Dear Nitrosamines investigators,
What is your experience and knowledge regarding conducting a BE study for your generic products when your Drug substance of study is one of the known-to-contain nitrosamines?
Is it sufficient to submit IMPs with nitrosamines results lower than the AI either for the brand batch or the test batch?
Is it mandatory to submit your risk assessment and root-cause analysis to the drug authority where the BE study will be conducted?
Are there any guidelines or authority circulars that discuss this issue?