Designing PK Studies Flashcards
1
Q
What is meant by the primary objective
A
the main reason you are undertaking the trial
2
Q
What is meant by the secondary objective?
A
additional data being collected that can be adding a PK objective
3
Q
What are 2 types of study design
A
- cross-over study
2. parallel study
4
Q
What is PK sampling
A
a number of blood samples taken over a period of time to determine of the body handles the drug
Can measure the AUC to determine this to show the variation in drug concentration
5
Q
Why is the coefficient variation used in PK studies
A
The SDV is converted into a % which will show the variability of the test results
This allows you to compare one data set to another
