Webinar on Antioxidants, a safe and viable inhibition strategy for Nitrosamine formation in drug products

[DAB]

Enclosed is the Regisatration link for the session​

Welcome! You are invited to join a webinar: Antioxidants, a safe and viable...

[Zdravka]

@DAB great, thanks for sharing. What is your opinion of this mitigation strategy?

[Naiffer_Host]

@Zdravka There are several posts on this control strategy topic. I suggest you search for topics connected to community member Dr. Aloka Srinivasan (@ASrinivasan).

FDA currently published "Updates on possible mitigation strategies to reduce the risk of nitrosamine..."

Was information was based on a public comment in FDA’s GDUFA Complex Generic workshop in June 2021, way before the article was published. Please see this presentation. I was the presentator on prevention of ntirosation. Additionally the SVPs from Apotex and TEva discussed this. FDA took the gist of the presentations and put it in the website. [Public Comment - GDUFA Science and Research Initiatives Public Workshop]

[Zdravka]

@Naiffer_Host thank you, I will

[DAB]

Hi @Zdravka
Antioxidants are often employed in drug substances and drug products to mitigate /reduce formation of potential oxidative degradants. The same concept can also be extended in mitigating/reducing formation of Nitrosamines. it is one of the risk mitigating strategies being proposed and evaluated.
https://www.raps.org/news-and-articles/news-articles/2021/10/fda-suggests-alternative-approaches-for-nitrosamin

[DAB]

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Nitrosamine-free pharmaceuticals