Mining biomarkers in human sera using proteomic tools
Zhang, Rulin, Barker, Lisa, Pinchev, Deborah, Marshall, John, Rasamoelisolo, Michèle, Smith, Chris, Kupchak, Peter, Kireeva, Inga, Ingratta, Leslee, Jackowski, George
Published in Proteomics (Weinheim) (01.01.2004)
Published in Proteomics (Weinheim) (01.01.2004)
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Journal Article
Immunogenicity of biologic therapies for migraine: a review of current evidence
Cohen, Joshua M., Ning, Xiaoping, Kessler, Yoel, Rasamoelisolo, Michele, Campos, Verena Ramirez, Seminerio, Michael J., Krasenbaum, Lynda J., Shen, Honglue, Stratton, Jennifer
Published in Journal of headache and pain (07.01.2021)
Published in Journal of headache and pain (07.01.2021)
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Journal Article
Su1788 FIRST-IN-HUMAN PHARMACOKINETIC AND SAFETY STUDY OF AN ANTITL1A ANTIBODY, TEV-48574, IN HEALTHY VOLUNTEERS AND ASTHMA PATIENTS
Balyan, Rajiv, Ghibellini, Giulia, Sunzel, Eva Maria, Dreymann, Jennifer, Radivojevic, Andrijana, Dotan, Or, Angeles, Thelma, Li, Shawn, Papp, Andrea, Rasamoelisolo, Michele, Rabinovich-Guilatt, Laura
Published in Gastroenterology (New York, N.Y. 1943) (18.05.2024)
Published in Gastroenterology (New York, N.Y. 1943) (18.05.2024)
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Journal Article
A phase 1 study to assess the pharmacokinetics, safety, and tolerability of fremanezumab doses (225 mg, 675 mg and 900 mg) in Japanese and Caucasian healthy subjects
Cohen-Barak, Orit, Weiss, Sivan, Rasamoelisolo, Michele, Faulhaber, Nicola, Yeung, Paul P, Loupe, Pippa S, Yoon, Esther, Gandhi, Mohit D, Spiegelstein, Ofer, Aycardi, Ernesto
Published in Cephalalgia (01.11.2018)
Published in Cephalalgia (01.11.2018)
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Journal Article
Population pharmacokinetic modelling and simulation of fremanezumab in healthy subjects and patients with migraine
Fiedler‐Kelly, Jill B., Cohen‐Barak, Orit, Morris, Denise N., Ludwig, Elizabeth, Rasamoelisolo, Michele, Shen, Honglue, Levi, Micha
Published in British journal of clinical pharmacology (01.12.2019)
Published in British journal of clinical pharmacology (01.12.2019)
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Journal Article
Dose selection for fremanezumab (AJOVY) phase 3 pediatric migraine studies using pharmacokinetic data from a pediatric phase 1 study and a population pharmacokinetic modeling and simulation approach
Cohen-Barak, Orit, Radivojevic, Andrijana, Jones, Aksana, Fiedler-Kelly, Jill, Gillespie, Michael, Brennan, Michael, Gutman, Dikla, Rasamoelisolo, Michele, Hallak, Hussein, Loupe, Pippa, Kessler, Yoel, Ning, Xiaoping, Levi, Micha, Ahn, Andrew H, Rabinovich-Guilatt, Laura
Published in Cephalalgia (01.09.2021)
Published in Cephalalgia (01.09.2021)
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Journal Article
Safety, pharmacokinetic and pharmacodynamic properties of TV-1106, a long-acting GH treatment for GH deficiency
Cohen-Barak, Orit, Sakov, Anat, Rasamoelisolo, Michele, Bassan, Merav, Brown, Kurt, Mendzelevski, Boaz, Spiegelstein, Ofer
Published in European journal of endocrinology (01.11.2015)
Published in European journal of endocrinology (01.11.2015)
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Journal Article
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays
Pan, Luying, Mora, Johanna, Walravens, Karl, Wagner, Leslie, Hopper, Shirley, Loo, Lina, Bettoun, David, Bond, Sarah, Dessy, Francis, Downing, Sean, Garofolo, Fabio, Gupta, Soumi, Henderson, Neil, Irwin, Chad, Ishii-Watabe, Akiko, Kar, Sumit, Jawa, Vibha, Joseph, Julie, Malvaux, Ludovic, Marshall, Jean-Claude, McDevitt, Jessica, Mohapatra, Susovan, Seitzer, Jessica, Smith, Justin, Solstad, Therese, Sugimoto, Hiroshi, Tounekti, Omar, Wu, Bonnie, Wu, Yuling, Xu, Yuanxin, Xu, Joshua, Yamamoto, Takenori, Yang, Lin, Torri, Albert, Kirshner, Susan, Maxfield, Kimberly, Vasconcelos, Joao Pedras, Abhari, Mohsen Rajabi, Verthelyi, Daniela, Brodsky, Eric, Carrasco-Triguero, Montserrat, Kamerud, John, Andisik, Matthew, Baltrukonis, Daniel, Bivi, Nicoletta, Cludts, Isabelle, Coble, Kelly, Gorovits, Boris, Gunn, George R, Gupta, Swati, Millner, Anders Holm, Joyce, Alison, Kubiak, Robert J, Kumar, Seema, Liao, Karen, Manangeeswaran, Mohanraj, Partridge, Michael, Pine, Samuel, Poetzl, Johann, Rajadhyaksha, Manoj, Rasamoelisolo, Michele, Richards, Susan, Song, Yuan, Swanson, Steven, Thacker, Seth, Wadhwa, Meenu, Wolf, Andreas, Zhang, Lucia, Zhou, Lin
Published in Bioanalysis (01.07.2023)
Published in Bioanalysis (01.07.2023)
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Journal Article
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)
Mora, Johanna, Palmer, Rachel, Wagner, Leslie, Wu, Bonnie, Partridge, Michael, Meena, Sonderegger, Ivo, Smeraglia, John, Bivi, Nicoletta, Dakappagari, Naveen, Diebold, Sandra, Garofolo, Fabio, Grimaldi, Christine, Kalina, Warren, Kamerud, John, Kar, Sumit, Marshall, Jean-Claude, Mayer, Christian, Melton, Andrew, Merdek, Keith, Nolan, Katrina, Picard, Serge, Shao, Weiping, Seitzer, Jessica, Tanaka, Yoichi, Tounekti, Omar, Vigil, Adam, Walravens, Karl, Xu, Joshua, Xu, Weifeng, Xu, Yuanxin, Yang, Lin, Zhu, Liang, Verthelyi, Daniela, Kubiak, Robert J, Coble, Kelly, Gupta, Swati, Abhari, Mohsen Rajabi, Richards, Susan, Song, Yuan, Ullmann, Martin, Calderon, Boris, Cludts, Isabelle, Gunn, George R, Gupta, Shalini, Ishii-Watabe, Akiko, Manangeeswaran, Mohanraj, Maxfield, Kimberly, McCush, Fred, O'Day, Christine, Peng, Kate, Poetzl, Johann, Rasamoelisolo, Michele, Saad, Ola M, Scheibner, Kara, Shubow, Sophie, Song, Sam, Thacker, Seth
Published in Bioanalysis (01.04.2024)
Published in Bioanalysis (01.04.2024)
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Journal Article
Safety and PK/PD correlation of TV-1106, a recombinant fused human albumin-growth hormone, following repeat dose administration to monkeys
Ashkenazi, Nurit, Rosenstock, Moti, Hallak, Hussein, Bassan, Merav, Rasamoelisolo, Michele, Leuschner, Jost, Shinar, Doron
Published in Growth hormone & IGF research (01.10.2016)
Published in Growth hormone & IGF research (01.10.2016)
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Journal Article
A Pharmacokinetic Bioequivalence Study of Fremanezumab Administered Subcutaneously Using an Autoinjector and a Prefilled Syringe
Cherniakov, Irina, Cohen‐Barak, Orit, Tiver, Ryan, Gillespie, Michael, Kessler, Yoel, Gutierrez, Maria, Rasamoelisolo, Michele, Li, Shawn, Shen, Honglue, Hallak, Hussein, Loupe, Pippa S., Smith, Michael, Rabinovich‐Guilatt, Laura, Spiegelstein, Ofer
Published in Clinical pharmacology in drug development (01.09.2021)
Published in Clinical pharmacology in drug development (01.09.2021)
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Journal Article
A phase I clinical study of VB4-845: weekly intratumoral administration of an anti-EpCAM recombinant fusion protein in patients with squamous cell carcinoma of the head and neck
MacDonald, Glen C, Rasamoelisolo, Michèle, Entwistle, Joycelyn, Cizeau, Jeannick, Bosc, Denis, Cuthbert, Wendy, Kowalski, Mark, Spearman, Maureen, Glover, Nick
Published in Drug design, development and therapy (06.02.2009)
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Published in Drug design, development and therapy (06.02.2009)
Journal Article
Assessment of the Pharmacokinetics, Pharmacodynamics, and Safety of Single Doses of TV‐1106, a Long‐Acting Growth Hormone, in Healthy Japanese and Caucasian Subjects
Cohen‐Barak, Orit, Barkay, Hadas, Rasamoelisolo, Michele, Butler, Kathleen, Yamada, Kazumasa, Bassan, Merav, Yoon, Esther, Spiegelstein, Ofer
Published in Clinical pharmacology in drug development (01.07.2017)
Published in Clinical pharmacology in drug development (01.07.2017)
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Journal Article
Preclinical assessment of an anti-EpCAM immunotoxin: locoregional delivery provides a safer alternative to systemic administration
Brown, Jennifer, Rasamoelisolo, Michele, Spearman, Maureen, Bosc, Denis, Cizeau, Jeannick, Entwistle, Joycelyn, MacDonald, Glen C
Published in Cancer biotherapy & radiopharmaceuticals (01.08.2009)
Published in Cancer biotherapy & radiopharmaceuticals (01.08.2009)
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Journal Article
Diagnostic methods for congestive heart failure
VAN LIESHOUT TRACY, YANTHA JASON, THATCHER BRAD, JACKOWSKI GEORGE, ZHANG RULIN, RASAMOELISOLO MICHELE
Year of Publication 11.09.2012
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Year of Publication 11.09.2012
Patent
Diagnostic methods for congestive heart failure
Jackowski, George, Van Lieshout, Tracy, Thatcher, Brad, Zhang, Rulin, Yantha, Jason, Rasamoelisolo, Michele
Year of Publication 11.09.2012
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Year of Publication 11.09.2012
Patent
DIAGNOSTIC METHODS FOR CONGESTIVE HEART FAILURE
YANTHA, JASON, VAN LIESHOUT, TRACY, RASAMOELISOLO, MICHELE, ZHANG, RULIN, THATCHER, BRAD, JACKOWSKI, GEORGE
Year of Publication 06.06.2012
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Year of Publication 06.06.2012
Patent
DIAGNOSTIC METHODS FOR CONGESTIVE HEART FAILURE
VAN LIESHOUT TRACY, YANTHA JASON, THATCHER BRAD, JACKOWSKI GEORGE, ZHANG RULIN, RASAMOELISOLO MICHELE
Year of Publication 28.07.2011
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Year of Publication 28.07.2011
Patent