期刊文献+

申报皮肤外用抗感染药物临床试验设计与评价的考虑要点 被引量:3

Point on consideration of the clinical trial design and evaluation on the skin external antimicrobial drugs
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摘要 良好的临床试验设计有助于综合评价药物应用于临床的安全性和有效性。因此,本文结合皮肤感染性疾病的特点及皮肤外用药物局部给药、局部起效的作用特点,探讨皮肤局部外用抗感染药物申报时、对临床试验设计考虑要点,为国内该类药物的研发及临床评价提供参考。
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2006年第5期374-377,共4页 The Chinese Journal of Clinical Pharmacology
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参考文献3

  • 1US Food and Drug Administration.Guidance for Industry:Uncomplicated and Complicated Skin and Skin Structure Infections-Developing Antimicrobial Drug for Treatment[J/OL].http://www.fda.gov,1998-07 -01.
  • 2US Food and Drug Administration.Guidance for Industry:Developing Antimicrobial Drugs-general Considerations for Clinical Trials[J/OL].http://www.fda.gov,1998 -07 -05.
  • 3US Food and Drug Administration.Guidance for Industry:Evaluating Clinical Studies of Antimicrobials in The Division of Anti-Infective of Drug Products[J/OL].http://www.fda.gov,1997-02-07.

同被引文献27

  • 1郑萍,杜开蓉,王舸.反相高效液相色谱法测定咪喹莫特乳膏的有关物质及含量[J].中国抗生素杂志,2004,29(10):598-600. 被引量:5
  • 2方军.药物临床试验过程中的护理管理[J].中国实用护理杂志(下旬版),2005,21(8):40-40. 被引量:11
  • 3田少苗.药物临床试验与GCP.北京:北京大学医学出版社.2003:15
  • 4谢松梅.创新性皮肤局部外用药物研发应关注皮肤药代动力学研究[J].中国临床药理学杂志,2007,23(4):313-315. 被引量:10
  • 5PELLANDA C, OTTIKER E, STRUB C, et al. Topical bioavailability of triamcinolone acetonide: effect of dose and application frequency [J]. Arch Dermatol Res, 2006, 298 (5):221-230.
  • 6HERKENNE C, NAIK A, KALIA Y N, et al. Dermatopharmacokinetic prediction of topical drug bioavailability in vivo [J]. J Invest Dermatol, 2007, 127 (4):887-894.
  • 7WIEDERSBERG S, LEOPOLD C S, GUY R H. Dermatopharmacokinetics of betamethasone 17-valerate: Influence of formulation viscosity and skin surface cleaning procedure [J]. Eur J Pharm Biopharm, 2009,71 (2):362-366.
  • 8CHAURASIA C S, MULLER M, BASHAW E D, et al. AAPS-FDA workshop white paper: microdialysis principles, application and regulatory perspectives[J]. Pharm Res, 2007, 24(5): 1014-1025.
  • 9BENFELDT E, HANSEN S H, VOLUND A, et al. Bioequivalence of topical formulations in humans: evaluation by dermal microdialysis sampling and the dermatopharmacokinetic method[J]. J Invest Dermatol, 2007, 127 (1): 170-178.
  • 10MATHY F X, LOMBRY C, VERBEECK R K, et al. Study of the percutaneous penetration of flurbiprofen by cutaneous and subcutaneous microdialysis after iontophoretic delivery in rat[J]. J Pharm Sci, 2005, 94 (1):144-152.

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