Element card for assessment element C0002 in HTA Core Model Application for Pharmaceuticals (2.0) application

C. Safety

Patient safety

Are the harms related to dosage or frequency  of applying the technology?

Core

Information should be included if safe use of the technology is sensitive to even small changes of the dose because this may have implications for the training and organisation of care. The potential for accumulated harm due to repeated dosage or testing should also be considered.

For further information see Endpoints used in REA of pharmaceuticals – Safety

http

://www.eunethta.eu/sites/5026.fedimbo.belgium.be/files/Safety.pdf

Phase 1 studies for pharmaceuticals, other research articles, HTAs, manufacturers' product data sheets, safety monitoring databases. Method: Systematic review.

Critical
Complete

A0017

B0001

A0017

B0001

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