Statistics in Drug Development
by Ralph B. D'Agostino, Ph. D. Christy Chuang-Stein, Ph. D. Alex Dmitrienko
Pharmaceutical Statistics Using SAS
- Praise from the Experts
- Copyright
- Preface
- Statistics in Drug Development
- Modern Classification Methods for Drug Discovery
- Model Building Techniques in Drug Discovery
- Statistical Considerations in Analytical Method Validation
- Some Statistical Considerations in Nonclinical Safety Assessment
- Nonparametric Methods in Pharmaceutical Statistics
- Optimal Design of Experiments in Pharmaceutical Applications
- Optimal Design problem
- Quantal Dose-Response Models
- Nonlinear Regression Models with a Continuous Response
- Regression Models with Unknown Parameters in the Variance Function
- Models with a Bounded Response (Beta Models
- Models with a Bounded Response (Logit Link)
- Bivariate Probit Models for Correlated Binary Responses
- Pharmacokinetic Models with Multiple Measurements per Patient
- Models with Cost Constraints
- Summary
- References
- Analysis of Human Pharmacokinetic Data
- Allocation in Randomized Clinical Trials
- Sample-Size Analysis for Traditional Hypothesis Testing: Concepts and Issues
- Introduction
- Research Question 1: Does "QCA" Decrease Mortality in Children with Severe Malaria?
- p-Values, α, β and Power
- A Classical Power Analysis
- Beyond α and β: Crucial Type I and Type II Error Rates
- Research Question 1, Continued: Crucial Error Rates for Mortality Analysis
- Research Question 2: Does "QCA" Affect the "Elysemine: Elysemate" Ratios (EER)?
- Crucial Error Rates When the Null Hypothesis Is Likely to Be True
- Table of Crucial Error Rates
- Acknowledgments
- References
- Appendix A Guidelines for "Statistical Considerations" Sections
- Appendix B SAS Macro Code to Automate the Programming
- Design and Analysis of Dose-Ranging Clinical Studies
- Analysis of Incomplete Data
- Reliability and Validity: Assessing the Psychometric Properties of Rating Scales
- Decision Analysis in Drug Development
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