Question: The 90% confidence interval for the geometric mean ratios (Test/Reference) of log-transformed AUC and Cmax Group of answer choices Establishes no difference between two formulations

The 90% confidence interval for the geometric mean ratios (Test/Reference) of log-transformed AUC and Cmax Group of answer choices Establishes no difference between two formulations if either boundary (lower or upper) of the 90% CI falls outside the 0.8 to 1.25 range Is typically shown in reference to a 0.75 to 1.30 (75% - 130%) ratio scale Can be used to judge bioequivalence of two formulations if the number of subjects enrolled in a study provides a statistical power of 80%. Is not applicable to food effect bioavailability studies Cannot correct for the skewed distribution of PK parameters such as AUC and Cmax

Step by Step Solution

There are 3 Steps involved in it

1 Expert Approved Answer
Step: 1 Unlock blur-text-image
Question Has Been Solved by an Expert!

Get step-by-step solutions from verified subject matter experts

Step: 2 Unlock
Step: 3 Unlock

Students Have Also Explored These Related Mathematics Questions!