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COFEPRIS regulation and the Mexican context In Mexico, the Comisin Federal para la Proteccin contra Riesgos Sanitarios (COFEPRIS) regulates pharmaceutical substances and the clinical settings in which they are administered
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A Therapeutic Use Exemption (TUE) will be necessary for any therapeutic use that exceeds these permitted limits
7,8 Though safety and efficacy data is not yet available, an upcoming phase 1 study looking at ivermectin in patients with triple negative breast cancer (in combination with balstilimab, a chemotherapeutic agent) plans to evaluate dosing at 30, 45, or 60mg daily on days 1-2, 8-10, and 15-17 in a 21 day cycle until disease progression or intolerance
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