PharmPK Discussion - Justification for BE results falling just outside the limits

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On 7 Dec 2004 at 04:13:37, Nirmalya Chatterjee (nchatterjeein.at.yahoo.co.in) sent the message


The following message was posted to: PharmPK

Dear All,
I have a small query.

Suppose the BE results show that my test product is
failing marginally. Can we still justify it. Let us
take 2 hypothetical results:

1) BE result is 79

2) BE result is 126

In either of thse cases is it possible to justify the
results or maybe do some additional testings to
justify.

Please let me know how to proceed in either of these 2
cases.

Thanks,
Nirmalya

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On 7 Dec 2004 at 10:57:35, "Vuong Trieu" (vtrieu.-a-.AmericanBioScience.com) sent the message


The following message was posted to: PharmPK

Hi Nirmalya:

The fact that you are failing BE create problems for you:

1) You can repeat and repeat until you get BE; however, all data are to
be reported and pretty soon you will loose all credibility with the FDA.

2) Though 20% is the stated range; all ANDAs approved has 10% as range.
Here you are failing complete.

3) If your product is narrowly making into BE, it will be a nightmare to
devise a batch release assay to predict the BE batch versus the non-BE
batch.

You are better off going back to formulation.

Vuong

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