新药临床评价

LosartanALS-3N-P450AP450A P450BP450P450P450P450IIIIBP450II

P450 3A4H1Torsades

pointes1998FDA

19861996WHO1797698 De 2001

colestimideCarmoxirole Fantofarone Rufinamide NXY059CeroviveAGM1470 PEGABI007Ferumoxtran-10.

2007101

161747520James Lindt 19481951Robert Austrian

whathowwhy

1.123456

2.3.1/2/34

4.5.6.

-100PK

- a75-100// b100-400

FDAFDA

ICH:1991FDA 2

ICH-E1E2AE2B E2C E2D E2E E3 E4 E5

ICH-E6 GCPE7 E8 E9 E10 E11E12AE14QT/QTc

185010%

20-40 16-8 2-4 6-8 1

1/21/41/10

Blach well LD501/600 1/60Blach well () LD501/600 1/60 Dollry ( 1/50-1/100Fibonacci () LD101/100 1/40-1/30

1/10 1/5-1/2

((1) ( Fibonacci ): ,+1/3, +100%, +67%, +50%, +30%+35%, +1/3 I ---------------------------------------------------- 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3.3 5 6.7 9 12 16 21 28 38 50 1/1 1 2 4 8 16 32 64 128 1/2 1 1.5 2.2 3.4 5 7.6 11 17 26 38 58 87 1/3 1 1.3 1.8 2.4 3.2 4 5.6 7.5 10 13 18 24 ----------------------------------------------------(2) +1/1,+1/3,+1/2

212-166-85-10

ABCcSSSI

- 18702a.>38C >37.5C b. WBC >10 x109/L10%; c. d (1cm) e f 48

()()4(

144144

2100mg50mg 1g2 2g3 MSSA

7-14 14

- ()()

GCP200391Good Clinical Practice, GCP)

GCP GCP

GCP- SFDA2007L00394GMP

GCP Independent Ethics CommitteeIEC Institutional Review BoardIRBSFDA

GCP5 SAE

GCP-PI

GCP- SAE

GCP-CRF5

GCP- SOP

30-60P450EXP3174EXP3174AT1AT110~40AT1EXP3174EXP3174 Boris Schmidt [1]1ABAP450EXP3179EXP3174EXP31747[2]II BP450

新药临床评价

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