PharmPK Discussion - Question about drugs in clinical trials

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On 8 Jul 2004 at 21:56:24, David Bourne (david-bourne.at.ouhsc.edu) sent the message

I need the group's help on something. I would like to Know if in
clinical trials (bioequivalence studies) the bacth of the
investigational product(s)should be the same one or not. Is there any
guide or official document?
ThanKs

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On 9 Jul 2004 at 11:07:26, "HIMANSHU SHAH" (himanshu.shah.-at-.ranbaxy.com) sent the message

Different batches of the investigational products can be used in BE
studies. But it should be ensured that sufficient quantities of IP of
both the batches are to be retained as per guidelines.
refer sec IV of the document.
http://www.fda.gov/OHRMS/DOCKETS/98fr/2002d-0350-gdl0002.pdf
hope this will help.

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On 9 Jul 2004 at 10:27:41, "Gregory Telfer" (greg.at.tipt.com) sent the message

In Response to:
"I need the group's help on something. I would like to Know if in
clinical trials (bioequivalence studies) the bacth of the
investigational product(s)should be the same one or not. Is there any
guide or official document?"
Refer to the FDA's website where you can find guidance documents on this
topic.  In particular, you can review the file found at this link:
www.fda.gov/cder/mapp/5225-1.pdf
I hope this helps.

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On 10 Jul 2004 at 10:18:04, "Hitesh maheshwari" (hmaheshwari.-at-.astron-research.com) sent the message

Himanshu,
The section which you are refering to doesnt speaks anything about
multiple batches of the IPs in BE studies, rather it recommends for
sample retentions in cases of multiple BE studies (e.g. fed, fasted,
ss, etc) with the same batch numbers of IPs.
Regards,
Hitesh Maheshwari
  Astron Research Ltd.
Ahmedabad, India

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On 12 Jul 2004 at 12:12:47, "HIMANSHU SHAH" (himanshu.shah.-at-.ranbaxy.com) sent the message

Dear Hitesh,
Could you please refer the same section again. I am quoting the same
for your ready reference.
" If the same batches of the test articles and reference standards
initially provided to the testing
facility are used in performing more than one study, only one reserve
sample of the test article
and reference standard in sufficient quantity need to be retained. The
reserve samples should be
identified as having come from the same batches as used in each study.
However, if additional
supplies of the test article and reference standard will be used by a
testing facility to perform the
same study or additional studies, the testing facility should retain a
sufficient quantity of reserve
samples from the subsequent shipment."
However the use of different batches is not clearly mentioned here. I
will get back to the group with more details.
Many Thanks,
Himanshu

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On 12 Jul 2004 at 12:12:47, "HIMANSHU SHAH" (himanshu.shah.-at-.ranbaxy.com) sent the message

Could you please clarify the question, whether you are referring to the
use of same batch in different BE studies or use of different batches
in the same study.
Many thanks.

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