书目名称 | Nonclinical Statistics for Pharmaceutical and Biotechnology Industries |
编辑 | Lanju Zhang |
视频video | |
概述 | Provides the first volume dedicated to nonclinical statistics.Brings together relevant statistical methods for nonclinical research in pharma/biotech industries with a mission promoting nonclinical st |
丛书名称 | Statistics for Biology and Health |
图书封面 |  |
描述 | .This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in thesenonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions. . |
出版日期 | Book 2016 |
关键词 | Animal studies; Biomarker; Chemistry, manufacturing and controls (CMC); Drug research and development; N |
版次 | 1 |
doi | https://doi.org/10.1007/978-3-319-23558-5 |
isbn_softcover | 978-3-319-79499-0 |
isbn_ebook | 978-3-319-23558-5Series ISSN 1431-8776 Series E-ISSN 2197-5671 |
issn_series | 1431-8776 |
copyright | Springer International Publishing Switzerland 2016 |