平成22年度第5回臨床試験審査委員会 会議の記録 1. 日 時 ： 平成22年
Contents
1. 2010 8 23 2010 9 14 2010 8 18 2008031 11X RO4964913 2 2 2008030 11X TSU 68 S 1 1 22. 2 1 2 2008039 11X CDP870 MTX 3 2008038 11X CDP870 MTX 23 2008036 11X NPB 01 2 2008033 1
3. 2010015 11X LCZ696 2 2010014 11X SITAXENTAN 3 a 1
4. 3 AIN457 2 5 HB AMT 0902 1
5. P2010027 11X 1 P2010026 11Y AMS800 P2010025 11X P2010024 11X MM
6. Ll UE 6 sl ITM 014 2 I ED NT S 1 Sorafenib UN Wn AIN457 DE 105 Es in Ro47 0203
7. 2010 7 5 LY170053 3 8 9 10 BLP415 3 2 Es in
8. 4 _ 9
9. 21 3DB 01 060600600000606 SPP100 2 3 CMLI jHI 01 B ZD4054 3 2007048 11X 2007044 11X 2007040 11Y
10. 2010020 11X JNS024ER 2 0 EA Co 2010019 11X 3 Q amp A 1 2010018 11X eeeee 0 9 1 2
11. F Lal al i sl SAEreport Pl 1 AMG531 ITP ZD4054 3 3 I HD I HD NT RNTC06
12. DS Ll E 7 DS sl DS Lal E 7 sl nl DS sl Amendment07 8
13. Es nin P2009011 11X P2008057 11X P2008051 11X P2008050 11X P2008047 11X EE P2008042 11X P2008040 11X P
14. LAC RAC B C
15. 1 FH ES 9 2009008 11Y I 2009006 11X CDP870 MTX Ss ua 2009005 11X CDP870 MTX
16. P2010023 11X P2010022 11X M 21 P2010021 11X P2010019 11Z y 6 P2010017 11X P2010002 11X EMPATHY
17. 3 3 2010009 11X 3 3 Tf 2010008 11X 3 a 9 3 Df 3 2010007 11Y 2010006 11X 2010005 11X 2010004 11X 2010003 11Y
18. CP 690 550 3 LVAS CO1 I HD NT I HD NT 3 Ph CML CP 3 LY170053 Es in 2007018 11X 2007004 11DX 2005026 11X 2004029 11DX 2004028 11DX P2010032 11X P2010031 11X P2010029 11Y P2010028 11X
19. 2010017 11Y ODK 1001 1002 MDS p 2010016 11X LCZ696 2
20. P2009032 11X REAL CAD P2009030 11Y P2009015 11X H EED 300 250
21. ADNI P2007039 11X P2007022 11X P2007018 11X P2007017 11X P2006043 11X P2005021 11X N
22. 1 2010013 11X MK 8669 0 2 2010012 11X OPC 262 2 3 2010011 11X 3 3 2010010 11X
23. 2008017 11X 2008012 11Z 2008007 11Y 2008005 11X 2008003 11Y 2008001 11X 1 Z 208 1 2 1 2 5 1 2 3 4
24. 2007039 11X 2007026 11Y 2007021 11X 2007019 11X Lal
25. S 1 Appendix 2008028 11Y TRE 689 2008026 11X GSK1325760A 3 1 2008023 11DX 6 Rg IDEC C2B8 3 1 2008022 11DX a IDEC C2B8 3
26. 4 NP007 Ek mp P1 QTI571 NB F 3 Tanezumab e69e 0 2 A mm U INN NB 7 NB Ph CML CP 4 Es mw BB MJO10 mo BMS 582664 A HD 3 NB NB 3 2009026 11X S S 3 Tf D3 3 2009025 11X 3 2009024 11X
27. 2009003 11X 6 6000600600 2 2009001 11X QAB149 3 2008052 11Y e0000000606 e000 0000000606060 0606 2008049 11X SR25990C 3 SAE
28. 2009023 11X 2009022 11X 2009021 11X 2009020 11X 2009017 11X J sl S 1 Appendix 5
29. 2008047 11X JNS020QD 3 a EE C 12 2008045 11X BAY63 2521 PAH PATENT 2 1 2008044 11X BAY63 2521 PAH
30. syntocinon ASD RAS PPI 3 I HD NT P2008022 11X P2008020 11X P2008013 11X P2008012 11X
31. 2 ERCP A A OF 3 Niti s Syntocinon ASD
32. H 2010002 11Y 2010001 11X 2009032 11X ES uw SE 2009031 11Z ee 2009030 11Y 2009027 11X HH E DS 9 I
33. MAG NS 304 6 2 MRA SC 3 3 2 8 AIN457 3 6 NP007 P2 II
34. 3 2 E 2 E 3 ThermoDox I NT 3 QTI571 I HD NT SK 0403 SU 1 Es in 3 2 3 a fe i a y a 2009015
35. 22 5 1 22 9 30 15 00 16 50 2 2 7 a 3 17 13 2010022 11X ASP3550 2 6 a 2010021 11X JNS024ER 2
36. BAY63 2521 CHEPH CHEST 1 0 ER 1 2 IRB 2008041 11X 3 2008040 11X S 1 L OHP 2
37. 11X 6 AD NE KW 6002 3 MI 2009014 11X NMR KW 6002 3 NN 2009013 11X ot SPP100 3 5 a 2009012 11X NUM MIMO 3 Y t 2009010 11X I MD 0701 2 3 5 MA
38. 1X BAY43 9006 3 1 2 LY450139 CO to CO ww 2 lt A _
39. 2008037 11X P2008035 11X P2008031 11X P2008028 11X RF36 MP Es mn
40. PATENT 1 I 1 2008043 11X BAY63 2521 CHEPH CHEST 2 2 1 Pu 2008042 11X
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