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Vildaglibtin and Metformin in combinationy
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1
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542
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October 17, 2023
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USP - CPCA Nitrosamines Case Study
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7
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1489
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August 30, 2024
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Resources to help educate reluctant excipient suppliers?
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7
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338
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August 28, 2024
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Seventh European Medicines Agency - Medicines for Europe annual bilateral meeting
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1
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102
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August 27, 2024
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Analytical methodologies to detect N-nitrosamine impurities in active pharmaceutical ingredients, drug products and other matrices -Pub
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0
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290
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August 27, 2024
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🇧🇷 Guideline for the control of Nitrosamines Rev. 4
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24
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1638
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August 21, 2024
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AI for NDSRI by Brazil regulatory
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6
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871
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August 7, 2024
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South African Health Products Regulatory Authority (Nitrosamines)
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2
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701
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August 5, 2024
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32
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3656
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August 2, 2024
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🇲🇽 Coming July Mexico Nitrosamines Guideline
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5
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478
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August 2, 2024
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2
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199
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July 30, 2024
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The clinical and regulatory status of NDSRI: A global imperative -Pub
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1
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256
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July 30, 2024
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EMA/CHMP Concept paper on the revision of the guideline on the chemistry of active substances
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4
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597
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July 29, 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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521
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February 1, 2024
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0
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273
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July 24, 2024
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🇪🇺 EMA/409815/2020 Rev.21 (19-Jul-24)
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1
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2416
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July 22, 2024
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ICH M7 plans to harmonize AI limits for Nitrosamines
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1
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308
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June 13, 2024
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Nitrosamines in food raise a health concern (EFSA)
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7
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1079
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June 11, 2024
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Update: EFPIA workflows for Quality Risk management Jun 2024 v03
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2
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858
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June 4, 2024
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0
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326
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May 31, 2024
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Justify the presence of amine in the API chemical structure
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3
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291
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May 29, 2024
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FDA releases FY23 GDUFA Science and Research Report
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0
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275
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May 24, 2024
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🇪🇺 EDQM - top 10 deficiencies observed in new CEP applications
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0
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945
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March 14, 2024
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An Organic Guide to N-Nitrosamines: Structure, Reactivity, and Role as Contaminants
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1
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516
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May 13, 2024
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APIC NA Risk Assessment Template
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5
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3461
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May 11, 2024
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🇪🇺 EDQM - Certification of suitability to Monographs of the European Pharmacopoeia
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1
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581
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April 12, 2024
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EMA - Update Appendix 3: Enhanced Ames Test conditions for N-nitrosamines
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8
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1770
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April 2, 2024
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USP-NF General Notices Revision open for Comments
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0
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1172
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March 7, 2024
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Updated: IPEC Position Paper on Role of Excipients in Determining N-Nitrosamine Risks for Drug Products
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3
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1149
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March 7, 2024
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New ICH Guideline Q14
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0
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492
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February 12, 2024
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