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  "documentTitle": "Harmony Biosciences (HRMY)",
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  "notes": "The slide documents the source data used by a consultant to derive a linear regression model for QTc vs. plasma levels.",
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      "text": "Our pharmacology consultant then 1) used the single-dose plasma levels to calculate plasma levels at steady-state, and 2) used the change in QTcF vs. plasma level from another table in the same paper to develop a simple linear regression model.",
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      "text": "We were able to locate the raw data the FDA used to construct the graph, from a later review paper that included a table from both QT safety studies P09-11 (TQT study) and P14-05 (SAD study).",
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      "text": "Source: https://pubmed.ncbi.nlm.nih.gov/26879827/",
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      "text": "Table 3: Estimated mean (90 % CI) placebo-corrected change from baseline (ΔΔQTcF)",
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      "text": "Table 2: Pitolisant pharmacokinetic parameters in the male subjects in the two studies",
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