Browsing Ethiopian Food and Drug Authority (EFDA) by Subject "Malaria"

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Operational feasibility of appropriate radical cure of Plasmodium vivax with tafenoquine or primaquine after semi-quantitative G6PD testing in Ethiopia: a mixed methods study

Ethiopian Food and Drug Authority (Feb 2024)

Primaquine (PQ) and tafenoquine (TQ) can be used for the radical cure (RC) of P. vivax malaria. PQ requires a 14-day dose, compared to a single-day dose for TQ, which is likely to improve patient adherence to the treatment. ...
A revised Tafenoquine dose to improve radical cure for Vivax malaria -Tafenoquine dosing revised

Ethiopian Food and Drug Authority (2024)

Tafenoquine (TQ), as a single dose regimen, has significant advantages over the longer courses of primaquine (PQ) needed to achieve radical cure of P. vivax. The current data available show that the recommended fixed ...
Single-dose oral bioequivalence study of Primaquine 15 mg tablet (test product) and Primaquine 15 mg tablet (reference product) in healthy adult human subjects under fasting conditions

Ethiopian Food and Drug Authority (2024)

WHO prequalification offers the possibility of a line extension based on demonstrating proportionality with the adult 15 mg tablet. For a generic manufacturer, a bioequivalence study must be performed comparing the generic ...

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