Advancing innovative clinical trials to efficiently deliver medicines to patients
Beckman, Robert A., Natanegara, Fanni, Singh, Pritibha, Cooner, Freda, Antonijevic, Zoran, Liu, Yi, Mayer, Cristiana, Price, Karen, Tang, Rui, Xia, Amy, Apostolaros, Maria, Granville, Courtney, Michaels, Debra
Published in Nature reviews. Drug discovery (01.08.2022)
Published in Nature reviews. Drug discovery (01.08.2022)
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Journal Article
Donanemab (LY3002813) dose‐escalation study in Alzheimer's disease
Lowe, Stephen Loucian, Willis, Brian A., Hawdon, Anne, Natanegara, Fanni, Chua, Laiyi, Foster, Joanne, Shcherbinin, Sergey, Ardayfio, Paul, Sims, John R.
Published in Alzheimer's & dementia : translational research & clinical interventions (2021)
Published in Alzheimer's & dementia : translational research & clinical interventions (2021)
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Journal Article
Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development
Clark, Jennifer, Muhlemann, Natalia, Natanegara, Fanni, Hartley, Andrew, Wenkert, Deborah, Wang, Fei, Harrell, Frank E., Bray, Ross
Published in Therapeutic innovation & regulatory science (01.05.2023)
Published in Therapeutic innovation & regulatory science (01.05.2023)
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Journal Article
Why are There not More Bayesian Clinical Trials? Ability to Interpret Bayesian and Conventional Statistics Among Medical Researchers
Bray, Ross, Hartley, Andrew, Wenkert, Deborah, Muehlemann, Natalia, Natanegara, Fanni, Harrell, Frank E., Wang, Fei, Clark, Jennifer
Published in Therapeutic innovation & regulatory science (01.05.2023)
Published in Therapeutic innovation & regulatory science (01.05.2023)
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Journal Article
Decision making in clinical trials: Interim analyses, innovative design, and biomarkers
Welsh‐Bohmer, Kathleen A., Kerchner, Geoffrey A., Dhadda, Shobha, Garcia, Miguel, Miller, David S., Natanegara, Fanni, Raket, Lars Lau, Robieson, Weining, Siemers, Eric R., Carrillo, Maria C., Weber, Christopher J.
Published in Alzheimer's & dementia : translational research & clinical interventions (01.10.2023)
Published in Alzheimer's & dementia : translational research & clinical interventions (01.10.2023)
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Journal Article
Pharmacodynamics and pharmacokinetics of single doses of prasugrel 30 mg and clopidogrel 300 mg in healthy chinese and white volunteers: An open-label trial
Small, David S., PhD, Payne, Christopher D., MS, Kothare, Prajakti, PhD, Yuen, Eunice, BPharm, Natanegara, Fanni, PhD, Teng Loh, Mei, PhD, Jakubowski, Joseph A., PhD, Richard Lachno, D., DPhil, Li, Ying G., MS, Winters, Kenneth J., MD, Farid, Nagy A., PhD, Ni, Lan, PhD, Salazar, Daniel E., PhD, Tomlin, Molly, MS, Kelly, Ronan, MD, DPhil
Published in Clinical therapeutics (01.02.2010)
Published in Clinical therapeutics (01.02.2010)
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Journal Article
Study protocol: systematic review and meta-analysis of randomized controlled trials in first-line treatment of squamous non-small cell lung cancer
DeLozier, Amy M, Brown, Jacqueline, Natanegara, Fanni, Zhao, Luping, Cui, Zhanglin Lin, Able, Stephen L, Bowman, Lee, Treat, Joseph, Hess, Lisa M
Published in Systematic reviews (16.09.2014)
Published in Systematic reviews (16.09.2014)
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Journal Article
Design and Execution of Sustainable Decentralized Clinical Trials
Singh, Pritibha, Burden, Andrea M., Natanegara, Fanni, Beckman, Robert A.
Published in Clinical pharmacology and therapeutics (01.10.2023)
Published in Clinical pharmacology and therapeutics (01.10.2023)
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Journal Article
Evaluation of the performance of alternative models in analyzing longitudinal data for Alzheimer clinical trials compared to MMRM
Wang, Guoqiao, Li, Yan, Xiong, Chengjie, Liu, Lei, Kennedy, Richard E, Schneider, Lon S., Natanegara, Fanni, McDade, Eric, Bateman, Randall J.
Published in Alzheimer's & dementia (01.12.2022)
Published in Alzheimer's & dementia (01.12.2022)
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Journal Article
MEDI1814 selectively reduces free Aβ42 in cerebrospinal fluid of non-clinical species and Alzheimer's disease patients
Lloyd, Christopher, Freskgård, Per-Ola, Newton, Philip, Lowne, David, Nickson, Adrian, Bogstedt, Anna, Eketjäll, Susanna, Höglund, Kina, Gustavsson, Susanne, Welsh, Fraser, Chessell, Tharani, McFarlane, Mary, Bhat, Ratan V, Turner, Richard, Perkinton, Michael S, Santisteban Valencia, Zulma, Lindqvist, Eva, Pomfret, Michael, Dudley, Amanda D, Vaughan, Tristan J, Groves, Maria T, Natanegara, Fanni, Feng, Yingdong, Sims, John R, Proctor, Nicholas Kyle, Dage, Jeffrey L, Shering, Craig, Tan, Keith, Ostenfeld, Thor, Billinton, Andy, Chessell, Iain P
Published in Alzheimer's & dementia (25.09.2024)
Published in Alzheimer's & dementia (25.09.2024)
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Journal Article
Phase II (NAVIGATE-AD study) Results of LY3202626 Effects on Patients with Mild Alzheimer’s Disease Dementia
Lo, Albert C., Evans, Cynthia Duggan, Mancini, Michele, Wang, Hong, Shcherbinin, Sergey, Lu, Ming, Natanegara, Fanni, Willis, Brian A.
Published in JAD reports (29.04.2021)
Published in JAD reports (29.04.2021)
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Journal Article
Bayesian methods for the design and analysis of noninferiority trials
Gamalo-Siebers, Margaret, Gao, Aijun, Lakshminarayanan, Mani, Liu, Guanghan, Natanegara, Fanni, Railkar, Radha, Schmidli, Heinz, Song, Guochen
Published in Journal of biopharmaceutical statistics (02.09.2016)
Published in Journal of biopharmaceutical statistics (02.09.2016)
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Journal Article
IMPLEMENTATION OF DUAL-PHASE FLORBETAPIR PET IN THE MULTICENTER PHASE 2 NAVIGATE-AD CLINICAL TRIAL
Shcherbinin, Sergey, Hesterman, Jacob, Devous, Michael D., Natanegara, Fanni, You, Wenqi, Evans, Cynthia Duggan, Collins, Emily C., Lo, Albert, Sims, John R., Mintun, Mark A.
Published in Alzheimer's & dementia (01.07.2019)
Published in Alzheimer's & dementia (01.07.2019)
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Journal Article
PLASMA NF-L AS A BIOMARKER FOR NEURODEGENERATION IN MILD AD SUBJECTS IN THE PHASE 2 NAVIGATE-AD STUDY
Wang, Hong, Charil, Arnaud, Shcherbinin, Sergey, Natanegara, Fanni, Chao, Georgia, Evans, Cynthia Duggan, Dage, Jeffrey, Irizarry, Michael C., Lo, Albert, Sims, John R.
Published in Alzheimer's & dementia (01.07.2019)
Published in Alzheimer's & dementia (01.07.2019)
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Journal Article
P3‐026: IMPLEMENTATION OF DUAL‐PHASE FLORBETAPIR PET IN THE MULTICENTER PHASE 2 NAVIGATE‐AD CLINICAL TRIAL
Shcherbinin, Sergey, Hesterman, Jacob, Devous, Michael D., Natanegara, Fanni, You, Wenqi, Evans, Cynthia Duggan, Collins, Emily C., Lo, Albert, Sims, John R., Mintun, Mark A.
Published in Alzheimer's & dementia (01.07.2019)
Published in Alzheimer's & dementia (01.07.2019)
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Journal Article
P1‐048: PLASMA NF‐L AS A BIOMARKER FOR NEURODEGENERATION IN MILD AD SUBJECTS IN THE PHASE 2 NAVIGATE‐AD STUDY
Wang, Hong, Charil, Arnaud, Shcherbinin, Sergey, Natanegara, Fanni, Chao, Georgia, Evans, Cynthia Duggan, Dage, Jeffrey, Irizarry, Michael C., Lo, Albert, Sims, John R.
Published in Alzheimer's & dementia (01.07.2019)
Published in Alzheimer's & dementia (01.07.2019)
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Journal Article
Statistical Opportunities to Accelerate Development for COVID-19 Therapeutics
Natanegara, Fanni, Zariffa, Névine, Buenconsejo, Joan, Cooner, Freda, Lakshminarayanan, Divya, Ghosh, Samiran, Schindler, Jerald S., Gamalo, Margaret
Published in Statistics in biopharmaceutical research (02.01.2022)
Published in Statistics in biopharmaceutical research (02.01.2022)
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Journal Article
Brain target occupancy of LY3372689, an inhibitor of the O‐GlcNAcase (OGA) enzyme: Translation from rat to human: Neuroimaging / evaluating treatments
Shcherbinin, Sergey, Kielbasa, William, Dubois, Susan, Lowe, Stephen L, Phipps, Krista M, Tseng, James, Kevin, Donnelly B, Natanegara, Fanni, Warner, Susan, Dreyfus, Nicolas, Lindsay‐Scott, Peter, Hawk, Mai Khanh, McDonald, Nicholas, Zhang, Xiaoyu, Gilmore, Julie A, Biglan, Kevin, Mergott, Dustin J, Russell, David, Gunn, Roger N, Constantinescu, Cristian, Nuthall, Hugh Norman, Collins, Emily C
Published in Alzheimer's & dementia (01.12.2020)
Published in Alzheimer's & dementia (01.12.2020)
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Journal Article
Brain target occupancy of LY3372689, an inhibitor of the O‐GlcNAcase (OGA) enzyme: Translation from rat to human
Shcherbinin, Sergey, Kielbasa, William, Dubois, Susan, Lowe, Stephen L, Phipps, Krista M, Tseng, James, Kevin, Donnelly B, Natanegara, Fanni, Warner, Susan, Dreyfus, Nicolas, Lindsay‐Scott, Peter, Hawk, Mai Khanh, McDonald, Nicholas, Zhang, Xiaoyu, Gilmore, Julie A, Biglan, Kevin, Mergott, Dustin J, Russell, David, Gunn, Roger N, Constantinescu, Cristian, Nuthall, Hugh Norman, Collins, Emily C
Published in Alzheimer's & dementia (01.12.2020)
Published in Alzheimer's & dementia (01.12.2020)
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Journal Article
A single ascending dose study in healthy volunteers to assess the safety and PK of LY3372689, an inhibitor of O‐GlcNAcase (OGA) enzyme
Kielbasa, William, Phipps, Krista M, Tseng, James, Natanegara, Fanni, Cheng, Eden, Monk, Scott A., Bundgaard, Christoffer, Kevin, Donnelly B., Nuthall, Hugh Norman, McDonald, Nicholas, Lindsay‐Scott, Peter, Dreyfus, Nicolas, Hawk, Mai Khanh, Warner, Susan, Biglan, Kevin, Gilmore, Julie A., Zhang, Xiaoyu, Mergott, Dustin J., Lowe, Stephen L.
Published in Alzheimer's & dementia (01.12.2020)
Published in Alzheimer's & dementia (01.12.2020)
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