Fiscal Year (FY) 2023 Generic Drug Science and Research Initiatives Public Workshop May 11-12, 2023

Methods to Address Impurities in Generic Products such as Nitrosamines
This session will discuss what research is needed to develop efficient bioequivalence standards for products that are reformulated to mitigate potential risks of nitrosamines, such as elucidating excipient effects related to nitrosamine impurity formation, addressing potential concerns related to the mutagenicity or carcinogenicity of reactive impurities in certain drug products, and identifying other aspects of emerging issues related to nitrosamines.


Great topic to cover. Appreciate you getting the word out on this.

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Now recording is available. Please check the following link.

Day1(May 11)

Day2(May 12)


Thanks a lot! :grinning: It is very interesting!!