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Original Research

Assessment of pharmacokinetic proportionality of levofloxacin and cyclosporine over a 100-fold dose range in healthy human volunteers

, MD, , MD, , MS, , MS, , MS, , MD PhD, , MD & , MD PhD show all
Pages 399-405 | Published online: 09 Mar 2012

Bibliography

  • Chien SC, Rogge MC, Gisclon LG, Pharmacokinetic profile of levofloxacin following once-daily 500-milligram oral or intravenous doses. Antimicrob Agents Chemother 1997;41(10):2256-60
  • Verho M, Malerczyk V, Dagrosa E, Korn A. Dose linearity and other pharmacokinetics of ofloxacin: a new, broad-spectrum antimicrobial agent. Pharmatherapeutica 1985;4(6):376-82
  • Chow AT, Fowler C, Williams RR, Safety and pharmacokinetics of multiple 750-milligram doses of intravenous levofloxacin in healthy volunteers. Antimicrob Agents Chemother 2001;45(7):2122-5
  • Chien SC, Wong FA, Fowler CL, Double-blind evaluation of the safety and pharmacokinetics of multiple oral once-daily 750-milligram and 1-gram doses of levofloxacin in healthy volunteers. Antimicrob Agents Chemother 1998;42(4):885-8
  • Ptachcinski RJ, Venkataramanan R, Burckart GJ. Clinical pharmacokinetics of cyclosporin. Clin Pharmacokinet 1986;11(2):107-32
  • Mueller EA, Kovarik JM, van Bree JB, Improved dose linearity of cyclosporine pharmacokinetics from a microemulsion formulation. Pharm Res 1994;11(2):301-4
  • Anglicheau D, Legendre C, Beaune P, Thervet E. Cytochrome P450 3A polymorphisms and immunosuppressive drugs: an update. Pharmacogenomics 2007;8(7):835-49
  • EMEA, Position Paper on non-clinical safety studies to support clinical trials with a single microdose. Position paper CPMP/SWP/2599, 23 June 2004
  • Food and Drug Administration US Department of Health and Human Services, Guidance for Industry Investigators and Reviewers. Exploratory IND Studies, MD, USA; 2006
  • Lappin G, Kuhnz W, Jochemsen R, Use of microdosing to predict pharmacokinetics at the therapeutic dose: experience with 5 drugs. Clin Pharmacol Ther 2006;80(3):203-15
  • Lappin G, Garner R C. The utility of microdosing over the past 5 years. Expert Opin Drug Metab Toxicol 2008;4(12):1499-506
  • Lappin G, Garner RC. Big physics, small doses: the use of AMS and PET in human microdosing of development drugs. Nat Rev Drug Discov 2003;2(3):233-40
  • Balani SK, Nagaraja NV, Qian MG, Evaluation of microdosing to assess pharmacokinetic linearity in rats using liquid chromatography-tandem mass spectrometry. Drug Metab Dispos 2006;34(3):384-8
  • Ni J, Ouyang H, Aiello M, Microdosing assessment to evaluate pharmacokinetics and drug metabolism in rats using liquid chromatography-tandem mass spectrometry. Pharm Res 2008;25(7):1572-82
  • Sandhu P, Vogel JS, Rose MJ, Evaluation of microdosing strategies for studies in preclinical drug development: demonstration of linear pharmacokinetics in dogs of a nucleoside analog over a 50-fold dose range. Drug Metab Dispos 2004;32(11):1254-9
  • Vuong LT, Ruckle JL, Blood AB, Use of accelerator mass spectrometry to measure the pharmacokinetics and peripheral blood mononuclear cell concentrations of zidovudine. J Pharm Sci 2007;97(7):2833-43
  • Yamane N, Tozuka Z, Sugiyama Y, Microdose clinical trial: quantitative determination of fexofenadine in human plasma using liquid chromatography/electrospray ionization tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2007;58(1-2):118-28
  • Madan A, O'Brien Z, Wen J, A pharmacokinetic evaluation of five H1 antagonists after an oral and intravenous microdose to human subjects. Br J Clin Pharmacol 2009;67(3):288-98
  • Bertino JS Jr, Greenberg HE, Reed MD. American college of clinical pharmacology position statement on the use of microdosing in the drug development process. J Clin Pharmacol 2007;47(4):418-22
  • Rowland M. Commentary on ACCP position statement on the use of microdosing in the drug development process. J Clin Pharmacol 2007;47(12):1595-6; author reply 1597-8

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