1、 (GLP) GLP in vitro , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)318912012, - 1.092 . - 1.22009 . , . -, , , 1 : - , , ( ); 339 , ; 339 , 2 3 , ( 9 2012 . 53-) : ( 3166) 00497 ( 3166) 00497 AMBYKGMDRUTJ -4 OECD series on Principles of GoodLaboratory Practice and Compli
2、ance Monitoring No 14 Advisory document of the working group on GoodLaboratory Practice. The application of the Principles of GLP to in vitro studies:2004 ( - . in vitro:2004, 14 - () GLP ). , - . GLP. (en). , , . (IDT). : . 5 27 2012 . 2154- 318912012 - 1 2013 .II 3189120126 , - . () . - , , 2013 -
3、, III 3189120121 .12 13 in vitro .33.1 33.2 .33.3 .43.4 .53.5 63.6 , .63.7 -.73.8 ( ) 83.9 83.10 93.11 9 () in vitro .1011IV 318912012 , in vitro in vivo. - , , , - , , in vitro - . (GLP) - , GLP () 1 in vitro. , (Bern) 12 13 2004 . in vitro, : , , , , , , . , , , 18-2004.,37- , - .V 318912012 (GLP)
4、 GLP in vitroPrinciplesofGoodLaboratoryPractice(GLP).pplicationofGLPprinciplesto in vitro studies1 (GLP)1in vitro,- , , , -, , , .- , - . /. , GLP,-,-, , , ,.2 :2.1 in vitro (in vitro studies): in vitro , -,-,.invitro,GLP1,-.- 2, .2.2 () (reference item): invitro-, / (, ), , - 1, -. ,/(), , / . - ,
5、().1 318912012 201301012.3 (aseptic conditions): , , / .2.4 (cell lines): , in vitro, .- , , , , , -, .2.5 (negative control): -, (), , - ; , - - .2.6 (positive control): -, (), -; , - .2.7 (untreated control): -, ; - .2.8 (, ) (control vehicle): -, , (); - .2.9 (critical phases): , - , , .2.10 (cro
6、ss-contamination): (-) - -, -, -.2.11 (cryopreservation): , .2.12 (cryovial): . - , , - , .2.13 ex vivo: , , .2.14 (gene transfection): ( ) -.2.15 (high through-put screening): - - -, , , . ., .2.16 () (micro-arrays): , , . - , - /.2.17 (primary cells): , - . - . , , , - . , . , ., .2.18 (proprietary material): , - (, , ).2 3189120122.19 , - (test kit): , , , () .2.20 (tissues): , - , .2.21 (toxicogenomics): , - - . , -.
