Average_bioequivalence

Average bioequivalence output

Average Bioequivalence 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.

FormVar: Input data column mapped to the Formulation context.

FormRef: Reference formulation.

RefLSM: Reference least squares mean.

RefLSM_SE: Standard error computed for reference least squares mean.

RefGeoLSM: Geometric reference least squares mean.

Test: Test formulation.

TestLSM: Test least squares mean.

TestLSM_SE: Standard error computed for test least squares mean.

TestGeoLSM: Geometric test least squares mean.

Difference: Difference between test and reference LSM values.

Diff_SE: Standard error of the difference in LSM values.

Diff_DF: Degrees of freedom for the difference in LSM values.

Ratio_%REF_: Percent ration of test LMS to reference LSM values. (See the “Least squares means” section for more details.)

CI_xx_Lower(Upper): Confidence interval computations. (See the “Classical intervals” section for more details.)

t1_TOST: Left-tail test result. (See the “Two one-sided t-tests” section for more details.)

t2_TOST: Right-tail test result. (See the “Two one-sided t-tests” section for more details.)

Prob_80(125)_00: Probability results for the two one-sided t-tests. (See the “Two one-sided t-tests” section for more details.)

MaxProb: Largest value of the probability results (Prob_80 and Prob_125). (See the “Two one-sided t-tests” section for more details.)

TotalProb: Sum of the probability results. (See the “Two one-sided t-tests” section for more details.)

Power_TOST: Power of the two one-sided t-tests. (See the “Power of the two one-sided t-tests procedure” section for more details.)

AHpval: Anderson-Hauck test statistic. (See the“Anderson-Hauck test” section for more details.)

Power_80_20: Power to detect a difference in least square means equal to 20% of the reference LSM. (See the “Power for 80/20 Rule” section for more details.)

Prob_Eq_Var: Probability of equal variance. (See the “Tests for equal variances” section for more details.)

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

User Settings Worksheet: User-specified settings.

For convenience, the Linear Mixed Effects Modeling output is also included with Average Bioequivalence but note that, since there is no specification of test or reference in Linear Mixed Effects Modeling, the LSM differences are computed alphabetically, which could correspond to reference minus test formulation rather than test minus reference.

Diagnostics: Number of observations, number of observations used, residual sums of squares, residual degrees of freedom, residual variance, restricted log likelihood, AIC, SBC, and Hessian eigenvalues.

Final Fixed Parameters: Sort variables, dependent variable(s), units, effect level, parameter estimate, t-statistic, p-value, intervals, etc.

Final Variance Parameters: Final estimates of the variance parameters.

Initial Variance Parameters: Parameter and estimates for variance parameters.

Iteration History: Iteration, Obj_function, and column for each variance parameter.

Least Squares Means: Sort variable(s), dependent variable(s), units, and the least squares means for the test formulation.

LSM Differences: Difference in least squares means.

Parameter Key: Variance parameter names assigned by Phoenix.

Partial SS: Only for 2x2 crossover designs using the default model: ANOVA sums of squares, degrees of freedom, mean squares, F-tests and p-values for partial test.

Partial Tests: Sort Variable(s), Dependent Variable(s), Units, Hypothesis, Hypothesis degrees of freedom, Denominator degrees of freedom, F statistic, and p-value.

Residuals: Sort Variable(s), Dependent Variable(s), Units, and information on residual effects vs. predicted and observed effects.

Sequential SS: Only for 2x2 crossover designs using the default model: ANOVA sums of squares, degrees of freedom, mean squares, F-tests and p-values for sequential test.

Sequential Tests: Sort Variable(s), Dependent Variable(s), Units, Hypothesis, Hypothesis degrees of freedom, Denominator degrees of freedom, F statistic, and p-value.