TABLE 1.
Description | True mean‐ratio a (%) | Subjects | Sampling times (hours after dose) |
---|---|---|---|
Oral formulation | |||
Power analysis | |||
Crossover design with rich sampling | 90 | 24 | 0.25, 0.5, 1, 2, 3.5, 5, 7, 9, 12, 24 |
Crossover design with sparse sampling | 90 | 40 | 0.25, 3.35, 24 |
Type I error analysis | |||
Crossover design with rich sampling | 125 | 24 | 0.25, 0.5, 1, 2, 3.5, 5, 7, 9, 12, 24 |
Crossover design with sparse sampling | 125 | 40 | 0.25, 3.35, 24 |
Ophthalmic formulation | |||
Power analysis | |||
Parallel design | 90 | 480 | 0.25, 1.5, 5, 15, 24 b |
Crossover design | 90 | 120 | 0.25, 1.5, 5, 15, 24 b |
Type I error analysis | |||
Parallel design | 125 | 480 | 0.25, 1.5, 5, 15, 24 b |
Crossover design | 125 | 120 | 0.25, 1.5, 5, 15, 24 b |
β TRT,F value used for test formulation in simulations.
For ophthalmic formulations: In parallel trials, each subject is sampled once, in crossover trials, each subject is sampled twice at the same time after the dose, once per study period. Subjects are assigned evenly across timepoints.