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The FDA's 2003 guidance on pharmacokinetics in patients with impaired hepatic function acknowledges that drugs primarily cleared by non-hepatic mechanisms may not require dedicated hepatic impairment studies [5]

Handle as a research chemical under appropriate laboratory controls

(4) How long the elevation lasts depends on the formulation, the regimen, and the assay, so a fixed clearance time cannot be assumed

doi: 10.15835/buasvmcn-fst:2020.0061 128

Data from nine studies (two randomized controlled trials and seven observational studies) with 2,651 patients was analyzed

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