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Etanercept（ENBREL®）RMP摘要
研究的目的：这是一项大型前瞻性观察性研究，从常规临床实践中获取数据，其目的是评估RA AS AS和PSA患者的各种不良事件的任何过量风险，允许允许混淆因素，尤其是疾病的严重性和和解性风湿病治疗。此外，将使用来自BSRBR的数据进行的长期药物养生监测，比较了在引入新的高容量药物制造过程中依那耐酸的安全性。要监测的安全性问题是在现实生活中的市场后环境中使用SFPHC工艺制造的Etanercept的免疫原性特征和相关的临床结果。
草稿指导线 - 临床开发中的中型产品...
5-ASA 5-aminosalicylic acid Ab antibody ASCVD atherosclerotic cardiovascular disease ADR adverse drug reaction AE adverse event AIDS acquired immunodeficiency syndrome ALC absolute lymphocyte count ALT alanine aminotransferase ANC absolute neutrophil count aRMM additional risk minimisation measure ART 20 Article 20 procedure ARTIS Anti-rheumatic Therapies in Sweden AS （浓度时间）曲线平均每日剂量在（浓度时间）平均每日剂量蝙蝠棕色脂肪组织BCC基础细胞癌BCR乳腺癌抗癌蛋白BDMARD生物学疾病调节抗rheumaumatic Bibis in Die（Twice Demakic in Demand）pede rean Inde Bikikeric inde Bikikeric inde bikiakic， BIOBADASER Registro Español De Acontecimientos Adversos De Terapias Biológicas En Enfermedades Reumáticas BMI body mass index BSRBR British Society for Rheumatology Biologics Register CARRA Childhood Arthritis and Rheumatology Research Alliance CHF congestive heart failure CI confidence interval Cmax peak plasma concentration CNS central nervous system CrCl creatinine clearance csDMARDs conventional synthetic disease-modifying anti-rheumatic drug CTC Common Terminology Criteria CV cardiovascular CVD cardiovascular disease CYP cytochrome P450 DHPC Direct Healthcare Professional Communication DILI drug-induced liver injury DLP data lock point DMARD disease-modifying anti-rheumatic drug DNA deoxyribonucleic acid DUS drug utilisation study DVT深静脉血栓形成EBV EBV EBV EBV EBV病毒EEA EEA EEA EEA EEA EEF EFD EFD胚胎 - 纤维 - 纤维化EHR电子保健记录EM广泛代谢EMA EMA EMA欧洲药物局Eneida estudio eneeida estudio nacional nacional nacional enfermedAd infamatoria infamatoria infamatoria Intestinal sobre sobre sobre sobre sobre sabientans ygenéticosygenéticosygenéticientesygenéticientementailesy/divales