Question

What should be the disadvantage of cross over study on volunteers?

(a) Minimize the intersubject variability in plasma drug levels

(b) Minimize the carry-over effect

(c) Minimizes variations due to time effect

(d) Takes a lot of time to get the result of the study

I had been asked this question during a job interview.

This question is from Bioequivalence Studies topic in division Compartment Modelling, Non Linear Pharmacokinetics, Bioavailability and Bioequivalence of Drug Biotechnology

Answer 1

Right answer is (d) Takes a lot of time to get the result of the study

Best explanation: The advantages of randomized, balanced, cross-over study is it minimizes the intersubject variability in plasma drug levels, minimize the carry-over effect, minimizes variations due to time effect, makes it possible to focus on formulation variables. But this method takes a long time because a specific time has to be given for the washout of the previous administration.