Reformualtion bridging studies

Have you submitted a variation to the authority of reformulated prodcut to reduce the nitrosmaine formation?
If yes, what type of bridgin studies have you provided? Which studies the authority asked you to provide?
Accdorgint to FDA: * For approved NDAs and ANDAs that require reformulation as part of a mitigation strategy, in vitro or in vivo bioequivalence bridging studies.
But it’s not clear what sort of studies (other than BE study).

Updates on possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products | FDA.
Looking forward to knowing your experince.

1 Like

@Alaaelkazak There has been couple key presentation from FDA on this topic. At a recent Pharmaceutical Quality Symposium, Dr. Dongmei Lu presented research from FDA on potential strategies and BE approaches…

Slides and post are available here:

@Naiffer_Host, now YouTube video is available. Please check the following link.

1 Like

Perfect. This slide showed the summary. One should not assume an in human BE study will be needed.

1 Like