ADA抗药物抗体吸收,分布,代谢,消除AE不良事件Alt丙氨酸氨基转移酶API API活性药物成分AST ASTASPATE ASPATESPARTATE ASPATE ASPATE ASPATE氨基转移酶ATC解剖学治疗酶ATC解剖学治疗化学分类系统AUC在plasma浓度浓度下的浓度为0-24-24-24 interval BID bis in die , twice a day CI Confidence interval C max Maximum observed plasma/serum concentration of drug CMV Cytomegalovirus CYP Cytochrome P450 DDI Drug-drug interaction EMA European Medicines Agency ERA Environmental risk assessment FDA Food and Drug Administration (USA) GI Gastrointestinal GLP Good Laboratory Practice GMR Geometric mean ratio HIV Human immunodeficiency virus HPLC High-performance liquid chromatography IAT Investigator-assigned anti-CMV treatment IC/EC 50 Half-maximal inhibitory/effective concentration ICH International Council for Harmonisation Ig Immunoglobulin INN International non-proprietary name ITT Intention-to-treat LoQ List of Questions MAH Marketing authorisation holder MAR Maribavir Max Maximum Min Minimum MRHD Maximum recommended human dose N/A Not applicable NO(A)EL No observed (不良)效应水平PBPK生理学基于药代动力学PD药效学PIP儿科研究计划(EMA)PK Pharmacokinetics POPPK POPPK POPPK POPPK POPPK PREMACOKINICS PSP儿科研究计划(US FDA)QD Quaque Die;每天一次RMP风险管理计划SAE严重不良事件SCT干细胞移植SOC系统器官类SOT SOT SOT ORNANS移植瑞士瑞士瑞士公共评估报告Teae Emergergert-Extrergert EffersEnd Edverse Everse Everse tid TID TID ter ter ter in Die;一天三次。
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