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"An alignment with this guideline would be highly desirable for pharmaceutical companies who develop products which are intended for registration in multiple markets covering both EU and US." Echoing other stakeholders, Xellia asked FDA to ensure it harmonizes terminologies and thresholds with EMA and ICH.

Impairment of macrophage functions after ingestion of Plasmodium falciparum-infected erythrocytes or isolated malarial pigment

The dose has been chosen so that the same total amount is given every 16 h

Caution is needed with alpha-blockers and in men with unstable cardiovascular disease

Effect of glutathione monoethyl ester on glutathione level and cardiac energetics in reperfused pig heart

A reduction in glutathione levels in the lens has been associated with cataract formation as well as changes in the permeability of the lens that make it harder for nutrient exchange to occur[13], [14]