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English to Spanish: Prenatal HIV testing General field: Medical
Source text - English Findings regarding prenatal HIV testing are mixed in the literature. Previous testing may be a proxy for risk. One recent study suggests that previous HIV testing (ie, knowing one’s status) may promote risky behaviors. A study of sex workers in West Africa found that prior HIV testing was associated with decreased condom use (25). In contrast, a study of men who have sex with men found no association between risk (sex and drug use) behaviors and testing during the preceding year (26). In the XYZ data, previous HIV testing was not significantly correlated with condom use (among those women not trying to get pregnant) or with the measure of HIV risk (intravenous drug use, treatment for sexually transmitted infection, or multiple sex partners) in the total sample or in B County. However, previous HIV testing was correlated with condom use in A (P = .05), where a greater proportion of women who were previously tested for HIV did not use condoms at the time of conception (results not shown).
Translation - Spanish Los hallazgos referentes a la realización de la prueba prenatal de VIH están mezclados en la literatura. La realización previa de la prueba puede ser representativa de riesgo. Un estudio reciente sugiere que la realización previa de la prueba de VIH (p. ej., conociendo el estatus propio) puede promover la práctica de comportamientos riesgosos. En un estudio con trabajadores del sexo en Africa Occidental se encontró que la realización previa de la prueba de VIH estaba asociada con el descenso en el uso del condón (25). En contraste, en un estudio con hombres que tuvieron relaciones sexuales con personas de su mismo sexo no se encontró asociación entre los comportamientos de riesgo (sexo y uso de drogas) y la realización de la prueba durante el año precedente (26). En los datos del XYZ, la realización previa de la prueba de VIH no fue correlacionada significativamente con el uso del condón (entre aquellas mujeres que no intentaron embarazarse) o con la medida del riesgo de VIH (uso de drogas intravenosas, tratamiento de enfermedades de transmisión sexual o múltiples compañeros sexuales) en la muestra total o en el Condado de B. Sin embargo, la realización previa de la prueba de VIH estaba correlacionada con el uso del condón en A (P = 0.05), en donde una mayor proporción de mujeres que se efecturaron la prueba de VIH previamente no utilizaron condones en el momento de la concepción (resultados no mostrados).
English to Spanish: Antidepressives General field: Medical Detailed field: Medical: Health Care
Source text - English Paroxetine selectively and potently inhibits the serotonin transporters (Ki = 0.1 nmol/l), thereby prolonging serotonin at its postsynaptic receptors and enhancing serotonergic neurotransmission. Paroxetine has been found to be a more potent inhibitor of serotonin reuptake in vitro than citralopram (Ki = 1.58 nmol/l), fluoxetine (1.10 nmol/l) and fluvoxamine (Ki = 2.30 nmol/l) [45]. Neuroadaptive changes associated with paroxetine are thought to be central to its therapeutic efficacy. These changes include adaptations to the serotonergic receptors, including desensitisation of somatodendritic serotonin 5- HT1A and terminal 5-HT1B/1D autoreceptors, which result in an increase in serotonin release. Other pharmacodynamic properties include moderate inhibitions of noradrenaline (Ki = 45 nmol/l), weak inhibition of the dopamine transporters (Ki = 268 nmol/l), and weak affinity for the cholinergic receptors (Ki = 89 nmol/l) in rat brain tissue [45]. As with other SSRIs, paroxetine suppresses rapid eye movement sleep in healthy volunteers. Paroxetine 30 mg, has not been found to potentiate alcohol induced psychomotor impairment in healthy volunteers [45].
Translation - Spanish La paroxetina inhibe selectiva y potencialmente a los transportadores de serotonina (Ki = 0.1 nmol/l), prolongando por tanto la estancia de la serotonina en sus receptores postsinápticos y mejorando la neurotransmisión serotonérgica. Se ha encontrado que la paroxetina es un inhibidor de la recaptura de serotonina in vitro más potente que el citalopram (Ki = 1.58 nmol/l), fluoxetina (1.10 nmol/l) y fluvoxamina (Ki = 2.30 nmol/l) [45]. Se piensa que los cambios neuroadaptativos asociados con la paroxetina son fundamentales para su eficacia terapéutica. Estos cambios incluyen adaptaciones a los receptores serotonérgicos, incluyendo desensitización de los autoreceptores somatodendríticos de serotonina 5 - HT1A y 5-HT1B/1D terminal, lo cual resulta en un incremento en la liberación de serotonina. Otras propiedades farmacodinámicas incluyen inhibiciones moderadas de noradrenalina (Ki = 45 nmol/l), inhibición débil de los transportadores de dopamina (Ki = 268 nmol/), así como una débil afinidad por los receptores colinérgicos (Ki = 89 nmol/l) en tejido cerebral de rata [45]. Al igual que con otros ISRSs, la paroxetina suprime el sueño con movimiento ocular rápido en voluntarios sanos. No se ha encontrado que la paroxetina 30 mg potencíe la incapacidad psicomotora inducida por alcohol en voluntarios sanos [45].
English to Spanish: Institutional Review Boards General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English § 56.103 Circumstances in which IRB review is required.
(a) Except as provided in §§ 56.104 and 56.105, any clinical investigation which must meet the requirements for prior submission (as required in parts 312, 812, and 813) to the Food and Drug Administration shall not be initiated unless that investigation has been reviewed and approved by, and remains subject to continuing review by, an IRB meeting the requirements of this part.
(b) Except as provided in §§ 56.104 and 56.105, the Food and Drug Administration may decide not to consider in support of an application for a research or marketing permit any data or information that has been derived from a clinical investigation that has not been approved by, and that was not subject to initial and continuing review by, an IRB meeting the requirements of this part. The determination that a clinical investigation may not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any other applicable regulations to submit the results of the investigation to the Food and Drug Administration.
(c) Compliance with these regulations will in no way render inapplicable pertinent Federal, State, or local laws or regulations.
Translation - Spanish § 56.103 Circunstancias en las que se requiere de la revisión por parte del CRI.
(a) Excepto por lo previsto en las secciones §§ 56.104 y 56.105, no deberá iniciarse ninguna investigación clínica que deba cumplir con los requerimientos para la presentación previa (como se requiere en las partes 312, 812 y 813) ante la Administración de Alimentos y Medicamentos, a menos que la investigación haya sido revisada y aprobada por, y permanezca sujeta a la revisión continua por parte de, un CRI que cumpla con los requerimientos de esta parte.
(b) Excepto por lo previsto en la secciones §§ 56.104 y 56.105, la Administración de Alimentos y Medicamentos podrá decidir no considerar como apoyo para una solicitud de permiso de investigación o comercialización cualesquiera datos o información derivados de una investigación clínica que no haya sido aprobada por, y que no haya estado sometida a la revisión inicial y continua por parte de, un CRI que cumpla con los requerimientos de esta parte. La determinación de que una investigación clínica pueda no ser considerada como soporte para una solicitud de permiso de investigación o comercialización, no exime, sin embargo, al solicitante de tal permiso, de cualquier obligación según cualesquiera otras regulaciones aplicables, de presentar los resultados de la investigación ante la Administración de Alimentos y Medicamentos.
(c) El cumplimiento con estas regulaciones de ninguna manera hará inaplicables las regulaciones o leyes pertinentes federales, estatales o locales.
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Experience
Years of experience: 17. Registered at ProZ.com: Mar 2008.
I've been translating freelance since 2007, processing annually an average of 1 million words.
I love languages and translation, the process of conveying an idea into another language is a really passionate job.
So much I enjoy this pleasure that I pour this joy into every project by consistently assuring that it has such a good quality that the reader will be unaware that it is actually a translation.
If you entrust me with your documents/projects, I will be much honored to serve you, and share with you this joy translated into the precise result that you need.
I respect and value your privacy, your time and you, in all senses, as a professional looking for the services of another professional, so I adhere to Proz professional guidelines http://www.proz.com/professional-guidelines?pg_version=1.1.
Some customers for which I have translated through different agencies are:
Laboratories: AstraZeneca, BMS, Eli Lilly, Takeda (and before Nycomed), Boehringer Ingelheim, Hoffman-La Roche.
Other companies: Motorola, Hino Motors, Nintendo, Bosch.
Type of translation projects on which I have worked include:
•Marketing authorization application dossiers or parts of them
•Investigator's Brochures
•Drug Master Files
•Clinical Study Protocols
•Clinical Study Reports
•Clinical and nonclinical overviews of drugs
•Press releases for pharmaceutical companies
•Procedures for analytical methods and validation of the same
•Prescribing informations for several drugs
•Scientific articles
•Documents for regulatory authorities (like COFEPRIS in Mexico, FDA in USA)
•Corporate news and press releases of pharmaceutical companies
Other areas:
•Sales, team working, leadership, marketing, company communications
•Office equipment manuals of instructions
My professional experience includes the quality control and assurance in the food industry (flavors and colorants for food and pharmaceutical industry), medical sales and biotechology product sales (enzymes, minerals for fortification).
I obtained a degree in Biotechnology Engineering in the "Unidad Profesional Interdisciplinaria de Biotecnología" from Mexico's Instituto Politécnico Nacional.
