图 书 馆
关于医疗产品管理的生物统计学Biostatistics for Medical Product Regulation |
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| 课程网址: | http://ocw.jhsph.edu/courses/BiostatMedicalProductRegulation/ |
| 主讲教师: | Mary Foulkes; Simon Day |
| 开课单位: | 布隆博格公共卫生学院 |
| 开课时间: | 信息不详。欢迎您在右侧留言补充。 |
| 课程语种: | 英语 |
| 中文简介: |  |
| 课程简介: | Provides a broad understanding of the application of biostatistics in a regulatory context. Reviews the relevant regulations and guidance documents. Includes topics such as basic study design, target population, comparison groups, and endpoints. Addresses analysis issues with emphasis on the regulatory aspects, including issues of missing data and informative censoring. Discusses safety monitoring, interim analysis and early termination of trials with a focus on regulatory implications. |
| 关 键 词: | 生物统计学; 监管环境; 安全监控 |
| 课程来源: | 信息不详。欢迎您在右侧留言补充。 |
| 最后编审: | 2016-06-20：lkn |
| 阅读次数: | 31 |