Long-term efficacy, safety, and patient-reported outcomes of apitegromab in patients with spinal muscular atrophy: results from the 36-month TOPAZ study
Crawford, Thomas O., Day, John W., De Vivo, Darryl C., Krueger, Jena M., Mercuri, Eugenio, Nascimento, Andres, Pasternak, Amy, Mazzone, Elena Stacy, Duong, Tina, Song, Guochen, Marantz, Jing L., Baver, Scott, Yu, Dongzi, Liu, Lan, Darras, Basil T.
Published in Frontiers in neurology (22.07.2024)
Published in Frontiers in neurology (22.07.2024)
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Responses to antipsychotic therapy among patients with schizophrenia or schizoaffective disorder and either predominant or prominent negative symptoms
Stauffer, Virginia L, Song, Guochen, Kinon, Bruce J, Ascher-Svanum, Haya, Chen, Lei, Feldman, Peter D, Conley, Robert R
Published in Schizophrenia research (01.02.2012)
Published in Schizophrenia research (01.02.2012)
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Randomized Phase IIa Clinical Study of an Anti-αvβ6 Monoclonal Antibody in Idiopathic Pulmonary Fibrosis
Raghu, Ganesh, Mouded, Majd, Prasse, Antje, Stebbins, Christopher, Zhao, Guolin, Song, Guochen, Arefayene, Million, Violette, Shelia M, Gallagher, Diana, Gibson, Kevin F
Published in American journal of respiratory and critical care medicine (01.11.2022)
Published in American journal of respiratory and critical care medicine (01.11.2022)
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Randomized Phase IIa Clinical Study of an Anti-α v β 6 Monoclonal Antibody in Idiopathic Pulmonary Fibrosis
Raghu, Ganesh, Mouded, Majd, Prasse, Antje, Stebbins, Christopher, Zhao, Guolin, Song, Guochen, Arefayene, Million, Violette, Shelia M, Gallagher, Diana, Gibson, Kevin F
Published in American journal of respiratory and critical care medicine (01.11.2022)
Published in American journal of respiratory and critical care medicine (01.11.2022)
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Safety and Efficacy of Apitegromab in Patients With Spinal Muscular Atrophy Types 2 and 3: The Phase 2 TOPAZ Study
Crawford, Thomas O, Darras, Basil T, Day, John W, Dunaway Young, Sally, Duong, Tina, Nelson, Leslie L, Barrett, Doreen, Song, Guochen, Bilic, Sanela, Cote, Shaun, Sadanowicz, Mara, Iarrobino, Ryan, Xu, Tiina J, O'Neil, Janet, Rossello, José, Place, Amy, Kertesz, Nathalie, Nomikos, George, Chyung, Yung
Published in Neurology (12.03.2024)
Published in Neurology (12.03.2024)
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Relationship of pharmacokinetics and pharmacodynamics to apitegromab efficacy in patients with later-onset spinal muscular atrophy (Types 2 and 3 SMA): Results from the TOPAZ study
Crawford, Thomas, Place, Amy, Barrett, Doreen, Cote, Shaun, Nomikos, George, Song, Guochen, Bilic, Sanela, Kalra, Ashish, Sadanowicz, Mara, O'Neil, Janet, Iarrobino, Ryan, Kertesz, Nathalie, Chyung, Yung
Published in Journal of the neurological sciences (01.10.2021)
Published in Journal of the neurological sciences (01.10.2021)
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First-in-human phase 1 trial (DRAGON) of SRK-181, a potential first-in-class selective latent TGFβ1 inhibitor, alone or in combination with anti-PD-(L)1 treatment in patients with advanced solid tumors
Yap, Timothy A., Barve, Minal A., Gainor, Justin F., Weekes, Colin D., Bockorny, Bruno, Ju, Yawen, Faucette, Ryan, Bilic, Sanela, Lee-Hoeflich, Si Tuen, Song, Guochen, Chyung, Yung, Legler, Michelle, Gan, Lu, Bendell, Johanna C.
Published in Journal of clinical oncology (20.05.2021)
Published in Journal of clinical oncology (20.05.2021)
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Statistical modeling for Bayesian extrapolation of adult clinical trial information in pediatric drug evaluation
Gamalo‐Siebers, Margaret, Savic, Jasmina, Basu, Cynthia, Zhao, Xin, Gopalakrishnan, Mathangi, Gao, Aijun, Song, Guochen, Baygani, Simin, Thompson, Laura, Xia, H. Amy, Price, Karen, Tiwari, Ram, Carlin, Bradley P.
Published in Pharmaceutical statistics : the journal of the pharmaceutical industry (01.07.2017)
Published in Pharmaceutical statistics : the journal of the pharmaceutical industry (01.07.2017)
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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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A Time-response Measure to Assess Clinical Equivalence in Rheumatoid Arthritis: an Assessment Using Data From Clinical Trials of Biosimilars
O'Kelly, Michael, Zhang, Aijing, Lipkovich, Ilya, Song, Guochen, Reeve, Russell, Ratitch, Bohdana, Li, Siying, Behnke, Martha, Kay, Jonathan, Chow, Shein-Chung, Baek, Inyoung
Published in Statistics in biopharmaceutical research (03.04.2022)
Published in Statistics in biopharmaceutical research (03.04.2022)
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Comparing oncology clinical programs by use of innovative designs and expected net present value optimization: Which adaptive approach leads to the best result?
Parke, Tom, Marchenko, Olga, Anisimov, Vladimir, Ivanova, Anastasia, Jennison, Christopher, Perevozskaya, Inna, Song, Guochen
Published in Journal of biopharmaceutical statistics (01.01.2017)
Published in Journal of biopharmaceutical statistics (01.01.2017)
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