博文

[转载]国际骨髓瘤工作组多发性骨髓瘤反应和最小残留病评估共识标准(2016)

2024-5-13 12:12

International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma 国际骨髓瘤工作组多发性骨髓瘤反应和最小残留病评估共识标准 Treatment of multiple myeloma has substantially changed over the past decade with the introduction of sever ...

个人分类: CAR-T|265 次阅读|没有评论

[转载]复发性和难治性多发性骨髓瘤的治疗：国际骨髓瘤工作组的建议（2023）

2024-5-13 10:38

Treatment of relapsed and refractory multiple myeloma: recommendations from the International Myeloma Working Group 复发性和难治性多发性骨髓瘤的治疗：国际骨髓瘤工作组的建议 This Policy Review presents the International Myeloma Working Group’s clinical practice recommendations fo ...

个人分类: CAR-T|254 次阅读|没有评论

[转载]Management of toxicities from immunotherapy-ESMO Clinical...

2024-5-10 20:48

Highlights •This ESMO Clinical Practice Guideline provides key recommendations for managing immunotherapy-related toxicity. •The guideline covers assessment, diagnosis and treatment of the most common and severe immunotherapy-related toxicities. •Recommended as ...

个人分类: CAR-T|225 次阅读|没有评论

[转载]（WHO）评估用于预防传染病的 mRNA 疫苗的质量、安全性和有效性

2024-4-30 20:05

Evaluation of the quality, safety and efficacy of mRNA vaccines for the prevention of infectious diseases: regulatory considerations 评估用于预防传染病的 mRNA 疫苗的质量、安全性和有效性：监管方面的考虑因素 7. Nonclinical evaluation of mRNA vaccines 7.mRNA 疫苗的非临床评估 ...

个人分类: 疫苗|356 次阅读|没有评论

[转载]疫苗临床评估指南-EMA

2024-4-30 19:48

Guideline on clinical evaluation of vaccines 疫苗临床评估指南 Executive summary 执行摘要 This guideline addresses the clinical evaluation of vaccines intended for the prevention of infectious diseases . It includes considerations for trials intended to document t ...

个人分类: 疫苗|340 次阅读|没有评论

[转载]系统性红斑狼疮 - 开发用于治疗的医疗产品（FDA）

2024-4-30 19:20

Systemic Lupus Erythematosus —Developing Medical Products for Treatment 系统性红斑狼疮 - 开发用于治疗的医疗产品 TABLE OF CONTENTS 目录 I. INTRODUCTION I. 引言 II.& ...

个人分类: SLE|350 次阅读|没有评论

[转载]临床试验中的多个终点-FDA

2024-4-30 18:38

Multiple Endpoints in Clinical Trials 临床试验中的多个终点 TABLE OF CONTENTS 目录 MULTIPLE ENDPOINTS IN CLINICAL TRIALS 临床试验中的多个终点 I. INTRODUCTION. I. 引言 II.&n ...

个人分类: 临床试验|304 次阅读|没有评论

[转载]CAR T 细胞在癌症治疗中的免疫原性

2024-4-23 19:47

Immunogenicity of CAR T cells in cancer therapy CAR T 细胞在癌症治疗中的免疫原性 Key points 要点 1.Pre-existing and/or treatment-induced immunity to chimeric antigen receptor(CAR) constructs containing mouse-derived single-chain variable fragments are associated with treatment f ...

个人分类: CAR-T|307 次阅读|没有评论

[转载]EMA-疫苗临床评估指南

2024-4-18 17:49

Guideline on clinical evaluation of vaccines 疫苗临床评估指南 Executive summary 执行摘要 This guideline addresses the clinical evaluation of vaccines intended for the prevention of infectious diseases . It includes considerations for trials intended to document the safety, ...

个人分类: 疫苗|317 次阅读|没有评论

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