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CDER Drug Safety Priorities Fiscal Year 2023
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1
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416
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February 16, 2024
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Risk characterization of N-nitrosodimethylamine in pharmaceuticals -Pub
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6
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558
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February 16, 2024
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New Validated LC-MS Method Development and Estimation of Nitrosamine impurities in Canaglifozin -Pub
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0
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374
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February 16, 2024
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Testig method for nitroso Ciprofloxacin
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12
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1010
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February 16, 2024
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NDSRIs standards (for confirmatory testing or ames/other tests)
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15
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1219
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February 14, 2024
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Discussion on Cleaning Validation Requirements for Nitrosamines
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2
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345
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February 14, 2024
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Developing and validating read-across workflows that enable decision making for toxicity and potency: Case studies with N-nitrosamines -Pub
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4
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378
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February 14, 2024
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Nitrosamines Severity (impact) - a quantitative model proposal?
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3
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760
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February 12, 2024
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Analytical Challenge for detecting NDSRI in Ritonavir Tablets
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8
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303
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February 12, 2024
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New ICH Guideline Q14
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0
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334
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February 12, 2024
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Nitrosamine requirements for probiotics
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4
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204
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February 12, 2024
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TALK SERIES: Navigating Nitrosamine and NDSRIs regulations with Dr. Reddy´s Laboratories
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1
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587
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February 11, 2024
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Defining nitrosamine acceptable intake based on technical feasibible limit rather than CPCA
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6
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310
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February 11, 2024
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Skipping risk assessment
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4
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318
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February 11, 2024
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Top 10 deficiencies observed in new CEP applications for chemical purity assessed in 2023
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1
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482
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February 9, 2024
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In Silico Prediction of N-Nitrosamine Formation Pathways of Pharmaceutical Products -Pub
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0
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420
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February 8, 2024
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🗃 Poll: Interest of having a commercial directory here in the community?
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13
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1014
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February 8, 2024
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N- nitroso Nitazoxanide
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1
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266
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February 8, 2024
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Can we bypass confirmatory testing of DP based on Theoretical Calc. of NDSRI's
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5
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530
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February 7, 2024
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Notifying FDA of a Discontinuance or Interruption in Manufacturing
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0
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174
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February 7, 2024
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TGA (Australia) :australia: Updates Published Acceptable Intakes
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3
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562
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February 7, 2024
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The effect of nitrite and nitrate presence in raw materials on nitrosamine risk
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15
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2198
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February 6, 2024
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Mechanisms of Nitrosamine Mutagenicity and Their Relationship to Rodent Carcinogenic Potency -Pub
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0
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491
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February 6, 2024
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Could gelatin contains amine functionalities, which react with nitrosating agents to form nirosamines?
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20
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1818
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February 6, 2024
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Metabolic activation of short-chain alkyl N-nitrosamines using Aroclor 1254 or phenobarbital/beta-naphthoflavone-induced rat or hamster S9 – a comparative analysis -Pub
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4
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377
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February 2, 2024
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Aromatic nitrogen "Is it possible for aromatic nitrogen to convert nitrosamine?"- Indole
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10
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1453
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February 2, 2024
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Formaldehyde Catalysis of Nitrosamine Formation
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1
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328
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February 1, 2024
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Swissmedic updated requirements for dealing with potential nitrosamine impurities in medicinal products
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2
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232
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February 1, 2024
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Nitrosamine Impurities in Topical Drug Product
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3
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487
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February 3, 2024
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Patient In-Use Stability Testing of FDA-Approved Metformin Combination Products for N-Nitrosamine Impurity
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6
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360
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January 31, 2024
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