Hi Yosuke,
is getting more and more weird…as far as i know this drug is for patients for advanced cancer, so the corresponding nitrosamine should be controlled under the limits of ICHQ3, according to the ICHS9.
‘‘The FDA has sought to reduce patient exposure to nitrosamine impurities over worries they might cause cancer in Ph-3 trials of breast cancer drug Kisqali.’’ !!! is this a joke? It is not reasonable to me to set limits to address any cancer risk <1/100000 to patients who are suffering from cancer.
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