Detection of carryover effect in bioequivalence study

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Contributor
Posts: 26

Detection of carryover effect in bioequivalence study

Hi All,
Pl help me to find program to detect carryover effect. Grizzle test is appropriate statistically.
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Posts: 0

Re: Detection of carryover effect in bioequivalence study

As per regulatory guidelines it is not necessary to use any test or nither test is suggested by the regulatory.

You have to find out the cmax for each period for each subject and whatever is the concentration value in the predose sample for the specified subject and specified period, check whether it is greater than 5% of cmax.

If it is so then exclude that subject from the pharmacokinetic as well as statisical analysis.

If not then include that subject with the actual concentration value for the same.

If your study passes in the boundry line then produce both the results in your repot.
Hope this will clear your doubt,
Contributor
Posts: 26

Re: Detection of carryover effect in bioequivalence study

Thanx a lot.

Do u have proper reference?

If yes Pl give me.

I have been using Grizzle test (statistically appropriate) for many years.

I had few analyses where Grizzle test detected carry over effect and we had to throw the data.

Anil
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