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Nonclinical Statistics for Pharmaceutical and Biotechnology Industries

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Cover of 'Nonclinical Statistics for Pharmaceutical and Biotechnology Industries'

Table of Contents

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    Book Overview
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    Chapter 1 Introduction to Nonclinical Statistics for Pharmaceutical and Biotechnology Industries
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    Chapter 2 Regulatory Nonclinical Statistics
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    Chapter 3 How To Be a Good Nonclinical Statistician
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    Chapter 4 Statistical Methods for Drug Discovery
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    Chapter 5 High-Throughput Screening Data Analysis
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    Chapter 6 Quantitative-Structure Activity Relationship Modeling and Cheminformatics
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    Chapter 7 GWAS for Drug Discovery
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    Chapter 8 Statistical Applications in Design and Analysis of In Vitro Safety Screening Assays
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    Chapter 9 Nonclinical Safety Assessment: An Introduction for Statisticians
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    Chapter 10 General Toxicology, Safety Pharmacology, Reproductive Toxicology, and Juvenile Toxicology Studies
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    Chapter 11 Clinical Assays for Biological Macromolecules
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    Chapter 12 Recent Research Projects by the FDA’s Pharmacology and Toxicology Statistics Team
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    Chapter 13 Design and Evaluation of Drug Combination Studies
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    Chapter 14 Biomarkers
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    Chapter 15 Overview of Drug Development and Statistical Tools for Manufacturing and Testing
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    Chapter 16 Assay Validation
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    Chapter 17 Lifecycle Approach to Bioassay
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    Chapter 18 Quality by Design: Building Quality into Products and Processes
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    Chapter 19 Process Validation in the Twenty-First Century
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    Chapter 20 Acceptance Sampling
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    Chapter 21 Process Capability and Statistical Process Control
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    Chapter 22 Statistical Considerations for Stability and the Estimation of Shelf Life
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    Chapter 23 In Vitro Dissolution Testing: Statistical Approaches and Issues
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    Chapter 24 Assessing Content Uniformity
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    Chapter 25 Chemometrics and Predictive Modelling
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    Chapter 26 Statistical Methods for Comparability Studies
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Title
Nonclinical Statistics for Pharmaceutical and Biotechnology Industries
Published by
Springer International Publishing, January 2016
DOI 10.1007/978-3-319-23558-5
ISBNs
978-3-31-923557-8, 978-3-31-923558-5
Editors

Lanju Zhang

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X Demographics

The data shown below were collected from the profiles of 3 X users who shared this research output. Click here to find out more about how the information was compiled.
Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 39 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 39 100%

Demographic breakdown

Readers by professional status Count As %
Student > Ph. D. Student 2 5%
Researcher 1 3%
Student > Bachelor 1 3%
Student > Master 1 3%
Unknown 34 87%
Readers by discipline Count As %
Chemical Engineering 1 3%
Pharmacology, Toxicology and Pharmaceutical Science 1 3%
Biochemistry, Genetics and Molecular Biology 1 3%
Business, Management and Accounting 1 3%
Engineering 1 3%
Other 0 0%
Unknown 34 87%