Statistical Thinking for Non Statisticians in Drug Regulation pdf epub mobi txt 电子书 下载 2025
- 统计思维
- 药物监管
- 统计学应用
- 非统计人员
- 药物研发
- 数据分析
- 法规
- 生物统计
- 临床试验
- 决策制定
具体描述
Written by a well-known lecturer and consultant to the pharmaceutical industry, this book focuses on the pharmaceutical non-statisticianworking within a very strict regulatory environment. Statistical Thinking for Clinical Trials in Drug Regulation presents the concepts and statistical thinking behind medical studies with a direct connection to the regulatory environment so that readers can be clear where the statistical methodology fits in with industry requirements. Pharmaceutical-related examples are used throughout to set the information in context.As a result, this book provides a detailed overview of the statistical aspects of the design, conduct, analysis and presentation of data from clinical trials within drug regulation. Statistical Thinking for Clinical Trials in Drug Regulation: Assists pharmaceutical personnel in communicating effectively with statisticians using statistical language Improves the ability to read and understand statistical methodology in papers and reports and tocritically appraise that methodology Helps to understand the statistical aspects of the regulatory framework better quoting extensively from regulatory guidelines issued by the EMEA (European Medicines Evaluation Agency), ICH (International Committee on Harmonization and the FDA (Food and Drug Administration)
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