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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 studyI 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

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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.



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