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. 2024 Aug 28;13(10):1748–1761. doi: 10.1002/psp4.13217

TABLE 1.

Overview of studied simulation scenarios.

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
a

β TRT,F value used for test formulation in simulations.

b

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.