Bioequivalence and Bioavailability Forum

Dear all,

below a message from the FIP.

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Discussion Forum on Biowaiver Monographs opened!

A Public Discussion Forum on the published Biowaiver Monographs has been opened by the Special Interest Group BCS and Biowaiver.

All comments making these monographs more useful are welcome, but in particular data not yet covered in the published monographs, especially results of in vivo bioequivalence studies, both "positive" and "negative" studies. Details on the reference product ("comparator"), the composition and manufacturing process of the test product and the results of any in vitro dissolution testing, with a report of the test conditions, would make it an even more valuable contribution.

Every year, thousands of in vivo bioequivalence studies are performed globally, but only a very small fraction of these studies and their results ever reach the scientific community, hampering progress in this field. So, contribute to the progress of the science of pharmacokinetics by posting your data to this Discussion Forum!

If there is a sufficient package of new data, an Addendum to a published Biowaiver Monographs will be considered.

Anyone can post a contribution, the only requirement being a verification of his or her e-mail address. FIP Individual Members have the advantage that they do not have to go through the e-mail address verification step to post a contribution, as long as they are logged in as an FIP Member.

Comments can be posted by clicking here. Then click the link to "Comments to Biowaiver Monographs" and use the "Post a new message" option.

The Moderator of the Discussion Forum is Dirk Maarten Barends, Chair of the SIG BCS and Biowaiver.