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CPCA Calculation System (Python Desktop)
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1
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824
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November 22, 2023
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Limit for API having two NDSRI
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9
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996
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November 21, 2023
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Use of the TD50 99 % CI for single dose rodent carcinogenicity studies -Pub
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5
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399
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November 16, 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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434
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November 9, 2023
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TGA Australia Published Acceptable intakes for Nitrosamines
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1
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897
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October 18, 2023
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N-Nitroso desmethyl bedaquiline
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0
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458
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October 6, 2023
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Nitrosamine in DS and DP specifications
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2
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676
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September 20, 2023
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N-nitroso-duloxetine
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1
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371
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September 19, 2023
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Nitrosamines without published AI, and possibly negative for carcinogenicity
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9
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861
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September 18, 2023
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Omission of specification <10% AI
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2
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618
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September 12, 2023
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Read-across/SAR posts Collection
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10
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2256
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September 7, 2023
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Kinetic model to estimate the amount of nitrosamines
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5
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632
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September 6, 2023
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Higher limits allowed by FDA for Nitroso-sitagliptin
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20
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3587
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August 28, 2023
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Nitroso-methylphenidate
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4
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515
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August 25, 2023
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CPCA - Methyl group bonded to beta carbon (cyclic/acyclic) (activating factor)
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2
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909
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August 23, 2023
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N-Nitroso N-Desmethyl Nefopam
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4
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637
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August 18, 2023
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Total impurities limit if more than one nitrosamine impurities are observed in product
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4
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508
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August 14, 2023
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N-nitroso-hydrochlorothiazide limit
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2
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443
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August 14, 2023
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Testing of APIs for NDSRI
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4
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791
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August 10, 2023
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Common nitrosamine impurity limit calculation when it is contributing from both API as well as excipients
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9
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1134
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August 8, 2023
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NDMA in Drug Product
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2
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395
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August 3, 2023
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N-Nitroso mirabegron
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4
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1687
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August 2, 2023
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Use of the less-than lifetime (LTL) concept or the use of interim limits
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3
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625
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August 1, 2023
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LTL in simple terms?
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7
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557
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July 1, 2022
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Case Studies for CPCA Scoring
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12
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2832
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July 25, 2023
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N-nitroso desloratadine?
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13
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1393
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July 22, 2023
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How important clinically are nitrosamines?
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5
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411
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July 19, 2023
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N-Nitroso Hydrochlorothiazide in Hydrochlorothiazide drug substance
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11
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3287
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July 8, 2023
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Proposed approach to Temporary Acceptable intake Limits for NDSRIs
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10
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1202
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July 6, 2023
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Nitrosamines Published Limits -reference
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77
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11938
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July 5, 2023
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