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1 FK506 FK ,2) J. W

2 NRDC C CC CC CC CC CCNa ACA ACA FK156 FK565 FK565 FK A CsA 1972 J. T 1986 CsA 1982 FK506 FK FK )

3 FK Candida FR FR FK ) HDAC FK228ras NIH- 3T3 I II Gloucester FDA Food and Drug Administration, FDA T cutaneous T-cell lymphoma, CTCLIstodax Romidepsin Celgene T peripheral T-cell lymphoma, PTCL FDA 1960 T T 3 6) T T IL-2 IL-2 IL-2 1) 3 H ,000 No.9993 Streptomyces tsukubaensis No l HP g 4 2 1) mixed lymphocyte reaction MLR

4 C C44H69NO12 H2O 5) FK506 X FK506 L- 6,8) FR FR, Fujisawa Research No. FK506 FK, Fujisawa Kaihatsu No. Tsukuba t macrolide acrol immunosuppressant ims tacrolimus FK506 No.9993 FK506 FR FR FR FR FR ) 3 T in vitro 2) T IL-2 IL-3 INF- IL-2 CsA in vivo 3) CsA 3 6) II 1 SLE 41 FK FK506 2) in vitro 3) in vivo

5 FK506 FK506 FK506 ELISA FK506 FK506 FK pg/ml 1993 Abbott IMX 2 3 g/ml BA 20 CsA 14 C-FK C Amersham GE FK506 in vivo F344 WKA FK mg/kg mg/kg mg/kg FK mg/kg 4 FK506 CsA C-FK506 Tmax 1 BA, bioavailability C-FK FK506 8 Tmax

6 FK T 6 FKFKBP FK506 FKBP FK506 FKBP FK506 FK506-FKBP 6 T FK FK

7 FK506 E FK506 FK506 FK FK506 FK FK506 FDAIND Investigational New Drug FK FK506 FK506 FK506 FK506 FK FK FK

8 FK FK506 FK FK FK FK FK506 FK506 FK FK FK ) FK USA USA 245 FK )Orphan Drug

9 10 FK506 1 FK506 10) FK506 1 FK506 HPLC FK506 11) FDA EMEA European Medicines Agency GMP 5) 1989 FK506 FK506 7ACA 5) GMP: Good Manufacturing Practice FDA 1938 FK506 FK506 FK506 FIL GMP

10 PV 6) FDA 7) FDA FK506 FK506 FDA EMEA ) Process Validation PV GMP 7) GMP USA

11 Topical Immunomodurators TIM FHI FDA FDA FK Graceptor Advagraf XL FHI GI FDA GI

12 m FK FK506 FK506 GMP FR FDA FK FDA EMEA m

13 BSE FK FK in vitro CsA FK506 FK

14 ) 100 (1994). 2) (2005). 3), 168, 163 (1994). 4), 70, 1 (1996). 5) Kino, T. et al.: J. Antibiotics, 40, 1249 (1987). 6), 117, 542 (1997). 7), 83, 123 (2005). 8) Tanaka, H. et al.: J. Am. Chem. Soc., 109, 5031 (1987). 9) Hatanaka, H. et al.: J. Antibiotics, 41, 1586 (1988). 10), 76, 389 (1998). 11) Akashi, T. et al.: J. Pharm. Biomed. Anal., 14, 330 (1996)

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