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doi: 10.3389/fmicb.2025.1591745
Limitations: Animal models only
To translate this to human parameters, we apply the FDAs Body Surface Area (BSA) normalization method
The EMPA-REG OUTCOME (Zinman et al., 2015) trial, however, reported increased levels of hematocrit and viscosity of blood, which they attributed to raised osmotic diuresis, a natriuretic effect, that subsequently increase the risk of dehydration
In fact, the inspector continued, your written procedures inhibit these activities. The FDA has discussed the findings of this inspection with Novo, according to the warning letter, which is dated March 5
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