Trong khi c\u00e1c thu\u1eadt ng\u1eef in vivo v\u00e0 in vitro nghe r\u1ea5t gi\u1ed1ng nhau, nh\u01b0ng \u00fd ngh\u0129a c\u1ee7a ch\u00fang th\u00ec kh\u00f4ng.<\/p>\n\n\n\n

In vivo l\u00e0 ti\u1ebfng Latinh c\u00f3 ngh\u0129a l\u00e0 \u201cb\u00ean trong cu\u1ed9c s\u1ed1ng\u201d. \u0110\u00e2y l\u00e0 m\u1ed9t m\u00f4 h\u00ecnh nghi\u00ean c\u1ee9u \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho m\u1ed9t quy tr\u00ecnh ho\u1eb7c th\u1ee7 t\u1ee5c \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh \u201ctr\u00ean\u201d m\u1ed9t sinh v\u1eadt s\u1ed1ng h\u01a1n l\u00e0 trong c\u00e1c m\u1eabu t\u1ebf b\u00e0o. <\/p>\n\n\n\n

Ph\u01b0\u01a1ng ph\u00e1p in vivo m\u00f4 ph\u1ecfng c\u00e1c \u0111i\u1ec1u ki\u1ec7n sinh h\u1ecdc \u0111\u01b0\u1ee3c t\u00ecm th\u1ea5y trong m\u1ed9t \u0111\u1ed1i t\u01b0\u1ee3ng s\u1ed1ng. C\u00e1c nghi\u00ean c\u1ee9u in vivo c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n tr\u00ean \u0111\u1ed9ng v\u1eadt v\u00e0 con ng\u01b0\u1eddi.<\/p>\n\n\n\n

2. Invitro1 <\/sup>\u2013 B\u00ean trong \u1ed1ng nghi\u1ec7m<\/strong><\/h3>\n\n\n\n

In vitro l\u00e0 ti\u1ebfng Latinh c\u00f3 ngh\u0129a l\u00e0 \u201ctrong k\u00ednh\u201d. \u0110\u00e2y l\u00e0 m\u1ed9t m\u00f4 h\u00ecnh nghi\u00ean c\u1ee9u trong \u0111\u00f3 m\u1ed9t th\u1ee7 t\u1ee5c \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh trong ph\u00f2ng th\u00ed nghi\u1ec7m. C\u00e1c can thi\u1ec7p c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n tr\u00ean m\u1ed9t m\u1eabu c\u1ea5y t\u1ebf b\u00e0o c\u1ee5 th\u1ec3 \u0111\u1ec3 ph\u00e1t tri\u1ec3n vi r\u00fat, vi khu\u1ea9n ho\u1eb7c n\u1ea5m ho\u1eb7c \u0111\u1ec3 th\u1eed nghi\u1ec7m m\u1ed9t lo\u1ea1i thu\u1ed1c m\u1edbi. B\u1edfi v\u00ec ch\u00fang t\u00f4i xem x\u00e9t c\u00e1c t\u1ebf b\u00e0o c\u1ee5 th\u1ec3 trong quy tr\u00ecnh “trong \u1ed1ng nghi\u1ec7m” ch\u1ee9 kh\u00f4ng ph\u1ea3i to\u00e0n b\u1ed9 sinh v\u1eadt, nh\u1eefng th\u00ed nghi\u1ec7m n\u00e0y ph\u00f9 h\u1ee3p h\u01a1n cho vi\u1ec7c nghi\u00ean c\u1ee9u v\u00e0 ph\u00e2n t\u00edch.<\/p>\n\n\n\n

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3. Phase – Giai \u0111o\u1ea1n<\/strong><\/h3>\n\n\n\n

M\u1eb7c d\u00f9 c\u00e1c th\u1eed nghi\u1ec7m ti\u1ec1n l\u00e2m s\u00e0ng (preclinical research) tr\u1ea3 l\u1eddi c\u00e2u h\u1ecfi c\u01a1 b\u1ea3n v\u00e0 n\u1ec1n t\u1ea3ng v\u1ec1 t\u00ednh an to\u00e0n c\u1ee7a thu\u1ed1c, tuy nhi\u00ean n\u00f3 kh\u00f4ng ph\u1ea3i l\u00e0 c\u00e1ch thay th\u1ebf nh\u1eefng nghi\u00ean c\u1ee9u tr\u1ea3 l\u1eddi cho c\u00e2u h\u1ecfi nh\u1eefng thu\u1ed1c n\u00e0y t\u01b0\u01a1ng t\u00e1c nh\u01b0 th\u1ebf n\u00e0o tr\u00ean c\u01a1 th\u1ec3 con ng\u01b0\u1eddi. Th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng \u0111\u1ec1 c\u1eadp \u0111\u1ebfn nh\u1eefng nghi\u00ean c\u1ee9u\/th\u1eed nghi\u1ec7m ti\u1ebfn h\u00e0nh \u1edf con ng\u01b0\u1eddi.<\/p>\n\n\n\n

C\u00e1c danh m\u1ee5c, do C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m (FDA) x\u00e1c \u0111\u1ecbnh, \u0111\u1ec3 m\u00f4 t\u1ea3 th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng c\u1ee7a m\u1ed9t lo\u1ea1i thu\u1ed1c d\u1ef1a tr\u00ean c\u00e1c \u0111\u1eb7c \u0111i\u1ec3m c\u1ee7a nghi\u00ean c\u1ee9u, ch\u1eb3ng h\u1ea1n nh\u01b0 m\u1ee5c ti\u00eau v\u00e0 s\u1ed1 l\u01b0\u1ee3ng ng\u01b0\u1eddi tham gia. C\u00f3 b\u1ed1n giai \u0111o\u1ea1n ^{2<\/sup>:<\/p>\n\n\n\n}

Th\u1eed nghi\u1ec7m giai \u0111o\u1ea1n I<\/strong> ki\u1ec3m tra m\u1ed9t lo\u1ea1i thu\u1ed1c, v\u1eafc xin ho\u1eb7c thi\u1ebft b\u1ecb th\u1eed nghi\u1ec7m trong m\u1ed9t nh\u00f3m nh\u1ecf ng\u01b0\u1eddi \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 \u0111\u1ed9 an to\u00e0n<\/strong>, x\u00e1c \u0111\u1ecbnh t\u00e1c d\u1ee5ng ph\u1ee5 v\u00e0<\/strong> x\u00e1c \u0111\u1ecbnh li\u1ec1u l\u01b0\u1ee3ng an to\u00e0n<\/strong>. <\/p>\n\n\n\n

Th\u1eed nghi\u1ec7m giai \u0111o\u1ea1n II<\/strong> li\u00ean quan \u0111\u1ebfn c\u00e1c nh\u00f3m ng\u01b0\u1eddi l\u1edbn h\u01a1n giai \u0111o\u1ea1n I v\u00e0 ch\u00fang \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 li\u1ec7u ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb th\u1eed nghi\u1ec7m c\u00f3 an to\u00e0n hay kh\u00f4ng v\u00e0 li\u1ec7u n\u00f3 c\u00f3 hi\u1ec7u qu\u1ea3 hay kh\u00f4ng. Giai \u0111o\u1ea1n n\u00e0y c\u00f3 th\u1ec3 k\u00e9o d\u00e0i v\u00e0i n\u0103m. <\/p>\n\n\n\n

Th\u1eed nghi\u1ec7m giai \u0111o\u1ea1n III<\/strong> th\u01b0\u1eddng l\u00e0 c\u00e1c nghi\u00ean c\u1ee9u l\u1edbn so s\u00e1nh thu\u1ed1c ho\u1eb7c v\u1eafc xin th\u1eed nghi\u1ec7m v\u1edbi gi\u1ea3 d\u01b0\u1ee3c ho\u1eb7c ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb ti\u00eau chu\u1ea9n, \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 xem thu\u1ed1c c\u00f3 ho\u1ea1t \u0111\u1ed9ng hay kh\u00f4ng v\u00e0 thu th\u1eadp th\u00f4ng tin \u0111\u1ec3 cho ph\u00e9p s\u1eed d\u1ee5ng thu\u1ed1c m\u1ed9t c\u00e1ch an to\u00e0n. <\/p>\n\n\n\n

Th\u1eed nghi\u1ec7m giai \u0111o\u1ea1n IV<\/strong> \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n khi m\u1ed9t lo\u1ea1i thu\u1ed1c \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng, \u0111\u1ec3 cung c\u1ea5p th\u00eam th\u00f4ng tin v\u1ec1 vi\u1ec7c s\u1eed d\u1ee5ng thu\u1ed1c t\u1ed1t nh\u1ea5t.<\/p>\n\n\n\n

T\u1ed5ng quan v\u1ec1 c\u00e1c giai \u0111o\u1ea1n (phase) c\u1ee7a th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng<\/strong>3<\/sup><\/h3>\n\n\n\n

Phase<\/strong><\/td>	S\u1ed1 l\u01b0\u1ee3ng ng\u01b0\u1eddi tham gia <\/strong><\/td>	M\u1ee5c ti\u00eau ch\u00ednh c\u1ee7a th\u1eed nghi\u1ec7m<\/strong><\/td>	Th\u1eddi gian<\/strong><\/td>	T\u00ednh kh\u1ea3 thi<\/strong><\/td><\/tr>
0 <\/td>	Invivo\/Invitro<\/td>	Ki\u1ec3m ra xem \u1edf m\u1ee9c li\u1ec1u th\u1ea5p c\u1ee7a th\u1eed nghi\u1ec7m c\u00f3 g\u00e2y h\u1ea1i hay kh\u00f4ng? (Testing a low dose of the treatment to check it isn\u2019t harmful)<\/td>	<\/td>	<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n Thu\u1ed1c \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn th\u1eed nghi\u1ec7m \u1edf con ng\u01b0\u1eddi (Drug approved for human testing)<\/strong><\/p>\n\n\n\n 1<\/td> Nh\u1ecf – 20 \u0111\u1ebfn 100 ng\u01b0\u1eddi t\u00ecnh nguy\u1ec7n kh\u1ecfe m\u1ea1nh<\/td> T\u00ecm v\u1ec1 c\u00e1c t\u00e1c d\u1ee5ng ph\u1ee5 v\u00e0 \u0111i\u1ec1u g\u00ec x\u1ea3y ra khi \u0111i\u1ec1u tr\u1ecb trong c\u01a1 th\u1ec3 con ng\u01b0\u1eddi (Finding out about side effects, and what happens to the treatment in the body)<\/td> V\u00e0i th\u00e1ng<\/td> Kho\u1ea3ng 70% thu\u1ed1c chuy\u1ec3n sang giai \u0111o\u1ea1n ti\u1ebfp theo<\/td><\/tr> 2<\/td> Trung b\u00ecnh \u2013 th\u01b0\u1eddng tr\u00ean 100<\/td> T\u00ecm hi\u1ec3u v\u1ec1 t\u00e1c d\u1ee5ng ph\u1ee5 v\u00e0 t\u00ecm hi\u1ec3u xem n\u00f3 t\u00e1c d\u1ee5ng nh\u01b0 th\u1ebf n\u00e0o (Finding out more about side effects and looking at how well the treatment works)<\/td> V\u00e0i th\u00e1ng \u0111\u1ebfn 2 n\u0103m<\/td> Kho\u1ea3ng 33% thu\u1ed1c chuy\u1ec3n sang giai \u0111o\u1ea1n ti\u1ebfp theo<\/td><\/tr> 3<\/td> L\u1edbn \u2013 300 \u0111\u1ebfn 3000 t\u00ecnh nguy\u00ean vi\u00ean c\u00f3 b\u1ec7nh ho\u1eb7c trong t\u00ecnh tr\u1ea1ng<\/td> So s\u00e1nh hi\u1ec7u qu\u1ea3 c\u1ee7a \u0111i\u1ec1u tr\u1ecb hi\u1ec7n t\u1ea1i so v\u1edbi \u0111i\u1ec1u tr\u1ecb chu\u1ea9n (Comparing the new treatment to the standard treatment)<\/td> 1 \u0111\u1ebfn 4 n\u0103m<\/td> Kho\u1ea3ng 25-30% thu\u1ed1c chuy\u1ec3n sang giai \u0111o\u1ea1n ti\u1ebfp theo<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n N\u1ed9p cho FDA \u0111\u1ec3 xin \u0111\u1ed3ng thu\u1eadn l\u01b0u h\u00e0nh th\u1ecb tr\u01b0\u1eddng (Submit to FDA for approval<\/strong>)<\/p>\n\n\n\n Thu\u1ed1c \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn<\/strong> (Drug is approved<\/strong>)<\/p>\n\n\n\n 4<\/td> Trung b\u00ecnh \u0111\u1ebfn l\u1edbn, \u0111a d\u1ea1ng, th\u01b0\u1eddng v\u00e0i ng\u00e0n ng\u01b0\u1eddi \u0111ang c\u00f3 b\u1ec7nh ho\u1eb7c trong t\u00ecnh tr\u1ea1ng<\/td> T\u00ecm hi\u1ec3u v\u1ec1 nh\u1eefng l\u1ee3i \u00edch d\u00e0i h\u1ea1n v\u00e0 t\u00e1c d\u1ee5ng ph\u1ee5 (Finding out more about long term benefits and side effects)<\/td> 1 \u0111\u1ebfn h\u00e0ng ch\u1ee5c n\u0103m<\/td> <\/td> Thu\u1ed1c \u0111\u00e3 \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh t\u1ea1i th\u01b0\u01a1ng tr\u01b0\u1eddng<\/td> <\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n \u0110\u00e2y l\u00e0 h\u00ecnh \u1ea3nh t\u00f3m t\u1eaft c\u00e1c giai \u0111o\u1ea1n c\u1ee7a th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng m\u00e0 Th\u01b0\u01a1ng Library th\u1ea5y r\u1ea5t d\u1ec5 hi\u1ec3u v\u00e0 \u0111\u1ea7y \u0111\u1ee7. B\u1ea1n \u0111\u1ecdc c\u00f3 th\u1ec3 tham kh\u1ea3o v\u00e0 t\u00ecm hi\u1ec3u k\u0129 h\u01a1n ph\u00eda d\u01b0\u1edbi<\/p>\n\n\n\n