메뉴 건너뛰기




Volumn 70, Issue 21, 2013, Pages 1879-1880

Workshop on the challenges in substitution of nonbiological complex drugs

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; DRUG; IRON SACCHARATE; NONBIOLOGICAL COMPLEX DRUG; UNCLASSIFIED DRUG;

EID: 84901738787     PISSN: 10792082     EISSN: 15352900     Source Type: Journal    
DOI: 10.2146/ajhp130141     Document Type: Letter
Times cited : (4)

References (8)
  • 2
    • 84868273323 scopus 로고    scopus 로고
    • Nanoparticle iron medicinal products - Requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies
    • Borchard G, Flühmann B, Mühlebach S. Nanoparticle iron medicinal products - requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies. Regul Toxicol Pharmacol. 2012; 64:324-8.
    • (2012) Regul Toxicol Pharmacol , vol.64 , pp. 324-328
    • Borchard, G.1    Flühmann, B.2    Mühlebach, S.3
  • 3
    • 80051940762 scopus 로고    scopus 로고
    • Do two intravenous iron sucrose preparations have the same efficacy?
    • Rottembourg J, Kadri A, Leonard E et al. Do two intravenous iron sucrose preparations have the same efficacy? Nephrol Dial Transplant. 2011; 26:3262-7.
    • (2011) Nephrol Dial Transplant , vol.26 , pp. 3262-3267
    • Rottembourg, J.1    Kadri, A.2    Leonard, E.3
  • 4
    • 84872225362 scopus 로고    scopus 로고
    • Comparison of adverse event profile of intravenous iron sucrose and iron sucrose similar in postpartum and gynecologic operative patients
    • Lee ES, Park BR, Kim JS et al. Comparison of adverse event profile of intravenous iron sucrose and iron sucrose similar in postpartum and gynecologic operative patients. Curr Med Res Opin. 2013; 29:141-7.
    • (2013) Curr Med Res Opin , vol.29 , pp. 141-147
    • Lee, E.S.1    Park, B.R.2    Kim, J.S.3
  • 5
    • 84856507284 scopus 로고    scopus 로고
    • Clinical case reports raise doubts about the therapeutic equivalence of an iron sucrose similar preparation compared with iron sucrose originator
    • Stein J, Dignass A, Chow KU. Clinical case reports raise doubts about the therapeutic equivalence of an iron sucrose similar preparation compared with iron sucrose originator. Curr Med Res Opin. 2012; 28:241-3.
    • (2012) Curr Med Res Opin , vol.28 , pp. 241-243
    • Stein, J.1    Dignass, A.2    Chow, K.U.3
  • 6
    • 66149166994 scopus 로고    scopus 로고
    • Differences between original intravenous iron sucrose and iron sucrose similar preparations
    • Toblli JE, Cao G, Oliveri L et al. Differences between original intravenous iron sucrose and iron sucrose similar preparations. Drug Res. 2009; 59:176-90.
    • (2009) Drug Res , vol.59 , pp. 176-190
    • Toblli, J.E.1    Cao, G.2    Oliveri, L.3
  • 8
    • 84907143440 scopus 로고    scopus 로고
    • Mar
    • Food and Drug Administration. Draft guidance on iron sucrose (Mar 2012). www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM297630.pdf (accessed 2013 May 20).
    • (2012) Draft Guidance on Iron Sucrose


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.