Clinical Trial Application Dossier

Portuguese translation: Dossiê de Desenvolvimento Clínico de Medicamento

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21:59 May 25, 2018
English to Portuguese translations [PRO]
Medical - Medical (general)
English term or phrase: Clinical Trial Application Dossier
Clinical Trial Application Dossier provided to the applicant is an accurate reflection of all information known about the product.
Andre Damasceno
Brazil
Local time: 00:44
Portuguese translation:Dossiê de Desenvolvimento Clínico de Medicamento
Explanation:
Termo encontrado em uma resolução da Anvisa que dispõe sobre o Regulamento para a realização de ensaios clínicos com medicamentos no Brasil
Selected response from:

Marilia Silva
Brazil
Local time: 00:44
Grading comment
Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +3Dossiê de Desenvolvimento Clínico de Medicamento
Marilia Silva
4 +1dossiê específico de ensaio clínico
Rafael Sousa Brazlate


  

Answers


58 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +3
clinical trial application dossier
Dossiê de Desenvolvimento Clínico de Medicamento


Explanation:
Termo encontrado em uma resolução da Anvisa que dispõe sobre o Regulamento para a realização de ensaios clínicos com medicamentos no Brasil


    Reference: http://abiquifi.org.br/legislacoes/do/do2015/DOU_03_03_2015....
Marilia Silva
Brazil
Local time: 00:44
Meets criteria
Works in field
Native speaker of: Native in PortuguesePortuguese
PRO pts in category: 4
Grading comment
Selected automatically based on peer agreement.

Peer comments on this answer (and responses from the answerer)
agree  Paulo Gasques: ou dossiê para a realização de ensaios clínicos
4 hrs

agree  itineuropa
2 days 10 hrs

agree  Patricia Mortada: https://www.servicos.gov.br/servico/obter-autorizacao-de-anu...
3 days 21 hrs
Login to enter a peer comment (or grade)

2 days 16 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
clinical trial application dossier
dossiê específico de ensaio clínico


Explanation:
Cuidado!

O desenvolvimento é o processo como um todo, pode compreender mais de um estudo clínico.

Aqui parece que estamos falando da documentação relativa a apenas um estudo clínico (que ora é estudo, ora é ensaio).

Eu iria com este termo que sugiro, veja esta publicação aqui:

http://portal.anvisa.gov.br/documents/33836/2492465/Manual p...

Rafael Sousa Brazlate
Brazil
Local time: 00:44
Meets criteria
Specializes in field
Native speaker of: Native in PortuguesePortuguese
PRO pts in category: 440

Peer comments on this answer (and responses from the answerer)
agree  Flávia Pires
4 days
  -> Obrigado, Flávia.
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