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Table of Contents
A Brief and Superficial History of Statistics for Drug Developers
Design and Interpretation of Clinical Trials as Seen by a Statistician
Probability, Bayes, P-values, Tests of Hypotheses and Confidence Intervals
The Work of the Pharmaceutical Statistician
Allocating Treatments to Patients in Clinical Trials
Baselines and Covariate Information
The Measurement of Treatment Effects
Demographic Subgroups : Representation and Analysis
Multiplicity
Intention to Treat, Missing Data and Related Matters
One-sided and Two-sided Tests and other Issues to Do with Significance and P-values
Determining the Sample Size
Multicentre Trials
Active Control Equivalence Studies
Meta-Analysis
Cross-over Trials
n-of-1 Trials
Sequential Trial
Dose-finding
Concerning Pharmacokinetics and Pharmacodynamics
Bioequivalence Studies
Safety Data, Harms, Drug Monitoring and Pharmaco-epidemiology
Pharmaco-economics and Portfolio Management
Concerning Pharmacogenetics, Pharmacogenomics and Related Matters.
Design and Interpretation of Clinical Trials as Seen by a Statistician
Probability, Bayes, P-values, Tests of Hypotheses and Confidence Intervals
The Work of the Pharmaceutical Statistician
Allocating Treatments to Patients in Clinical Trials
Baselines and Covariate Information
The Measurement of Treatment Effects
Demographic Subgroups : Representation and Analysis
Multiplicity
Intention to Treat, Missing Data and Related Matters
One-sided and Two-sided Tests and other Issues to Do with Significance and P-values
Determining the Sample Size
Multicentre Trials
Active Control Equivalence Studies
Meta-Analysis
Cross-over Trials
n-of-1 Trials
Sequential Trial
Dose-finding
Concerning Pharmacokinetics and Pharmacodynamics
Bioequivalence Studies
Safety Data, Harms, Drug Monitoring and Pharmaco-epidemiology
Pharmaco-economics and Portfolio Management
Concerning Pharmacogenetics, Pharmacogenomics and Related Matters.