藥師應(yīng)該關(guān)注“藥品說明書之外的用法”doc(參考版)
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【正文】 14(1):1~5.15 / 15。 111(2):291~295.[30] [No authors listed]. ASHP statement on the use of medica?鄄tions for unlabeled uses. Am J Hosp Pharm. 1992 Aug。 27(13):1059~1067.[28] Picard D, Carvalho P, Bonnavia C, et al. Assessment offlabel prescribing in Dermatology. Ann Dermatol Venere?鄄ol. 2003 May。 75(2):491~497.[26] Bavdekar SB, Gogtay NJ. Unlicensed and offlabel drug use in children. J Postgrad Med. 2005 OctDec。 29(4):183~189.[24] Periti E, Comparetto C, Villanucci A, et al. The use of intravenous methotrexate in the treatment of ectopic pregnancy. J Chemother. 2004 Apr。 6(5):358~370.[22] Jadhav SB, Jain GK. Statins and osteoporosis: new role for old drugs. J Pharm Pharmacol. 2006 Jan。 141(6):1044~1050.[17] Stone KJ, Viera AJ, Parman CL. Offlabel applications for SSRIs. Am Fam Physician. 2003 Aug 1。 75(7):951~957. [15] Abraham LM, Selva D, Casson R, et al. Mitomycin: clini?鄄cal applications in ophthalmic practice. Drugs. 2006。 Patel RP. Unlabeled uses of bo?鄄tulinum toxins: a review, part 1. Am J Health Syst Pharm. 2006。 33(3):486~489.[13] Cheng CM。 116(12):1827~1830.[11] Petrovic R, Stojanovic R, NovicicSasic D, et al. Therapy of lupus nephritis with standard therapeutic protocols and cyclosporine. Srp Arh Celok Lek. 2002 Aug。 33(7):1442~1446. [9] Zver S, Zupan IP, Cernelc P. Cyclosporin A as an immuno?鄄suppressive treatment modality for patients with refractory autoimmune thrombocytopenic purpura after splenectomy failure. Int J Hematol. 2006 Apr。12(2):142~145.[7] Griffiths CE, Katsambas A, Dijkmans BA, et al. Update on the use of ciclosporin in immunemediated dermatoses. Br J Dermatol. 2006 Jul。61(10):775~779[5] Poole SG, Dooley MI. Offlabel prescribing in oncology. Support Care Cancer. 2004 May。 48 :15 ~18[3] Pandolfini C, Bonati M. A literature review on offlabel drug use in children. Eur J Pediatr. 2005 Sep。參考文獻(xiàn)[1] Wilson JT. An Update on the therapeutic orphan. Pedi?。同時，一些歐洲國家也采取了一系列措施鼓勵進(jìn)行更多的新藥兒童試驗[26,31]。由于效果不明顯，1997年在FDA modernization Act （FDAMA）又推出了一個鼓勵性的政策“pediatric exclusivity Provision （PE）”，即藥品審批前進(jìn)行兒童臨床試驗驗證其有效性和安全性則可額外獲得6個月的藥品專利期的延長優(yōu)惠，到1999年推出的新政策“Pedi?鄄atric Rule （PR）”要求新藥審批時提供兒童試驗資料。 影響政府相關(guān)的政策可
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