PharmPK Discussion - Mefenamic Acid Bioequivalence

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On 24 Jul 2003 at 09:13:16, "Mahesh" (gargimv.-at-.omantel.net.om) sent the message


We have done Bio-equivalence study for Mefenamic Acid 500 mg tablet.
Results shows that, the Ratio of AUC [0-t] & AUC [0-oo] is with in the
range of 0.8 - 1.20. But we have slight problem on the Cmax [Cmax ratio
is 0.76] {The europian guide lines permitt Cmax ratio from 0.75 - 1.33,
while us is 0.8 - 1.2}
The drug Mefenamic Acid is very insoluble in nature and literature
shows that, the absorption is delayed.
Also dosage is 3 - 4 times a day [Which shows that, the therapeutic
index is not narrow.

I would like to know,

1) Can we say that, both products are bioequivalent ?

2) What are the literature which can be used to support the above
statement ?

Dr. Mahesh Samarth

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On 24 Jul 2003 at 13:48:39, RPop.aaa.pharmamedica.com sent the message


Hi Mahesh,
The European guidance requires that the "90% confidence interval of
Cmax" to be between 0.8-1.25 and for some drugs larger range is
acceptable (e.g. 0.75-1.33) based on safety and efficacy data.

The test/reference ratio for Cmax in your data seems to be much too low
to be able to comply with the above requirements.
My advice will be to check the data for outlying values. If the
individual ratios for Cmax are consistent and low than the
formulation should be improved.
Best regards,
radu

Radu D. Pop
Director Biopharmaceutics
Pharma Medica Research Inc.

966 Pantera Drive
Mississauga, Ontario
Canada, L4W 2S1

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