A Framework for Meta-Analysis of Veterinary Drug Pharmacokinetic Data Using Mixed Effect Modeling

Journal of Pharmaceutical Sciences

Volumn 104, Issue 4, 2015, Pages 1230-1239

  Li, Mengjie ^a   Gehring, Ronette ^a   Lin, Zhoumeng ^a   Riviere, Jim ^a  

^a KANSAS STATE UNIVERSITY   (United States)

Author keywords

clearance; distribution; drug depletion; drug withdrawal time; formulation; meta analysis; nonlinear mixed effect modeling; pharmacokinetics; population pharmacokinetics; veterinary medicine

Indexed keywords

VETERINARY DRUG;

ABSORPTION; ABSORPTION HALF-LIFE; AGE DISTRIBUTION; ALLOMETRY; ANALYTICAL ERROR; BODY WEIGHT; CLINICAL TRIAL (TOPIC); DATA MINING; DEPENDENT VARIABLE; DRUG CLEARANCE; DRUG DISPOSITION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DRUG WITHDRAWAL; ENZYME ACTIVITY; INDEPENDENT VARIABLE; INFORMATION PROCESSING; LIPID SOLUBILITY; MEDICAL RESEARCH; META ANALYSIS (TOPIC); MOLECULAR SIZE; MONTE CARLO METHOD; NONHUMAN; NONLINEAR SYSTEM; POPULATION DISTRIBUTION; POPULATION RESEARCH; PREDICTIVE VALUE; REFERENCE VALUE; REVIEW; SAMPLE SIZE; SEX DIFFERENCE; STATISTICAL MODEL; TIME PERCEPTION; VETERINARY CLINIC; VETERINARY MEDICINE; ANIMAL; BIOLOGICAL MODEL; COMPUTER SIMULATION; FACTUAL DATABASE; HUMAN; REPRODUCIBILITY; SPECIES DIFFERENCE;

ANIMALS; COMPUTER SIMULATION; DATA MINING; DATABASES, FACTUAL; HUMANS; META-ANALYSIS AS TOPIC; MODELS, BIOLOGICAL; MODELS, STATISTICAL; NONLINEAR DYNAMICS; REPRODUCIBILITY OF RESULTS; SPECIES SPECIFICITY; VETERINARY DRUGS;

EID: 84924755729     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.24341     Document Type: Review

References (74)

1. Akos J. 2012. Comparative veterinary pharmacokinetics. In: Readings in advanced pharmacokinetics theory, methods and applications; Noreddin A, Ed. InTech, Croatia,pp 179-198.
2. Walker E, Hernandez AV, Kattan MW. 2008. Meta-analysis: Its strengths and limitations. Cleve Clin J Med 75(6):431-439.
3. Marquis-Gravel G, Stevens LM, Mansour S, Avram R, Noiseux N. 2014. Stem cell therapy for the treatment of nonischemic cardiomyopathy: A systematic review of the literature and meta-analysis of randomized controlled trials. Can J Cardiol 30(11):1378-1384.
4. McCormick N, Lacaille D, Bhole V, Avina-Zubieta JA. 2014. Validity of heart failure diagnoses in administrative databases: A systematic review and meta-analysis. PloS one 9(8):e104519.
5. Li M, Gehring R, Tell L, Baynes R, Huang Q, Riviere JE. 2014. Interspecies mixed-effect pharmacokinetic modeling of penicillin G in cattle and swine. Antimicrob Agents Chemother 58(8):4495-4503.
6. Sheiner LB, Grasela TH. 1991. An introduction to mixed effect modeling - Concepts, definitions, and justification. J Pharmacokinet Biop 19(3):S11-S24.
7. Mould DR, Upton RN. 2013. Basic concepts in population modeling, simulation, and model-based drug development-part 2: Introduction to pharmacokinetic modeling methods. CPT Pharmacometrics Syst Pharmacol 2:e38.
8. Tatarinova T, Neely M, Bartroff J, Van Guilder M, Yamada W, Bayard D, Jelliffe R, Leary R, Chubatiuk A, Schumitzky A. 2013. Two general methods for population pharmacokinetic modeling: Nonparametric adaptive grid and non-parametric Bayesian. J Pharmacokinet Pharmacodyn 40(2):189-199.
9. Mould DR, Upton RN. 2012. Basic concepts in population modeling, simulation, and model-based drug development. CPT Pharmacometrics Syst Pharmacol 1:e6.
10. Lazaro A, Badia A, Castells I, Ruiz J, Mane E. 1979. Pharmacokinetic evaluation and mammary excretion of tamethicillin in the healthy goat. Am J Vet Res 40(8):1173-1176.
11. Ranheim B, Risberg AI, Spadavecchia C, Landsem R, Haga HA. 2014. The pharmacokinetics of dexmedetomidine administered as a constant rate infusion in horses. J Vet Pharmacol Ther.[Epub ahead of print]
12. Fink M, Letellier I, Peyrou M, Mochel JP, Jung M, King JN, Gruet P, Giraudel JM. 2013. Population pharmacokinetic analysis of blood concentrations of robenacoxib in dogs with osteoarthritis. Res Vet Sci 95(2):580-587.
13. Freeman KS, Thomasy SM, Stanley SD, Van Bonn W, Gulland F, Friedlaender AS, Maggs DJ. 2013. Population pharmacokinetics of doxycycline in the tears and plasma of northern elephant seals (Mirounga angustirostris) following oral drug administration. J Am Vet Med Assoc 243(8):1170-1178.
14. Cox SR, Liao S, Payne-Johnson M, Zielinski RJ, Stegemann MR. 2011. Population pharmacokinetics of mavacoxib in osteoarthritic dogs. J Vet Pharmacol Ther 34(1):1-11.
15. Cox SR, Lesman SP, Boucher JF, Krautmann MJ, Hummel BD, Savides M, Marsh S, Fielder A, Stegemann MR. 2010. The pharmacokinetics of mavacoxib, a long-acting COX-2 inhibitor, in young adult laboratory dogs. J Vet Pharmacol Ther 33(5):461-470.
16. EMEA. 2013.EuropeanMedicinesAgency,Trocoxil:EPRA-product information. Accessed on, at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Summary-for-the-public/veterinary/000132/WC500069275.pdf (last accessed date: 01/05/2015).
17. Mitka M. 2012. Antibiotic breakpoints. JAMA 307(10):1015.
18. Dalhoff A, Ambrose PG, Mouton JW. 2009. A long journey from minimum inhibitory concentration testing to clinically predictive breakpoints: Deterministic and probabilistic approaches in deriving breakpoints. Infection 37(4):296-305.
19. Rey JF, Laffont CM, Croubels S, De Backer P, Zemirline C, Bousquet E, Guyonnet J, Ferran AA, Bousquet-Melou A, Toutain PL. 2014. Use of Monte Carlo simulation to determine pharmacodynamic cutoffs of amoxicillin to establish a breakpoint for antimicrobial susceptibility testing in pigs. Am J Vet Res 75(2):124-131.
20. Pagel SW, Gautier P. 2012. Use of antimicrobial agents in livestock. Rev Sci Tech 31(1):145-188.
21. Wang W, Chen H, Yu B, Mao X, Chen D. 2014. Tissue deposition and residue depletion of melamine in fattening pigs following oral administration. Food Addit Contam Part A Chem Anal, Control Expo Risk Assess 31(1):7-14.
22. Romanet J, Smith GW, Leavens TL, Baynes RE, Wetzlich SE, Riviere JE, Tell LA. 2012. Pharmacokinetics and tissue elimination of tulathromycin following subcutaneous administration in meat goats. Am J Vet Res 73(10):1634-1640.
23. Payne MA, Craigmill A, Riviere JE, Webb AI. 2006. Extralabel use of penicillin in food animals. J Am Vet Med Assoc 229(9):1401-1403.
24. Baynes RE, Payne M, Martin-Jimenez T, Abdullah AR, Anderson KL, Webb AI, Craigmill A, Riviere JE. 2000. Extralabel use of ivermectin and moxidectin in food animals. J Am Vet Med Assoc 217(5):668-671.
25. Smith G. 2013. Extralabel use of anesthetic and analgesic compounds in cattle. Vet Clin North Am Food Anim Pract 29(1):29-45.
26. Code of federal regulation: 21 CFR part 530. 2014. Accessed on, at:http://www.gpo.gov/fdsys/pkg/CFR-2014-title21-vol6/pdf/CFR-2014-title21-vol6-part530.pdf (last accessed date: 01/05/2015).
27. Payne MA, Craigmill AL, Riviere JE, Baynes RE, Webb AI, Sundlof SF. 1999. The Food Animal Residue Avoidance Databank (FARAD). Past, present and future. Vet Clin North Am Food Anim Pract 15(1):75-88.
28. US Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Veterinary Medicine,Guideline #3, parts I-VIII.General principles for evaluating the safety of compounds used in food producing animals. 2005. Accessed on, at: http://www.fda.gov/ohrms/dockets/98fr/05d-0219-gdl0001.pdf (last accessed date: 01/05/2015)
29. Wu H, Baynes RE, Leavens T, Tell LA, Riviere JE. 2013. Use of population pharmacokinetic modeling and Monte Carlo simulation to capture individual animal variability in the prediction of flunixin withdrawal times in cattle. J Vet Pharmacol Ther 36(3):248-257.
30. Kissell LW, Baynes RE, Riviere JE, Smith GW. 2013. Occurrence of flunixin residues in bovine milk samples from the USA. Food Addit Contam Part A Chem Anal Control Expos Risk Assess 30(9):1513-1516.
31. Chiesa OA, Von Bredow J, Smith M, Heller D, Condon R, Thomas MH. 2006. Bovine kidney tissue/biological fluid correlation for penicillin. J Vet Pharmacol Ther 29(4):299-306.
32. Zhao DH, Zhang CY, Zhang Z, Liu ZC, Liu BT, Yu JJ, Guo JP, Deng H, Liu YH. 2013. Population pharmacokinetics of cefquinome in pigs. J Vet Pharmacol Ther 36(4):313-319.
33. Forthal DN. 1991. Inosine pranobex for preventing AIDS in patients with HIV infection. The N Engl J Med 324(7):491-492.
34. Guo QJ, Huang LL, Fang K, Wang YL, Chen DM, Tao YF, Dai MH, Liu ZL, Peng DP, Yuan ZH. 2010. Population pharmacokinetics of enrofloxacin and its metabolite ciprofloxacin in chicken based on retrospective data, incorporating first-pass metabolism. J Vet Pharmacol Ther 33(1):84-94.
35. Fu LX, Jiang ZG, Ding HZ, Liu YH. 2008. Population pharmacokinetics of enrofloxacin and its active metabolite ciprofloxacin in ill cows. J Vet Pharmacol Ther 31(3):240-245.
36. Martin-Jimenez T, Papich MG, Riviere JE. 1998. Population pharmacokinetics of gentamicin in horses. Am J Vet Res 59(12):1589-1598.
37. Regnier A, Concordet D, Schneider M, Boisrame B, Toutain PL. 2003. Population pharmacokinetics of marbofloxacin in aqueous humor after intravenous administration in dogs. Am J Vet Res 64(7):889-893.
38. Lehr T, Narbe R, Jons O, Kloft C, Staab A. 2010. Population pharmacokinetic modelling and simulation of single and multiple dose administration of meloxicam in cats. J Vet Pharmacol Ther 33(3):277-286.
39. Chinnadurai SK, Messenger KM, Papich MG, Harms CA. 2014. Meloxicam pharmacokinetics using nonlinear mixed-effects modeling in ferrets after single subcutaneous administration. J Vet Pharmacol Ther 37(4):382-387.
40. Fink M, Letellier I, Peyrou M, Mochel JP, Jung M, King JN, Gruet P, Giraudel JM. 2013. Population pharmacokinetic analysis of blood concentrations of robenacoxib in dogs with osteoarthritis. Res Vet Sci 95(2):580-587.
41. Mason SE, Almond GW, Riviere JE, Baynes RE. 2012. Evaluation of factors important in modeling plasma concentrations of tetracycline hydrochloride administered in water in swine. Am J Vet Res 73(10):1641-1649.
42. Kinney ME, Lamberski N, Wack R, Foster R, Neely M, Tell L, Gehring R. 2014. Population pharmacokinetics of a single intramuscular administration of tulathromycin in adult desert tortoises (Gopherus agassizii). J Vet Pharmacol Ther 37(5):500-507.
43. Zhao DH, Zhang Z, Zhang CY, Liu ZC, Deng H, Yu JJ, Guo JP, Liu YH. 2014. Population pharmacokinetics of valnemulin in swine. J Vet Pharmacol Ther 37(1):59-65.
44. Wu H, Baynes RE, Tell LA, Riviere JE. 2013. Prediction of flunixin tissue residue concentrations in livers from diseased cattle. Food Chem Toxicol 62:876-879.
45. Whittem T. 1999. Pharmacokinetics and milk discard times of pirlimycin after intramammary infusion: A population approach. J Vet Pharmacol Ther 22(1):41-51.
46. Lindquist D, Wu H, Mason S, Yeatts J, Brooks J, Barlow B, Schill K, Baynes R. 2014. Tetracycline residues in porcine stomach after administration via drinkingwater on a swine farm. J Food Prot 77(1):122-126.
47. KuKanich B, Huff D, Riviere JE, Papich MG. 2007. Naive averaged, naive pooled, and population pharmacokinetics of orally administered marbofloxacin in juvenile harbor seals. J Am Vet Med Assoc 230(3):390-395.
48. Craigmill AL, Miller GR, Gehring R, Pierce AN, Riviere JE. 2004. Meta-analysis of pharmacokinetic data of veterinary drugs using the Food Animal Residue Avoidance Databank: Oxytetracycline and procaine penicillin G. J Vet Pharmacol Ther 27(5):343-353.
49. Martin-Jimenez T, Riviere JE. 2001. Mixed effects modeling of the disposition of gentamicin across domestic animal species. J Vet Pharmacol Ther 24(5):321-332.
50. Martin-Jimenez T, Riviere JE. 2002. Mixed-effects modeling of the interspecies pharmacokinetic scaling of oxytetracycline. J Pharm Sci 91(2):331-341.
51. Baggot JD. 1992. Clinical pharmacokinetics in veterinary medicine. Clin Pharmacokinet 22(4):254-273.
52. Toutain PL, Ferran A, Bousquet-Melou A. 2010. Species differences in pharmacokinetics and pharmacodynamics. Handb Exp Pharmacol (199):19-48.
53. Lees P. 2009. Analgesic, antiinflammatory, antipyretic drugs. In Veterinary pharmacology and therapeutics; Riviere JE, Papich MG, Eds. 9th ed. Ames, Iowa: Wiley-Blackwell, p xvi, pp 1524.
54. Huang Q, Riviere JE. 2014. The application of allometric scaling principles to predict pharmacokinetic parameters across species. Expert Opin Drug Metab Toxicol 10(9):1241-1253.
55. Riviere JE, Martin-Jimenez T, Sundlof SF, Craigmill AL. 1997. Interspecies allometric analysis of the comparative pharmacokinetics of 44 drugs across veterinary and laboratory animal species. J Vet Pharmacol Ther 20(6):453-463.
56. Huang Q, Gehring R, Tell LA, Li M, Riviere JE. 2014. Interspecies allometric meta-analysis of the comparative pharmacokinetics of 85 drugs across veterinary and laboratory animal species. J Vet Pharmacol Ther. [Epub ahead of print]
57. Boxenbaum H. 1982. Interspecies scaling, allometry, physiological time, and the ground plan of pharmacokinetics. J Pharm Biopharm 10(2):201-227.
58. Brischoux F, Bonnet X, Cook TR, Shine R. 2008. Allometry of diving capacities: Ectothermy vs. endothermy. J Evol Biol 21(1):324-329.
59. Jones H, Rowland-Yeo K. 2013. Basic concepts in physiologically based pharmacokinetic modeling in drug discovery and development. CPT Pharmacometrics Syst Pharmacol 2:e63.
60. Lin Z, Li M, Gehring R, Riviere JE. 2014. Development and application of a multiroute physiologically based pharmacokinetic model for oxytetracycline in dogs and humans. J Pharm Sci 104(1):233-243.
61. Leavens TL, Tell LA, Kissell LW, Smith GW, Smith DJ, Wagner SA, Shelver WL, Wu H, Baynes RE, Riviere JE. 2014. Development of a physiologically based pharmacokinetic model for flunixin in cattle (Bos taurus). Food Addit Contam Part A Chem Anal Control Expos Risk Assess 31(9):1506-1521.
62. Dumont C, Mentre F, Gaynor C, Brendel K, Gesson C, Chenel M. 2013. Optimal sampling times for a drug and its metabolite using SIMCYP((R)) simulations as prior information. Clin Pharm 52(1):43-57.
63. Lees P, Toutain PL. 2012. The role of pharmacokinetics in veterinary drug residues. Drug Test Anal 4 Suppl 1:34-39.
64. Gibaldi M, Koup JR. 1981. Pharmacokinetic concepts - Drug binding, apparent volume of distribution and clearance. Eur J Clin Pharm 20(4):299-305.
65. Buur JL, Baynes RE, Riviere JE. 2008. Estimating meat withdrawal times in pigs exposed to melamine contaminated feed using a physiologically based pharmacokinetic model. Regul Toxicol Pharm 51(3):324-331.
66. Brown SA, Coppoc GL, Riviere JE. 1986. Effects of dose and duration of therapy on gentamicin tissue residues in sheep. Am J Vet Res 47(11):2373-2379.
67. Toutain PL, Raynaud JP. 1983. Pharmacokinetics of oxytetracycline in young cattle: Comparison of conventional vs long-acting formulations. Am J Vet Res 44(7):1203-1209.
68. Sadozai H, Saeidi D. 2013. Recent developments in liposome-based veterinary therapeutics. ISRN Vet Sci 2013:167521.
69. Richard BM, Newton P, Ott LR, Haan D, Brubaker AN, Cole PI, Ross PE, Rebelatto MC, Nelson KG. 2012. The safety of EXPAREL® (bupivacaine liposome injectable suspension) administered by peripheral nerve block in rabbits and dogs. J Drug Deliv 2012:962101.
70. Deyrup CL, Southern KJ, Cornett JA, Shultz CE, Cera DA. 2012. Examining the occurrence of residues of flunixin meglumine in cull dairy cows by use of the flunixin cull cow survey. J Am Vet Med Assoc 241(2):249-253.
71. Haley K, Black WD, Barnum DA. 1981. Optimal milk penicillin levels for the treatment of experimentally induced mastitis in cows. Canad J Comp Med 45(3):239-242.
72. Schulz O, Kirchner K, Heide B. 1982. [Residual behavior of sulfonamides in the animal body. 1. Residue formation of the musculature, liver and kidneys after the oral administration of sulfadimidine (2-(4-aminobenzenesulfonamido)-4,6-dimethylpyrimidine) to young cattle]. Arch Exp Veterinarme 36(6):895-897.
73. Verbeke R, Debackere M, Hicquet R, Lauwers H, Pottie G, Stevens J, Van Moer D, Van Hoof J, Vermeersch G. 1976. Quality of the meat after the application of anabolic agents in young calves. Environ Qual Saf Suppl (5):123-130.
74. Nouws JF. 1992. Pharmacokinetics in immature animals: A review. J Anim Sci 70(11):3627-3634.