一项在首次接受同种异体肝或肾移植儿童受者中评价Modigraf®(他克莫司颗粒)药代动力学、长期安全性和有效性的多中心、开放性、非对照研究
[Translation] A multicenter, open-label, uncontrolled study to evaluate the pharmacokinetics, long-term safety and efficacy of Modigraf® (tacrolimus granules) in pediatric naive allogeneic liver or kidney transplant recipients
●在首次接受同种异体肝或肾移植的儿童受试者中,测定首剂口服给药及达到稳定状态后,Modigraf 口服给药后的他克莫司药代动力学特征。
● 在首次接受同种异体肝或肾移植的儿童受者中,观察Modigraf 的安全性和有效性。
[Translation] ●The pharmacokinetics of tacrolimus following oral administration of Modigraf was determined in pediatric subjects undergoing naive allogeneic liver or kidney transplantation after the first oral dose and after reaching steady state.
● To observe the safety and efficacy of Modigraf in pediatric recipients receiving allogeneic liver or kidney transplantation for the first time.
一项在首次接受同种异体肝或肾移植的儿童受者中评价Modigraf®为基础的免疫抑制方案的安全性和有效性的长期、开放性、非对照研究
[Translation] A long-term, open-label, uncontrolled study evaluating the safety and efficacy of a Modigraf®-based immunosuppressive regimen in pediatric naive allogeneic liver or kidney transplant recipients
● 观察 Modigraf对首次同种异体肝和肾移植儿童受者的安全性和有效性。
● 监测基于 Modigraf的免疫抑制方案的他克莫司的剂量变化和全血谷浓度。
[Translation] ● To observe the safety and efficacy of Modigraf in pediatric first-time allogeneic liver and kidney transplant recipients.
• Monitor dose changes and whole blood trough concentrations of tacrolimus on a Modigraf-based immunosuppressive regimen.
一项在健康中国女性受试者中评估Fezolinetant的药代动力学和安全性的开放、单次给药及多次给药研究
[Translation] An open-label, single-dose and multiple-dose study evaluating the pharmacokinetics and safety of Fezolinetant in healthy Chinese female subjects
评价健康中国女性受试者中单次和多次给药后Fezolinetant的药代动力学和安全性。
[Translation] To evaluate the pharmacokinetics and safety of Fezolinetant following single and multiple doses in healthy Chinese female subjects.
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Key points for responding to regulatory inspections successfully during the COVID-19 pandemic
Author: Abe, Kiyohito ; Morikawa, Takashi ; Yagi, Yoko ; Taguchi, Satomi ; Bannai, Fusa ; Miura, Takeshi ; Hakomori, Tadashi
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Basic of solid dispersion
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Calling up the image of powder
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