ENGLISH

Nonclinical Statistics for Pharmaceutical and Biotechnology Industries

By Lanju Zhang (eds.)

Book information

Publisher
Springer International Publishing
Year
2016
ISBN
978-3-319-23557-8, 978-3-319-23558-5
DOI
10.1007/978-3-319-23558-5
Language
english
Format
PDF
Filesize
9 MB (9671641 bytes)
Series
Statistics for Biology and Health
Edition
1
Pages
XXII, 698\705
Time added
2016-03-14 21:35:01
general; Pharmacology/ToxicologyHealth Sciences; Medicine/Public HealthMedicineStatistics for Life Sciences

Description

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 these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions.

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