[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

饶玉清 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|358 次阅读|没有评论

[转载]疫苗临床评估指南-EMA

饶玉清 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|342 次阅读|没有评论

[转载]EMA-疫苗临床评估指南

饶玉清 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

[转载]5岁以下婴幼儿接种肺炎球菌结合疫苗：世卫组织立场文件

饶玉清 2024-4-18 16:47

Pneumococcal conjugate vaccines in infants and children under 5 years of age: WHO position paper – February 2019 5岁以下婴幼儿接种肺炎球菌结合疫苗：世卫组织立场文件 - 2019年2月 Introduction 导言 In accordance with its mandate to provide guidance to Memb ...

个人分类: 疫苗|283 次阅读|没有评论

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