{"id":138717,"date":"2022-06-23T10:39:57","date_gmt":"2022-06-23T09:39:57","guid":{"rendered":"https:\/\/test.merieuxnutrisciences.com\/nitrozamin-uyarilari-20-mayis-2022de-ema-nitrozamin-safsizliklari-hakkindaki-soru-cevap-belgelerini-guncelledi\/"},"modified":"2025-03-03T11:13:09","modified_gmt":"2025-03-03T11:13:09","slug":"nitrozamin-uyarilari-20-mayis-2022de-ema-nitrozamin-safsizliklari-hakkindaki-soru-cevap-belgelerini-guncelledi","status":"publish","type":"post","link":"https:\/\/www.merieuxnutrisciences.com\/tr\/nitrozamin-uyarilari-20-mayis-2022de-ema-nitrozamin-safsizliklari-hakkindaki-soru-cevap-belgelerini-guncelledi\/","title":{"rendered":"Nitrozamin uyar\u0131lar\u0131: 20 May\u0131s 2022&#8217;de EMA, nitrozamin safs\u0131zl\u0131klar\u0131 hakk\u0131ndaki soru-cevap belgelerini g\u00fcncelledi"},"content":{"rendered":"\n<p><strong>20 May\u0131s 2022 \u2013 EMA\/409815\/2020 Rev.9<\/strong><\/p>\n\n\n\n<p>EMA, &#8220;(EC) No 726\/2004 say\u0131l\u0131 T\u00fcz\u00fc\u011f\u00fcn 5(3) Maddesi&#8217;nin be\u015feri t\u0131bbi \u00fcr\u00fcnlerdeki nitrozamin safs\u0131zl\u0131klar\u0131na ili\u015fkin tavsiyesine ili\u015fkin CHMP G\u00f6r\u00fc\u015f\u00fc hakk\u0131nda ruhsat sahipleri\/ba\u015fvuru sahipleri i\u00e7in sorular ve cevaplar&#8221; belgesini a\u015fa\u011f\u0131dakilerle g\u00fcncelledi:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Senaryo A vakalar\u0131yla ilgilenmek i\u00e7in d\u00fczenleyici ad\u0131mlar\u0131n neler oldu\u011funa dair a\u00e7\u0131klamalar<\/li><li>Soru-Cevap 10&#8217;u yeni AI&#8217;larla g\u00fcncellenmesi (Nnitrozometilfenidat, N-nitrosopiperidin, N-nitrosorasagilen, 7-Nitroso-3-(triflorometil)-5,6,7,8-tetrahidro[1,2,4]triazolo-[4,3-a]pirazin, N- nitroso-1,2,3,6-tetrahidropiridin, Nnitrosonortriptilin, N-metil-N-nitrosofenetilamin)<\/li><li>Ames testinin kullan\u0131m\u0131na ili\u015fkin rehberlik<\/li><\/ul>\n\n\n\n<p>Detayl\u0131 bilgi i\u00e7in\u00a0<strong><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/nitrosamines-emea-h-a53-1490-questions-answers-marketing-authorisation-holders\/applicants-chmp-opinion-article-53-regulation-ec-no-726\/2004-referral-nitrosamine-impurities-human-medicinal-products_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Sorular &amp; Cevaplar<\/a>\u00a0<\/strong>dok\u00fcman\u0131n\u0131 inceleyin.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-size-nasil-yardimci-olabiliriz\">Size Nas\u0131l Yard\u0131mc\u0131 Olabiliriz?<\/h2>\n\n\n\n<p>Nitrozamin analizlerindeki uzun s\u00fcreli deneyim sayesinde M\u00e9rieux NutriSciences&#8217;\u0131n Farmas\u00f6tik ve Ar-Ge B\u00f6l\u00fcmleri, farmas\u00f6tik \u00fcr\u00fcnlerde geni\u015f bir nitrozamin limit belirleme aral\u0131\u011f\u0131 ve N-Nitroso Nortriptyline veya N-nitroso rasagilin gibi belirli NO-API&#8217;leri i\u00e7in uygun y\u00fcksek duyarl\u0131 LC-MS\/MS y\u00f6ntemleri geli\u015ftirdi ve onaylad\u0131. M\u00fc\u015fterilerimize h\u0131zl\u0131 bir \u015fekilde yan\u0131t verebilmek i\u00e7in nitrozamin analizi i\u00e7in h\u0131zl\u0131 ve hedefe y\u00f6nelik analitik hizmetler sunmak \u00fczere \u00f6zel ileti\u015fim hatlar\u0131 hayata ge\u00e7irilmi\u015ftir.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-horizontal is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-499968f5 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link\" href=\"https:\/\/baptister83.sg-host.com\/tr\/nitrozamin-safsizliklari\/\" target=\"_blank\" rel=\"noopener\">Daha Fazlas\u0131n\u0131 Ke\u015ffedin<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>20 May\u0131s 2022 \u2013 EMA\/409815\/2020 Rev.9 EMA, &#8220;(EC) No 726\/2004 say\u0131l\u0131 T\u00fcz\u00fc\u011f\u00fcn 5(3) Maddesi&#8217;nin be\u015feri t\u0131bbi \u00fcr\u00fcnlerdeki nitrozamin safs\u0131zl\u0131klar\u0131na ili\u015fkin tavsiyesine ili\u015fkin CHMP G\u00f6r\u00fc\u015f\u00fc hakk\u0131nda ruhsat sahipleri\/ba\u015fvuru sahipleri i\u00e7in sorular ve cevaplar&#8221; belgesini a\u015fa\u011f\u0131dakilerle g\u00fcncelledi: Senaryo A vakalar\u0131yla ilgilenmek i\u00e7in d\u00fczenleyici ad\u0131mlar\u0131n neler oldu\u011funa dair a\u00e7\u0131klamalar Soru-Cevap 10&#8217;u yeni AI&#8217;larla g\u00fcncellenmesi (Nnitrozometilfenidat, N-nitrosopiperidin, N-nitrosorasagilen, 7-Nitroso-3-(triflorometil)-5,6,7,8-tetrahidro[1,2,4]triazolo-[4,3-a]pirazin,&#8230;<\/p>\n","protected":false},"author":17,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"_kad_post_classname":"","footnotes":""},"categories":[1453],"tags":[],"post_folder":[],"class_list":["post-138717","post","type-post","status-publish","format-standard","hentry","category-blog-2-2-4"],"acf":[],"taxonomy_info":{"category":[{"value":1453,"label":"Blog"}]},"featured_image_src_large":false,"author_info":{"display_name":"Diana Sanchez","author_link":"https:\/\/www.merieuxnutrisciences.com\/tr\/author\/diana\/"},"comment_info":0,"category_info":[{"term_id":1453,"name":"Blog","slug":"blog-2-2-4","term_group":0,"term_taxonomy_id":1453,"taxonomy":"category","description":"","parent":0,"count":20,"filter":"raw","cat_ID":1453,"category_count":20,"category_description":"","cat_name":"Blog","category_nicename":"blog-2-2-4","category_parent":0}],"tag_info":false,"_links":{"self":[{"href":"https:\/\/www.merieuxnutrisciences.com\/tr\/wp-json\/wp\/v2\/posts\/138717","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.merieuxnutrisciences.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.merieuxnutrisciences.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/tr\/wp-json\/wp\/v2\/users\/17"}],"replies":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/tr\/wp-json\/wp\/v2\/comments?post=138717"}],"version-history":[{"count":1,"href":"https:\/\/www.merieuxnutrisciences.com\/tr\/wp-json\/wp\/v2\/posts\/138717\/revisions"}],"predecessor-version":[{"id":138718,"href":"https:\/\/www.merieuxnutrisciences.com\/tr\/wp-json\/wp\/v2\/posts\/138717\/revisions\/138718"}],"wp:attachment":[{"href":"https:\/\/www.merieuxnutrisciences.com\/tr\/wp-json\/wp\/v2\/media?parent=138717"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/tr\/wp-json\/wp\/v2\/categories?post=138717"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/tr\/wp-json\/wp\/v2\/tags?post=138717"},{"taxonomy":"post_folder","embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/tr\/wp-json\/wp\/v2\/post_folder?post=138717"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}