Designing pharmacokinetic studies

Question 1

Why are sampling schedules more complex in monoclonal antibody studies?

Answer 1

Due to the long drug half-life which makes it difficult to characterise the profile with intensive sampling

Question 2

Give examples of clinical studies with PK as a secondary objective

Answer 2

Phase 2a (proof of concept); a small patient population study used to determine if the molecule has an effect based on the anticipated pharmacology

Question 3

State the advantages and disadvantages of a cross-over study design

Answer 3

Advantages:

• Each subject acts as their own control
• Subjects and randomised to the treatment sequence (removes bias)

Disadvantages:

• Takes longer to conduct
• May have carry over effects
• It can be difficult when studying time dependent effects such as enzyme induction

Question 4

State the advantages and disadvantages of a parallel group design

Answer 4

Advantages:

-Quick to conduct

Disadvantages:

Question 5

State the advantages and disadvantages of a parallel group design

Answer 5

Advantages:

• Quick to conduct
• No carry over effects
• Subjects are randomised to the treatment sequence (remove bias)

Disadvantages:

• Comparisons between groups based on means
• Less sensitive when one treatment is placebo