Search Results - "Arkin, S."

Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides—Harmonized Terminology and Tactical Recommendations by Shankar, G., Arkin, S., Cocea, L., Devanarayan, V., Kirshner, S., Kromminga, A., Quarmby, V., Richards, S., Schneider, C. K., Subramanyam, M., Swanson, S., Verthelyi, D., Yim, S.

“…Immunogenicity is a significant concern for biologic drugs as it can affect both safety and efficacy. To date, the descriptions of product immunogenicity have…”
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A first‐in‐human study of the safety, tolerability, pharmacokinetics and pharmacodynamics of PF‐06741086, an anti‐tissue factor pathway inhibitor mAb, in healthy volunteers by Cardinal, M., Kantaridis, C., Zhu, T., Sun, P., Pittman, D. D., Murphy, J. E., Arkin, S.

“…Essentials Tissue factor pathway inhibitor (TFPI) is an antagonist of FXa and the TF‐FVIIa complex. PF‐06741086 is an IgG1 monoclonal antibody that targets the…”
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Phase 1 dose‐escalating study to evaluate the safety, pharmacokinetics, and pharmacodynamics of a recombinant factor Xa variant (FXaI16L) by Parsons‐Rich, D., Hua, F., Li, G., Kantaridis, C., Pittman, D. D., Arkin, S.

“…Essentials FXaI16L is a recombinant zymogen‐like variant of activated coagulation factor X (FXa). A phase 1 dose escalation clinical trial of FXaI16L was…”
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Constraints on microbial metabolism drive evolutionary diversification in homogeneous environments by GUDELJ, I., BEARDMORE, R. E., ARKIN, S. S., MACLEAN, R. C.

“…Understanding the evolution of microbial diversity is an important and current problem in evolutionary ecology. In this paper, we investigated the role of two…”
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Phase 1, single‐dose escalating study of marzeptacog alfa (activated), a recombinant factor VIIa variant, in patients with severe hemophilia by Gruppo, R. A., Malan, D., Kapocsi, J., Nemes, L., Hay, C. R. M., Boggio, L., Chowdary, P., Tagariello, G., Drygalski, A., Hua, F., Scaramozza, M., Arkin, S., Hermans, C. R. J. R., Claes, C., Hanes, I., Huyghe, I., Kantaridis, C., Costa, L. M., Ndongo, M.‐N., Petit, W., Santagostino, E. M., Cannavo, A., Fasulo, M. R., Mancuso, M. E., Tosetto, A., Castaman, G., Candiotto, L., Radossi, P., Scarpa, E., Smith, M. P., Dick, A. E., Robson, R. A., Waaka, D. S., Wynne, C. J., Punt, Z. E., Kavakli, K. R., Balkan, C., Duyu, M., Goksel, S., Karapinar, B., Ozyurek, A. R., Saydam, G., Karapinar, D. Y., Laffan, M., Millar, C. M., Suppiah, P. I., Rizleigh, C. K., Chowdary, G. P., Davies, J. S., Fosbury, E. L., Gill, S., Pike, G. N., Varghese Thachil, J., Recht, M., Deutsche, J., Taylor, J., Kalinyak, K. A., Mullins, E. S., Palumbo, J. S., Quinn, C. T., Tarango, C., Tarabar, S., Chandler, P. A., Deats, L., Deshpande, S. R., Epstein, N. U., Hansson, A. G., Pawlak, S. S., Rudin, D., Valentino, L. A. J., Kakodkar, N. C., Simpson, M. L., Fogarty, P. F., Bach, Tami L., Chiang, Elaine Y., Adamson, J. W., Glass, C. S., Sidhu, N., Tucker‐Greene, T. D.

“…Essentials Marzeptacog alfa (activated) [MarzAA] is a novel variant of activated human factor VII. A phase 1 dose escalation trial of MarzAA was conducted in…”
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Evolution of Future Black Sea Fish Stocks under Changing Environmental and Climatic Conditions by Salihoglu, Baris, Arkin, Sinan S., Akoglu, Ekin, Fach, Bettina A.

“…Here we present a case study towards producing quantitative scientific advice on the application of the EU Common Fisheries Policy (CFP) in the Black Sea. We…”
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Clinical evaluation of moroctocog alfa (AF-CC), a new generation of B-domain deleted recombinant factor VIII (BDDrFVIII) for treatment of haemophilia A: demonstration of safety, efficacy, and pharmacokinetic equivalence to full-length recombinant factor VIII by RECHT, M., NEMES, L., MATYSIAK, M., MANCO-JOHNSON, M., LUSHER, J., SMITH, M., MANNUCCI, P., HAY, C., ABSHIRE, T., O'BRIEN, A., HAYWARD, B., UDATA, C., ROTH, D.A., ARKIN, S.

“…BDDrFVIII is a B‐domain deleted recombinant factor VIII (rFVIII) product for haemophilia A. Manufacture uniquely includes purification chromatography by…”
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Investigating the impact of cross-shelf transport and local retention in the Black Sea Rim Current system on small pelagic fishes by Fach, Bettina A., Cagdas, Bulut, Arkin, Sinan S., Salihoglu, Baris, Tezcan, Devrim

“…Advection of pelagic fish larvae through ocean currents is a source of dispersal that is known to structure marine populations by directly impacting population…”
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BDDrFVIII (Moroctocog alfa [AF-CC]) for surgical haemostasis in patients with haemophilia A: results of a pivotal study by WINDYGA, J., RUSEN, L., GRUPPO, R., O'BRIEN, A. C., KELLY, P., ROTH, D. A, ARKIN, S.

“…Moroctocog alfa (AF‐CC) (Xyntha™, BDDrFVIII) is manufactured by a process designed to enhance the theoretical viral safety profile relative to ReFacto®, its…”
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Human recombinant DNA‐derived antihemophilic factor in the treatment of previously untreated patients with hemophilia A: final report on a hallmark clinical investigation by Lusher, J., Abildgaard, C., Arkin, S., Mannucci, P. M., Zimmermann, R., Schwartz, L., Hurst, D.

“…Background: Development of recombinant factor VIII (rFVIII) replacement therapy represents a milestone in the treatment of hemophilia A. Objective: The…”
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B-domain deleted recombinant factor VIII preparations are bioequivalent to a monoclonal antibody purified plasma-derived factor VIII concentrate: a randomized, three-way crossover study by Kessler, C. M., Gill, J. C., White II, G. C., Shapiro, A., Arkin, S., Roth, D. A., Meng, X., Lusher, J. M.

“…Background:  Deletion of the B‐domain of recombinant blood coagulation factor VIII (BDDrFVIII) increases the manufacturing yield of the product but does not…”
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Surgical interventions in a cohort of patients with haemophilia A and inhibitors: an experiential retrospective chart review by KRAUT, E. H., ALEDORT, L. M., ARKIN, S., STINE, K. C., WONG, W.-Y.

“…Strategies for the management of perioperative bleeding in patients with haemophilia and inhibitors have evolved rapidly as a result of the development of the…”
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Elder Rehab: A Student-Supervised Exercise Program for Alzheimer's Patients by Arkin, Sharon M., Morrow-Howell, Nancy

“…The physical and mental benefits of exercise are universally recognized, but seldom available to persons with early to moderate stage dementia. Difficulty in…”
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Alzheimer rehabilitation by students: Interventions and outcomes by Arkin, Sharon M.

“…This article advocates proactive Alzheimer treatment, describes rehab interventions implemented by students, and reports positive first year outcomes for 11…”
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Climatic controls on biophysical interactions in the Black Sea under present day conditions and a potential future (A1B) climate scenario by Cannaby, Heather, Fach, Bettina A., Arkin, Sinan S., Salihoglu, Baris

“…A dynamical downscaling approach has been applied to investigate climatic controls on biophysical interactions and lower trophic level dynamics in the Black…”
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Insight in Alzheimer's patients: Results of a longitudinal study using three assessment methods by Arkin, Sharon, Mahendra, Nidhi

“…Three direct measures of dementia insight were administered to 20 participants in a longitudinal Alzheimer's disease (AD) rehabilitation research project 1 and…”
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Discourse analysis of Alzheimer's patients before and after intervention: Methodology and outcomes by Arkin, Sharon, Mahendra, Nidhi

“…This article describes a content-focused easy-to-use method of analysing the discourse of Alzheimer's patients. It also reports the results of the method's…”
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Understanding the limits to generalizability of experimental evolutionary models by Forde, Samantha E., Beardmore, Robert E., Gudelj, Ivana, Arkin, Sinan S., Thompson, John N., Hurst, Laurence D.

“…Microbe models get real Experiments using simple microbial systems can potentially cast light on evolutionary and ecological processes. But are such results…”
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Human coagulation factor FVIIa (recombinant) in the management of limb-threatening bleeds unresponsive to alternative therapies: results from the NovoSeven emergency-use programme in patients with severe haemophilia or with acquired inhibitors by Arkin, S, Blei, F, Fetten, J, Foulke, R, Gilchrist, G S, Heisel, M A, Key, N, Kisker, C T, Kitchen, C, Shafer, F E, Shah, P C, Strickland, D

“…This open-label, emergency-use study evaluated the efficacy and safety of activated human coagulation factor VIIa (recombinant) (rFVIIa) (NovoSeven; Novo…”
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Chlamydia trachomatis in patients who used oral contraceptives and had intermenstrual spotting by Krettek, J E, Arkin, S I, Chaisilwattana, P, Monif, G R

“…To identify the incidence of positive assays for direct antigen detection of Chlamydia trachomatis in oral contraceptive (OC) users with and without…”
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