Controversy in the allometric application of fixed- versus varying-exponent models: A statistical and mathematical perspective

Journal of Pharmaceutical Sciences

Volumn 100, Issue 2, 2011, Pages 402-410

  Tang, Huadong ^a   Hussain, Azher ^a   Leal, Mauricio ^b   Fluhler, Eric ^c   Mayersohn, Michael ^d  

^a MERCK RESEARCH LABORATORIES   (United States)

^b WYETH RESEARCH   (United States)

^c PFIZER INC   (United States)

^d UNIVERSITY OF ARIZONA   (United States)

Author keywords

Allometry; Clearance; Fixed exponent allometry; PK predictions; Varying exponent allometry

Indexed keywords

ALLOMETRY; ARTICLE; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG EXCRETION; DRUG METABOLISM; HUMAN; IN VITRO STUDY; IN VIVO STUDY; MATHEMATICAL ANALYSIS; NONHUMAN; STATISTICAL ANALYSIS;

EID: 78650540435     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22316     Document Type: Article

References (33)

1. Mahmood I. 2009. 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 98:2472-2493.
2. Tang H, Hussain A, Leal M, Mayersohn M, Fluhler E. 2007. Interspecies prediction of human drug clearance based on scaling data from one or two animal species. Drug Metab Dispos 35:1886-1893.
3. Ward KW, Smith BR. 2004. A comprehensive quantitative and qualitative evaluation of extrapolation of intravenous pharmacokinetic parameters from rat, dog, and monkey to humans, part I: Clearance. Drug Metab Dispos 32:603-611.
4. Hosea NA, Collard WT, Cole S, Maurer TS, Fang RX, Jones H, Kakar SM, Nakai Y, Smith BJ, Webster R, Beaumont K. 2009. Prediction of human pharmacokinetics from preclinical information: Comparative accuracy of quantitative prediction approaches. J Clin Pharmacol 49:513-533.
5. Huang C, Zheng M, Yang Z, Rodrigues AD, Marathe P. 2008. Projection of exposure and efficacious dose prior to first-in-human studies: How successful have we been? Pharm Res 25:713-726.
6. Jones HM, Parrott N, Ohlenbusch G, Lavé T. 2006. A novel strategy for physiologically based predictions of human pharmacokinetics. Clin Pharmacokinet 45:511-42.
7. Sinha VK, De Buck SS, Fenu LA, Smit JW, Nijsen M, Gilissen RA, Van Peer A, Lavrijsen K, Mackie CE. 2008. Predicting oral clearance in humans: How close can we get with allometry? Clin Pharmacokinet 47:35-45.
8. 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 95:1783-1799.
9. 1/2 be predicted from in-vivo rat data? Eur J Drug Metab Pharmacokinet 29:133-43.
10. Mahmood I. 1996. 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 21:275-278.
11. Mahmood I. 1998. Interspecies scaling of renally secreted drugs. Life Sci 63(26):2365-2371.
12. Mahmood I. 2002. Interspecies scaling: Predicting oral clearance in humans. Am J Ther 9:35-42.
13. Gould SJ. 1966. Allometry and size in ontogeny and phylogeny. Biol Rev Camb Philos Soc 41: 587-640.
14. Huxley J. 1932. Problems of relative growth. London, UK: Methuen.
15. Kleiber M. 1932. Body size and metabolism. Hilgardia 6:315-353.
16. Adolph EF. 1949. Quantitative relations in the physiological constitutions of mammals. Science 109:579-585.
17. White CR, Seymour RS. 2003. Mammalian basal metabolic rate is proportional to body mass2/3. Proc Natl Acad Sci U S A 100:4046-4049.
18. Tang H, Mayersohn M. 2005. Accuracy of allometrically predicted pharmacokinetic parameters in humans: Role of species selection. Drug Metab Dispos 33:1288-1293.
19. Bonate P. 2006. Pharmacokinetic-pharmacodynamic modeling and simulation. New York: Springer, pp 152-153.
20. 2) in assessing the accuracy of interspecies allometric predictions: Illumination or illusion? Drug Metab Dispos 35:2139-2142.
21. Sietsema WK. 1989. The absolute oral bioavailability of selected drugs. Int J Clin Pharmacol Ther Toxicol 27:179-211.
22. Tang H, Mayersohn M. 2005. A mathematical description of the functionality of correction factors used in allometry for predicting human drug clearance. Drug Metab Dispos 33:1294-1296.
23. Mahmood I. 2006. Comments on a mathematical description of the functionality of correction factors used in allometry for predicting human drug clearance. Drug Metab Dispos 34:507-509.
24. Tang H, Mayersohn M. 2006. Response to comments on a mathematical description of the functionality of correction factors used in allometry for predicting human drug clearance. Drug Metab Dispos 34:510-511.
25. Scatina JA, Hicks DR, Kraml M, Cayen MN. 1989. Disposition of a new tetrahydrocarbazole analgesic drug in laboratory animals and man. Xenobiotica 19:991-1002.
26. Agutter PS, Wheatley DN. 2004. Metabolic scaling: Consensus or controversy? Theor Biol Med Model 1:13.
27. West GB, Brown JH. 2005. The origin of allometric scaling laws in biology from genomes to ecosystems: Towards a quantitative unifying theory of biological structure and organization. J Exp Biol 208:1575-1592.
28. Box GE, Draper NR. 1987. Empirical model-building and response surfaces. New York: Wiley, pp 424.
29. Food and Drug Administration. 2005. Guidance for industry estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. Silver Spring, MD: Food and Drug Administration.
30. Ito K, Houston JB. 2005. Prediction of human drug clearance from in vitro and preclinical data using physiologically based and empirical approaches. Pharm Res 22:103-112.
31. Rowland M, Balant L, Peck C. 2004. Physiologically based pharmacokinetics in drug development and regulatory science: A workshop report (Georgetown University, Washington, DC, May 29-30, 2002). AAPS Pharm Sci 6(1):E6.
32. Rostami-Hodjegan A, Tucker GT. 2007. Simulation and prediction of in vivo drug metabolism in human populations from in vitro data. Nat Rev Drug Discov 6:140-148.
33. Obach RS, Baxter JG, Liston TE, Silber BM, Jones BC, MacIntyre F, Rance DJ, Wastall P. 1997. The prediction of human pharmacokinetic parameters from preclinical and in vitro metabolism data. J Pharmacol Exp Ther 283:46-58.