Week 2 Homework Q1A
Let x be the response for ln-AUC for a subject following the Test
formulation, and let y be the response be the response for
ln-AUC for a subject following the Reference formulation.
2 2 2
x µT σB + σW σB
∼ BV N ,
2 2 2
y µR σB σB + σW
Prove that the variance of x − y is 2(σW ).
Week 2 Homework Q1B
x µT σT σB 2 2 2
∼ BV N , where σT = σBT + σW T ,
y µR σB σR
2 2 2
σR = σBR + σW R , between-subject variances are homogeneous
across formulations, and within-subject variances are homogeneous
across formulations, prove that the variance of x − y is again 2(σW ).
Week 2 Homework Q2
Consider the Tmax data in Example 1 (recall this is in data set
twobytwo of exam3.1.sas).
Calculate the individual diﬀerences for this Tmax data and
construct NPPs and histograms.
Decide whether this data looks normally distributed.
Week 2 Homework Q3
Consider data set week2 available at
Calculate the individual diﬀerences for ln −AUC and for
ln −Cmax and construct paired agreement plots. Descriptively
assess whether period or sequence eﬀects are present.
Perform average bioequivalence assessment for AUC and Cmax
and review MIXED output.
Check for outliers and perform sensitivity analysis if needed.
Week 2 Homework Assignment
Review Sections 4.1-4.5 of Chapter 4 and Section 5.4 of Chapter 5.