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Instem SOT 2023 Presentation on Assessing N-nitrosamines Potency Classes
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1
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678
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May 2, 2023
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A Consideration of the Extent That Tertiary Amines Can Form N-Nitroso Dialkylamines in Pharmaceutical Products
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1
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1320
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April 25, 2023
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NDMA formation Due to Active Ingredient Degradation and Nitrite Traces in Drug Product
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0
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775
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March 24, 2023
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Formation of Dialkyl-N-nitrosamines in Aqueous Solution: An Experimental Validation of a Conservative Predictive Model and a Comparison of the Rates of Dialkyl and Trialkylamine Nitrosation
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6
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1411
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February 25, 2023
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Anybody has working with a Gliclazide nitrosamine?
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3
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1210
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February 14, 2023
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IPEC Europe announces the availability of the revised “Questionnaire for Excipient Nitrosamines Risk Evaluation” (Version 4, 2022)
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11
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1852
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February 14, 2023
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Lhasa Tutorial Vid on new Mirabilis 4.0
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2
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601
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January 31, 2023
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What to do with Nitrite content reported by Excipients?
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0
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676
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January 25, 2023
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What's your experience on API risk assessments?
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4
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648
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November 25, 2022
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Checklist for EMA Q&A Q4
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0
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523
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July 30, 2022
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Fate purge study
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0
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418
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July 14, 2022
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Sufficient AMES test, parameters
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6
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1310
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July 13, 2022
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Como conducir El Análisis de Riesgo?
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0
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399
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May 9, 2022
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What is the probability of nitrosamine formation during DP production
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6
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647
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April 26, 2022
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200+ USP Monograph w/ Tertiary amines
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1
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484
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April 5, 2022
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How Relevant is a 'check list'?
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0
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342
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March 2, 2022
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FDA Warning letter <Nitrosamine or NOT>
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0
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468
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February 14, 2022
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Update of the CMDh's Q&A Document on Nitrosamine Impurities
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2
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945
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January 26, 2022
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Nitrosamine Workshop USP / Sindusfarma / ANF ACFB -live discussion
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7
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1080
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December 8, 2021
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When minimum information is provided for risk assessment?
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1
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335
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November 23, 2021
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Screening vs **Risk Assessment**?
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11
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657
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September 7, 2021
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Q&A Nitrosamine SAR working group (23 companies and universities)
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12
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1540
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August 25, 2021
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What steps is FDA taking or planing to take, to collaborate with other regulatory authorities to align on expectations for Step 2 confirmatory testing?
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4
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371
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July 28, 2021
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Determining structural similarity for read-across
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2
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367
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July 8, 2021
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Residual amines and risk assessment - how far do you go?
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2
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608
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July 4, 2021
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Are all N-nitrosamines a concern?
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2
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674
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June 24, 2021
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Nitrosamine Risk on shared equipment?
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2
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230
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June 23, 2021
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How ID all conditions and mechanism of Nitrosamine formations?
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2
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289
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June 21, 2021
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USP <1469> goes live Today
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3
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300
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June 16, 2021
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Managing The Risk of Nitrosamine Impurities
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0
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299
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June 7, 2021
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