Interspecies extrapolation

Methods in Molecular Biology

Volumn 929, Issue , 2012, Pages 501-520

  Kenyon, Elaina M ^a  

^a U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

Author keywords

Allometry; Cross species; Extrapolation; In vitro scale up; In vitro to in vivo extrapolation (IVIVE); Scaling

Indexed keywords

ALLOMETRY; ARTICLE; BIOLOGICAL MODEL; BIOLOGICAL PHENOMENA AND FUNCTIONS CONCERNING THE ENTIRE ORGANISM; EXPERIMENTAL ANIMAL; EXPOSURE; HUMAN; IN VITRO STUDY; IN VIVO STUDY; INTERSPECIES EXTRAPOLATION; METABOLISM; NONHUMAN; PARAMETERS; PHARMACODYNAMICS; PHARMACOKINETICS; PRIORITY JOURNAL; RISK ASSESSMENT; SCALE UP; SPECIES; TOXICOLOGICAL PARAMETERS;

EID: 84934441925     PISSN: 10643745     EISSN: None     Source Type: Book Series    
DOI: 10.1007/978-1-62703-50-2_19     Document Type: Article

References (68)

1. Dedrick RL (1973) Animal scale-up. J Pharmacokinet Biopharm 1:435-461
2. U.S. EPA (U.S. Environmental Protection Agency) (1992) Draft report: a cross-species scaling factor for carcinogen risk assessment based on equivalence of mg/kg3/4/day. Notice Fed Reg 57:24152-24173
3. Kleiber M (1932) Body size and metabolism. Hilgardia 6:315-353
4. Kleiber M (1947) Body size and metabolic rate. Physiol Rev 27:511-541
5. Kleiber M (1961) The fire of life: an introduction to animal energetics.Wiley, New York, NY
6. O?Flaherty EJ (1989) Interspecies conversion of kinetically equivalent doses. Risk Anal 9:587-598
7. Rhomberg LR, Lewandowski TA (2006) Methods for identifying a default cross-species scaling factor. Hum Ecol Risk Assess 12:1094-1127
8. Travis CC, White RK (1988) Interspecies scaling of toxicity data. Risk Anal 8:119-125
9. U.S. EPA (2005) Guidelines for carcinogen risk assessment. EPA/630/P-03/001F Risk Assessment Forum, Washington, DC
10. U.S. EPA (2011) Harmonization in interspecies extrapolation: use of body weight3/4 as the default method in derivation of the oral reference dose. EPA/100/R11/0001 Risk Assessment Forum, Washington, DC
11. Clewell HJ, Reddy MB, Lave T, Andersen ME (2008) Physiologically based pharmacokinetic modeling. In: Gad SC (ed) Preclinical development handbook: ADME and biopharmaceutical properties.Wiley,New York,NY, pp 1167-1227
12. Lipscomb JC, Poet TS (2008) In vitro measurements of metabolism for application in pharmacokinetic modeling. Pharmacol Ther 118:82-103
13. Matthews JC (1993) Fundamentals of receptor, enzyme and transport kinetics. CRC, Boca Raton, FL
14. Cornish-Bowden A (1995) Analysis of enzyme kinetic data. Oxford University Press, Oxford
15. Cornish-Bowden A (2004) Fundamentals of enzyme kinetics, 3rd edn. Portland Press, London
16. Rubner M (1883) Uber den einfluss der korpergrosse auf stoff- und kraftwechsel. Zeit Biol 19:536-562
17. McMahon TA (1975)Using body size to understand the structural design of animals: quadrupedal locomotion. J Appl Physiol 39:619-627
18. West GB, Brown JH, Endquist BJ (1997) A general model for the origin of allometric scaling laws in biology. Science 276:122-126
19. West GB,WoodruffWH, Brown JH(2002)Allometric scaling of metabolic rate from molecules and mitochondria to cells and mammals. Proc Natl Acad Sci U S A 99(Suppl 1):2473-2478
20. Banavar J.R., Maritan A, Rinaldo A (1999) Size and form in efficient transportation networks. Nature 399:130-131
21. Bejan A (2000) Shape and structure, from engineering to nature. Cambridge University Press, Cambridge
22. WhiteCR, SeymourRS (2003)Mammalian basal metabolic rate is proportional to body mass2/3. Proc Natl Acad Sci U S A 100:4046-4049
23. Dodds PS, Rothman DH, Weitz JS (2001) Re-examination of the "3/4-law" of metabolism. J Theor Biol 209:9-27
24. IPCS (International Programme on Chemical Safety) (2005) Guidance document for the use of data in development of chemical-specific adjustment factors (CSAFs) for interspecies differences and human variability in dose/concentration- response assessment. World Health Organization, Geneva
25. U.S. EPA (1994) Methods for derivation of inhalation reference concentrations and application of inhalation dosimetry. EPA/600/8-90/066F. Environmental Criteria and Assessment Office, Washington, DC
26. Boxenbaum H (1982) Interspecies scaling, allometry, physiological time, and the ground plan of pharmacokinetics. J Pharmacokinet Biopharm 10:201-227
27. Reddy MB, Yang RSH, Clewell HJ, Andersen ME (2005) Physiologically based pharmacokinetic modeling-science and applications. Wiley Interscience, Hoboken, NJ
28. Adolph EF (1949) Quantitative relations in the physiological constitutions of mammals. Science 109:579-585
29. Mordenti J (1986) Man versus beast: pharmacokinetic scaling in mammals. J Pharm Sci 75:1028-1040
30. Andersson TB, Sjoberg H, Hoffman K-J, Boobis AR,Watts P, Edwards RJ, Lake BJ, Price RJ, Renwick AB, Gomez-Lechon MJ, Castell JV, Ingelman-Sundberg M, Hidestrand M, Goldfarb PS, Lewis DFV, Corcos L, Guillouzo A, Taavitsainen P, PelkonenO(2001) An assessment of human liver-derived in vitro systems to predict the in vivo metabolism and clearance of almokalant. Drug Metab Dispos 29:712-720
31. Carlile DJ, Zomorodi K, Houston JB (1997) Scaling factors to relate drug metabolic clearance in hepatic microsomes, isolated hepatocytes and the intact liver-studies with induced livers involving diazepam. Drug Metab Dispos 25:903-911
32. Tang W, Wang RW, Lu AYH (2005) Utility of recombinant cytochrome P450 enzymes: a drug metabolism perspective. Curr Drug Metab 6:503-517
33. Brown RP, Delp MD, Lindstedt SL, Rhomberg LR, Beliles RP (1997) Physiological parameter values for physiologically based pharmacokinetic models. Toxicol Ind Health 13:407-484
34. U.S. EPA (Lipscomb JC, Kedderis GL) (2005) Use of physiologically based pharmacokinetic models to quantify the impact of human age and interindividual differences in physiology and biochemistry pertinent to risk: final report for cooperative agreement ORD/NCEA Cincinnati, OH EPA/600/R-06-014A
35. Lipscomb JC, Teuschler LK, Swartout JC, Popken D, Cox T, Kedderis GL (2003) The impact of cytochrome P450 2E1-dependent metabolic variance on a risk relevant pharmacokinetic outcome in humans. Risk Anal 23:1221-1238
36. Lipscomb JC, Kedderis GL (2002) Incorporating human interindividual biotransformation variance in health risk assessment. Sci Total Environ 288:12-21
37. Lipscomb JC (2004) Evaluating the relationship between variance in enzyme expression and toxicant concentration in health risk assessment. Hum Ecol Risk Assess 10:39-55
38. Thrall KD, Gies RA, Muniz J, Woodstock AD, Higgins G (2002) Route-of-entry and brain tissue partition coefficients for common superfund contaminants. J Toxicol Environ Health Part A 65:2075-2086
39. Gargas ML, Burgess RJ, Voisard DE, Cason GH, Andersen ME (1989) Partition coefficients of low-molecular-weight volatile chemicals in various liquids and tissues. Toxicol Appl Pharmacol 98:87-99
40. Lilly PD, Andersen ME, Ross TM, Pegram RA (1997) Physiologically based estimation of in vivo rates of bromodichloromethane metabolism. Toxicology 124:141-152
41. Kenyon EM, Kraichely RE, Hudson KT, MedinskyMA( 1996) Differences in rates of benzene metabolism correlate with observed genotoxicity. Toxicol Appl Pharmacol 136:649-656
42. GargasML, AndersenME, ClewellHJ (1986) A physiologically based simulation approach for determiningmetabolic constants fromgas uptake data. Toxicol Appl Pharmacol 86:341-352
43. Lipscomb JC, Barton H, Tornerol-Velez R (2004) The metabolic rate constants and specific activity of human and rat hepatic cytochrome P450 2E1 toward chloroform. J Toxicol Environ Health 67:537-553
44. Delic JI, Lilly PD, MacDonald AJ, Loizou GD (2000) The utility of PBPK in the safety assessment of chloroform and carbon tetrachloride. Reg Toxicol Pharmacol 32:144-155
45. Corley RA, Mendrala AL, Smith FA et al (1990) Development of a physiologically based pharmacokinetic model for chloroform. Toxicol Appl Pharmacol 103:512-527
46. Beck BD, Clewell HJ III (2001) Uncertainty/safety factors in health risk assessment: opportunities for improvement. Hum Ecol Risk Assess 7:203-207
47. Travis CC (1990) Tissue dosimetry for reactive metabolites. Risk Anal 10:317-321
48. Rhomberg LR, Wolff SK (1998) Empirical scaling of single oral lethal doses across mammalian species base on a large database. Risk Anal 18:741-753
49. Burzala-Kowalczyk L, Jongbloed G (2011) Allometric scaling: analysis of LD50 data. Risk Anal 31:523-532
50. Ginsberg G, Hattis D, Sonawane B, Russ A, Banati P, Kozlak M, Smolenski S, Goble R (2002) Evaluation of child/adult pharmacokinetic differences from a database derived from the therapeutic drug literature. Toxicol Sci 66:185-200
51. Ginsberg G, Hattis D, Miller R, Sonawane B (2004) Pediatric pharmacokinetic data: implications for environmental risk assessment for children. Pediatrics 113(Suppl):973-983
52. Hattis D (2004) Role of dosimetric scaling and species extrapolation in evaluating risks across life stages IV pharmacodynamic dosimetric considerations. Report to the U.S. Environmental Protection Agency under RFQ No DC-03-00009
53. Finlay BL, Darlington RB (1995) Linked regularities in the development and evolution of mammalian brains. Science 268:1578-1584
54. Renwick AG, Lazarus NR (1998) Human variability and noncancer risk assessment-an analysis of the default uncertainty factor. Regul Toxicol Pharmacol 27:3-20
55. Clancy B, Darlington RB, Finlay BL (2001) Translating developmental time across mammalian species. Neuroscience 105:7-17
56. Krishnam K, Andersen ME (1994) Physiologically based pharmacokinetic modeling in toxicology. In: Hayes AW (ed) Principles and methods of toxicology, 3rd edn. Raven Press, New York, NY, pp 149-188
57. Jepson GW, Hoover DK, Black RK, McCafferty JD, Mahle DA, Gearhart JM (1994) A partition coefficient determination method for nonvolatile chemicals in biological tissues. Fundam Appl Toxicol 22:519-524
58. Gallo JM, Lam FC, Perrier DG (1987) Area method for the estimation of partition coefficients for physiological pharmacokinetic models. J Pharmacokinet Biopharm 15:271-280
59. Teo SKO, Kedderis GL, Gargas ML (1994) Determination of tissue partition coefficients for volatile tissue-reactive chemicals: acrylonitrile and its metabolite 2-cyanoethylene oxide. Toxicol Appl Pharmacol 128:92-96
60. Khor SP,MayersohnM(1991) Potential error in the measurement of tissue to blood distribution coefficients in physiological pharmacokinetic modeling residual tissue blood I theoretical considerations. Drug Metab Dispos 19:478-485
61. Poulin P, Krishnan K (1995) An algorithm for predicting tissue:blood partition coefficients or organic chemicals from n-octanol:water partition coefficient data. J Toxicol Environ Health 46:117-129
62. Poulin P, Krishnan K (1996) A mechanistic algorithm for predicting blood:air partition coefficients of organic chemicals with the consideration of reversible binding in hemoglobin. Toxicol Appl Pharmacol 136:131-137
63. Barter ZE, Bayliss MK, Beaune PH, Bobbis AR, Carlile DJ, Edwards RJ, Houston JB, Lake BG, Lipscomb JC, Pelkonen OR, Tucker GT, Rostami-Hodjegan A (2007) Scaling factors for the extrapolation of in vivo metabolic drug clearance from in vitro data: reaching a consensus on values of human microsomal protein and hepatocellularity per gram of liver. Curr Drug Metab 8:33-45
64. Houston JB (1994) Utility of in vitro drug metabolism data in predicting in vivo metabolic clearance. Biochem Pharmacol 47:1469-1479
65. Blaauboer BJ (2010) Biokinetic modeling and in vitro-in vivo extrapolations. J Toxicol Environ Health Part B 13:242-252
66. Howgate EM, Yeo KR, Proctor NJ, Tucker GT, Rostami-Hodjegan A (2006) Prediction of in vivo drug clearance from in vitro data I impact of inter-individual variability. Xenobiotica 36:473-497
67. Obach RS (1999) Prediction of human clearance of twenty-nine drugs from hepatic microsomal intrinsic clearance data: an examination of in vitro half-life approach and nonspecific binding to microsomes. Drug Metab Dispos 27:1350-1359
68. Kedderis GL (1997) Extrapolation of in vitro enzyme induction data to human in vivo. Chem-Biol Interact 107:109-121