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October 1999

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Subject:
From:
"Harder, Joel" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Wed, 13 Oct 1999 11:27:22 -0400
Content-Type:
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What is an "inhibition/enhancement profile"? How does it relate to LAL
testing? Thanks in advance.

Joel C. Harder
* v-mail: 703-351-5942
* e-mail: [log in to unmask]


-----Original Message-----
From:   Tony Coyle [mailto:[log in to unmask]]
Sent:   Wednesday, October 06, 1999 10:09 AM
To:     [log in to unmask]; [log in to unmask]
Subject:        Re: [PMFLIST] Endotoxin testing of dry products on stability

Dear Mark

The draft guidance document is ambiguous and leaves
the decsion to the stability study administrators. The
reason for this is that ascientific judgement has to
be made as to whether the degradation products are
likely to have an effect on the analytical method.

For LAL testing I advise that the
inhibition/enhancement profile be determined for
stabilty study lots if available to account for this
possibility.
Remember that the registered LAL procedure should be
valid throughout the life of the product so it would
be prudent to include this requirement in the
stability study protocol.

I hope that this helps but should you require any
further information please don't hesitate to get in
touch.


--- Mark E Claerbout <[log in to unmask]>
wrote:
> Dear forum members,
>
> I am interested in getting opinions as to the need
> to perform LAL testing on
> dry sterile dosage forms on stability, and whether
> of not companies are
> routinely doing this.  The 1998 FDA draft guidance
> document on Stability
> Testing of Drug Substances and Drug Products
> indicates it "may" not be
> necessary (page 38 of the document), which seems
> rather ambiguous to me.
>
> thanks in advance for any responses,
>
> Mark Claerbout
>
>
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