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English to Spanish: Investigator's Brochure General field: Medical
Source text - English Summary of Clinical Data
The clinical Phase 1/2a program for DRUG consists of 36 completed studies, including a radiolabelled mass balance study, bioavailability and food interaction studies in healthy subjects and in subjects with epilepsy, studies in special populations (elderly subjects, Japanese subjects, subjects with renal impairment, and subjects with hepatic impairment) and a neurocognition study.
Two ongoing studies in the pediatric program include an open-label, single-arm, multicenter PK, safety, and efficacy study of adjunctive administration of DRUG in subjects with epilepsy and a long-term study. The clinical phase of these studies is completed, and data analysis and reporting are ongoing.
Translation - Spanish Resumen de datos clínicos
El programa clínico de fase 1/2a de FÁRMACO consta de 36 estudios finalizados, incluido un estudio de equilibrio de masas con radiomarcación, estudios de biodisponibilidad e interacciones con alimentos en sujetos sanos y en sujetos con epilepsia, estudios en poblaciones especiales (sujetos de edad avanzada, sujetos japoneses, sujetos con deterioro de la función renal y sujetos con deterioro de la función hepática) y un estudio de neurocognición.
En el programa pediátrico, dos estudios siguen en curso e incluyen un estudio de etiqueta abierta, en un solo grupo, multicéntrico, sobre la farmacocinética, seguridad y eficacia de la administración adyuvante de FÁRMACO en sujetos con epilepsia y un estudio a largo plazo. La fase clínica de estos estudios está completa, y el análisis y el informe de los datos están en curso.
English to Spanish: Investigator's Brochure General field: Medical
Source text - English Drug-Drug Interactions
DRUG has the potential to interact with compounds that are substrates of epoxide hydrolase. The potential of DRUG to interact with compounds that are substrates of CYP2C19 and CYP3A4 is low at therapeutic doses. DRUG did not impair the efficacy of a combination oral contraceptive containing 150 μg levonorgestrel and 30 μg ethinylestradiol. DRUG did not modify the plasma concentrations of CBZ, LTG, LEV, OXC metabolite (MHD), PB, PHT, TPM, VPA, and ZNS. However, the epoxide metabolite of CBZ was significantly increased from Baseline at doses above 15 mg/day, nearly reaching the upper limit of normal (2.0 μg/mL) at doses of 100 and 150 mg/day.
FÁRMACO posee el potencial de interactuar con compuestos que son sustratos de la epóxido hidrolasa. En dosis terapéuticas, el potencial de interacción de FÁRMACO con compuestos que son sustratos de CYP2C19 y CYP3A4 es bajo. FÁRMACO no alteró la eficacia de un anticonceptivo oral que combina 150 μg de levonorgestrel y 30 μg de etinilestradiol. FÁRMACO no modificó las concentraciones plasmáticas de CBZ, LTG, LEV, el metabolito OXC (MHD), PB, PHT, TPM, VPA y ZNS. Sin embargo, el metabolito epóxido de la CBZ aumentó significativamente con respecto al valor inicial con las dosis superiores a 15 mg/día, y casi alcanzó el límite superior normal (3.0 μg/ml) con dosis de 100 y 150 mg/día.
English to Spanish: Informed Consent Form General field: Medical
Source text - English Purpose
DRUG NAME is a prescription medication that has been approved to treat anemia by regulatory authorities such as the US FDA and the European Medicines Agency (EMA). It is used to treat anemia as it increases the amount of red blood cells in the blood. DRUG NAME will be given as an injection just under the skin or as an injection into your dialysis access.
If you agree to take part in this study, and have signed this document, the study doctor will do some tests to see if you qualify for the study. If you are eligible, you will be randomly assigned (like flipping a coin) to one of two treatment groups. You will have a one-in-two chance of receiving the study drug and a one-in-two chance of receiving placebo. You will not be told which group you are assigned to.
Translation - Spanish Objetivo
El FÁRMACO es un medicamento de venta con receta para el tratamiento de la anemia que cuenta con la aprobación de las autoridades reguladoras como la Administración de Medicamentos y Alimentos de EE. UU. (FDA, por sus siglas en inglés) y la Agencia Europea de Medicamentos (EMA). Se usa para tratar la anemia, pues aumenta la cantidad de glóbulos rojos en la sangre. El FÁRMACO se administrará en forma de inyección debajo de la piel o se inyectará en su acceso de diálisis.
Si acepta participar en este estudio y ha firmado este documento, el médico del estudio realizará algunos análisis para ver si usted es apto para el estudio. Si resulta elegible para participar, se le asignará al azar (como cuando se lanza una moneda al aire) a uno de dos grupos de tratamiento. Tendrá una de dos probabilidades de recibir el medicamento del estudio y una de dos probabilidades de recibir el placebo. No se le dirá a cuál grupo fue asignado.
English to Spanish: Letter to Local Health Authority General field: Medical Detailed field: Law (general)
Source text - English To whom it may concern,
Herewith, COMPANY NAME informs the local health authority about an upcoming change in the quality documentation to clinical study XXXXXX, related to drug substance and drug product specifications of DRUG NAME. The letter is intended to transparently describe the link between the specifications for the clinical trial supply and commercial product.
For clinical supplies of study XXXXXX commercial drug substance as well as commercial DRUG NAME pellets are used, which are encapsulated in HPMC capsules of different sizes to manufacture DRUG NAME capsules of 50 mg, 75 mg and 110 mg strenghts. While the 50 mg strength is currently specific to the paediatric development, both other strengths are commercially available, with small differences in the colour of the capsule shell.
Translation - Spanish A quien corresponda:
Por medio del presente, NOMBRE DE LA EMPRESA informa a la autoridad sanitaria local acerca de un cambio próximo en la documentación de calidad del estudio clínico XXXXXX, con relación a las especificaciones del principio activo y el fármaco NOMBRE DEL FÁRMACO. El objeto de esta carta es describir de forma transparente el vínculo entre las especificaciones para el suministro del ensayo clínico y el producto comercial.
Para los suministros del estudio XXXXXX se utiliza tanto el principio activo comercial como los microgránulos de NOMBRE DEL FÁRMACO comercial, las cuales se colocan en cápsulas de hipromelosa (HPMC) de distintos tamaños para fabricar cápsulas de NOMBRE DEL FÁRMACO de 50 mg, 75 mg y 110 mg. Aunque la concentración de 50 mg está especificada para el desarrollo pediátrico actualmente, las otras dos concentraciones están disponibles a nivel comercial, con pequeñas diferencias en el color de la cubierta de las cápsulas.
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Experience
Years of experience: 14. Registered at ProZ.com: Jun 2018.
Hi, I'm an English>Spanish certified translator with over 10 years of experience. I'm specialized on the Life-Sciences field, translating both patient-facing and specialist-facing materials of all kinds from investigator's brochures and protocols to informed consent forms and patient cards for clients such as Quintiles, which is a company that manages clinical studies all over the world for clients such as AstraZeneca, Novartis, Samsung Bioepis, etc.
Although that's my most frequent field of expertise, I have also translated legal documents, engineering manuals (mostly OSHA complying lightning manuals) and advertisements or internal communications for companies such as Fruit of the loom, Forever 21, Cooper Std, EOS, etc.
I love reading a lot about various themes and am an eager constant learner of poetry, literature, history and art.
I will be very happy to work with you, so feel free to contact me whenever you like!
All the best,
Emmanuel Díaz.
Keywords: English, Spanish, Mexico, Localization, Translation, Proofreading, Post Editing, Quality Management, Life Sciences, Medicine. See more.English, Spanish, Mexico, Localization, Translation, Proofreading, Post Editing, Quality Management, Life Sciences, Medicine, Clinical, Clinical Studies, Protocol, ICF, IB, CRO, Agreements. See less.
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