{"id":6560,"date":"2026-10-13T23:18:24","date_gmt":"2026-10-13T16:18:24","guid":{"rendered":"https:\/\/dykhoa.com\/blog\/?post_type=thuat_ngu&#038;p=6560"},"modified":"2026-10-13T23:18:24","modified_gmt":"2026-10-13T16:18:24","slug":"nghien-cuu-tien-lam-sang-preclinical-study","status":"publish","type":"thuat_ngu","link":"https:\/\/dykhoa.com\/blog\/thuat-ngu\/nghien-cuu-tien-lam-sang-preclinical-study\/","title":{"rendered":"Nghi\u00ean c\u1ee9u ti\u1ec1n l\u00e2m s\u00e0ng (preclinical study) l\u00e0 g\u00ec?"},"content":{"rendered":"<p>Tr\u01b0\u1edbc khi m\u1ed9t lo\u1ea1i thu\u1ed1c m\u1edbi \u0111\u01b0\u1ee3c th\u1eed tr\u00ean ng\u01b0\u1eddi, nh\u00e0 nghi\u00ean c\u1ee9u ph\u1ea3i bi\u1ebft n\u00f3 c\u00f3 kh\u1ea3 n\u0103ng g\u00e2y h\u1ea1i nghi\u00eam tr\u1ecdng hay kh\u00f4ng, t\u1ee9c \u0111\u1ed9c t\u00ednh (FDA, 2018). Giai \u0111o\u1ea1n ki\u1ec3m tra n\u00e0y g\u1ecdi l\u00e0 nghi\u00ean c\u1ee9u ti\u1ec1n l\u00e2m s\u00e0ng.<\/p>\n<h2>Nghi\u00ean c\u1ee9u ti\u1ec1n l\u00e2m s\u00e0ng g\u1ed3m nh\u1eefng g\u00ec?<\/h2>\n<p>Theo C\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m M\u1ef9 (FDA, 2018), c\u00f3 hai lo\u1ea1i nghi\u00ean c\u1ee9u ti\u1ec1n l\u00e2m s\u00e0ng:<\/p>\n<ul>\n<li><strong>In vitro:<\/strong> l\u00e0m trong ph\u00f2ng th\u00ed nghi\u1ec7m, v\u00ed d\u1ee5 tr\u00ean t\u1ebf b\u00e0o.<\/li>\n<li><strong>In vivo:<\/strong> l\u00e0m tr\u00ean c\u01a1 th\u1ec3 s\u1ed1ng, v\u00ed d\u1ee5 \u0111\u1ed9ng v\u1eadt th\u00ed nghi\u1ec7m.<\/li>\n<\/ul>\n<p>C\u00e1c nghi\u00ean c\u1ee9u n\u00e0y ph\u1ea3i cung c\u1ea5p th\u00f4ng tin chi ti\u1ebft v\u1ec1 li\u1ec1u v\u00e0 m\u1ee9c \u0111\u1ed9c t\u00ednh, tu\u00e2n theo th\u1ef1c h\u00e0nh t\u1ed1t ph\u00f2ng th\u00ed nghi\u1ec7m (GLP), v\u00e0 th\u01b0\u1eddng kh\u00f4ng l\u1edbn v\u1ec1 quy m\u00f4 (FDA, 2018). <strong>Ph\u00e2n bi\u1ec7t v\u1edbi nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng:<\/strong> ti\u1ec1n l\u00e2m s\u00e0ng di\u1ec5n ra tr\u01b0\u1edbc khi th\u1eed tr\u00ean ng\u01b0\u1eddi; ch\u1ec9 nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng m\u1edbi cho bi\u1ebft thu\u1ed1c c\u00f3 t\u00e1c d\u1ee5ng v\u00e0 an to\u00e0n \u1edf ng\u01b0\u1eddi hay kh\u00f4ng.<\/p>\n<h2>V\u00ec sao tin \u201c\u0111\u1ed9t ph\u00e1\u201d t\u1eeb chu\u1ed9t th\u01b0\u1eddng b\u1ecb th\u1ed5i ph\u1ed3ng?<\/h2>\n<p>Sumner v\u00e0 cs. (2014) ph\u00e2n t\u00edch th\u00f4ng c\u00e1o b\u00e1o ch\u00ed do 20 tr\u01b0\u1eddng \u0111\u1ea1i h\u1ecdc h\u00e0ng \u0111\u1ea7u c\u1ee7a Anh ph\u00e1t h\u00e0nh n\u0103m 2011 v\u00e0 tin b\u00e0i \u0111i k\u00e8m. Trong s\u1ed1 c\u00e1c th\u00f4ng c\u00e1o v\u1ec1 nghi\u00ean c\u1ee9u tr\u00ean \u0111\u1ed9ng v\u1eadt, 36% \u0111\u00e3 suy di\u1ec5n qu\u00e1 m\u1ee9c sang ng\u01b0\u1eddi. Khi th\u00f4ng c\u00e1o ph\u00f3ng \u0111\u1ea1i, 86% tin b\u00e0i c\u0169ng ph\u00f3ng \u0111\u1ea1i theo; khi th\u00f4ng c\u00e1o kh\u00f4ng ph\u00f3ng \u0111\u1ea1i, t\u1ef7 l\u1ec7 n\u00e0y ch\u1ec9 kho\u1ea3ng 10%.<\/p>\n<p>B\u00e0i <a href=\"https:\/\/dykhoa.com\/blog\/mot-nghien-cuu-moi-co-du-de-ket-luan\/\">m\u1ed9t nghi\u00ean c\u1ee9u m\u1edbi c\u00f3 \u0111\u1ee7 \u0111\u1ec3 k\u1ebft lu\u1eadn \u0111i\u1ec1u g\u00ec \u0111\u00fang<\/a> gi\u1ea3i th\u00edch v\u00ec sao m\u1ed9t k\u1ebft qu\u1ea3 \u0111\u01a1n l\u1ebb, nh\u1ea5t l\u00e0 t\u1eeb \u0111\u1ed9ng v\u1eadt, ch\u01b0a \u0111\u1ee7 \u0111\u1ec3 k\u1ebft lu\u1eadn.<\/p>\n<h2>C\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p<\/h2>\n<h3>K\u1ebft qu\u1ea3 t\u1ed1t tr\u00ean \u0111\u1ed9ng v\u1eadt c\u00f3 ngh\u0129a l\u00e0 s\u1ebd t\u1ed1t tr\u00ean ng\u01b0\u1eddi?<\/h3>\n<p>Kh\u00f4ng ch\u1eafc. Nghi\u00ean c\u1ee9u ti\u1ec1n l\u00e2m s\u00e0ng ch\u1ee7 y\u1ebfu nh\u1eb1m s\u00e0ng l\u1ecdc \u0111\u1ed9c t\u00ednh v\u00e0 \u0111\u1ecbnh h\u01b0\u1edbng li\u1ec1u tr\u01b0\u1edbc khi th\u1eed tr\u00ean ng\u01b0\u1eddi (FDA, 2018); hi\u1ec7u qu\u1ea3 \u1edf ng\u01b0\u1eddi c\u1ea7n \u0111\u01b0\u1ee3c ki\u1ec3m ch\u1ee9ng ri\u00eang b\u1eb1ng nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng.<\/p>\n<h3>L\u00e0m sao nh\u1eadn ra m\u1ed9t tin l\u00e0 nghi\u00ean c\u1ee9u ti\u1ec1n l\u00e2m s\u00e0ng?<\/h3>\n<p>T\u00ecm c\u00e1c ch\u1eef nh\u01b0 \u201ctr\u00ean chu\u1ed9t\u201d, \u201ctr\u00ean t\u1ebf b\u00e0o\u201d, \u201cin vitro\u201d, \u201cm\u00f4 h\u00ecnh \u0111\u1ed9ng v\u1eadt\u201d. N\u1ebfu tin b\u00e0i kh\u00f4ng n\u00f3i r\u00f5, h\u00e3y m\u1edf nghi\u00ean c\u1ee9u g\u1ed1c, nh\u01b0 h\u01b0\u1edbng d\u1eabn trong b\u00e0i <a href=\"https:\/\/dykhoa.com\/blog\/kiem-tra-nghien-cuu-chia-se-tren-mang\/\">l\u00e0m sao ki\u1ec3m tra m\u1ed9t nghi\u00ean c\u1ee9u \u0111\u01b0\u1ee3c chia s\u1ebb tr\u00ean m\u1ea1ng<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Nghi\u00ean c\u1ee9u ti\u1ec1n l\u00e2m s\u00e0ng (preclinical study) l\u00e0 th\u1eed nghi\u1ec7m tr\u00ean t\u1ebf b\u00e0o v\u00e0 \u0111\u1ed9ng v\u1eadt tr\u01b0\u1edbc khi th\u1eed tr\u00ean ng\u01b0\u1eddi. V\u00ec sao kh\u00f4ng n\u00ean v\u1ed9i suy ra ng\u01b0\u1eddi?<\/p>\n","protected":false},"author":1,"featured_media":0,"template":"","nhom_thuat_ngu":[476],"class_list":["post-6560","thuat_ngu","type-thuat_ngu","status-publish","hentry","nhom_thuat_ngu-nghien-cuu-bang-chung"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nghi\u00ean c\u1ee9u ti\u1ec1n l\u00e2m s\u00e0ng (preclinical study) l\u00e0 g\u00ec? - Dy Khoa Blog<\/title>\n<meta name=\"description\" content=\"Nghi\u00ean c\u1ee9u ti\u1ec1n l\u00e2m s\u00e0ng (preclinical study) l\u00e0 th\u1eed nghi\u1ec7m tr\u00ean t\u1ebf b\u00e0o v\u00e0 \u0111\u1ed9ng v\u1eadt tr\u01b0\u1edbc khi th\u1eed tr\u00ean ng\u01b0\u1eddi. 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