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Review

Misconceptions and issues regarding allometric scaling during the drug development process

Pages 843-854 | Received 02 Mar 2018, Accepted 09 Jul 2018, Published online: 19 Jul 2018

References

  • Schmidt-Nielsen K. Scaling: the size of living things. In: Why is animal size so important? Cambridge: Cambridge University Press. 1984. p. 1–6.
  • Lindstedt SL, Schaeffer PJ. Use of allometry in predicting anatomical and physiological parameters of mammals. Lab Animals. 2002;36:1–19.
  • Chappell WR, Mordenti J. Extrapolation of toxicological and pharmacological data from animals to humans. Adv Drug Res. 1991;20:1–116.
  • Huxley JS, Teissier G. Terminology of relative growth. Nature. 1936;137:780–781.
  • Huxley JS, Teissier G. Terminologie et notation dans la description de la croissance relative. Comptes Rendus Se´Ances Soc. Biol. Fil. 1936;121:934–937.
  • Mcmohan TA, Bonner JT. Proportions and size. In: On size and life. Scientific American Library. New York; 1983. p. 25–67.
  • Gould JS. Allometry and size in ontogeny and phylogeny. Biol Rev Camb Philos Soc. 1966;41:587–640.
  • Chappell WR, Mordenti J. The use of interspecies scaling in toxicokinetics. In: Yacobi A, Skelly JP, Batra VK, editors. Toxicokinetics and new drug development. New York, NY: Pergamon Press; 1989.
  • Gayon J. History of the concept of allometry. Amer Zool. 2000;40:748–758.
  • Kleiber M. Body size and metabolism. Hilgardia. 1932;6:315–353.
  • Kleiber M. Body size and metabolic rate. Physiological Rev. 1947;4:511–541.
  • Brody S, Procter RC, Ashworth US. Basal metabolism, endogenous nitrogen, creatinine and neutral sulphur excretions as functions of body weight. Univ Missouri Agric Exp Sta Res Bull. 1934;220:1–40.
  • Brody S. Bioenergetics and growth, with special reference to the efficiency complex in domestic animals. London: Hafner Press, New York, and MacMillan Publishers; 1945.
  • Weibel ER, Hoppeler H. Exercise-induced maximal metabolic rate scales with muscle aerobic capacity. J Exp Biol. 2005;208(Pt 9):1635–1644.
  • DeLong JP, Okie JG, Moses ME, et al. Shifts in metabolic scaling, production, and efficiency across major evolutionary transitions of life. Proc Natl Acad Sci U S A. 2010;107:12941–12945.
  • Snelling EP, Seymour RS, Matthews PG, et al. Scaling of resting and maximum hopping metabolic rate throughout the life cycle of the locust locusta migratoria. J Exp Biol. 2011;214:3218–3224.
  • West GB, Brown JH, Enquist BJ. A general model for the origin of allometric scaling laws in biology. Science. 1997;276:122–126.
  • West GB, Brown JH, Enquist BJ. The fourth dimension of life: fractal geometry and allometric scaling of organisms. Science. 1999;284:1677–1679.
  • Kozłowski J, Konarzewski M. Is West, Brown and Enquist’s model of allometric scaling mathematically correct and biologically relevant? Functional Ecology. 2004;18:283–289.
  • Kozłowski J, Konarzewski M. West, Brown and Enquist’s model of allometric scaling again: the same questions remain. Functional Ecology. 2005;19:739–743.
  • Glazier DS. Metabolic scaling in complex living systems. Systems. 2014;2:451–540.
  • Painter PR. The fractal geometry of nutrient exchange surfaces does not provide an explanation for 3/4-power metabolic scaling. Theor Biol Med Model. 2005;2:30.
  • Chaui-Berlinck JG. A critical understanding of the fractal model of metabolic scaling. J Exp Biol. 2006;209:3045–3054.
  • Beuchat CA. Allometric scaling laws in biology. Science. 1997 Oct 17;278(5337):371.
  • Author reply. Science. 1997 Oct 17;278(5337):372–373.
  • Petit G, Anfodillo T. Plant physiology in theory and practice: an analysis of the WBE model for vascular plants. J Theor Biol. 2009;259:1–4.
  • Bejan A. The constructal law of organization in nature: tree-shaped flows and body size. J Exp Biol. 2005;208:1677–1686.
  • Bokma F. Evidence against universal metabolic allometry. Func Ecology. 2004;18:184–187.
  • Dodds PS, Rothman DH, Weitz JS. Re-examination of the “3/4-law” of metabolism. J Theor Biol. 2001;209:9–27.
  • Glazier DS. Beyond the ‘3/4-power law’: variation in the intra- and interspecific scaling of metabolic rate in animals. Biol Rev Camb Philos Soc. 2005;80:611–662.
  • White CR, Cassey P, Blackburn TM. Allometric exponents do not support a universal metabolic allometry. Ecology. 2007;88:315–323.
  • Packard GC, Birchard GF. Traditional allometric analysis fails to provide a valid predictive model for mammalian metabolic rates. J Exp Biol. 2008;211(Pt 22):3581–3587.
  • Mahmood I. Theoretical versus empirical allometry: facts behind theories and application to pharmacokinetics. J Pharm Sci. 2010;99:2927–2933.
  • West D, West BJ. Physiologic time: a hypothesis. Phys Life Rev. 2013;10:210–224.
  • Bentley LP, Stegen JC, Savage VM, et al. An empirical assessment of tree branching networks and implications for plant allometric scaling models. Ecol Lett. 2013;16:1069–1078.
  • Duncan RP, Forsyth DM, Hone J. Testing the metabolic theory of ecology: allometric scaling exponents in mammals. Ecology. 2007;88:324–333.
  • Capellini I, Venditti C, Barton RA. Phylogeny and metabolic scaling in mammals. Ecology. 2010;91:2783–2793.
  • White CR, Seymour RS. Sample size and mass range effects on the allometric exponent of basal metabolic rate. Comp Biochem Physiol A Mol Integr Physiol. 2005;142:74–78.
  • Heusner AA. Energy metabolism and body size I. Is the 0.75 Mass Exponent of Kleiber’s Equation a Statistical Artifact? Resp Physiol. 1982;48:13–25.
  • Feldman HA, McMahon TA. The ¾ mass exponent for energy metabolism is not a statistical artifact? Resp Physiol. 1983;52:149–163.
  • Heusner AA. Body mass, maintenance and basal metabolism in dogs. J Nutr. 1991;121(11 Suppl):S8–17.
  • Hayssen V, Lacy RC. Basal metabolic rates in mammals: toxonomic differences in the allometry of BMR and body mass. Comp Biochem Physiol. 1985;81A:741–754.
  • Ritschel WA, Banerjee PS. Physiological pharmacokinetic models: principles, applications, limitations and outlook. Meth and Find Exptl Clin Pharmacol. 1986;8:603–614.
  • Stahl WR. Scaling of respiratory variables in mammals. Science. 1967;150:1039–1042.
  • Savage VM, Gillooly JF, Woodruff WH, et al. The predominance of quarter-power scaling in biology. Funct Ecol. 2004;18:257–282.
  • Savage VM, Deeds EJ, Fontana W. Sizing up allometric scaling theory. PLos Comput Biol. 2008;4:e1000171.
  • Shargel L, Abc YU. Introduction to pharmacokinetics. In: Applied biopharmaceutics and Pharmacokinetics. Norwalk, CT: Appleton & Lange; p. 1993.
  • Mahmood I. Interspecies scaling of clearance. In: Interspecies Pharmacokinetic scaling: principles and application of allometric scaling.Rockville, MD: Pine House Publishers; p. 2005.
  • Dedrick RL, Bischoff KB, Zahrako DZ. Interspecies correlation of plasma concentration history of methotrexate (NSC-740). Cancer Chemother Rep Part I. 1970;54:95–101.
  • Boxenbaum H. Interspecies scaling, allometry, physiological time and the ground plan of pharmacokinetics. J Pharmacokin Biopharm. 1982;10:201–227.
  • Boxenbaum H. Interspecies pharmacokinetic scaling and the evolutionary-comparative paradigm. Drug Metab Rev. 1984;15(5 & 6):1071–1121.
  • Boxenbaum H. Time concepts in physics, biology, and pharmacokinetics. J Pharm Sci. 1986;75:1053–1062.
  • Boxenbaum H, Fertig JB. Scaling of camptothecin plasma protein binding in 24 species. Biopharm Drug Dispos. 1984;5:405–408.
  • Boxenbaum H, Fertig JB. Scaling of antipyrine intrinsic clearance of unbound drug in 15 mammalian species. Eur J Drug Metab Pharmacokinet. 1984;9:177–183.
  • Boxenbaum H, Ronfeld R. Interspecies pharmacokinetic scaling and the Dedrick plots. Am J Physiol. 1983;245:R768–75.
  • Boxenbaum H, DiLea C. First-time-in-human dose selection: allometric thoughts and perspectives. J Clin Pharmacol. 1995;35:957–966.
  • Mahmood I, Balian JD. Interspecies scaling: predicting clearance of drugs in humans. Three Different Approaches. Xenobiotica. 1996;26:887–895.
  • Mahmood I. Interspecies scaling of renally secreted drugs. Life Sci. 1998;63:2365–2371.
  • Mahmood I. Interspecies scaling of biliary excreted drugs: a comparison of several methods. J Pharm Sci. 2005;94:883–892.
  • 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;91:2489–2499.
  • 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;86:584–590.
  • Mahmood I. Integration of in vitro data and brain weight in allometric scaling to predict clearance in humans: some suggestions. J Pharm Sci. 1998;87:527–529.
  • 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.
  • Mahmood I. In-vitro drug metabolism and allometric scaling. In: Interspecies Pharmacokinetic scaling: principles and application of allometric scaling. Rockville, MD: Pine House Publishers; p. 2005.
  • Shiran MR, Proctor NJ, Howgate EM, et al. Prediction of metabolic drug clearance in humans: in vitro-in vivo extrapolation vs allometric scaling. Xenobiotica. 2006;36:567–580.
  • Tang H, Mayersohn M. A novel model for prediction of human drug clearance by allometric scaling. Drug Metab Dispos. 2005;33:1297–1303.
  • Mahmood I. Prediction of human drug clearance from animal data: application of the rule of exponents and ‘Fu Corrected Intercept Method’ (FCIM). J Pharm Sci. 2006;95:1810–1821.
  • Goteti K, Garner CE, Mahmood I. Prediction of human drug clearance from two species: a comparison of several allometric methods. J Pharm Sci. 2010;99:1601–1613.
  • Goteti K, Brassil PJ, Good SS, et al. Estimation of human drug clearance using multiexponential techniques. J Clin Pharmacol. 2008;48:1226–1236.
  • Gibaldi M, Perrier D. Apparent volume of distribution. In: Pharmacokinetics. 2ndedition ed. New York, NY: Marcel Dekker; 1982. p. 199–219.
  • Ochs HR, Greenblatt DJ, Bodem G. Single- and multiple-dose kinetics of intravenous digoxin. Clin Pharmacol Ther. 1980;28:340–345.
  • McAllister RG Jr, Kirsten EB. The pharmacology of verapamil. IV. Kinetic and dynamic effects after single intravenous and oral doses. Clin Pharmacol Ther. 1982;31:418–426.
  • Wise R, Lockley RM, Webberly M, et al. Pharmacokinetics of intravenously administered ciprofloxacin. Antimicrob Agents Chemother. 1984;26:208–210.
  • Prothero JW. Scaling of blood parameters in mammals. Comp Biochem Physiol. 1980;67A:649–657.
  • Mahmood I. Interspecies scaling of volumes of distribution. In: Interspecies Pharmacokinetic scaling. principles and application of allometric scaling. Rockville, MD: Pine House Publishers; 2005. p. 188–205.
  • Mahmood I. Interspecies scaling of elimination half-life and mean residence time. In: Interspecies Pharmacokinetic scaling. Principles and application of allometric scaling. Rockville, MD: Pine House Publishers; 2005. p. 206–218.
  • Mahmood I. Prediction of drug clearance in preterm and term neonates: different exponents for different age groups?. In: Pharmacokinetic allometric scaling in pediatric drug development. Rockville: Pine House Publishers; 2013. p. 88–100.
  • Mahmood I. Prediction of volume of distribution and half-life in pediatrics. In: Pharmacokinetic allometric scaling in pediatric drug development. Rockville: Pine House Publishers; 2013. p. 101–120.
  • Mahmood I. Prediction of clearance, volume of distribution, and half-life of drugs in extremely low to low birth weight neonates: an allometric approach. Eur J Drug Metab Pharmacokinet. 2017;42:601–610.
  • Mahmood I. Prediction of drug clearance in children from adults: a comparison of several allometric methods. Br J Clin Pharmacol. 2006;61:545–557.
  • Mahmood I. Prediction of drug clearance in children: impact of allometric exponents, body weight and age. Therap Drug Monitor. 2007;29:271–278.
  • Mahmood I. Prediction of drug clearance in premature and mature neonates, infants, and children ≤2 years of age: a comparison of the predictive performance of 4 allometric models. J Clin Pharmacol. 2016;56:733–739.
  • Calvier EA, Krekels EH, Välitalo PA. Allometric scaling of clearance in paediatric patients: when does the magic of 0.75 Fade? Clin Pharmacokinet. 2017;56:273–285.
  • Mahmood I, Staschen CM, Goteti K. Prediction of drug clearance in children: an evaluation of the predictive performance of several models. AAPS J. 2014;16:1334–1343.
  • Wang C, Peeters MY, Allegaert K, et al. A bodyweight-dependent allometric exponent for scaling clearance across the human life-span. Pharm Res. 2012;29:1570–1581.
  • Wang C, Allegaert K, Peeters MY, et al. The allometric exponent for scaling clearance varies with age: a study on seven propofol datasets ranging from preterm neonates to adults. Br J Clin Pharmacol. 2014;77:149–159.
  • Bartelink IH, Boelens JJ, Bredius RG, et al. Body weight-dependent pharmacokinetics of busulfan in paediatric haematopoietic stem cell transplantation patients: towards individualized dosing. Clin Pharmacokinet. 2012;51:331–345.
  • Wang C, Sadhavisvam S, Krekels EH, et al. Developmental changes in morphine clearance across the entire paediatric age range are best described by a bodyweight-dependent exponent model. Clin Drug Investig. 2013;33:523–534.
  • Staschen CM, Mahmood I. A population pharmacokinetic model of remifentanil in pediatric patients using body-weight-dependent allometric exponents. Drug Metabol Drug Interact. 2013;28:231–237.
  • Mahmood I, Staschen CM. Prediction of human glomerular filtration rate from preterm neonates to adults: evaluation of predictive performance of several empirical models. AAPS J. 2016;18:445–454.
  • Mahmood I, Tegenge MA. Population pharmacokinetics: some observations in pediatric modeling for drug clearance. Clin Pharmacokinet. 2017;56:1567–1576.
  • Edginton AN, Shah B, Sevestre M, et al. The integration of allometry and virtual populations to predict clearance and clearance variability in pediatric populations over the age of 6 years. Clin Pharmacokinet. 2013;52:693–703.
  • Momper JD, Mulugeta Y, Green DJ, et al. Adolescent dosing and labeling since the food and drug administration amendments act of 2007. JAMA Pediatr. 2013;167:926–932.
  • Wieser W. A distinction must be made between the ontogeny and the phylogeny of metabolism in order to understand the mass exponent of energy metabolism. Respiratory Physiology. 1984;55:1–9.
  • Anand KJ, Anderson BJ, Holford NH, et al. NEOPAIN trial investigators group. Morphine pharmacokinetics and pharmacodynamics in preterm and term neonates: secondary results from the NEOPAIN trial. Br J Anaesth. 2008;101:680–689.
  • Mahmood I. Evaluation of a morphine maturation model for the prediction of morphine clearance in children: how accurate is the predictive performance of the model? Br J Clin Pharmacol. 2011;71:88–94.
  • Mahmood I. Response to the comments of professors Anderson & Holford. Br J Clin Pharmacol. 2011;72:521–523.
  • Mahmood I. Evaluation of sigmoidal maturation and allometric models: prediction of propofol clearance in neonates and infants. Am J Ther. 2013;20:21–28.
  • Rhodin MM, Anderson BJ, Peters AM, et al. Human renal function maturation: a quantitative description using weight and postmenstrual age. Pediatr Nephrol. 2009;24:67–76.
  • Holford NH, Ma SC, Anderson BJ. Prediction of morphine dose in humans. Paediatr Anaesth. 2012;22:209–222.
  • Eleveld DJ, Proost JH, Cortínez LI, et al. A general purpose pharmacokinetic model for propofol. Anesth Analg. 2014;118:1221–1237.
  • McCune JS, Bemer MJ, Barrett JS, et al. Busulfan in infant to adult hematopoietic cell transplant recipients: a population pharmacokinetic model for initial and bayesian dose personalization. Clin Cancer Res. 2014;20:754–763.
  • Diestelhorst C, Boos J, McCune JS, et al. Population pharmacokinetics of intravenous busulfan in children: revised body weight-dependent NONMEM® model to optimize dosing. Eur J Clin Pharmacol. 2014;70:839–847.
  • Holford N, Heo YA, Anderson B. A pharmacokinetic standard for babies and adults. J Pharm Sci. 2013;102:2941–2952.
  • Pathirana S, Jayawardena S, Meeves S, et al. Brompheniramine and chlorpheniramine pharmacokinetics following single-dose oral administration in children aged 2 to 17 years. J Clin Pharmacol. 2018;58:494–503.
  • Balan G, Thompson GA, Gibb R, et al. Doxylamine pharmacokinetics following single dose oral administration in children ages 2-17 years. J Clin Pharmacol. 2013;53:58–1177.
  • Knell JM. On the analysis of non-linear allometries. Ecological Entomology. 2009;34:1–11.
  • Hoppeler H, Weibel ER. Scaling functions to body size: theories and facts. J Exp Biol. 2005;208:1573–1574.

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