Bioequivalence and Bioavailability Forum

Dear Jasmin,

answering only some of your questions...

❝ is there necessary to submit protocol in any regulatory bodies before

❝ initiation of BE study?

It depends on the particular country's regulation.

In the European Union Directive 2001/20/EC (Implementation of GCP in the Conduct of Clinical Trials on Medicinal Products for Human Use) is in operation since summer 2004.
According to Article 9 clinical study protocols and informed consent forms have to be approved by local ethics committees and regulatory bodies (for details see this document from Apr 2003).
All clinical studies are registered at the EudraCT database in London/UK.

For the US-FDA see this page and linked documents.

Dear Jasmin,
There is no need to submit protocol to regulatory bodies, it can only be done to make sure that your protocol design or any other clarifications are required before initiating the BE study.

Regards,
Dr.Sridhar

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Edit: Full quote removed. Please see this post! [HS]

Hi Jasmin,

I just want to add one scenario:
If you are doing a BA/BE study of a drug which is not yet marketed / available in India, then you need to prepare protocol and send it to DCGI for approval as a special case. You can only proceed with the trial if you get a no objection certificate from DCGI.
~G