To provide the student with statistical tools for the exploration, validation and improvement of pharmaceutical processes and products.
Single-factor Experiments
Principles of experimental design: randomisation, replication, blocking. Hypotheses, models, and assumptions. One-way Analysis of Variance.
Two-factor Experiments
Main effects and interaction effects. Design and analysis of two-factor experiments. Interpreting ANOVA tables and interaction plots.
Multi-factor experiments
Fractional factorial experiments. Curvature. Aliasing. Effects plots.
The General Linear Model
Factors and covariates. Fixed and random factors. Crossed and nested designs. Repeated measures.
Stability Studies
Determination of shelf-life of drug products. Expiry dates. Statistical analysis of stability study data. Poolability and model selection. Bracketing and matrixing.
Measurement System Validation
Gage linearity and bias studies. Gage R&R studies: number of distinct categories; signal-to-noise ratio; precision to tolerance ratio.
Lectures, demonstrations, exercises, tutorials, software demonstrations, project support and feedback.
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Formal Examination | 70 |
| Other Assessment(s) | 30 |