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Hi all,
I would like to know in general, the points that sponsor should monitor
during a bioequivalence studies.
If there are guidelines regarding this please let me know.
Thanks in advance
Best Regards
Vardhini
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For the responsibilities of the sponsor towards bioequivalence
studies. it is better to go through the ICH GCP (E6) guidelines.
Regards
Bollu Prasad
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Dear Vardhini
There is guideline available on FDA.GOV site for moniotiring of clinical
investigation. Might it will help to solve your doubts. This guideline
doesnot specifiy for activity or points to be moniotored. But it
describes
in details that who can be monitor, what are the responsibilities etc.
Mitesh Gandhi
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The following message was posted to: PharmPK
Dear Vardhini,
There is no specific guideline available for Monitoring of BE studies,
look
in the monitor responsibilities section of ICH guidelines, which
details
the responsibilities of a monitor in a clinical trial.
With Regards,
V.Radhakrishna
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Hi Vardhini,
There is a guideline for Monitoring of BE studies issued for US FDA
auditors. It captures all the essential components, both clinical and
anlaytical
part covered in a BE study.
Check it out..
http://www.fda.gov/ora/compliance_ref/bimo/7348_001/foi48001.pdf
If you monitor the studies as per
this guideline, you can assess whether the releavnat regulaions are met.
Hope this helps.
Regards
Ganesh
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