Bioequivalence_criterion

Population bioequivalence (PBE) criteria are:

Phoenix_UserDocs_Bioequivalence_Object_image1661

Phoenix_UserDocs_Bioequivalence_Object_image1663

where s_P defaults to 0.2 and q_P=(ln(1 – PercentReference)+e_P) /s_P². The default value for PercentReference is 0.20. In the Bioequivalence object, s_P is called the Total SD standard. s_R²is computed by the program and is the total variance of the reference formulation, i.e., the sum of within- and between-subject variance. The criteria take the linearized form:

Phoenix_UserDocs_Bioequivalence_Object_image1665 [

Individual bioequivalence (IBE) criteria are:

Phoenix_UserDocs_Bioequivalence_Object_image1667

where s_I defaults to 0.2 and q_I=(ln(1 – PercentReference)+e_I) /s_I². The default value for Percent Reference is 0.20, and the default value for e_I is 0.05. In the Bioequivalence object, s_I is called the within-subject SD standard. s_WR is computed by Phoenix, and its square, s_WR², is the within-subject variance of the reference formulation.

The IBE criteria take the linearized form:

Phoenix_UserDocs_Bioequivalence_Object_image1669

For reference scaling, use h_P1 or h_I1. For constant scaling, use h_P2 or h_I2. For mixed scaling, use one of the following.

Population

If s_R > s_Pv, use h_P1

If s_R £ s_P, use h_P2

Individual

If s_WR > s_I, useh_I1

If s_WR £ s_I, use h_I2

If the upper bound on the appropriate h is less than zero, then the product is bioequivalent in the chosen sense. The interval is set in the Bioequivalence object’s Options tab. The method of calculating that upper bound follows.