Population_and_individual_bioequivalence

Population and individual bioequivalence output

The worksheets that are created depend on which model options are selected.

Population Individual Worksheet: Output from the bioequivalence analysis. Columns include:

Dependent: Input data column mapped to the Dependent context.

Units: Units, if specified in the input dataset.

Statistic: Name of the statistic.

Value: Computed value of the statistic.

Upper_CI: Upper bound (an upper bound < 0 indicates bioequivalence).

Conclusion: Bioequivalence conclusion.

Ratios Test Worksheets: Ratios of reference to test mean. One worksheet for each test formulation.

User Settings Worksheet: User-specified settings.

The population/individual bioequivalence statistics include:

Difference (Delta): Difference in sample means between the test and reference formulations.

Ratio(%Ref): Ratio of the test to reference means, expressed as a percent. This is compared with the “percent of reference to detect” that was user-specified, to determine if bioequivalence has been shown. The ratio is expected to be 100% if both formulations are exactly equal. If the values of the two dependents are both over 100, it indicates that the test formulation resulted in higher average exposure than the reference. Values <100 indicate the reverse. For example, if a percent of reference to detect of 20% was specified, along with a ln-transform, then Ratio(%Ref) needs to be in the interval (80%, 125%) to show bioequivalence for the ratio test. See the “Least squares means” section for more details.

SigmaR: Value that is compared with sigmaP, the Total SD Standard, to determine whether mixed scaling for population bioequivalence will use the constant-scaling values or the reference-scaling values.

SigmaWR: Value that is compared with sigmaI, the Within Subject SD Standard, to determine whether mixed scaling for individual bioequivalence will use the constant-scaling values or the reference-scaling values. See the “Bioequivalence criterion” section for more details.

Computed bioequivalence statistics include:

Ref_Pop_eta: Test statistic for population bioequivalence with reference scaling.

Const_Pop_eta: Test statistic for population bioequivalence with constant scaling.

Mixed_Pop_eta: Test statistic for population bioequivalence with mixed scaling.

Ref_Indiv_eta: Test statistic for individual bioequivalence with reference scaling.

Const_Indiv_eta: Test statistic for individual bioequivalence with constant scaling.

Mixed_Indiv_eta: Test statistic for individual bioequivalence with mixed scaling.

Because population/individual bioequivalence only allows crossover designs, the output also contains the ratios test, described in the “Ratios test” section.