Bioequivalence and Bioavailability Forum

Dear all.
I have been working for a Pharmaceutical Company... And my English is very poor.

Please be understanding even if I make a English conversation.

I have a question.

I determined seleted the sample size as follows
Based upon the mean ISCV from the literature, a sample size is determined to have a power of over 0.8 (80%) with T/R ratio of 5%.
However, if no reviewed literatures suggest ISCV of over 30%, the sample size is determined to have a power of ≥ 0.8 (80%) with T/R ratio of 5% based upon the maximum ISCV.

For example
As no reviewed literatures indicated that the ISCV is over 30%, the sample size of Pantoprazole bioequivalence trial was determined based upon ISCV of 22.5% and T/R ratio of 5%.

The sample size was determined to include 23 subjects.
However, according to the local bioequivalence trial standards, a total number of subjects should be over 24 (12 per treatment group).
Given the possible dropouts, the number of subjects was finally determined to be 30

However other review of Pantoprazole is regarded as a "HVD"
Therefore I think Pantoprzole has to be treated as a "HVD"

I want to hear your opinon
Do you think my calculation is right?

Please do not hestitate to give comments to me after review ASAP because my boss is "Angel"

Thank you for your help in advance

Literature #1
Comparative BA study with two pantoprazole delayed-released Tablet formulations administered with and without food in healthy subjects
Arzneimittel-Forschung(Drug Research),2008;58(3):141-148

AUClast, Cmax
Mean ratio : 95.66, 104.65
90% CI : 0.8526~1.0732, 0.9086~1.2054
CV Intra-subject : 33.82%, 30.12%

Literature #2
Bioequivalence of Two enteric coated formulations of pantoprzole in healthy volunteers under fasting and fed conditions
Arzneimittel-Forschung(Drug Research),2007;57(6):309-314

AUClast, AUCinf, Cmax
Mean ratio : 94.31, 94.36, 98.76
90% CI : 0.89~0.99, 0.89~0.99, 0.94~1.03
CV Intra-subject : 11.23%, 11.16%, 10.16%


Byung-Ju Kim.
Bioequivalence Scientist
Tel: +82 2 317 2081 / +82 10 3955 1601

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