[1] Buoen C, Bjerrum OJ, Thomsen MS. How first-time-in-human studies are being performed:a survey of phase Ⅰ dose-escalation trials in healthy volunteers published between 1995 and 2004[J].Clin Pharmacol,2005,45(10):1123-1126.
[2] ABPI. Guidelines for Phase Ⅰ Clinical Trials[EB/OL].http://www.abpi.org.uk/our-work/ library/guidelines/Pages/phase-1-trials.aspx
[3] Tanguay M.Phase i efficiency[EB/OL].http://www.samedanltd.com/magazine/13/issue/130 /article/2662
[4] Eypasch E, Lefering R, Kum C, et al. Probability of adverse events that have not yet occurred:a statistical[J].BMJ,1995,(311):619-620.
[5] FDA,Center for Drug Evaluation and Research (CDER).Guidance for industry: estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers[EB/OL].http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065014.htm.
[6] Expert scientific group on phase one clinical trials(ESG).Final report of the Expert Scientific Group [EB/OL].http://www.trialformsupport.com/business/doc/Final_Report_of_ the_Expert_Scientific_Group_(ESG).pdf
[7] EMEA,Cmmittee for Medicinal Products for Human Use(CHMP).Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products[EB/OL].http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002988.pdf
[8] ABPI/BIA.Early stage clinical trial taskforce[EB/OL].http://www.abpi.org.uk/information /pdfs/BIAABPI_taskforce2.pdf
[9] Lowe PJ, Hijazi Y, Luttringer O, et al. On the anticipation of the human dose in first-in-man trials from preclinical and prior clinical information in early drug development[J]. Xenobiotica, 2007,37(10/11):1331-1354.
[10]Mahmood I,Balian J.Interspecies scaling:Predicting clearance of drugs in humans.Three different approaches[J].Xenobiotica,1996,26(9):887-895.
[11]Mahmood I,Balian J.The pharmacokinetic principles behind scaling from preclinical results to phase I protocols[J].J Clin Pharmacol,1999,36(1):1-11.
[12]Obach R,Baxter J,Liston T, et al.The prediction of human pharmacokinetic parameters from preclinical and in vitro metabolism data[J]. J Pharmacol Exp Ther, 1997,283(1):46-58.
[13]Ito K, Houston J. Prediction of human drug clearance from in vitro and preclinical data using physiologically based and empirical approaches[J].Pharmacol Res,2005,22(1):103-112.
[14]Jones HM, Parrott N, Jorga K,et al.A novel strategy for physiologically based predictions of human pharmacokinetics[J].Clin Pharmacokinetics,2006,45(5):511-542.
[15]Hosea N, Collard W, Cole S, et al. Prediction of human pharmacokinetics from preclinical information: comparative accuracy of quantitative prediction approaches[J].J Clin Pharmacol,2009,49(5):513-533.
[16]Williams P,O'Connell D,Dewit O.First in human studies: points to consider in study placement, design and conduct[EB/OL].http://www.abpi.org.uk/our-work/library/guidelines/ Documents/First%20in%20Human%20Studies.pdf
[17]Sellers E,Souich P,Chapter 6.Phase Ⅰ studies (human pharmacology)[EB/OL].http://ww w.iuphar.org/pdf/hum_40.pdf
[18]汪秀琴,熊宁宁,刘芳,等.临床试验的风险评估与安全监察[J].中国新药,2005,14:520-523.
[19]MRC/DH joint project,Trial management and monitoring A) clinical trial risk assessment[EB/OL].http://www.ct-toolkit.ac.uk/_db/_documents/Trial_RA.pdf
[20]MRC/DH joint project,Trial management and monitoring A) clinical trial risk assessment[EB/OL].http://www.ct-toolkit.ac.uk/_db/_documents/Trial_RA.pdf |
