- CRA
, , .
. . , . .
Sulfonilamide (1938)Talidomide (1960) Kefauver-Harris Amendment (1962) IDN, NDA (1963)Helsinki (1964)GCP (1981)ICH (1992)
: , , , : , , , , , , , , : profile : Profile :
, spectrum, Litchfield (1962): - Positive prediction - Negative prediction Allometry : (MTD)
spectrum, , (1) , , (2) (, ) (3) hormone circardian rhythm (4) ( non-linear kinetics) (5) (skin rash hemolytic anemia) ideosyncratic reaction
1960 3 . 1 2 3
1 , , , ( 20-80) (pharmacokinetics), , () cytotoxicitiy 1
2 (controlled) , , pilot study (pivotal) 100-200
3 (controlled) (uncontrolled) , (multicenter study) 1/1000
4 2 . (PMS)1) ( ), 2) , , 3) 3 , 4) , 5) .
ICH Human Pharmacology Therapeutic Exploratory Trial Therapeutic Confirmatory Trial Therapeutic Use Trial Bridging study
1964 Helsinki : 1) 2) ( (IRB))
1978 Belmont Report:- 1) 2) 3)
(US FDA) (IRB) (1978. 8) (1979. 8) (1977 .9) (1977. 9)
GCP KGCP (1987) KGCP 1995 10 KGCP ICH-GCP KGCP (2001.1.)
(1)
SK 1999. 7.14.2001. 7. 6. 2001. 12.17.LG 2002. 12.27 ()2003. 4. 4.(), 2003. 10. 6.Bio EGF 2001. 5.30.2001. 1.30. SK 2001. 7. 5./2002. 6.12.
(2) 15 . Global company
. 1, 2, 3 . . 15 , .
Top Related