“Statistical Thinking for Non-Statisticians in Drug Regulation” - это книга, написанная группой авторов, которые специализируются на обучении и консультировании специалистов в области фармацевтики. Она ориентирована на фармацевтических специалистов, работающих в очень строгих условиях регулирования. Книга предоставляет детальный обзор статистических аспектов дизайна, проведения, анализа и представления данных клинических испытаний в рамках регулирования лекарственных препаратов.
Книга содержит информацию о концептуальных основах и статистическом мышлении медицинских исследований и связывает их с регулятивной средой, чтобы читатели могли понять, как статистическая методология соотносится с требованиями промышленности. Примерами, связанными с фармацевтикой, авторы иллюстрируют эту информацию в контексте. В результате, книга помогает фармацевтическому персоналу эффективно общаться со статистиками, используя статистический язык, улучшает способность читать и понимать статистическую методологию в статьях и отчетах, а также критически оценивать эту методологию. Кроме того, книга помогает лучше понять статистические аспекты регулятивной рамки, часто цитируя из нормативных руководств, изданных Европейским медицинским агентством (EMA).
Written by a well - known lecturer and consultancy service for the pharmaceutical company, the text assumes knowledge of non - statistiKal scientific methods working in general dosimik conditions environment. It contains the essence of statistical thinking and reliavarne approach in médtsal examinations connected with the regulating system of state, backed by examination data, which helps readers understand what statistical procedure is necessary for business needs. A pharmaceutical topics are suggested everyday to coincide information basis of issues. The text thus provides an accessible context for study statistical components in the final stages of designing, conduction, analysis, and processing data from medical discoveries in regards with business conditions.
Written by a renowned lecturer and a consultant to the pharma industry, Statistical Thinking for Drug Regulation is the essential guide for colleagues within the industry who may lack statistical knowledge but need to deal with complex statistics requiring regulatory oversight. Through lively examples, the book promotes awareness across various aspects:
· Statistical concepts relevant to clinical drug trials · The role of these concepts within the complex regulatory process · How to effectively present statistical findings in ways that regulators will understand.
By the end of this book, the reader should not only learn the basics of statistics, but also have the confidence to apply them, negotiate with colleagues, and apply the necessary language when dealing with pharmaceutical regulators. This course material provides ideas and guides which pharmaceutical professionals can use as stepping stones to demonstrate their worth to the world of regulation, whilst keeping at the forefront of advances in the science of medicine.
Электронная Книга «Statistical Thinking for Non-Statisticians in Drug Regulation» написана автором Группа авторов в году.
Минимальный возраст читателя: 0
Язык: Английский
ISBN: 9780470513255
Описание книги от Группа авторов
Written by a well-known lecturer and consultant to the pharmaceutical industry, this book focuses on the pharmaceutical non-statistician working 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 to critically 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)
