{"id":2458,"date":"2024-02-02T15:28:53","date_gmt":"2024-02-02T15:28:53","guid":{"rendered":"http:\/\/aqpbiocenter.com.vn\/?p=2458"},"modified":"2024-02-20T10:20:54","modified_gmt":"2024-02-20T10:20:54","slug":"su-can-thiet-cua-nghien-cuu-tuong-duong-sinh-hoc-la-gi","status":"publish","type":"post","link":"https:\/\/aqpbiocenter.com.vn\/en\/su-can-thiet-cua-nghien-cuu-tuong-duong-sinh-hoc-la-gi\/","title":{"rendered":"S\u1ef1 c\u1ea7n thi\u1ebft c\u1ee7a nghi\u00ean c\u1ee9u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc l\u00e0 g\u00ec?"},"content":{"rendered":"<p><strong>Nghi\u00ean c\u1ee9u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc:<\/strong> \u0110\u00e1nh gi\u00e1 t\u00ednh an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a thu\u1ed1c<\/p>\n<p>Nghi\u00ean c\u1ee9u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc th\u01b0\u1eddng \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u0111\u1ed1i v\u1edbi thu\u1ed1c generic. Nghi\u00ean c\u1ee9u \u0111\u00e1nh gi\u00e1 s\u1ef1 kh\u00e1c bi\u1ec7t l\u00e2m s\u00e0ng v\u1ec1 sinh kh\u1ea3 d\u1ee5ng c\u1ee7a hai lo\u1ea1i thu\u1ed1c ri\u00eang bi\u1ec7t. Nh\u1eefng nghi\u00ean c\u1ee9u n\u00e0y \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3 c\u1ee7a m\u1ed9t s\u1ea3n ph\u1ea9m thu\u1ed1c m\u1edbi c\u00f3 th\u1ec3 c\u00f3 m\u1ed9t s\u1ed1 t\u00e1 d\u01b0\u1ee3c ho\u1eb7c th\u00e0nh ph\u1ea7n kh\u00f4ng c\u00f3 ho\u1ea1t t\u00ednh kh\u00e1c nhau. T\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc c\u1ee7a thu\u1ed1c \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh xem c\u00e1c c\u00f4ng th\u1ee9c kh\u00e1c nhau c\u00f3 cho ph\u00e9p c\u00f9ng m\u1ed9t l\u01b0\u1ee3ng ho\u1ea1t ch\u1ea5t v\u00e0 hi\u1ec7u qu\u1ea3 trong c\u01a1 th\u1ec3 hay kh\u00f4ng. Sinh kh\u1ea3 d\u1ee5ng c\u1ee7a thu\u1ed1c \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 \u0111\u1ec3 xem bao nhi\u00eau ph\u1ea7n tr\u0103m thu\u1ed1c \u0111\u01b0\u1ee3c \u0111\u01b0a v\u00e0o h\u1ec7 tu\u1ea7n ho\u00e0n khi \u0111\u01b0\u1ee3c d\u00f9ng qua c\u00e1c \u0111\u01b0\u1eddng d\u00f9ng kh\u00f4ng ti\u00eam t\u0129nh m\u1ea1ch (v\u00ed d\u1ee5: \u0111\u01b0\u1eddng u\u1ed1ng). Nh\u1eefng nghi\u00ean c\u1ee9u n\u00e0y r\u1ea5t c\u1ea7n thi\u1ebft \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3 v\u00e0 ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c m\u1edbi.<\/p>\n<p>T\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc c\u00f3 th\u1ec3 ch\u1ea5p nh\u1eadn \u0111\u01b0\u1ee3c l\u00e0 khi kho\u1ea3ng tin c\u1eady 90% c\u1ee7a t\u1ef7 s\u1ed1 \u0111o ph\u01a1i nhi\u1ec5m chuy\u1ec3n \u0111\u1ed5i logarit (AUC v\u00e0\/ho\u1eb7c Cmax) n\u1eb1m ho\u00e0n to\u00e0n trong ph\u1ea1m vi 80-125%. Khi n\u1ed3ng \u0111\u1ed9 c\u1ee7a m\u1ed9t h\u1ee3p ch\u1ea5t thu\u1ed1c ho\u1eb7c ch\u1ea5t chuy\u1ec3n h\u00f3a c\u1ee7a n\u00f3 trong huy\u1ebft t\u01b0\u01a1ng ho\u1eb7c huy\u1ebft thanh \u0111\u1ed1i v\u1edbi hai s\u1ea3n ph\u1ea9m thu\u1ed1c l\u00e0 nh\u01b0 nhau th\u00ec n\u1ed3ng \u0111\u1ed9 t\u00ecm th\u1ea5y t\u1ea1i v\u1ecb tr\u00ed t\u00e1c d\u1ee5ng c\u0169ng s\u1ebd gi\u1ed1ng nhau. \u0110i\u1ec1u n\u00e0y cho th\u1ea5y k\u1ebft qu\u1ea3 l\u00e0 hai lo\u1ea1i thu\u1ed1c t\u01b0\u01a1ng t\u1ef1 nhau do c\u00f3 n\u1ed3ng \u0111\u1ed9 t\u01b0\u01a1ng t\u1ef1 nhau. Do \u0111\u00f3, nghi\u00ean c\u1ee9u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc ch\u1ee9ng minh t\u00ednh an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 t\u01b0\u01a1ng \u0111\u01b0\u01a1ng c\u1ee7a m\u1ed9t s\u1ea3n ph\u1ea9m thu\u1ed1c m\u1edbi. Tuy nhi\u00ean, \u0111\u1ed9 tinh khi\u1ebft v\u00e0 quy tr\u00ecnh s\u1ea3n xu\u1ea5t c\u1ee7a s\u1ea3n ph\u1ea9m cu\u1ed1i c\u00f9ng v\u1eabn ph\u1ea3i \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 ri\u00eang.<\/p>\n<p><strong>\u0110\u00e1nh gi\u00e1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc<\/strong><\/p>\n<p>Ph\u01b0\u01a1ng ph\u00e1p d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 sinh kh\u1ea3 d\u1ee5ng c\u1ee7a thu\u1ed1c l\u00e0 ph\u01b0\u01a1ng ph\u00e1p gi\u00e1n ti\u1ebfp theo d\u00f5i \u0111\u01b0\u1eddng \u0111i c\u1ee7a thu\u1ed1c t\u1eeb khi h\u1ea5p thu v\u00e0o c\u01a1 th\u1ec3 cho \u0111\u1ebfn khi b\u00e0i ti\u1ebft. \u0110\u00e1nh gi\u00e1 cu\u1ed1i c\u00f9ng cho th\u1ea5y ch\u1ec9 s\u1ed1 \u0111i\u1ec1u tr\u1ecb v\u00e0 li\u1ec1u t\u1ed1i \u01b0u c\u1ee7a thu\u1ed1c. Hai ph\u01b0\u01a1ng ph\u00e1p \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc l\u00e0 nghi\u00ean c\u1ee9u n\u1ed3ng \u0111\u1ed9 thu\u1ed1c trong huy\u1ebft t\u01b0\u01a1ng v\u00e0 n\u1ed3ng \u0111\u1ed9 thu\u1ed1c trong n\u01b0\u1edbc ti\u1ec3u. Trong c\u00e1c nghi\u00ean c\u1ee9u v\u1edbi huy\u1ebft t\u01b0\u01a1ng, m\u1ed1i quan h\u1ec7 gi\u1eefa n\u1ed3ng \u0111\u1ed9 thu\u1ed1c t\u1ea1i v\u1ecb tr\u00ed t\u00e1c d\u1ee5ng v\u00e0 trong huy\u1ebft t\u01b0\u01a1ng \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp. Trong c\u00e1c nghi\u00ean c\u1ee9u v\u1edbi n\u01b0\u1edbc ti\u1ec3u, n\u01b0\u1edbc ti\u1ec3u \u0111\u01b0\u1ee3c ph\u00e2n t\u00edch \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 xem thu\u1ed1c c\u00f3 \u0111\u01b0\u1ee3c chuy\u1ec3n h\u00f3a v\u00e0 b\u00e0i ti\u1ebft d\u01b0\u1edbi d\u1ea1ng kh\u00f4ng \u0111\u1ed5i hay kh\u00f4ng. C\u1ea7n ph\u00e2n t\u00edch n\u1ed3ng \u0111\u1ed9 thu\u1ed1c trong n\u01b0\u1edbc ti\u1ec3u \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc, \u0111\u1eb7c bi\u1ec7t khi n\u1ed3ng \u0111\u1ed9 thu\u1ed1c trong huy\u1ebft t\u01b0\u01a1ng ho\u1eb7c huy\u1ebft thanh kh\u00f4ng th\u1ec3 ph\u00e2n t\u00edch \u0111\u01b0\u1ee3c m\u1ed9t c\u00e1ch \u0111\u00e1ng tin c\u1eady.<\/p>\n<p><strong>\u0110\u00e1nh gi\u00e1 d\u01b0\u1ee3c l\u1ef1c h\u1ecdc<\/strong><\/p>\n<p>Ph\u01b0\u01a1ng ph\u00e1p d\u01b0\u1ee3c l\u1ef1c h\u1ecdc l\u00e0 ph\u01b0\u01a1ng ph\u00e1p tr\u1ef1c ti\u1ebfp ti\u1ebfn h\u00e0nh nghi\u00ean c\u1ee9u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc nh\u1eb1m ph\u00e1t hi\u1ec7n t\u00e1c \u0111\u1ed9ng sinh l\u00fd v\u00e0 sinh h\u00f3a c\u1ee7a thu\u1ed1c l\u00ean c\u01a1 th\u1ec3 s\u1ed1ng. Nghi\u00ean c\u1ee9u d\u01b0\u1ee3c l\u1ef1c h\u1ecdc s\u1eed d\u1ee5ng hai ph\u01b0\u01a1ng ph\u00e1p \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc, \u0111i\u1ec1u tr\u1ecb v\u00e0 \u0111\u00e1p \u1ee9ng d\u01b0\u1ee3c l\u00fd c\u1ea5p t\u00ednh. Trong \u0111\u00e1nh gi\u00e1 \u0111i\u1ec1u tr\u1ecb, ki\u1ec3m tra m\u1ed1i quan h\u1ec7 gi\u1eefa \u0111\u00e1p \u1ee9ng l\u00e2m s\u00e0ng khi n\u1ed3ng \u0111\u1ed9 thu\u1ed1c di chuy\u1ec3n \u0111\u1ebfn v\u1ecb tr\u00ed t\u00e1c d\u1ee5ng (ho\u1eb7c ph\u1ea3n \u1ee9ng v\u1edbi c\u00e1c tri\u1ec7u ch\u1ee9ng m\u00e0 thu\u1ed1c d\u1ef1 \u0111\u1ecbnh ch\u1eefa kh\u1ecfi). Trong \u0111\u00e1nh gi\u00e1 d\u01b0\u1ee3c l\u00fd c\u1ea5p t\u00ednh, t\u00e1c \u0111\u1ed9ng c\u1ee7a li\u1ec1u l\u01b0\u1ee3ng v\u00e0 n\u1ed3ng \u0111\u1ed9 thu\u1ed1c l\u00ean \u0111i\u1ec7n t\u00e2m \u0111\u1ed3 (ECG), \u0111\u01b0\u1eddng k\u00ednh\/k\u00edch th\u01b0\u1edbc \u0111\u1ed3ng t\u1eed, \u0111i\u1ec7n n\u00e3o \u0111\u1ed3 (EEG), v.v., \u0111\u1ec1u \u0111\u01b0\u1ee3c ki\u1ec3m tra v\u00e0 \u0111o l\u01b0\u1eddng.<\/p>\n<p>Hi\u1ec7n t\u1ea1i, C\u00f4ng ty c\u1ed5 ph\u1ea7n nghi\u00ean c\u1ee9u v\u00e0 ki\u1ec3m nghi\u1ec7m thu\u1ed1c AQP \u0111ang tri\u1ec3n khai \u0111\u00e1nh gi\u00e1 t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc theo ph\u01b0\u01a1ng ph\u00e1p \u0110\u00e1nh gi\u00e1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc \u2013 ph\u00e2n t\u00edch thu\u1ed1c trong huy\u1ebft t\u01b0\u01a1ng. V\u1edbi h\u01a1n 14 n\u0103m kinh nghi\u1ec7m v\u00e0 \u0111\u00e3 th\u1ef1c hi\u1ec7n h\u01a1n 82 h\u1ee3p \u0111\u1ed3ng nghi\u00ean c\u1ee9u, c\u00f9ng v\u1edbi \u0111\u1ed9i ng\u0169 nh\u00e2n s\u1ef1 ch\u1ea5t l\u01b0\u1ee3ng cao v\u00e0 trang thi\u1ebft b\u1ecb hi\u1ec7n \u0111\u1ea1i, ch\u00fang t\u00f4i t\u1ef1 tin c\u00f3 th\u1ec3 \u0111\u00e1p \u1ee9ng t\u1ed1t nh\u1ea5t m\u1ecdi nhu c\u1ea7u c\u1ee7a kh\u00e1ch h\u00e0ng. Ngo\u00e0i ra, v\u1edbi ch\u00ednh s\u00e1ch h\u1eadu m\u00e3i sau th\u1eed nghi\u1ec7m, AQP cam k\u1ebft \u0111\u1ed3ng h\u00e0nh c\u00f9ng v\u1edbi qu\u00fd kh\u00e1ch h\u00e0ng cho \u0111\u1ebfn khi h\u1ed3 s\u01a1 th\u1eed nghi\u1ec7m t\u01b0\u01a1ng \u0111\u01b0\u01a1ng \u0111\u01b0\u1ee3c c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd ch\u1ea5p thu\u1eadn.<\/p>\n<p><strong><sup>(*)<\/sup><\/strong><strong> T\u00e0i li\u1ec7u tham kh\u1ea3o<\/strong><\/p>\n<blockquote class=\"wp-embedded-content\" data-secret=\"HJqcWAghtx\"><p><a href=\"https:\/\/www.nebiolab.com\/bioequivalence-bioavailability-drug-studies\/\">Bioequivalence and Bioavailability Study<\/a><\/p><\/blockquote>\n<p><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; clip: rect(1px, 1px, 1px, 1px);\" title=\"&#8220;Bioequivalence and Bioavailability Study&#8221; &#8212; NorthEast BioLab\" src=\"https:\/\/www.nebiolab.com\/bioequivalence-bioavailability-drug-studies\/embed\/#?secret=iAtJqs5fjD#?secret=HJqcWAghtx\" data-secret=\"HJqcWAghtx\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Nghi\u00ean c\u1ee9u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc: \u0110\u00e1nh gi\u00e1 t\u00ednh an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a thu\u1ed1c Nghi\u00ean c\u1ee9u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng<\/p>\n","protected":false},"author":1,"featured_media":2462,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[32],"tags":[],"translation":{"provider":"WPGlobus","version":"2.6.6","language":"en","enabled_languages":["vi","en"],"languages":{"vi":{"title":true,"content":true,"excerpt":false},"en":{"title":false,"content":false,"excerpt":false}}},"_links":{"self":[{"href":"https:\/\/aqpbiocenter.com.vn\/en\/wp-json\/wp\/v2\/posts\/2458"}],"collection":[{"href":"https:\/\/aqpbiocenter.com.vn\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/aqpbiocenter.com.vn\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/aqpbiocenter.com.vn\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/aqpbiocenter.com.vn\/en\/wp-json\/wp\/v2\/comments?post=2458"}],"version-history":[{"count":3,"href":"https:\/\/aqpbiocenter.com.vn\/en\/wp-json\/wp\/v2\/posts\/2458\/revisions"}],"predecessor-version":[{"id":2464,"href":"https:\/\/aqpbiocenter.com.vn\/en\/wp-json\/wp\/v2\/posts\/2458\/revisions\/2464"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/aqpbiocenter.com.vn\/en\/wp-json\/wp\/v2\/media\/2462"}],"wp:attachment":[{"href":"https:\/\/aqpbiocenter.com.vn\/en\/wp-json\/wp\/v2\/media?parent=2458"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/aqpbiocenter.com.vn\/en\/wp-json\/wp\/v2\/categories?post=2458"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/aqpbiocenter.com.vn\/en\/wp-json\/wp\/v2\/tags?post=2458"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}