References
- Adolph EF. (1949). Quantitative relations in the physiological constitutions of mammals. Science 109:579–85
- Anderson BJ, Holford NH. (2008). Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol 48:303–32
- Boxenbaum H, DiLea C. (1995). First-time-in-human dose selection: allometric thoughts and perspectives. J Clin Pharmacol 35:957–66
- Dedrick RL. (1973). Animal scale-up. J Pharmacokinet Biopharm 1:435–61
- Gillooly JF, Brown JH, West GB, et al. (2001). Effects of size and temperature on metabolic rate. Science 293:2248–51
- Hallifax D, Foster JA, Houston JB. (2010). Prediction of human metabolic clearance from in vitro systems: retrospective analysis and prospective view. Pharm Res 27:2150–61
- Hosea NA, Collard WT, Cole S, et al. (2009). Prediction of human pharmacokinetics from preclinical information: comparative accuracy of quantitative prediction approaches. J Clin Pharmacol 49:513–33
- Lave T, Coassolo P, Reigner B. (1999). Prediction of hepatic metabolic clearance based on interspecies allometric scaling techniques and in vitro-in vivo correlations. Clin Pharmacokinet 36:211–31
- Lin JH. (1995). Species similarities and differences in pharmacokinetics. Drug Metab Dispos 23:1008–21
- Lombardo F, Obach RS, Varma MV, et al. (2014). Clearance mechanism assignment and total clearance prediction in human based upon in silico models. J Med Chem 57:4397–405
- Lombardo F, Waters NJ, Argikar UA, et al. (2013). Comprehensive assessment of human pharmacokinetic prediction based on in vivo animal pharmacokinetic data, part 2: clearance. J Clin Pharmacol 53:178–91
- Mahmood I. (1998). Interspecies scaling of renally secreted drugs. Life Sci 63:2365–71
- Mahmood I. (2000). Interspecies scaling: role of protein binding in the prediction of clearance from animals to humans. J Clin Pharmacol 40:1439–46
- Mahmood I. (2005). Interspecies scaling of biliary excreted drugs: a comparison of several methods. J Pharm Sci 94:883–92
- Mahmood I, Balian JD. (1996). Interspecies scaling: predicting pharmacokinetic parameters of antiepileptic drugs in humans from animals with special emphasis on clearance. J Pharm Sci 85:411
- Martignoni M, Groothuis GM, de Kanter R. (2006). Species differences between mouse, rat, dog, monkey and human CYP-mediated drug metabolism, inhibition and induction. Expert Opin Drug Metab Toxicol 2:875–94
- Mordenti J. (1986). Man versus beast: pharmacokinetic scaling in mammals. J Pharm Sci 75:1028–40
- Naritomi Y, Terashita S, Kimura S, et al. (2001). Prediction of human hepatic clearance from in vivo animal experiments and in vitro metabolic studies with liver microsomes from animals and humans. Drug Metab Dispos 29:1316–24
- Obach RS, Baxter JG, Liston TE, et al. (1997). The prediction of human pharmacokinetic parameters from preclinical and in vitro metabolism data. J Pharmacol Exp Ther 283:46–58
- Obach RS, Lombardo F, Waters NJ. (2008). Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds. Drug Metab Dispos 36:1385–405
- Ring BJ, Chien JY, Adkison KK, et al. (2011). PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 3: comparative assessement of prediction methods of human clearance. J Pharm Sci 100:4090–110
- Rowland M, Peck C, Tucker G. (2011). Physiologically-based pharmacokinetics in drug development and regulatory science. Annu Rev Pharmacol Toxicol 51:45–73
- Rowland M, Tozer TN. (1995) Clinical pharmacokinetics: concepts and applications. Philadelphia (PA): Lippincott Williams and Wilkins
- Sayama H, Komura H, Kogayu M. (2013). Application of hybrid approach based on empirical and physiological concept for predicting pharmacokinetics in humans-usefulness of exponent on prospective evaluation of predictability. Drug Metab Dispos 41:498–507
- Sharma V, McNeill JH. (2009). To scale or not to scale: the principles of dose extrapolation. Br J Pharmacol 157:907–21
- Tang H, Hussain A, Leal M, et al. (2007). Interspecies prediction of human drug clearance based on scaling data from one or two animal species. Drug Metab Dispos 35:1886–93
- Tang H, Mayersohn M. (2005). A novel model for prediction of human drug clearance by allometric scaling. Drug Metab Dispos 33:1297–303
- Tang H, Mayersohn M. (2006). A global examination of allometric scaling for predicting human drug clearance and the prediction of large vertical allometry. J Pharm Sci 95:1783–99
- Uno Y, Hosaka S, Matsuno K, et al. (2007). Characterization of cynomolgus monkey cytochrome P450 (CYP) cDNAs: is CYP2C76 the only monkey-specific CYP gene responsible for species differences in drug metabolism. Arch Biochem Biophys 466:98–105
- Varma MV, Steyn SJ, Allerton C, El-Kattan AF. (2015). Predicting clearance mechanism in drug discovery: extended clearance classification system (ECCS). Pharm Res 32:3785–802
- Ward KW, Smith BR. (2004). A comprehensive quantitative and qualitative evaluation of extrapolation of intravenous pharmacokinetic parameters from rat, dog, and monkey to humans. I. Clearance. Drug Metab Dispos 32:603–11
- Zou P, Yu Y, Zheng N, et al. (2012). Applications of human pharmacokinetic prediction in first-in-human dose estimation. Aaps J 14:262–81