T\u00fcm fazlara baksak m\u0131?<\/p>\n\n\n\n
Faz I: Bir ilac\u0131n veya cihaz\u0131n g\u00fcvenlik de\u011ferlendirmesidir. Tamamlanmas\u0131 birka\u00e7 ay s\u00fcrebilen bu ilk test a\u015famas\u0131, genellikle \u00e7al\u0131\u015fmaya kat\u0131lmalar\u0131 i\u00e7in \u00f6deme yahut ayr\u0131cal\u0131k alan az say\u0131da g\u00f6n\u00fcll\u00fc (20 ila 100) ile yap\u0131l\u0131r. \u00c7al\u0131\u015fma, ilac\u0131n veya cihaz\u0131n nas\u0131l emildi\u011fi, metabolize edildi\u011fi ve at\u0131ld\u0131\u011f\u0131 dahil olmak \u00fczere insanlar \u00fczerindeki etkilerini belirlemek i\u00e7in tasarlanm\u0131\u015ft\u0131r. Bu a\u015fama ayr\u0131ca dozaj seviyeleri artt\u0131k\u00e7a ortaya \u00e7\u0131kan yan etkileri de ara\u015ft\u0131r\u0131r. Deneysel ila\u00e7lar\u0131n yakla\u015f\u0131k %70’i bu test a\u015famas\u0131n\u0131 ge\u00e7er.<\/p>\n\n\n\n
Faz II: Bir ilac\u0131n veya cihaz\u0131n etkinli\u011fini test eder. Birka\u00e7 aydan iki y\u0131la kadar s\u00fcrebilir ve birka\u00e7 y\u00fcz hastay\u0131 i\u00e7erir. Faz II \u00e7al\u0131\u015fmas\u0131nda, bir hasta grubunun deneysel ilac\u0131 al\u0131rken, ikinci bir “kontrol” grubuna standart bir tedavi veya plasebo -yalandan ila\u00e7- ald\u0131\u011f\u0131 rastgele \u00f6rnek se\u00e7ilen \u00e7al\u0131\u015fmalard\u0131r. Genellikle bu \u00e7al\u0131\u015fmalar “k\u00f6r” olur, yani ne hastalar ne de ara\u015ft\u0131rmac\u0131lar deneysel ilac\u0131 kimin ald\u0131\u011f\u0131n\u0131 bilmez. Bu, ara\u015ft\u0131rmac\u0131lar\u0131n ila\u00e7 \u015firketine ve yap\u0131ld\u0131klar\u0131 \u00fclkenin \u0130la\u00e7 Ecza Kurulu yeni ilac\u0131n nispi g\u00fcvenli\u011fi ve etkinli\u011fi hakk\u0131nda kar\u015f\u0131la\u015ft\u0131rmal\u0131 bilgi sa\u011flar. Deneysel ila\u00e7lar\u0131n yakla\u015f\u0131k \u00fc\u00e7te biri hem Faz I hem de Faz II \u00e7al\u0131\u015fmalar\u0131n\u0131 ba\u015far\u0131yla tamamlamaktad\u0131r.<\/p>\n\n\n\n
Faz III: Birka\u00e7 y\u00fcz ila birka\u00e7 bin hastada rastgele ve k\u00f6r test \u00e7al\u0131\u015fmas\u0131d\u0131r. Birka\u00e7 y\u0131l s\u00fcrebilen bu ara\u015ft\u0131rma, ila\u00e7 \u015firketine ve \u0130la\u00e7 Ecza Kurulu’na ilac\u0131n veya cihaz\u0131n etkinli\u011fini, yararlar\u0131n\u0131 ve olas\u0131 yan etki aral\u0131\u011f\u0131n\u0131 daha kapsaml\u0131 bir \u015fekilde anlamas\u0131 konusunda bilgi verir. Faz III \u00e7al\u0131\u015fmalar\u0131na giren ila\u00e7lar\u0131n %70 ila %90’\u0131 bu test a\u015famas\u0131n\u0131 ba\u015far\u0131yla tamamlar. Faz III tamamland\u0131\u011f\u0131nda, bir ila\u00e7 \u015firketi ilac\u0131 pazarlamak i\u00e7in Kurul onay\u0131 isteyebilir.<\/p>\n\n\n\n
Genellikle Pazarlama Sonras\u0131 G\u00f6zetim Denemeleri olarak adland\u0131r\u0131lan Faz IV \u00e7al\u0131\u015fmalar\u0131, bir ila\u00e7 veya cihaz t\u00fcketici sat\u0131\u015f\u0131 i\u00e7in onayland\u0131ktan sonra ger\u00e7ekle\u015ftirilir. \u0130la\u00e7 \u015firketlerinin bu a\u015famada \u00e7e\u015fitli hedefleri vard\u0131r: (1) bir ilac\u0131 halihaz\u0131rda piyasada bulunan di\u011fer ila\u00e7larla kar\u015f\u0131la\u015ft\u0131rmak; (2) bir ilac\u0131n uzun s\u00fcreli etkilili\u011fini ve hastan\u0131n ya\u015fam kalitesi \u00fczerindeki etkisini izlemek; ve (3) di\u011fer geleneksel ve yeni terapilere g\u00f6re bir ila\u00e7 tedavisinin maliyet etkinli\u011fini belirlemek.<\/p>\n","protected":false},"excerpt":{"rendered":"
T\u00fcm fazlara baksak m\u0131? Faz I: Bir ilac\u0131n veya cihaz\u0131n g\u00fcvenlik de\u011ferlendirmesidir. Tamamlanmas\u0131 birka\u00e7 ay s\u00fcrebilen bu ilk test a\u015famas\u0131, genellikle \u00e7al\u0131\u015fmaya kat\u0131lmalar\u0131 i\u00e7in \u00f6deme yahut ayr\u0131cal\u0131k alan az say\u0131da g\u00f6n\u00fcll\u00fc (20 ila 100) ile yap\u0131l\u0131r. \u00c7al\u0131\u015fma, ilac\u0131n veya cihaz\u0131n nas\u0131l emildi\u011fi, metabolize edildi\u011fi ve at\u0131ld\u0131\u011f\u0131 dahil olmak \u00fczere insanlar \u00fczerindeki etkilerini belirlemek i\u00e7in tasarlanm\u0131\u015ft\u0131r.… Daha fazlas\u0131n\u0131 oku »Faz iki<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"neve_meta_sidebar":"","neve_meta_container":"","neve_meta_enable_content_width":"","neve_meta_content_width":0,"neve_meta_title_alignment":"","neve_meta_author_avatar":"","neve_post_elements_order":"","neve_meta_disable_header":"","neve_meta_disable_footer":"","neve_meta_disable_title":"","_ti_tpc_template_sync":false,"_ti_tpc_template_id":""},"categories":[4],"tags":[],"_links":{"self":[{"href":"http:\/\/temaslisozluk.com\/sozluk\/wp-json\/wp\/v2\/posts\/362"}],"collection":[{"href":"http:\/\/temaslisozluk.com\/sozluk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/temaslisozluk.com\/sozluk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/temaslisozluk.com\/sozluk\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/temaslisozluk.com\/sozluk\/wp-json\/wp\/v2\/comments?post=362"}],"version-history":[{"count":1,"href":"http:\/\/temaslisozluk.com\/sozluk\/wp-json\/wp\/v2\/posts\/362\/revisions"}],"predecessor-version":[{"id":363,"href":"http:\/\/temaslisozluk.com\/sozluk\/wp-json\/wp\/v2\/posts\/362\/revisions\/363"}],"wp:attachment":[{"href":"http:\/\/temaslisozluk.com\/sozluk\/wp-json\/wp\/v2\/media?parent=362"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/temaslisozluk.com\/sozluk\/wp-json\/wp\/v2\/categories?post=362"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/temaslisozluk.com\/sozluk\/wp-json\/wp\/v2\/tags?post=362"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}