Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials von Hanania, Nicola A, Dr, Korenblat, Phillip, Prof, Chapman, Kenneth R, Prof, Bateman, Eric D, Prof, Kopecky, Petr, MD, Paggiaro, Pierluigi, Prof, Yokoyama, Akihito, Prof, Olsson, Julie, MD, Gray, Sarah, PhD, Holweg, Cecile T J, PhD, Eisner, Mark, MD, Asare, Charles, MD, Fischer, Saloumeh K, PhD, Peng, Kun, PhD, Putnam, Wendy S, PhD, Matthews, John G, MB BS

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Pre-analytical stability of ocrelizumab in serum after delayed centrifugation of whole blood von Shim, Jeongsup, Carrasco-Triguero, Montserrat, Fischer, Saloumeh K.

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Evaluating the Use of Antibody Variable Region (Fv) Charge as a Risk Assessment Tool for Predicting Typical Cynomolgus Monkey Pharmacokinetics von Bumbaca Yadav, Daniela, Sharma, Vikas K., Boswell, Charles Andrew, Hotzel, Isidro, Tesar, Devin, Shang, Yonglei, Ying, Yong, Fischer, Saloumeh K., Grogan, Jane L., Chiang, Eugene Y., Urban, Konnie, Ulufatu, Sheila, Khawli, Leslie A., Prabhu, Saileta, Joseph, Sean, Kelley, Robert F.

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Characterization of IL-17AA and IL-17FF in rheumatoid arthritis and multiple sclerosis von Schofield, Cheryl, Fischer, Saloumeh K, Townsend, Michael J, Mosesova, Sofia, Peng, Kun, Setiadi, Alvernia Francesca, Song, An, Baruch, Amos

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Lebrikizumab in moderate-to-severe asthma: pooled data from two randomised placebo-controlled studies von Hanania, Nicola A, Noonan, Michael, Corren, Jonathan, Korenblat, Phillip, Zheng, Yanan, Fischer, Saloumeh K, Cheu, Melissa, Putnam, Wendy S, Murray, Elaine, Scheerens, Heleen, Holweg, Cecile TJ, Maciuca, Romeo, Gray, Sarah, Doyle, Ramona, McClintock, Dana, Olsson, Julie, Matthews, John G, Yen, Karl

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Point-of-care and utility in clinical trials: making quicker decisions to transform patient care and drug development von Fischer, Saloumeh K.

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Evaluation of low volume sampling devices for a pharmacodynamic biomarker analysis: Challenges and solutions von Yang, Xiaoyun, Logis, Evelin, Williams, Kathi, Sheng, X. Rebecca, Fischer, Saloumeh K.

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Overcoming Soluble Target Interference in Measurement of Total Bispecific Therapeutic Antibody Concentrations von Shim, Jeongsup, Chen, Jessica, Carrasco-Triguero, Montserrat, Fischer, Saloumeh K.

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Assessment of low volume sampling technologies: utility in nonclinical and clinical studies von Williams, Kathi J., Lutman, Jeff, McCaughey, Cynthia, Fischer, Saloumeh K.

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The assay design used for measurement of therapeutic antibody concentrations can affect pharmacokinetic parameters: Case studies von Fischer, Saloumeh K., Yang, Jihong, Anand, Banmeet, Cowan, Kyra, Hendricks, Robert, Li, Jing, Nakamura, Gerald, Song, An

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A generic anti-drug antibody assay for monoclonal antibody therapeutics with broad dynamic range eliminates the need for titer evaluation in preclinical studies von Li, Hao, Foley, Alejandro R., Shim, Jeongsup, Siradze, Ketevan, Webb-Vargas, Yenny, Sperinde, Gizette, Fischer, Saloumeh K.

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Development of an IL-6 point-of-care assay: utility for real-time monitoring and management of cytokine release syndrome and sepsis von Fischer, Saloumeh K, Williams, Kathi, Wang, Ling, Capio, Emmanuel, Briman, Mikhail

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Establishment of neurofilament light chain Simoa assay in cerebrospinal fluid and blood von Hendricks, Robert, Baker, Dana, Brumm, Jochen, Davancaze, Teresa, Harp, Chris, Herman, Ann, von Büdingen, H-Christian, Townsend, Michael, Fischer, Saloumeh K

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Successful Development of Nonclinical Anti-Drug Antibody Assays to Support Zinpentraxin Alfa Reproductive Toxicology Studies von Arjomandi, Audrey, Siradze, Ketevan, Cheu, Melissa, Davancaze, Teresa, Yadav, Rajbharan, Rao, Gautham K., Wong, Lisa, Fischer, Saloumeh K.

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Novel Selective Quantification of Zinpentraxin Alfa Biotherapeutic in the Presence of Endogenous Isomer in Plasma Samples of Idiopathic Pulmonary Fibrosis Patients Using Immunoaffi... von Li, Maoyin, Arjomandi, Audrey, Sun, Xiaowei, Lu, Erhu, Tyagi, Tulika, Lin, WeiYu, Fischer, Saloumeh K., Kaur, Surinder, Xu, Keyang

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Factors contributing to the nonlinear pharmacokinetics of astegolimab: a close examination of potential causes von Sperinde, Gizette, Dolton, Michael, Zhang, Wenhui, Mathews, Joel, Putnam, Wendy, Fischer, Saloumeh K

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Emerging Technologies to Increase Ligand Binding Assay Sensitivity von Fischer, Saloumeh K., Joyce, Alison, Spengler, Mark, Yang, Tong-Yuan, Zhuang, Yao, Fjording, Marianne Scheel, Mikulskis, Alvydas

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Critical role of bioanalytical strategies in investigation of clinical PK observations, a Phase I case study von Peng, Kun, Xu, Keyang, Liu, Luna, Hendricks, Robert, Delarosa, Reginald, Erickson, Rich, Budha, Nageshwar, Leabman, Maya, Song, An, Kaur, Surinder, Fischer, Saloumeh K

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The Development and Characterization of a Highly Sensitive Mature TGFβ3 Assay to Evaluate Anti-TGFβ3 Target Engagement von Setiadi, A. Francesca, Sperinde, Gizette, Cheu, Melissa, Liang, Wei-Ching, Lin, WeiYu, Mahood, Connie, Fischer, Saloumeh K.

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Measurement of IL-17AA and IL-17FF as Pharmacodynamic Biomarkers to Demonstrate Target Engagement in the Phase I Study of MCAF5352A von Peng, Kun, Wang, Yehong, Siradze, Ketevan, Erickson, Rich, Fischer, Saloumeh K., Staton, Tracy L.

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