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2011年美国FDA批准药物简介 被引量：6

Overviews and analysis to the U.S.FDA's new drug approvals in 2011
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摘要 2011年美国食品药品监督管理局(FDA)批准新分子实体20个、各种新生物制品7个及细胞治疗1项,合计28项。还批准修改说明书包括新适应证、用药人群、给药方案和剂量,共29项;新剂型18项;新组方3项及其他1项,合计79项。本文按FDA批准新药说明书首页处方资料要点,简介新药特性、化学名、化学结构、适应证、作用机制、剂量和用法、禁忌证、警告与注意事项、不良反应等。文章还概述FDA 2011年批准新药,包含多个药物开发研究史中的首次事件,并扼要介绍FDA 2011财政年度创新药批准、协同评审批准诊断和相应药物治疗的政策。 In 2011,the U.S.FDA totally approved 28 new drugs,including 20 new molecular entities,7 new biological products and 1 new cell therapy.According to the prescription information,this article highlights the properties,chemical names and structure,mechanism of action,manufacturer,indication,dosage and administration,dosage form and strength,contraindications,warning and precautions,adverse reactions and box warning,etc..In addition,the ＂first events＂ in the history of new drug research and development in 2011 are also discussed.This paper also briefly introduces the report of ＂ FY 2011 Innovative Drug Approvals＂ releases 2011 November.
作者 汤仲明
机构地区 军事医学科学院放射与辐射医学研究所
出处 《国际药学研究杂志》 CAS 2012年第1期71-85,共15页 Journal of International Pharmaceutical Research
关键词 新药批准 美国FDA 新分子实体 新生物制品 化学结构 作用机制 适应证 不良反应 new drug approval U.S.FDA new molecular entity new biological product chemical structure mechanism indications adverse reactions
分类号 R95 [医药卫生—药学] F416.72 [经济管理—产业经济]
  • 相关文献

参考文献6

  • 1Drugs. New drug approvals [EB/OL]. (2012-01-01) [2012-01- 01 ]. http://www.drugs.com/newdrugs.html.
  • 2USA FDA. Drug Approval Reports [EB/OL]. (2012-01-01) [ 2012 - 01 - 01 ]. http://www.accessdata.fda.gov/scfipts/cder/dru- gsatfda/.
  • 3USA FDA. Vaccines, Blood & Biologic [EB/OL].((2012-01- 01 ) [ 2012-01-01 ]. http://www.fda.gov/BiologicsBloodVaccines/ default.htm.
  • 4European Medicines Agency. EPARs for authorised medicinal products for human use [EB/OL]. (2012-01-01) [2012-01-01 ]. http://www.emea.europa.eu/htms/human/epar/a.htm.
  • 5USA FDA. FY 2011 Innovative Drug Approvals [EB/OL]. (2012-11-01 ) [2011-11-01 ]. http://www.fda.gov/downloads/Ab outFDA/ReportsManualsForms/Reports/UCM278358.pdf.
  • 6USA FDA. In Vitro Companion Diagnostic Devices [EB/OL]. (2011-07-01 ) [2011-07-01 ]. http://www.fda.gov/downloads/Me dicalDevices/DeviceRegulationandGuidance/GuidanceDocum- ents/UCM262327.pdf.

同被引文献53

  • 1Aletti R,Cheng-Lai A.Linagliptin: The newest dipeptidyl peptidase-4 inhibitor for type 2 diabetes mellitus[J].Cardiol Rev,2012,20(1):45-51.
  • 2Drucker D,Easley C,Kirkpatrick P.Sitagliptin[J].Nat Rev Drug Discov,2007,6(2):109-110.
  • 3He YL,Sabo R,Campestrini J,et al.The influence of hepatic impairment on the pharmacokinetics of the dipeptidyl peptidase Ⅳ (DPP-4) inhibitor vildagliptin[J].Eur J Clin Pharmacol,2007,63(7):677-686.
  • 4Fura A,Khanna A,Vyas V,et al.Pharmacokinetics of the dipeptidyl peptidase 4 inhibitor saxagliptin in rats,dogs,and monkeys and clinical projections[J].Drug Metab Dispos,2009,37(6):1164-1171.
  • 5Cho TP,Gang LZ,Long YF,et al.Synthesis and biological evaluation of bicyclo[3.3.0]octane derivatives as dipeptidyl peptidase 4 inhibitors for the treatment of type 2 diabetes[J].Bioorg Med Chem Lett,2010,20(12):3521-3525.
  • 6Deacon CF,Holst JJ.Linagliptin,a xanthine-based dipeptidyl peptidase-4 inhibitor with an unusual profile for the treatment of type 2 diabetes[J].Expert Opin Invest Drugs,2010,19(1):135-136.
  • 7Cornell S.Differentiating among incretin therapies: a multiple-target approach to type 2 diabetes[J].J Clin Pharm Ther,2012,37(5):510-524.
  • 8Thomas L,Eckhardt M,Langkopf E,et al.(R)-8-(3-aminopiperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methylquinazolin-2-yl methyl)-3,7-dihydropurine-2,6-d-done(BI 1356),a novel xanthine-based dipeptidyl peptidase 4 inhibitor,has a superior potency and longer duration of action compared with other dipeptidyl peptidase-4 inhibitors[J].J Pharmacol Exp Ther,2008,325(1):175-182.
  • 9Greischel A,Binder R,Baierl J.The dipeptidyl peptidase-4 inhibitor linagliptin exhibits time- and dose-dependent localization in kidney,liver,and intestine after intravenous dosing: results from high resolution autoradiography in rats[J].Drug Metab Dispos,2010,38(9):1443-1448.
  • 10Forst T,Uhlig-Laske B,Ring A,et al.The oral DPP-4 inhibitor linagliptin significantly lowers HbA1c after 4 weeks of treatment in patients with type 2 diabetes mellitus[J].Diabetes Obes Metab,2011,13(6):542-550.

引证文献6

二级引证文献42

国际药学研究杂志
2012年 第1期

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