm Stat· June 2015

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On model selections for repeated measurement data in clinical studies.
Baiming Zou, Bo Jin, Gary G Koch, Haibo Zhou, Stephen E Borst, Sandeep Menon

Stat Med· May 2015

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Protein expression of the chemokine receptor CXCR4 and its ligand CXCL12 in primary cutaneous melanoma--biomarkers of potential utility?
Brendon Mitchell, Dominick Leone, Kyle Feller, Sandeep Menon, Philip Bondzie

Hum Pathol· October 2014

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Inference of bioequivalence for log-normal distributed data with unspecified variances.
Siyan Xu, Steven Y Hua, Ronald Menton, Kerry Barker, Sandeep Menon

Stat Med· July 2014

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A Practical Guide to Data Monitoring Committees in Adaptive Trials.
Matilde Sanchez-Kam, Paul Gallo, John Loewy, Sandeep Menon, Zoran Antonijevic

Ther Innov Regul Sci· May 2014

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Design of oncology clinical trials: a review.
Revathi Ananthakrishnan, Sandeep Menon

Crit Rev Oncol Hematol· October 2013

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Corrected profile likelihood confidence interval for binomial paired incomplete data.
Vivek Pradhan, Sandeep Menon, Ujjwal Das

Pharm Stat· July 2013

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Views on Emerging Issues Pertaining to Data Monitoring Committees for Adaptive Trials.
Zoran Antonijevic, Paul Gallo, Christy Chuang-Stein, Vladimir Dragalin, John Loewy, Sandeep Menon

Ther Innov Regul Sci· July 2013

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Optimization of adaptive designs: efficiency evaluation.
Sandeep Menon, Mark Chang

J Biopharm Stat· October 2012

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Integration of cell biology, pharmacological modeling and statistical analysis: part I: cell biology and PK/PD in the Oncology paradigm.
Revathi Ananthakrishnan, Sandeep Menon

Crit Rev Oncol Hematol· August 2012

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Does hormone therapy improve age-related skin changes in postmenopausal women? A randomized, double-blind, double-dummy, placebo-controlled multicenter study assessing the effects of norethindrone acetate and ethinyl estradiol in the improvement of mild to moderate age-related skin changes in postmenopausal women.
Tania J Phillips, James Symons, Sandeep Menon,

J Am Acad Dermatol· September 2008

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