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N-Nitrosamine drug substance related impurities (NDSRIs) β A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da -Pub
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0
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313
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October 28, 2024
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π© CPCA Calculation Tool (excel-based) -Updated
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87
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12498
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September 27, 2024
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πΊπΈ FDA - Updated information on recommended AI for NDSRIs (23/Feb/2024) - Tables 2 & 3
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16
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4259
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July 28, 2024
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CPCA Calculation System (Python Desktop)
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1
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1579
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November 22, 2023
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AI for NDSRIs with positive EAT and/or in-vivo mutagenicity study - FDA position?
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2
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697
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November 9, 2023
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