The application of allometric scaling principles to predict pharmacokinetic parameters across species

Bibliography

• Huxley JS, Tessier G. Terminology of relative growth. Nature 1936;137:780-1
   Google Scholar
• Mahmood I. Interspecies pharmacokinetic scaling: principles and application of allometric scaling. Pine House Publishers, Rockville, MD; 2005
   Google Scholar
• Sarrus F, Rameaux JF. Mathématique appliquée à la physiologie. Bull Acad R Méd 1839;3:1094-100
   Google Scholar
• Benedict FG. Vital energetics: a study in comparative basal metabolism. Carnegie Institute of Washington, Washington DC; 1938
   Google Scholar
• Kleiber M. The fire of life:an introduction to animal energetics. Wiley, New York, NY; 1961
   Google Scholar
• Boxenbaum H. Interspecies scaling, allometry, physiological time, and the ground plan of pharmacokinetics. J Pharmacokinet Biopharm 1982;10:201-27
   PubMedGoogle Scholar
• USFDA. Guidance for industry: estimating the maximum safe starting dose in adult healthy volunteer. USFDA, Rockville, MD; 2005
   Google Scholar
• Freireich EJ, Gehan EA, Rall DP, et al. Quantitative comparison of toxicity of anticancer agents in mouse, rat, hamster, dog, monkey, and man. Cancer Chemother Rep 1966;50:219-44
   PubMedGoogle Scholar
• Mahmood I. Interspecies scaling: predicting clearance of anticancer drugs in humans. A comparative study of three different approaches using body weight or body surface area. Eur J Drug Metab Pharmacokinet 1996;21:275-8
   PubMed Web of Science ®Google Scholar
• Felici A, Verweij J, Sparreboom A. Dosing strategies for anticancer drugs: the good, the bad and body-surface area. Eur J Cancer 2002;38:1677-84
   PubMed Web of Science ®Google Scholar
• Boxenbaum H, DiLea C. First-time-in-human dose selection: allometric thoughts and perspectives. J Clin Pharmacol 1995;35:957-66
   PubMed Web of Science ®Google Scholar
• Hunter RP. Interspecies allometric scaling. Handb Exp Pharmacol 2010;199:139-57
   PubMedGoogle Scholar
• Martinez M, Mahmood I, Hunter RP. Interspecies allometric scaling: prediction of clearance in large animal species: part II: mathematical considerations. J Vet Pharmacol Ther 2006;29:425-32
   PubMed Web of Science ®Google Scholar
• Calder WA III. Scaling of physiological processes in homeothermic animals. Annu Rev Physiol 1981;43:301-22
   PubMed Web of Science ®Google Scholar
• Rogge M, Taft D. Preclinical drug development. 2nd edition. CRC Press, New York, NY; 2009
   Google Scholar
• Tang H, Mayersohn M. Accuracy of allometrically predicted pharmacokinetic parameters in humans: role of species selection. Drug Metab Dispos 2005;33:1288-93
   PubMed Web of Science ®Google Scholar
• Huh Y, Smith DE, Feng MR. Interspecies scaling and prediction of human clearance: comparison of small- and macro-molecule drugs. Xenobiotica 2011;41:972-87
   PubMed Web of Science ®Google Scholar
• Mahmood I, Balian JD. Interspecies scaling: predicting pharmacokinetic parameters of antiepileptic drugs in humans from animals with special emphasis on clearance. J Pharm Sci 1996;85:411-14
   PubMed Web of Science ®Google Scholar
• Ward KW, Azzarano LM, Bondinell WE, et al. Preclinical pharmacokinetics and interspecies scaling of a novel vitronectin receptor antagonist. Drug Metab Dispos 1999;27:1232-41
   PubMed Web of Science ®Google Scholar
• Mahmood I, Sahajwalla C. Interspecies scaling of biliary excreted drugs. J Pharm Sci 2002;91:1908-14
   PubMed Web of Science ®Google Scholar
• Mahmood I, Balian JD. Interspecies scaling: predicting clearance of drugs in humans. Three different approaches. Xenobiotica 1996;26:887-95
   PubMed Web of Science ®Google Scholar
• Mahmood I, Martinez M, Hunter RP. Interspecies allometric scaling. Part I: prediction of clearance in large animals. J Vet Pharmacol Ther 2006;29:415-23
   PubMed Web of Science ®Google Scholar
• Mahmood I. The correction factors do help in improving the prediction of human clearance from animal data. J Pharm Sci 2005;94:940-5
   PubMed Web of Science ®Google Scholar
• Mahmood I. Role of fixed coefficients and exponents in the prediction of human drug clearance: how accurate are the predictions from one or two species? J Pharm Sci 2009;98:2472-93
   PubMed Web of Science ®Google Scholar
• Ward KW, Smith BR. A comprehensive quantitative and qualitative evaluation of extrapolation of intravenous pharmacokinetic parameters from rat, dog, and monkey to humans. I. Clearance. Drug Metab Dispos 2004;32:603-11
   PubMed Web of Science ®Google Scholar
• Nagilla R, Ward KW. A comprehensive analysis of the role of correction factors in the allometric predictivity of clearance from rat, dog, and monkey to humans. J Pharm Sci 2004;93:2522-34
   PubMed Web of Science ®Google Scholar
• Mahmood I. The correction factors do help in improving the prediction of human clearance from animal data. J Pharm Sci 2005;94:940-5
   PubMed Web of Science ®Google Scholar
• Wajima T, Fukumura K, Yano Y, et al. Prediction of human clearance from animal data and molecular structural parameters using multivariate regression analysis. J Pharm Sci 2002;91:2489-99
   PubMed Web of Science ®Google Scholar
• Riond JL, Riviere JE. Allometric analysis of doxycycline pharmacokinetic parameters. J Vet Pharmacol Ther 1990;13:404-7
   PubMed Web of Science ®Google Scholar
• Obach RS, Baxter JG, Liston TE, et al. The prediction of human pharmacokinetic parameters from preclinical and in vitro metabolism data. J Pharmacol Exp Ther 1997;283:46-58
   PubMed Web of Science ®Google Scholar
• Björkman S, Redke F. Clearance of fentanyl, alfentanil, methohexitone, thiopentone and ketamine in relation to estimated hepatic blood flow in several animal species: application to prediction of clearance in man. J Pharm Pharmacol 2000;52:1065-74
   PubMed Web of Science ®Google Scholar
• Mahmood I. Interspecies scaling: role of protein binding in the prediction of clearance from animals to humans. J Clin Pharmacol 2000;40:1439-46
   PubMed Web of Science ®Google Scholar
• Lave T, Dupin S, Schmitt C, et al. Integration of in vitro data into allometric scaling to predict hepatic metabolic clearance in man: application to 10 extensively metabolized drugs. J Pharm Sci 1997;86:584-90
   PubMed Web of Science ®Google Scholar
• Lave T, Coassolo P, Reigner B. Prediction of hepatic metabolic clearance based on interspecies allometric scaling techniques and in vitro-in vivo correlations. Clin Pharmacokinet 1999;36:211-31
   PubMed Web of Science ®Google Scholar
• Mahmood I. Integration of in vitro data and brain weight in allometric scaling to predict clearance in humans: some suggestions. J Pharm Sci 1998;87:527-9
   PubMed Web of Science ®Google Scholar
• Dedrick R, Bischoff KB, Zaharko DS. Interspecies correlation of plasma concentration history of methotrexate (NSC-740). Cancer Chemother Rep 1970;54:95-101
   PubMedGoogle Scholar
• Martín-Jiménez T, Riviere JE. Mixed effects modeling of the disposition of gentamicin across domestic animal species. J Vet Pharmacol Ther 2001;24:321-32
   PubMed Web of Science ®Google Scholar
• Martín-Jiménez T, Riviere JE. Mixed-effects modeling of the interspecies pharmacokinetic scaling of oxytetracycline. J Pharm Sci 2002;91:331-41
   PubMed Web of Science ®Google Scholar
• Calder WA. Size, function, and life history. Harvard University Press, Cambridge, MA; 1984. p. 36-1
   Google Scholar
• Mahmood I, Boxenbaum H. Vertical allometry: fact or fiction? Regul Toxicol Pharmacol 2014;68:468-74
   PubMed Web of Science ®Google Scholar
• Tang H, Mayersohn M. A novel model for prediction of human drug clearance by allometric scaling. Drug Metab Dispos 2005;33:1297-303
   PubMed Web of Science ®Google Scholar
• Tang H, Mayersohn M. On the observed large interspecies overprediction of human clearance ("vertical allometry") of UCN-01: further support for a proposed model based on plasma protein binding. J Clin Pharmacol 2006;46:398-400
   PubMed Web of Science ®Google Scholar
• Tang H, Mayersohn M. A global examination of allometric scaling for predicting human drug clearance and the prediction of large vertical allometry. J Pharm Sci 2006;95:1783-99
   PubMed Web of Science ®Google Scholar
• Mahmood I. Application of allometric principles for the prediction of pharmacokinetics in human and veterinary drug development. Adv Drug Deliv Rev 2007;59:1177-92
   PubMed Web of Science ®Google Scholar
• Mahmood I. Interspecies scaling: predicting volumes, mean residence time and elimination half-life. Some suggestions. J Pharm Pharmacol 1998;50:493-9
   PubMed Web of Science ®Google Scholar
• Obach RS, Baxter JG, Liston TE, et al. The prediction of human pharmacokinetic parameters from preclinical and in vitro metabolism data. J Pharmacol Exp Ther 1997;283:46-58
   PubMed Web of Science ®Google Scholar
• Mahmood I. Application of allometric principles for the prediction of pharmacokinetics in human and veterinary drug development. Adv Drug Deliv Rev 2007;59:1177-92
   PubMed Web of Science ®Google Scholar
• Callan WM, Sunderman FW Jr. Species variations in binding of 63 NI(II) by serum albumin. Res Commun Chem Pathol Pharmacol 1973;5:459-72
   PubMedGoogle Scholar
• Berry LM, Li C, Zhao Z. Species differences in distribution and prediction of human V(ss) from preclinical data. Drug Metab Dispos 2011;39:2103-16
   PubMed Web of Science ®Google Scholar
• Testa B. Advances in drug research. (Volume 20), Academic Press, San Diego, CA; 1991
   Google Scholar
• Sawada Y, Hanano M, Sugiyama Y, et al. Prediction of the disposition of beta-lactam antibiotics in humans from pharmacokinetic parameters in animals. J Pharmacokinet Biopharm 1984;12:241-61
   PubMedGoogle Scholar
• Bachmann K, Pardoe D, White D. Scaling basic toxicokinetic parameters from rat to man. Environ Health Perspect 1996;104:400-7
   PubMed Web of Science ®Google Scholar
• Mahmood I. Allometric issues in drug development. J Pharm Sci 1999;88:1101-6
   PubMed Web of Science ®Google Scholar
• Riviere J. Comparative pharmacokinetics: principles, techniques, and applications. 2nd edition. Willey-Blackwell Publishers, West Sussex, UK; 2011
   Google Scholar
• Lin JH. Applications and limitations of interspecies scaling and in vitro extrapolation in pharmacokinetics. Drug Metab Dispos 1998;26:1202-12
   PubMed Web of Science ®Google Scholar
• Feng MR, Lou X, Brown RR, et al. Allometric pharmacokinetic scaling: towards the prediction of human oral pharmacokinetics. Pharm Res 2000;17:410-18
   PubMed Web of Science ®Google Scholar
• Gibaldi M. Drug disposition-elimination: biopharmaceutics and clinical pharmacokinetics. Lea and Febiger, Rockville, MD; 2005
   Google Scholar
• Ho RH, Kim RB. Transporters and drug therapy: implications for drug disposition and disease. Clin Pharmacol Ther 2005;78:260-77
   PubMed Web of Science ®Google Scholar
• Riviere JE. Of mice, men and nanoparticle biocoronas: are in vitro to in vivo correlations and interspecies extrapolations realistic? Nanomedicine (Lond) 2013;8:1357-9
   PubMed Web of Science ®Google Scholar
• Sahneh FD, Scoglio CM, Monteiro-Riviere NA, et al. Predicting the impact of biocorona formation kinetics on interspecies extrapolations of nanoparticle biodistribution modeling. Nanomedicine (Lond) 2014; In press
   PubMed Web of Science ®Google Scholar
• Riviere JE, Martin-Jimenez T, Sundlof SF, et al. Interspecies allometric analysis of the comparative pharmacokinetics of 44 drugs across veterinary and laboratory animal species. J Vet Pharmacol Ther 1997;20:453-63
   PubMed Web of Science ®Google Scholar
• Huang Q, Gehring R, Tell LA, et al. Interspecies allometric meta-analysis of the comparative pharmacokinetics of 85 drugs across veterinary and laboratory animal species. J Vet Pharmacol Therap 2014; Submitted
   Web of Science ®Google Scholar
• Hunter RP, Isaza R. Concepts and issues with interspecies scaling in zoological pharmacology. J Zoo Wildl Med 2008;39:517-26
   PubMed Web of Science ®Google Scholar
• Hunter RP, Isaza R, Koch DE. Oral bioavailability and pharmacokinetic characteristics of ketoprofen enantiomers after oral and intravenous administration in Asian elephants (Elephasmaximus). Am J Vet Res 2003;64:109-14
   PubMed Web of Science ®Google Scholar
• Bonate PL, Howard D. Prospective allometric scaling: does the emperor have clothes? J Clin Pharmacol 2000;40:665-70
   PubMedGoogle Scholar
• Sharma V, McNeill JH. To scale or not to scale: the principles of dose extrapolation. Br J Pharmacol 2009;157:907-21
   PubMed Web of Science ®Google Scholar
• Mahmood I. Critique of prospective allometric scaling: does the emperor have clothes? J Clin Pharmacol 2000;40:671-4
   Google Scholar