Publications by authors named "Pritibha Singh"

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Integrating Sustainability Pillars Into Trial Design Decision-Making: Results of an International Survey.
Pritibha Singh, Oleksandr Sverdlov, Robert A Beckman, Andrea M Burden

Clin Transl Sci· May 2025

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Incorporating Prior Data in Quantitative Benefit-Risk Assessments: Case Study of a Bayesian Method.
Sai Dharmarajan, Zhong Yuan, Yeh-Fong Chen, Leila Lackey, Saurabh Mukhopadhyay, Pritibha Singh

Ther Innov Regul Sci· May 2024

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Correction: Incorporating Prior Data in Quantitative Benefit-Risk Assessments: Case Study of a Bayesian Method.
Sai Dharmarajan, Zhong Yuan, Yeh-Fong Chen, Leila Lackey, Saurabh Mukhopadhyay, Pritibha Singh

Ther Innov Regul Sci· May 2024

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Design and Execution of Sustainable Decentralized Clinical Trials.
Pritibha Singh, Andrea M Burden, Fanni Natanegara, Robert A Beckman

Clin Pharmacol Ther· October 2023

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Platform trials to evaluate the benefit-risk of COVID-19 therapeutics: Successes, learnings, and recommendations for future pandemics.
Joan Buenconsejo, Ran Liao, Junjing Lin, Pritibha Singh, Freda Cooner

Contemp Clin Trials· September 2023

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Advancing innovative clinical trials to efficiently deliver medicines to patients.
Robert A Beckman, Fanni Natanegara, Pritibha Singh, Freda Cooner, Zoran Antonijevic

Nat Rev Drug Discov· August 2022

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A New Comprehensive Approach to Assess the Probability of Success of Development Programs Before Pivotal Trials.
Lisa V Hampson, Björn Holzhauer, Björn Bornkamp, Joseph Kahn, Markus R Lange, Pritibha Singh

Clin Pharmacol Ther· May 2022

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Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice.
Bohdana Ratitch, James Bell, Craig Mallinckrodt, Jonathan W Bartlett, Niti Goel, Pritibha Singh

Ther Innov Regul Sci· March 2020

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Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines.
Bohdana Ratitch, Niti Goel, Craig Mallinckrodt, James Bell, Jonathan W Bartlett, Pritibha Singh

Ther Innov Regul Sci· March 2020

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Healthy donor hematopoietic stem cell mobilization with biosimilar granulocyte-colony-stimulating factor: safety, efficacy, and graft performance.
Petra Becker, Arnd Schwebig, Susanne Brauninger, Heike Bialleck, Beate Luxembourg, Pritibha Singh

Transfusion· December 2016

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A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2), a Phase III, Randomized, Double-Blind Trial.
Kimberly Blackwell, Roman Donskih, C Michael Jones, Allen Nixon, Maria J Vidal, Pritibha Singh

Oncologist· July 2016

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Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.
Nadia Harbeck, Oleg Lipatov, Mona Frolova, Dmitry Udovitsa, Eldar Topuzov, Pritibha Singh

Future Oncol· June 2016

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Pharmacokinetics, Safety and Bioequivalence of Levetiracetam Intravenous Infusion and Oral Tablets in Healthy Chinese Subjects.
Nathalie Toublanc, Xinlu Du, Yun Liu, Qian Chen, Pritibha Singh

Clin Drug Investig· August 2015

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Switch from oral pramipexole or ropinirole to rotigotine transdermal system in advanced Parkinson's disease: an open-label study.
Sun Ju Chung, Jong-Min Kim, Jae Woo Kim, Beom Seok Jeon, Pritibha Singh

Expert Opin Pharmacother· May 2015

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Comparability of biosimilar filgrastim with originator filgrastim: protein characterization, pharmacodynamics, and pharmacokinetics.
Fritz Sörgel, Arnd Schwebig, Johann Holzmann, Stefan Prasch, Pritibha Singh

BioDrugs· April 2015

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Rotigotine transdermal system as add-on to oral dopamine agonist in advanced Parkinson's disease: an open-label study.
Jong-Min Kim, Sun Ju Chung, Jae Woo Kim, Beom Seok Jeon, Pritibha Singh

BMC Neurol· February 2015

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Academic outcomes in Asian children aged 8-11 years with attention-deficit/hyperactivity disorder treated with atomoxetine hydrochloride.
Luis Mendez, Pritibha Singh, Gavan Harrison, Yu-Shu Huang, Xingming Jin

Int J Psychiatry Clin Pract· June 2011

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Association between painful physical symptoms and clinical outcomes in Chinese patients with major depressive disorder: a three-month observational study.
Hui-chun Li, Ming-yuan Zhang, Gang Wang, Hong-geng Zhang, Hong-yan Zhang, Pritibha Singh

Chin Med J (Engl)· August 2010

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Factors associated with weight gain during olanzapine treatment in patients with schizophrenia or bipolar disorder: results from a six-month prospective, multinational, observational study.
Tamás Treuer, Vicki Poole Hoffmann, Antony Kuang-Peng Chen, Victoria Irimia, Magdalena Ocampo, Pritibha Singh

World J Biol Psychiatry· March 2010

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Association between Painful Physical Symptoms and Clinical Outcomes in Korean Patients with Major Depressive Disorder: A Three-Month Observational Study.
Min Soo Lee, Sun Young Yum, Jin Pyo Hong, Se Chang Yoon, Jai Sung Noh, Pritibha Singh

Psychiatry Investig· December 2009

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