Nonclinical statistics for pharmaceutical and biotechnology industries [electronic resource] / Lanju Zhang, editor ; Max Kuhn, Ian Peers, Stan Altan, section editors.
Zhang, Lanju, editor.
2016
RS57
Available Online

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Title
Nonclinical statistics for pharmaceutical and biotechnology industries [electronic resource] / Lanju Zhang, editor ; Max Kuhn, Ian Peers, Stan Altan, section editors.
ISBN
9783319235585 (electronic book)
3319235583 (electronic book)
9783319235578
DOI
https://doi.org/10.1007/978-3-319-23558-5
Published
Cham : Springer, 2016.
Language
English
Description
1 online resource (xxii, 698 pages) : illustrations.
Item Number
10.1007/978-3-319-23558-5 doi
Call Number
RS57
Dewey Decimal Classification
615/.1072
Summary
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.
Note
Includes index.
Access Note
Access limited to authorized users.
Source of Description
Online resource; title from PDF title page (SpringerLink, viewed January 21, 2016).
Added Author
Zhang, Lanju, editor.
Series
Statistics for biology and health.
Available in Other Form
Print version: 9783319235578
Linked Resources
Online Access
Record Appears in
Online Resources > Ebooks
All Resources
Introduction to Nonclinical Statistics for Pharmaceutical and Biotechnology Industries
Regulatory Nonclinical Statistics
How to be a good nonclinical statistician
Statistical Methods for Drug Discovery
High-throughput Screening Data Analysis
Quantitative-Structure Activity Relationship Modeling and Cheminformatics
GWAS for Drug Discovery
Statistical applications in Design and Analysis of In-Vitro Safety Screening Assays
Nonclinical safety assessment: an introduction for statisticians
General Toxicology, Safety Pharmacology, Reproductive Toxicology and Juvenile Toxicology Studies
Clinical Assays for Biological Macromolecules
Recent Research Projects by FDA's Pharmacology and Toxicology Statistics Team
Design and evaluation of drug combination studies
Biomarkers
Overview of Drug Development and Statistical Tools for Manufacturing and Testing
Assay Validation
Lifecycle Approach to Bioassay
Quality by Design: Building Quality into Products and Processes
Process Validation
Acceptance Sampling
Process Capability and Statistical Process Control
Statistical Considerations for Stability and the Estimation of Shelf Life.- In Vitro Dissolution Testing: Statistical Approaches and Issues
Assessing Content Uniformity
Chemometrics and Predictive Modelling
Statistical Methods for Comparability Studies.

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