Diferencia entre IB e IMPD

Consultas sobre palabras técnicas en inglés. Por ej, Cuaderno de Recogida de Datos (CRD) = Case Report Form (CRF)
Tom Bene
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Diferencia entre IB e IMPD

Mensajepor Tom Bene » 11 Nov 2007, 23:14

Hola

Ajunto una aclaración que me pareció intereante. Explica la diferencia entre IB e IMPD, está en Ingles (para hacer práctica):

5. Investigator's Brochure

An Investigator's Brochure is a compilation of clinical and non-clinical data on the investigational medicinal product(s) used in a clinical trial. The content, format and procedures for updating an Investigator's Brochure are described well in Section 7 of the ICH Harmonised Tripartite Guideline on Good Clinical Practice .

6. Investigational Medicinal Product Dossier (IMPD)

The IMPD provides information on the quality, pre-clinical and clinical characteristics of the investigational medicinal product to be used in the clinical trial, including reference products and placebos. An overall risk-benefit assessment, critically analysing the non-clinical and clinical data in relation to the potential risks and benefits of the proposed trial must also be included in the IMPD.

An IMPD should include summaries of data on the:

• Quality and manufacture and control of the IMP

• Toxicology and pharmacological tests (non-clinical data) on the products

• Information from previous clinical trials or its use as a marketed product

Some or parts of the IMPD can be cross-referenced to the Investigator's Brochure. A simplified IMPD can be submitted when a product is already marketed or has previously been granted a Clinical Trial Authorisation.

A full IMPD is required when:

• No previous information has been submitted to the MHRA (or competent authority in the EU Member state) where Clinical Trial Authorisation is being submitted

• There is no marketing authorisation for the product in any EU Member State

• When the competent authority (e.g. the MHRA) has not granted clinical trial authorisation/approval for the product use before

• When information about the chemical or biological product cannot be cross-referenced to information submitted by another sponsor

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