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Qinlock (ripretinib)
申请企业
DECIPHERA PHARMACEUTICALS LLC
药品名称
Qinlock (ripretinib)
承诺描述
Conduct a clinical pharmacokinetic trial to assess the effect of varying degrees of hepatic impairment on the exposure of ripretinib and DP-5439. This trial should be designed and conducted 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.” The results from this trial should determine the magnitude of increase in the exposure of ripretinib and DP-5439, and an appropriate dosage recommendation of ripretinib for patients with moderate or severe hepatic impairment and may inform labeling.