How to calculate a PDE (Permitted Daily Exposure) for eye drops (dose-levels in µL per eye, not in mg/kg)?

15 May 2025 1 8K Report

I need to calculate a PDE (Permitted Daily Exposure) according to EMA guideline but usually we use dose-levels in mg/kg/day.

How to manage eye drops (µL/eye). I assume the eye drop concentration has to be takene into consideration. Does it differ if both eyes are doses (vs. one single eye)?

Vitalii Illich Sheiko

Погоджуюсь з Вашою думкою, щдо врахування концентрації очних крапель та обєм тобто сумувати дозу, яка надходить в клжне око окремо.

I agree with your opinion that in order to take into account the concentration of eye drops and the volume, that is, to sum the dose that enters each eye separately.

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