👨‍💻 Dashboard Containing Published AI Limits

Are you looking for a central place for published AI limits? I have created a dashboard containing Acceptable Intake Limits from FDA, Health Canada and EMA.

I am looking for folks that are interest into contributing to this dashboard. Please reply to this post or message me to submit data for other countries or provide any relevant updates on the published AI limits. Any feedback or recommendation are always welcome!

Access here: https://public.tableau.com/app/profile/naiffer.romero/viz/NitrosaminesRegulatoryAILimits/Dashboard1

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Great initiative. I am happy to contribute what support i could do!

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Hi Naiffer, This is a great initiative. My team and I would be happy to review and contribute to this dashboard. For example, we can help add the AI values from Australia.

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Hola! En Chile se adoptaron los valores establecidos por la FDA para NDMA, NDEA, NMBA, NIPEA, NDIPA, NDBA y NMPA, según la siguiente resolución del Instituto de Salud Pública.

Saludos!

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Two additional dashboards have been created: 1) a Map with click country to access the country-specific national regulatory agency website dedicated to Nitrosamines, and 2) A data set combines the NDSRIs AI published limit by the FDA WITH the Orange book…

Thanks for all the data links and references folks have submitted to include in the original dashboard. I will initially provide contributors access exclusively to the dashboard to help build the data set. If you have data/information to submit, please send me a message, and I will include you in the close group.

Enjoy!

Dashboard #2

Dashboard #3

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Great initiative, all AI information in one click.

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Hai Naifer,
N-nitroso-rivaroxaban open-ring acid listed by EMA and the only NDSRI (5-chloro-N-[[(5S)-2-oxo-3-[4-(N-nitroso-2-(carboxymethoxy)ethylamino)phenyl]-5-oxazolidinyl]methyl]-2-thiophenecarboxamide) listed by HC are the same. Both are same it seems.

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Great work, Naiffer & team! This is so helpful.

I could really see including information on amine chemistry & adjacent functional groups. My team did a deep dive on that for FDA listed NDSRIs. If you figure out how to integrate it into your system, we can likely help take that step.

Thanks Jason,
If you send me a sample of the data, I’m sure I can look and find a way to integrate at least to try…
Thx

Thank you so much for this great initiative. Can you please share where to find these two dashboards? I am probably missing something obvious here, but I do not know how to find these…

@Tobias_Sch thanks for the inquiry. As I mentioned before I will provide access to the contributors of data first as a way to expand the data set and build it in a collaborative way. If you are interested, let me know or message me

Thank you so much for this great initiative. As per FDA Database there are Table 2 (Based on Compound-Specific Data or Read-Across Analysis from a Surrogate) and Table 3 (Interim AI limits for approved. currently marketed products).
On 18th April 2024, Ciprofloxacin has published in Table 3 with interim AI limit as 12,000 ng/day.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/updated-information-recommended-acceptable-intake-limits-nitrosamine-drug-substance-related

This is really great work. In one glance we can observed many more.

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Great work. Very useful information to all community…

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Dashboard updated to include TGA AI published limits, and recent Health Canada AI table updates

https://public.tableau.com/views/NitrosaminesRegulatoryAILimits/Dashboard1?:language=en-US&:sid=&:display_count=n&:origin=viz_share_link

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Great dashboard, Naiffer! One suggestion for a future update: you may want to add nitrosamines that have been accepted as non-mutagenic impurities, such as Nitroso-HCTZ (by EMA but not by FDA).

It’s in the dashboard…

Several members of the community helped with the review of this second dashboard. It provides a crossover between the published NDSRIs by FDA & the Orange Book Data set.

Please enjoy, and I welcome any feedback, contributions, or ideas to incorporate into the data set.

https://public.tableau.com/views/NitrosaminesAILimitsmatchedwithFDAOrangeBook/Dashboard2?:language=en-US&:sid=&:display_count=n&:origin=viz_share_link

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This is great! I will share this initiative in the MWCDG newsletter and encourage our members to contribute!

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