| 书目名称 | Quantitative Decisions in Drug Development |
| 编辑 | Christy Chuang-Stein,Simon Kirby |
| 视频video | |
| 概述 | Focuses on important decision points and evidence needed for making decisions at these points during the development of a new drug.Takes a holistic approach towards drug development by incorporating k |
| 丛书名称 | Springer Series in Pharmaceutical Statistics |
| 图书封面 |  |
| 描述 | .This book offers a high-level treatise of evidence-based decisions in drug development. Because of the inseparable relationship between designs and decisions, a good portion of this book is devoted to the design of clinical trials. The book begins with an overview of product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and decision making at different stages of drug development. The latter include selecting appropriate metrics to formulate decisions criteria, determining go/no-go decisions for progressing a drug candidate to the next stage and predicting the effectiveness of a product. Lastly, it points out common mistakes made by drug developers under the current drug-development paradigm..The book offers useful insights to statisticians, clinicians, regulatory affairs managers and decision-makers in the pharmaceutical industry who have a basic understanding of the drug-development processand the clinical trials conducted to support drug-marketing authorization.. .The authors provide software codes for select analytical approaches discussed in the book. The book includes enough technical details to allow stat |
| 出版日期 | Book 20171st edition |
| 关键词 | clinical trials; metric for decision; drug development; probability of study success; probability of pro |
| 版次 | 1 |
| doi | https://doi.org/10.1007/978-3-319-46076-5 |
| isbn_softcover | 978-3-319-83434-4 |
| isbn_ebook | 978-3-319-46076-5Series ISSN 2366-8695 Series E-ISSN 2366-8709 |
| issn_series | 2366-8695 |
| copyright | Springer International Publishing AG 2017 |
发表于 2025-3-21 19:10:40
