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DOBLE CIEGO [3 records]

Record 1 2016-12-21

English

Subject field(s)
  • Bioengineering
  • Toxicology
  • Effects of Pollution
CONT

In the parlance of environmental toxicology, a health effect caused by a hazardous agent is called an end point. Cancer is a relatively discrete, identifiable end point. But endocrine-disrupting end points are myriad, often subtle, and may take two or more generations to show themselves.

CONT

The Bureau of Chemical Hazards takes the lead in OECD guidelines development and updating... Existing test guidelines were prioritized for enhancement to include endocrine endpoints for assessment.

CONT

An acute non-cancer inhalation Reference Exposure Level (REL) of 1.9 x 10 g/m is listed for carbon tetrachloride in the California Air Pollution Control Officers Association Air Toxics "Hot Spots" Program, Revised 1992 Risk Assessment Guidelines. The toxicological endpoint considered for chronic toxicity is the central nervous system. Also, a chronic REL of 2.4 g/m is listed in the CAPCOA Risk Assessment Guidelines with the liver as the toxicological endpoint.

CONT

My personal approach is to start with the end-points, which include the important attributes to be evaluated, and then trace these back to the project.

OBS

endpoint; end-point: terms extracted from the “Glossaire de l’environnement” and reproduced with permission of the Organisation for Economic Co-operation and Development.

French

Domaine(s)
  • Technique biologique
  • Toxicologie
  • Effets de la pollution
OBS

end-point = endpoint : 1. <au sens strict> : valeur de seuil, seuil d'effet; 2. (au sens large) effet, résultat (final), aboutissement.

OBS

effet; aboutissement; résultat final : termes extraits du «Glossaire de l’environnement» et reproduits avec l’autorisation de l’Organisation de coopération et de développement économiques.

Spanish

Campo(s) temático(s)
  • Bioingeniería
  • Toxicología
  • Efectos de la polución
DEF

Información usada para dar término a las diferentes ramas de un estudio clínico o de un tratamiento.

CONT

Un "endpoint" en ciertos protocolos doble ciego, consiste en retirar a un participante que ha llegado a determinado límite, dándole en cambio un tratamiento abierto.

Save record 1

Record 2 2009-03-05

English

Subject field(s)
  • Pharmacodynamics
  • Scientific Research
DEF

An adverse reaction that is classed in nature as serious and which is not consistent with the information about the medicinal product in question set out : (a) in the case of a licensed product, in the summary of product characteristics (SmPC) for that product or, (b) in the case of any other investigational medicinal product, in the IB [Investigator's Brochure] relating to the trial in question.

CONT

This Standard Operating Procedure (SOP) describes to research staff the procedure for the recording, management and reporting of Adverse Events (AEs), Serious Adverse Events (SAEs), Suspected Serious Adverse Reactions (SSARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) for clinical trials that fall under the UK Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031) and the European Clinical Trials Directive (EUCTD).

French

Domaine(s)
  • Pharmacodynamie
  • Recherche scientifique
CONT

Chaque État membre veille à ce que toutes les suspicions d'effets indésirables graves inattendus d'un médicament expérimental qui ont été portées à sa connaissance soient immédiatement introduites dans une banque européenne de données accessible uniquement aux autorités compétentes des États membres, à l'Agence et à la Commission.

OBS

Même si l'abréviation «SUSAR» provient de l'anglais (suspected unexpected serious adverse reaction), elle est couramment utilisée dans les textes français.

OBS

Les expressions «suspicion d'effet indésirable grave inattendu» et «présomption d'effet indésirable grave inattendu» sont habituellement utilisées au pluriel.

Key term(s)
  • suspicions d'effets indésirables graves inattendus
  • suspicion d'effets indésirables graves inattendus
  • présomptions d'effets indésirables graves inattendus
  • présomption d'effets indésirables graves inattendus

Spanish

Campo(s) temático(s)
  • Farmacodinámica
  • Investigación científica
CONT

Cuando las sospechas de reacciones adversas graves e inesperadas ocurran en un ensayo clínico doble ciego, se deberá develar el código de tratamiento de ese paciente concreto a efectos de notificación.

OBS

sospecha de reacciones graves e inesperadas: Término utilizado generalmente en plural.

Save record 2

Record 3 2005-12-16

English

Subject field(s)
  • Diagnostic Procedures (Medicine)
  • Pharmacology
DEF

[Said of a test on or study of] the effects of a specific agent in which neither the administrator nor the recipient, at the time of administration, knows whether the active or an inert substance is given.

PHR

Double-blind test, study.

French

Domaine(s)
  • Méthodes diagnostiques (Médecine)
  • Pharmacologie
DEF

Suivant une méthode d'expérimentation consistant à donner à deux groupes de malades des comprimés d'apparence semblable, sans que ni les médecins ni les malades sachent quel est le groupe qui a reçu les comprimés contenant le produit à expérimenter, l'autre groupe ne recevant qu'un placebo.

PHR

Essai en double aveugle, enquête à double insu.

Spanish

Campo(s) temático(s)
  • Procedimientos diagnósticos (Medicina)
  • Farmacología
DEF

[Dícese de la] investigación clínica en que ni el médico, ni los participantes [saben] quiénes están recibiendo la sustancia activa y quiénes el placebo.

PHR

protocolo doble ciego.

Save record 3

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