| 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 focuses on important decision points and evidence needed for making decisions at these points during the development of a new drug. It takes a holistic approach towards drug development by incorporating explicitly knowledge learned from the earlier part of the development and available historical information into decisions at later stages. In addition, the book shares lessons learned from several select examples published in the literature since the publication of the first edition. ..The second edition reiterates the need for making evidence-based Go/No Go decisions in drug development discussed in the first edition. It substantially expands several topics that have seen great advances since the publication of the first edition. The most noticeable additions include three adaptive trials conducted in recent years that offer excellent learning opportunities, the use of historical data in the design and analysis of clinical trials, and extending decision criteria tothe cases when the primary endpoint is binary. The examples used to illustrate the additional materials all come from real trials with some post-trial reflections offered by the authors. ..The book begins with |
| 出版日期 | Book 2021Latest edition |
| 关键词 | clinical trials; metric for decision; drug development; probability of study success; probability of pro |
| 版次 | 2 |
| doi | https://doi.org/10.1007/978-3-030-79731-7 |
| isbn_softcover | 978-3-030-79733-1 |
| isbn_ebook | 978-3-030-79731-7Series ISSN 2366-8695 Series E-ISSN 2366-8709 |
| issn_series | 2366-8695 |
| copyright | The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerl |
发表于 2025-3-21 20:07:24
