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2 results on '"Hongyu (Jeanne) Jiang"'

1. SHP656, a polysialylated recombinant factor VIII (PSA‐rFVIII): First‐in‐human study evaluating safety, tolerability and pharmacokinetics in patients with severe haemophilia A

Author

Andreas Tiede, Pratima Chowdary, Margarita Timofeeva, Geoffrey Allen, Kathleen Kӧck, Martin J. Wolfsegger, Alexander Bauer, Hongyu Jeanne Jiang, Peter William Collins, Brahm Goldstein, István Takács, and Shouryadeep Srivastava

Subjects
safety, Adult, medicine.medical_specialty, polysialic acid, haemophilia A, 030204 cardiovascular system & hematology, Hemophilia A, Recombinant factor viii, Gastroenterology, 03 medical and health sciences, recombinant FVIII, 0302 clinical medicine, Pharmacokinetics, Internal medicine, medicine, Humans, In patient, tolerability, Clinical Haemophilia, Adverse effect, Genetics (clinical), Factor VIII, biology, business.industry, Immunogenicity, Original Articles, Hematology, General Medicine, Recombinant Proteins, Cohort, Sialic Acids, biology.protein, Original Article, Severe haemophilia A, Antibody, business, pharmacokinetics, 030215 immunology
Abstract

Introduction SHP656 is the first factor VIII (FVIII) product developed using polysialylation (PSA) technology, in which full‐length recombinant (r) FVIII (anti‐haemophilic factor [recombinant]) is conjugated with a 20 kDa PSA polymer. Aim To compare the safety, immunogenicity and pharmacokinetics of SHP656 vs the parent rFVIII (octocog alfa) after single infusions of 25‐75 IU/kg in patients with severe haemophilia A (FVIII activity

Published
2019

2. Fundamentals and Catalytic Innovation: The Statistical and Data Management Center of the Antibacterial Resistance Leadership Group.

Author

Huvane, Jacqueline, Komarow, Lauren, Hill, Carol, Tran, Thuy Tien T., Pereira, Carol, Rosenkranz, Susan L., Finnemeyer, Matt, Earley, Michelle, Hongyu (Jeanne) Jiang, Rui Wang, Lok, Judith, and Evans, Scott R.

Subjects
ANTIBACTERIAL agents, PUBLIC health, MEDICAL statistics, MEDICAL research, DRUG resistance in bacteria, THERAPEUTICS
Abstract

The Statistical and Data Management Center (SDMC) provides the Antibacterial Resistance Leadership Group (ARLG) with statistical and data management expertise to advance the ARLG research agenda. The SDMC is active at all stages of a study, including design; data collection and monitoring; data analyses and archival; and publication of study results. The SDMC enhances the scientific integrity of ARLG studies through the development and implementation of innovative and practical statistical methodologies and by educating research colleagues regarding the application of clinical trial fundamentals. This article summarizes the challenges and roles, as well as the innovative contributions in the design, monitoring, and analyses of clinical trials and diagnostic studies, of the ARLG SDMC. [ABSTRACT FROM AUTHOR]

Published
2017
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