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
- Basic Definitions and Concepts
- Data Graphics
- Introduction to Probability: The Binomial and Normal Probability Distributions
- Choosing Samples
- Statistical Inference: Estimation and Hypothesis Testing
- Sample Size and Power
- Linear Regression and Correlation
- Analysis of Variance
- Factorial Designs
- Transformations and Outliers
- Experimental Design in Clinical Trials
- Quality Control
- Validation
- Computer-Intensive Methods
- Nonparametric Methods
- 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
Answers to Exercises
Index
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