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邦訳 - 血液製剤調査機構
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1. WNV WNV NAT WNV 11 12 WNV WNV TV 6 V 105 0011 2 8
2. ID NAT NAT ID NAT a ID NAT b 120 D NAT 120 WNV ID NAT NAT
3. 2009 11 Guidance for Industry Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion November 2009 Ofice of Communication Outreach and Development OCOD HFM 40 1401 Rockville Pike Suite 200N Rockville MD 20852 1448 1 800 833 4709 301 827 1800 http www fda govBiologicsBloodVaccines GuidanceComplianceRegulatoryinformatiomdefault htm OCOD HHS TDA CBER 2009 11 A ee TI senna A
4. ITND IND 21 CFR 312 38 IND A 1 NAT WNV MP NAT ID NAT 1 1 WNV ID NAT B MP NAT
5. D NAT NAT MP NAT ID NAF ID NAT WNV MP NAT ID NAT WNV ID NAT
6. 2008 4 HCTPs 2008 4 28 73 FR 22938 3 WNV 1999 1 WNV WNV 2002
7. C 1 FDA WNV NAT 21 CFR 601 12 d WNV NAT 21 CFR 601 12 d 2 WNV NAT
8. MP NAT ID NAT MP NAT SOP WNV MP NAT D NAT TI NAT WNV ITND WNV NAT
9. TD NAT 120 120 WNV ID NAT NAT NAT WNV JE WNV WNV NAT
10. WNV 11 12 WNV WNV 1 WP NAT TD NAT 120 120 WNV D NAT NAT NAT WNV JE
11. 601 12 c 1 5 CBE 21 CFR RNA NAT PAS 21 CFR 601 12 b 21 CFR 606 122 h 1 MP NAT WNV TD NAT WNV MP NAT MP NAT ID NAT TD NAT
12. D NAT MP NAT ID NAT I D NAT IND 6 16 MP NAT ID NAT MP NAT 1 HLV 1 NAT C NAT TD NAT NAT ID NAT
13. 1 WNV 2 WNV MP NAT ID NAT MP NAT 3 48 MP NAT TID NAT 4 SOP WNV
14. ee B MP NAT ID NAT ee EC NE D uuuuuauaauutantsareareranranueraararareeartennmenneeme V D4 2 rp4 D4 7 4
15. WNV MP NAT TD NAT WNV 7 D NAT WNV MP NAT 2004 WNV MP NAT ID NAT 7 8 1 MP NAT TD NAT 4 ID NAT 2004 2006 WNV 3 2004 1 2006 2 2004 WNV
16. TD NAT 10 ID NAT WNV A 2002 WNV 23 3 2003 7 IND MP NAT WNV 2003 WNV 6 5 MP NAT ID NAT 235 MP NAT 6 WNV D NAT MP NAT
17. NAT WNV JE WNV WNV NAT ik WNV 11 12 WNV WNV FT ul 3 ID NAT 2 a 2 b B MP NAT ID NAT
18. 6 16 III NAT MP NAT ID NAT FDA TD NAT ID NAT NAT WNV 98 4 8 2 WNV ID NAT
19. 1 FDA WNV EDA NAT WNV WNV FDA NAT I CFR 640 1 Title 21 FDA FDA should L
20. MP NAT TD NAT ID NAT D NAT 9 2006 2 2 MP NAT 10 2006 1 WNV MP NAT 2 TD NAT WNV MP NAT ITD NAT
21. 1 FDA CDC WNV NAT WNV 2 3 WNV NAT FDA IND 21 CFR Part 312 2003 FDA WNV WNV 2005 FDA WNV RNA 2 NAT
22. 83 5 TEL 08 8438 4305 FAX 03 3437 4810 URL http www bpro orjjp
23. FDA 21 CFR 601 12 lt 1 CBE 21 CFR 601 12 b PAS D 21 CFR 606 122 hb Circular of Imformation instruction circular WNV NAT 21 CFR 606 122 h WNV NAT
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