How can I calculate the formulation, sequence, period and subject effect in case of bioequivalence study?

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Luis F. Gouveia

Dear Mohammad Safiqul Islam,

Is the BE study intended to be submitted to regulatory authorities?

Are you willing to know how to perform the stat calculations or advice regarding the software to use?

What is/was the design of the BE study (single-dose, two-way crossover, parallel, replicate,...)?

Have you checked the ICH/EMA guideline as well as the USP chapter 1090?

I would recommend the Chow and Liu, "Design and Analysis of Bioavailability and Bioequivalence Studies", and the Patterson and Jones "Bioequivalence and Statistics in Clinical Pharmacology" books for extensive and clear information on the subject. Regards, Luis

Mohammad Safiqul Islam

Thank you very much Mr. Luis F. Gouveia. My study was a open label, randomized, two period cross over design.

- Are you (a) willing to know how to perform the stat calculations (data transformation, ANOVA's, etc) or (b) asking advice regarding the software to use?

If True for (a) then

- Have you checked the Chow and Liu, "Design and Analysis of Bioavailability and Bioequivalence Studies", or the Patterson and Jones "Bioequivalence and Statistics in Clinical Pharmacology" books? You will find the answer to your questions there.

If True for (b) then

- Is the BE study intended to be submitted to drug regulatory authorities?

- Have you checked the ICH/EMA guideline as well as the USP chapter 1090?

- I advise you to check the requirements of your local Drug Regulatory Authority regarding the software accepted to be used.

Regards, Luis

Packiaraj Jeyachandran Manohari

Effect of formulation can be checked by evaluating the rate and extent. rate can be inferred from Tmax and extent from AUC0-t and AUC0-Inf. Period is nothing but time course of Fast or Fed. Sequence is the evaluation pattern tested in subject i.e Test followed by Reference or Reference followed by Test. Subjects - no of volunteers tested.

Renu Jain

hi..you would need a software to run the stats. Usually Phoenix® WinNonlin® SAS® are used,

Edwin López García

I have found this tool in the web, I think that it uses the IC of 90% and acceptance criteria of 80-125. Please check.

http://epitools.ausvet.com.au/content.php?page=bioequivalence