Unofficial/official surrogates for read-across

[Yosukemino]

AI limit for N-nitroso betahistine?

Hello Experts, Recently it has been came to the notice that N-nitroso betahistine is one of the NDSRI in the betahistine formulation whose limit has not been defined by any of the regulatory authority. Could any one suggest any AI limit based on the read across approach or literature based or any other leads? Your views are very much appreciated. Thanks, Sumit

AI Limit for Nitroso Nebivolol

Hi Everyone, Recently it has been came to the notice that N-nitroso nebivolol is one of the NDSRI in the Nebivolol Tablets formulation whose limit has not been defined by any of the regulatory authority. Could any one suggest any AI limit based on the read across approach or literature based or any other way? Someone can help me to prepare justification report based on PDE, read across, Q (SAR) for set the AI limit for N-nitroso nebivolol. As per my little bit knowledge gain by above literat…

Limit for Nitroso Ciprofloxacin

Anyone having idea about AI limit of Nitroso Ciprofloxacin? What could be the AI limit as per read across approach?