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Translation, Editing/proofreading, MT post-editing, Transcription, Training
English to Spanish: Nonclinical Report General field: Medical Detailed field: Medical (general)
Source text - English rFVIIIFc is a therapeutic recombinant protein being developed with the property of being longer lasting and having the potential to provide prolonged protection from bleeding for the treatment of Hemophilia A. The purpose of this study was to assess the pharmacokinetics, coagulation potential and thrombogenic potential at high doses (3,000, 10,000 and 20,000 IU/kg) of the rFVIIIFc in male and female cynomolgus monkeys.
Pharmacokinetic parameters were evaluated by measuring the concentration of rFVIIIFc in the plasma by ELISA.
Thrombogenicity was evaluated by measuring platelet numbers and fibrinogen values.
Coagulation potential was assessed by measuring activated partial thromboplastin times (aPTT) and prothrombin time (PT).
General tolerance of these high doses of test article was further evaluated by gross examination, organ weight values and histopathology on tissues collected seven days post dosing.
The study was not intended to be conducted in conformance with the Food and Drug Administration Good Laboratory Practice Regulations for non-clinical studies.
All portions of this study adhered to the study protocol and any applicable amendment(s) as well as testing facility standard operating procedures.
Translation - Spanish La rFVIIIFc es una proteína recombinada terapéutica desarrollada con la propiedad de ser más duradera y con el potencial de proporcionar una protección prolongada contra las hemorragias en el tratamiento de la hemofilia A. La finalidad de este estudio fue evaluar la farmacocinética, el potencial de coagulación y el potencial trombogénico cuando se administran dosis altas (3000, 10 000 y 20 000 IU/kg) de rFVIIIFc en macacos macho y hembra.
Los parámetros farmacocinéticos se evaluaron midiendo la concentración plasmática de rFVIIIFc mediante un ensayo por inmunoabsorción ligado a enzimas (enzyme-linked immunosorbent assay, ELISA).
La trombogenicidad se evaluó midiendo la cantidad de plaquetas y los valores de fibrinógeno.
El potencial de coagulación se evaluó midiendo los tiempos de tromboplastina parcial activada (activated partial thromboplastin times, aPTT) y el tiempo de protrombina (prothrombin time, PT).
Se evaluó en más detalle la tolerancia general a estas dosis altas del artículo de prueba mediante un examen macroscópico, el peso de los órganos y la histopatología de los tejidos obtenidos siete días después de la dosis.
No se pretendió que el estudio fuera realizado conforme a las Normas de Buenas Prácticas de Laboratorio de la Administración de Alimentos y Medicamentos para estudios no clínicos.
Todas las secciones de este estudio cumplieron con el protocolo y con todas las enmiendas correspondientes, así como con los procedimientos operativos estándares del centro de pruebas.
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Graduate diploma - School of Languages, Universidad Nacional de Córdoba
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Years of experience: 15. Registered at ProZ.com: Sep 2010.
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I am an English into Spanish translator with a five-year university degree in translation. I am an enthusiastic, hard-working and detail-oriented professional who is looking forward to growing personally and professionally. My strengths are my dedication to any job that I am given, my leading skills and my genuine interest in doing always my best.
Keywords: translation, translator, english, spanish, traductor de inglés, traductor de español, traductora, inglés, español, medicine. See more.translation, translator, english, spanish, traductor de inglés, traductor de español, traductora, inglés, español, medicine, healthcare, education, reports, general, social service translator, localization. See less.
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