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      "text": "175 ng/mL and 280 ng/mL plasma levels are incorrectly labeled as “steady state” when they are merely the level after a single dose",
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      "text": "175 ng/mL and 280 ng/mL plasma levels are incorrectly labeled as “steady state” when they are merely the level after a single dose",
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      "text": "The same error – incorrectly using plasma levels after a single-dose but confusing them as steady-state Cmax – appears in multiple places in the FDA review document. A table immediately before the preceding graph shows a table with a column labeled “Cmax at steady state.” However, the plasma levels used to compute safety windows for the 2.5-fold and 3.8-fold dose levels are once again NOT steady state. They show plasma levels after ONE dose, and hence grossly understate the actual plasma level as well as the QT prolongation, which the FDA admits is dose-dependent.",
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      "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211150Orig1s000ClinPharmR.pdf",
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      "text": "Safety Window | Cmax at steady state (ng/mL) | ΔΔQTcF (ms) & 90% CI",
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      "text": "Table 6: The Point Estimates and the 90% CIs for ΔΔQTcF (ms) increases at therapeutic and supra-therapeutic dose levels",
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