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About this guideline
Overseas effective date: 26 December 2014
Categories: Clinical efficacy and safety | Cardiovascular system | Arrythmias
TGA annotations:
Section 8.1:
The collection of plasma/serum samples for the measurement of drug level and/or anticoagulant effect at the time of outcome events (e.g. bleeding, SEE, stroke) is recommended.
The dossier must include specific discussion regarding non-specific and specific reversal agents and/or antidotes.
The dossier must include a discussion regarding the utility of routine and/or ad hoc laboratory monitoring (drug levels or measures of anticoagulant effect) for the safe and efficacious use of the product. The availability of the laboratory tests mentioned should be included in the discussion.
Section 6.2 (3):
Where a study includes outcomes from 'VKA-naïve patients' meeting the definition provided in this guidance, a sensitivity analysis must be conducted with results from patients with no previous VKA exposure.
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For more information see International scientific guidelines adopted in Australia.