我们很高兴在日内瓦 JETRO 接待来自日本标准协会 (JSA) 的新成员。标准化专家佐藤京子女士将接替远藤智之先生担任我们办公室的标准与合格评定总监。标准化在全球贸易和工业发展中发挥着至关重要的作用。它确保了跨境产品和服务的一致性、质量和互操作性。以精密工业闻名的瑞士和日本都依靠标准化来维护其质量和创新的声誉。这两个国家都认识到标准化在促进创新、降低成本和增强全球竞争力方面的重要性。日内瓦 JETRO 无疑将从佐藤女士在该领域的丰富经验中受益。她的专业知识对于驾驭复杂的国际标准格局将发挥无价之宝的作用。佐藤女士非常乐意在本期的时事通讯中分享她的见解,为我们的读者提供关于标准化在促进国际贸易方面的作用的独特视角。
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)
1L First-line 2L Second-line ADA Anti-drug antibody ADME Absorption, distribution, metabolism, elimination ADT Androgen deprivation therapy AE Adverse event ALT Alanine aminotransferase AST Aspartate aminotransferase API Active pharmaceutical ingredient ATC Anatomical Therapeutic Chemical Classification System AUC Area under the plasma concentration-time curve AUC 24小时给药间隔BMI体重指数BRCA BRCA BRCA BRCA BRCA BRCA BSC最佳护理BSOC BSOC BSOC最佳护理CI置信区间C最大观察到血浆/血清的血清cRPC cRPC cRPC cRPC cRPC耐药性 - 耐药前列腺p450 dcr p450 dcr ddi ddi ddi ddi ddi ddi ddi ddi ddi ddi ddii Electrocardiogram ECOG Eastern Cooperative Oncology Group EMA European Medicines Agency ERA Environmental risk assessment ESI-MS Electrospray ionisation ESMO European Society for Medical Oncology FDA Food and Drug Administration (USA) GC Gas chromatography GLP Good Laboratory Practice HPLC High-performance liquid chromatography IC/EC 50 Half-maximal inhibitory/effective concentration ICH International Council for Harmonisation ICP-MS Inductively Coupled Plasma Mass Spectrometry Ig Immunoglobulin INN International non-proprietary name ITT Intention-to-treat LoQ List of Questions MAH Marketing Authorisation Holder Max Maximum MCBS Magnitude of Clinical Benefit Scale mCRPC Metastatic castration-resistant prostate cancer mHNPC Metastatic hormone-naïve prostate cancer Min Minimum MRHD Maximum recommended human dose MS Mass spectrometry MTD Maximum tolerated dose不适用NAAD新型雄激素轴药物NCCN国家综合癌症网络
•存储技术之间的竞争(PTX) - Stes具有高度竞争力,容量成本为0.4欧元/千瓦时,水平的热成本低至0.01欧元/千瓦时
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