﻿ Pharmaceutical Statistics: Practical and Clinical Applications 5th edition by Sanford Bolton and Charles Bon

Pharmaceutical Statistics Reference from C.H.I.P.S.

Pharmaceutical Statistics
Practical and Clinical Applications
Fifth edition
by Sanford Bolton and Charles Bon

Pharmaceutical Statistics: Practical and Clinical Applications is an essential resource for those applying pharmaceutical statistics to scientific research and clinical evaluation.

Written in an easy-to-read format using practical examples and solutions, this resource is a perfect guide for pharmaceutical scientists and technologists who report on clinical trials data.

Features:

• Stay current with the latest industry information on modern principles and practices in statistics
• Determine sample size in bioequivalence and clinical trials, even for those with complicated designs
• Gain FDA acceptance of post-approval manufacturing changes quicker and easier through the in vitro in vivo correlation technique in the drug development process
• Analyze key concepts and text examples with SAS and Excel-based programs that offer step-by-step guidance
• Evaluate pharmaceutical data using various regression techniques

Contents

1. Basic Definitions and Concepts
2. Data Graphics
3. Introduction to Probability: The Binomial and Normal Probability Distributions
4. Choosing Samples
5. Statistical Inference: Estimation and Hypothesis Testing
6. Sample Size and Power
7. Linear Regression and Correlation
8. Analysis of Variance
9. Factorial Designs
10. Transformations and Outliers
12. Quality Control
13. Validation
14. Computer-Intensive Methods
15. Nonparametric Methods
16. Optimization Techniques and Screening Designs

Appendices

• Some Properties of the Variance
• Comparison of Slopes and Testing of Linearity: Determination of Relative Potency
• Multiple Regression
• Tables
• Outlier Tests and Chemical Assays
• Should a Single Unexplained Failing Assay Be Reason to Reject a Batch?
• When it is Appropriate to Average and its Relationship to the Barr Decision
• Excel Workbooks and SAS Programs
• An Alternative Solution to the Distribution of the Individual Bioequivalence Metric
• Some Statistical Considerations and Alternate Designs and Considerations for Bioequuivalence

Index

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Pharmaceutical Statistics
Practical and Clinical Applications
Fifth edition
by Sanford Bolton and Charles Bon

2009 • 608 pages • \$298.95 + shipping