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Onureg (azacitidine)
药品名称
Onureg (azacitidine)
承诺描述
Submit the final report and datasets from a clinical pharmacokinetic study to determine a safe and appropriate dose of oral azaciditine in patients with moderate and severe hepatic impairment that may inform product labeling. Design and conduct the study in accordance with the FDA Guidance for Industry titled; Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling.