{"id":2443,"date":"2024-02-02T15:20:53","date_gmt":"2024-02-02T15:20:53","guid":{"rendered":"http:\/\/aqpbiocenter.com.vn\/?p=2443"},"modified":"2024-02-02T15:24:32","modified_gmt":"2024-02-02T15:24:32","slug":"tong-quan-ve-tuong-duong-sinh-hoc-xem-xet-quy-dinh-doi-voi-san-pham-thuoc-generic","status":"publish","type":"post","link":"https:\/\/aqpbiocenter.com.vn\/en\/tong-quan-ve-tuong-duong-sinh-hoc-xem-xet-quy-dinh-doi-voi-san-pham-thuoc-generic\/","title":{"rendered":"T\u1ed5ng quan v\u1ec1 t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc: Xem x\u00e9t quy \u0111\u1ecbnh \u0111\u1ed1i v\u1edbi S\u1ea3n ph\u1ea9m thu\u1ed1c Generic (*)"},"content":{"rendered":"<p><strong>1. T\u1ed5ng quan<\/strong><\/p>\n<p>C\u00e1c thu\u1ed1c Generic c\u1ea7n ph\u1ea3i \u0111\u01b0\u1ee3c x\u00e1c nh\u1eadn c\u00f9ng m\u1ee9c ch\u1ea5t l\u01b0\u1ee3ng, hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n v\u1edbi s\u1ea3n ph\u1ea9m thu\u1ed1c g\u1ed1c (thu\u1ed1c ph\u00e1t minh). C\u1ee5 th\u1ec3, thu\u1ed1c Generic (thu\u1ed1c th\u1eed) ph\u1ea3i t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1ec1 m\u1eb7t \u0111i\u1ec1u tr\u1ecb v\u00e0 c\u00f3 th\u1ec3 thay th\u1ebf \u0111\u01b0\u1ee3c thu\u1ed1c tham chi\u1ebfu (thu\u1ed1c \u0111\u1ed1i ch\u1ee9ng). Th\u1eed nghi\u1ec7m t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc gi\u1eefa thu\u1ed1c th\u1eed c\u00f3 d\u01b0\u1ee3c ch\u1ea5t t\u01b0\u01a1ng \u0111\u01b0\u01a1ng (t\u01b0\u01a1ng \u0111\u01b0\u01a1ng b\u00e0o ch\u1ebf) ho\u1eb7c th\u1ebf ph\u1ea9m b\u00e0o ch\u1ebf so v\u1edbi thu\u1ed1c \u0111\u1ed1i ch\u1ee9ng trong nghi\u00ean c\u1ee9u d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc v\u1edbi s\u1ed1 l\u01b0\u1ee3ng NTN ph\u00f9 h\u1ee3p l\u00e0 m\u1ed9t c\u00e1ch \u0111\u1ec3 ch\u1ee9ng minh t\u00ednh t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1ec1 m\u1eb7t \u0111i\u1ec1u tr\u1ecb. \u1ee8ng d\u1ee5ng thu\u1ed1c Generic \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 \u201ccon \u0111\u01b0\u1eddng t\u1eaft\u201d v\u00ec ch\u00fang th\u01b0\u1eddng kh\u00f4ng c\u1ea7n b\u1eaft bu\u1ed9c ph\u1ea3i bao g\u1ed3m d\u1eef li\u1ec7u l\u00e2m s\u00e0ng v\u00e0 ti\u1ec1n l\u00e2m s\u00e0ng \u0111\u1ec3 thi\u1ebft l\u1eadp t\u00ednh an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3.<\/p>\n<p><strong>2. Gi\u1edbi thi\u1ec7u <\/strong><\/p>\n<p><em>Thu\u1ed1c Generic<\/em><\/p>\n<p>Theo C\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA), thu\u1ed1c Generic gi\u1ed1ng h\u1ec7t ho\u1eb7c n\u1eb1m trong ph\u1ea1m vi t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc c\u00f3 th\u1ec3 ch\u1ea5p nh\u1eadn \u0111\u01b0\u1ee3c v\u1edbi thu\u1ed1c g\u1ed1c v\u1ec1 c\u00e1c \u0111\u1eb7c t\u00ednh d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc v\u00e0 d\u01b0\u1ee3c l\u1ef1c h\u1ecdc. Do \u0111\u00f3, thu\u1ed1c generic \u0111\u01b0\u1ee3c FDA coi l\u00e0 gi\u1ed1ng h\u1ec7t v\u1ec1 li\u1ec1u l\u01b0\u1ee3ng, c\u01b0\u1eddng \u0111\u1ed9, \u0111\u01b0\u1eddng d\u00f9ng, \u0111\u1ed9 an to\u00e0n, hi\u1ec7u qu\u1ea3 v\u00e0 m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng v\u1edbi thu\u1ed1c g\u1ed1c.<\/p>\n<p><em>C\u00e1c kh\u00eda c\u1ea1nh quan tr\u1ecdng li\u00ean quan \u0111\u1ebfn t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc<\/em><\/p>\n<ul>\n<li><strong>Ti\u00eau chu\u1ea9n h\u00f3a nghi\u00ean c\u1ee9u<\/strong>: Trong th\u1eed nghi\u1ec7m t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc, c\u00e1c \u0111i\u1ec1u ki\u1ec7n th\u1eed nghi\u1ec7m ph\u1ea3i \u0111\u01b0\u1ee3c ti\u00eau chu\u1ea9n h\u00f3a \u0111\u1ec3 gi\u1ea3m thi\u1ec3u s\u1ef1 bi\u1ebfn thi\u00ean c\u1ee7a t\u1ea5t c\u1ea3 c\u00e1c t\u00e1c nh\u00e2n li\u00ean quan ngo\u1ea1i tr\u1eeb c\u00e1c y\u1ebfu t\u1ed1 c\u1ee7a s\u1ea3n ph\u1ea9m \u0111ang \u0111\u01b0\u1ee3c th\u1eed nghi\u1ec7m.<\/li>\n<li><strong>C\u1ee1 m\u1eabu<\/strong>: S\u1ed1 l\u01b0\u1ee3ng NTN \u0111\u01b0\u1ee3c l\u1ef1a ch\u1ecdn t\u00f9y thu\u1ed9c v\u00e0o m\u1ee9c \u0111\u1ed9 bi\u1ebfn thi\u00ean c\u1ee7a thu\u1ed1c v\u00e0 ti\u00eau ch\u00ed ch\u1ea5p nh\u1eadn c\u1ee7a thu\u1ed1c. V\u1edbi thi\u1ebft k\u1ebf nghi\u00ean c\u1ee9u ch\u00e9o \u0111\u00f4i, s\u1ed1 l\u01b0\u1ee3ng NTN t\u1ed1i thi\u1ec3u s\u1ebd l\u00e0 12 nh\u01b0ng c\u1ee1 m\u1eabu th\u00edch h\u1ee3p th\u01b0\u1eddng s\u1ebd \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh d\u1ef1a tr\u00ean d\u1eef li\u1ec7u c\u00f3 s\u1eb5n tr\u01b0\u1edbc \u0111\u00f3 ho\u1eb7c d\u1eef li\u1ec7u c\u00f3 s\u1eb5n t\u1eeb nghi\u00ean c\u1ee9u th\u00ed \u0111i\u1ec3m.<\/li>\n<li><strong>Lo\u1ea1i nghi\u00ean c\u1ee9u:<\/strong> S\u1ed1 l\u01b0\u1ee3ng nghi\u00ean c\u1ee9u v\u00e0 thi\u1ebft k\u1ebf nghi\u00ean c\u1ee9u ph\u1ee5 thu\u1ed9c v\u00e0o \u0111\u1eb7c t\u00ednh h\u00f3a l\u00fd c\u1ee7a ho\u1ea1t ch\u1ea5t, \u0111\u1eb7c t\u00ednh d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc, t\u1ef7 l\u1ec7 th\u00e0nh ph\u1ea7n c\u1ee7a ho\u1ea1t ch\u1ea5t v\u00e0 c\u1ea7n \u0111\u01b0\u1ee3c gi\u1ea3i th\u00edch ph\u00f9 h\u1ee3p. C\u00e1c lo\u1ea1i nghi\u00ean c\u1ee9u c\u0169ng c\u00f3 s\u1ef1 kh\u00e1c nhau \u1edf m\u1ed7i n\u01b0\u1edbc ho\u1eb7c m\u1ed7i khu v\u1ef1c.<\/li>\n<li><strong>H\u00e0m l\u01b0\u1ee3ng m\u1eabu nghi\u00ean c\u1ee9u:<\/strong> N\u1ebfu c\u00f3 nhi\u1ec1u h\u00e0m l\u01b0\u1ee3ng c\u1ee7a m\u1ed9t s\u1ea3n ph\u1ea9m th\u1eed nghi\u1ec7m th\u00ec ch\u1ec9 c\u1ea7n thi\u1ebft l\u1eadp t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc \u1edf m\u1ed9t ho\u1eb7c hai m\u1ee9c li\u1ec1u, t\u00f9y theo t\u1ef7 l\u1ec7 th\u00e0nh ph\u1ea7n gi\u1eefa c\u00e1c m\u1ee9c li\u1ec1u. M\u1ee9c li\u1ec1u l\u1ef1a ch\u1ecdn \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 c\u00f2n ph\u1ee5 thu\u1ed9c v\u00e0o d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a ho\u1ea1t ch\u1ea5t. \u1ede m\u1ed7i qu\u1ed1c gia ho\u1eb7c khu v\u1ef1c, t\u00f9y thu\u1ed9c v\u00e0o m\u1ee9c \u0111\u1ed9 tuy\u1ebfn t\u00ednh ho\u1eb7c kh\u00f4ng tuy\u1ebfn t\u00ednh v\u1ec1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a thu\u1ed1c m\u00e0 c\u00f3 th\u1ec3 l\u1ef1a ch\u1ecdn m\u1ee9c li\u1ec1u nghi\u00ean c\u1ee9u ph\u00f9 h\u1ee3p.<\/li>\n<li><strong>C\u00e1c th\u00f4ng s\u1ed1 c\u1ea7n x\u00e1c \u0111\u1ecbnh: <\/strong>\u0110\u1ed1i v\u1edbi c\u00e1c nghi\u00ean c\u1ee9u \u0111\u01a1n li\u1ec1u, c\u00e1c th\u00f4ng s\u1ed1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc Cmax, AUC<sub>0-t<\/sub> , AUC<sub>0-\u221e <\/sub>, Tmax, Kel, t<sub>1\/2<\/sub> \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh b\u1eb1ng c\u00e1ch s\u1eed d\u1ee5ng bi\u1ec3u \u0111\u1ed3 n\u1ed3ng \u0111\u1ed9 thu\u1ed1c trong huy\u1ebft t\u01b0\u01a1ng theo th\u1eddi gian. \u0110\u1ed1i v\u1edbi nghi\u00ean c\u1ee9u \u0111a li\u1ec1u: AUC<sub>0-\u03c4 <\/sub>, C<sub>max,ss <\/sub>, t<sub>max,ss <\/sub>\u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh b\u1eb1ng c\u00e1ch s\u1eed d\u1ee5ng bi\u1ec3u \u0111\u1ed3 n\u1ed3ng \u0111\u1ed9 thu\u1ed1c trong huy\u1ebft t\u01b0\u01a1ng theo th\u1eddi gian.<\/li>\n<li><strong>Ph\u00e2n t\u00edch th\u1ed1ng k\u00ea:<\/strong> Ph\u00e2n t\u00edch th\u1ed1ng k\u00ea s\u1ebd \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n tr\u00ean d\u1eef li\u1ec7u thu \u0111\u01b0\u1ee3c t\u1eeb c\u00e1c \u0111\u1ed1i t\u01b0\u1ee3ng NTN. Th\u1ed1ng k\u00ea m\u00f4 t\u1ea3 v\u1ec1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u00e1c th\u00f4ng s\u1ed1 s\u1ebd \u0111\u01b0\u1ee3c t\u00ednh to\u00e1n v\u00e0 b\u00e1o c\u00e1o. C\u00e1c c\u00f4ng c\u1ee5 th\u1ed1ng k\u00ea ch\u00ednh th\u01b0\u1eddng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng l\u00e0 ph\u00e2n t\u00edch ph\u01b0\u01a1ng sai (ANOVA), ph\u00e2n t\u00edch t\u1ec9 s\u1ed1 (Ratio analysis)\u2026<\/li>\n<li><strong>Ti\u00eau chu\u1ea9n ch\u1ea5p nh\u1eadn t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc<\/strong>: Trong ca\u0301c nghi\u00ean c\u01b0\u0301u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh ho\u0323c, c\u00e1c th\u00f4ng s\u00f4\u0301 \u0111\u01b0\u01a1\u0323c ph\u00e2n ti\u0301ch bao g\u00f4\u0300m AUC<sub>0-t<\/sub> ho\u0103\u0323c AUC<sub>0-\u221e<\/sub> va\u0300 C<sub>max<\/sub>. \u0110\u00f4\u0301i v\u01a1\u0301i ca\u0301c th\u00f4ng s\u00f4\u0301 na\u0300y, khoa\u0309ng tin c\u00e2\u0323y 90% cu\u0309a ty\u0309 s\u00f4\u0301 gi\u01b0\u0303a thu\u1ed1c th\u01b0\u0309 va\u0300 thu\u1ed1c \u0111\u1ed1i ch\u1ee9ng c\u00e2\u0300n n\u0103\u0300m trong gi\u01a1\u0301i ha\u0323n ch\u1ea5p nh\u1eadn l\u00e0 80 &#8211; 125% v\u00e0 \u0111a ph\u1ea7n c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd \u1edf c\u00e1c n\u01b0\u1edbc v\u00e0 c\u00e1c khu v\u1ef1c \u0111\u1ec1u ch\u1ea5p nh\u1eadn kho\u1ea3ng gi\u1edbi h\u1ea1n n\u00e0y.<\/li>\n<\/ul>\n<p><img loading=\"lazy\" class=\"aligncenter wp-image-2446 size-full\" src=\"http:\/\/aqpbiocenter.com.vn\/wp-content\/uploads\/2024\/02\/aaba2988a990b58693b509a6067ead49.jpg\" alt=\"\" width=\"777\" height=\"437\" srcset=\"https:\/\/aqpbiocenter.com.vn\/wp-content\/uploads\/2024\/02\/aaba2988a990b58693b509a6067ead49.jpg 777w, https:\/\/aqpbiocenter.com.vn\/wp-content\/uploads\/2024\/02\/aaba2988a990b58693b509a6067ead49-300x169.jpg 300w, https:\/\/aqpbiocenter.com.vn\/wp-content\/uploads\/2024\/02\/aaba2988a990b58693b509a6067ead49-768x432.jpg 768w\" sizes=\"(max-width: 777px) 100vw, 777px\" \/><\/p>\n<p><strong>3. T\u1ed5ng k\u1ebft<\/strong><\/p>\n<p>Ng\u00e0y nay, nhi\u1ec1u c\u00f4ng ty d\u01b0\u1ee3c ph\u1ea9m \u0111ang ph\u00e1t tri\u1ec3n c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c generic. Nghi\u00ean c\u1ee9u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc r\u1ea5t quan tr\u1ecdng \u0111\u1ed1i v\u1edbi qu\u00e1 tr\u00ecnh ph\u00ea duy\u1ec7t thu\u1ed1c generic. Ch\u00fang t\u00f4i hy v\u1ecdng r\u1eb1ng, \u0111\u00e1nh gi\u00e1 n\u00e0y s\u1ebd cung c\u1ea5p m\u1ed9t c\u00e1i nh\u00ecn t\u1ed5ng quan nhanh ch\u00f3ng v\u00e0 d\u1ec5 d\u00e0ng \u0111\u1ec3 xem x\u00e9t c\u00e1c quy \u0111\u1ecbnh c\u1ea7n thi\u1ebft cho nghi\u00ean c\u1ee9u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc \u1edf c\u00e1c qu\u1ed1c gia kh\u00e1c nhau.<\/p>\n<p><strong><sup>\u00a0(*)<\/sup><\/strong><strong> T\u00e0i li\u1ec7u tham kh\u1ea3o<\/strong><\/p>\n<ol>\n<li>Asif M. Tamboli*, Pavan Todkar, Priti Zope and F.J. Sayyad. (2010). An Overview on Bioequivalence: Regulatory Consideration for Generic Drug Products. <em>Journal of Bioequivalence &amp; Bioavailability<\/em>, <em>2<\/em>(4), 086-092.<\/li>\n<li>Th\u00f4ng t\u01b0 08\/2022\/TT-BYT \u201cQuy \u0111\u1ecbnh vi\u1ec7c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh thu\u1ed1c, nguy\u00ean li\u00eau l\u00e0m thu\u1ed1c\u201d \u2013 Ph\u1ee5 l\u1ee5c \u201cH\u01b0\u1edbng d\u1eabn th\u1ef1c hi\u1ec7n nghi\u00ean c\u1ee9u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc ASEAN\u201d.<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<a href=\"https:\/\/aqpbiocenter.com.vn\/wp-content\/uploads\/2024\/02\/AnOverviewonBioequivalence_RegulatoryConsiderationforGenericDrugProducts.pdf\" class=\"pdfemb-viewer\" style=\"\" data-width=\"max\" data-height=\"max\"  data-toolbar=\"bottom\" data-toolbar-fixed=\"off\">AnOverviewonBioequivalence_RegulatoryConsiderationforGenericDrugProducts<br\/><\/a>\n","protected":false},"excerpt":{"rendered":"<p>1. T\u1ed5ng quan C\u00e1c thu\u1ed1c Generic c\u1ea7n ph\u1ea3i \u0111\u01b0\u1ee3c x\u00e1c nh\u1eadn c\u00f9ng m\u1ee9c ch\u1ea5t l\u01b0\u1ee3ng, hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n<\/p>\n","protected":false},"author":1,"featured_media":2444,"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\/2443"}],"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=2443"}],"version-history":[{"count":5,"href":"https:\/\/aqpbiocenter.com.vn\/en\/wp-json\/wp\/v2\/posts\/2443\/revisions"}],"predecessor-version":[{"id":2450,"href":"https:\/\/aqpbiocenter.com.vn\/en\/wp-json\/wp\/v2\/posts\/2443\/revisions\/2450"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/aqpbiocenter.com.vn\/en\/wp-json\/wp\/v2\/media\/2444"}],"wp:attachment":[{"href":"https:\/\/aqpbiocenter.com.vn\/en\/wp-json\/wp\/v2\/media?parent=2443"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/aqpbiocenter.com.vn\/en\/wp-json\/wp\/v2\/categories?post=2443"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/aqpbiocenter.com.vn\/en\/wp-json\/wp\/v2\/tags?post=2443"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}