1L一线2L二线ADA抗药物抗体吸收,分布,新陈代谢,消除AE不良事件ALT ALT丙氨酸氨基转移酶Aspartate aspartate氨基转移酶API API API活性药物活性药物ATC ATC解剖学化学化学分类系统AUCAUD AUCMATION AUCMATIITS AUCMATIITS AUCMATIITS AUCMATION AUCMATION AUCMATIITS AUCMATIITS AUCMATINE AUCMATION AUC AUCMATION AUC AR AUC AR AUC AR AUC AR AUC AR AUC AR AUC AR AR A A AR缩减为4 curve for the 24-hour dosing interval CI Confidence interval C max Maximum observed plasma/serum concentration of drug CYP Cytochrome P450 DDI Drug-drug interaction DOR Duration of response ECOG Eastern Cooperative Oncology Group EMA European Medicines Agency ERA Environmental risk assessment FDA Food and Drug Administration (USA) GLP Good Laboratory Practice HPLC High-performance liquid chromatography 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 Max Maximum Min Minimum MRHD Maximum recommended human dose MTD Maximum tolerated dose N/A Not applicable NCCN National Comprehensive Cancer Network NO(A)EL No observed (adverse) effect level ORR Objective response rate OS Overall survival PBPK Physiology-based pharmacokinetics PD Pharmacodynamics PFS Progression-free survival PIP Paediatric Investigation Plan (EMA) PK Pharmacokinetics PopPK Population pharmacokinetics PSP Pediatric study plan (US FDA) RMP Risk management plan SAE Serious adverse event SwissPAR Swiss Public Assessment Report TEAE Treatment-emergent adverse event TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (SR 812.21)2018年9月21日的TPO条例(SR 812.212.21)