Use of a Monte Carlo analysis within a physiologically based pharmacokinetic model to predict doxycycline residue withdrawal time in edible tissues in swine

Food Additives and Contaminants - Part A Chemistry, Analysis, Control, Exposure and Risk Assessment

Volumn 29, Issue 1, 2012, Pages 73-84

  Yang, F ^a   Liu, H W ^a   Li, M ^a   Ding, H Z ^a   Huang, X H ^a   Zeng, Z L ^a  

^a SOUTH CHINA AGRICULTURAL UNIVERSITY   (China)

Author keywords

Animal products; Antimicrobials; Meat; Modelling; Risk assessment; Veterinary drug residues

Indexed keywords

FORECASTING; HISTOLOGY; MAMMALS; MEATS; MODELS; MONTE CARLO METHODS; PHARMACOKINETICS; PHYSIOLOGICAL MODELS; PHYSIOLOGY; REGRESSION ANALYSIS; RISK ASSESSMENT;

ACCURATE PREDICTION; ANIMAL PRODUCTS; ANTIMICROBIALS; INDIVIDUAL DIFFERENCES; MONTE CARLO ANALYSIS; PARTITION COEFFICIENT; PHYSIOLOGICALLY BASED PHARMACOKINETIC MODELS; VETERINARY DRUG RESIDUE;

TISSUE;

DOXYCYCLINE; DRUG RESIDUE;

ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; BIOLOGICAL MODEL; DRUG BLOOD LEVEL; DRUG DIFFUSION; DRUG METABOLISM; DRUG TISSUE LEVEL; DRUG WITHDRAWAL; FEMALE; INJECTION SITE; KIDNEY; LIVER; MALE; MONTE CARLO METHOD; MUSCLE; NONHUMAN; PRIORITY JOURNAL; SKIN; STEADY STATE; SWINE; TIME;

EID: 84863176374     PISSN: 19440049     EISSN: 19440057     Source Type: Journal    
DOI: 10.1080/19440049.2011.624126     Document Type: Article

References (48)

1. Abd El-Aty, AM, Goudah, A, and Zhou, HH. 2004. Pharmacokinetics of doxycycline after administration as a single intravenous bolus and intramuscular doses to non-lactating Egyptian goats. Pharmacol Res, 49:487–491.
2. Adir, J. 1975. Enterohepatic circulation of tetracycline in rats. J Pharm Sci, 64:1847–1850.
3. Andre, T. 1956. Studies on the distribution of tritium-labelled dihydrostreptomycin and tetracycline in the body. Acta Radiol Suppl, 142:1–89.
4. Antalovska, Z. 1966. Laws of tetracycline antibiotic deposition in rat incisors. J Dent Res, 45:1430–1438.
5. Aronson, AL. 1980. Pharmacotherapeutics of the newer tetracyclines. J Am Vet Med Assoc, 176:1061–1068.
6. Baert, K, Croubels, S, Gasthuys, F, De Busser, J, and De Backer, P. 2000. Pharmacokinetics and oral bioavailability of a doxycycline formulation (DOXYCYCLINE 75%) in nonfasted young pigs. J Vet Pharmacol Ther, 23:45–48.
7. Bousquet, E, Nouws, J, Terlouw, P, and De Kleyne, S. 1998. Pharmacokinetics of doxycycline in pigs following oral administration in feed. Vet Res, 29:475–485.
8. Brocklebank, JR, Namdari, R, and Law, FCP. 1997. An oxytetracycline residue depletion study to assess the physiologically based pharmokinetic (PBPK) model in farmed Atlantic salmon. Can Vet J, 38:645–646.
9. Bryant, SG, Fisher, S, and Kluge, RM. 1987. Increased frequency of doxycycline side effects. Pharmacotherapy, 7:125–129.
10. Buur, JL, Baynes, RE, Craigmill, AL, and Riviere, JE. 2005. Development of a physiologic-based pharmacokinetic model for estimating sulfamethazine concentrations in swine and application to prediction of violative residues in edible tissues. Am J Vet Res, 66:1686–1693.
11. Buur, JL, Baynes, RE, and Riviere, JE. 2008. Estimating meat withdrawal times in pigs exposed to melamine contaminated feed using a physiologically based pharmacokinetic model. Regul Toxicol Pharmacol, 51:324–331.
12. Buur, JL, Baynes, RE, Smith, G, and Riviere, J. 2006. Use of probabilistic modeling within a physiologically based pharmacokinetic model to predict sulfamethazine residue withdrawal times in edible tissues in swine. Antimicrob Agents Chemother, 50:2344–2351.
13. Buyske, DA, Eisner, HJ, and Kelly, RG. 1960. Concentration and persistence of tetracycline and chlortetracycline in bone. J Pharmacol Exp Ther, 130:150–156.
14. Castro, LJ, Sahagun, AM, Diez, MJ, Fernandez, N, Sierra, M, and Garcia, JJ. 2009. Pharmacokinetics of doxycycline in sheep after intravenous and oral administration. Vet J, 180:389–395.
15. Cortright, KA, Wetzlich, SE, and Craigmill, AL. 2009. A PBPK model for midazolam in four avian species. J Vet Pharmacol Ther, 32:552–565.
16. Craigmill, AL. 2003. A physiologically based pharmacokinetic model for oxytetracycline residues in sheep. J Vet Pharmacol Ther, 26:55–63.
17. CVMP Committee for Veterinary Medicinal. Products. Note for Guidance:Approach Towards Harmonisation of Withdrawal Periods. [Internet]. 1996. CVMP:EMA; [cited 2011 May 15]. Available from:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf
18. CVMP Committee for Veterinary Medicinal. Products. Guideline on injection site. [Internet]. 2005. CVMP:EMA; [cited 2011 August 24]. Available from:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004429.pdf
19. Davis, JL, Salmon, JH, and Papich, MG. 2006. Pharmacokinetics and tissue distribution of doxycycline after oral administration of single and multiple doses in horses. Am J Vet Res, 67:310–316.
20. El-Gendi, AYI, Atef, M, Amer, AMM, and Kamel, GM. 2010. Pharmacokinetic and tissue distribution of doxycycline in broiler chickens pretreated with either:Diclazuril or halofuginone. Food Chem Toxicol, 48:3209–3214.
21. EMA Committee for veterinary medicinal. products:Doxycycline (summary report 2). [Internet]. 1997. CVMP:EMA; [cited 2011 May 15]. Available from:http://www.ema.europa.eu/docs/en_GB/document_library/Maximum_Residue_Limits_-_Report/2009/11/WC500013941.pdf
22. European Commission. Commission regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (Text with EEA relevance) [Internet]. 2010. European Commission; [cited 2011 August 19]. Available from:http://ec.europa.eu/health/files/eudralex/vol-5/reg_2010_37/reg_2010_37_en.pdf
23. Falcao, AC. 2009. Predictive modeling and risk assessment, Berlin:Springer. Chapter 9, Antibiotics in Animal Products; p. 155–179
24. FDA Guidance for establishing. a withdrawal period [Internet]. 2006. FDA; [cited 2011 August 23]. Available from:http://www.fda.gov/downloads/animalveterinary/guidancecomplianceenforcement/guidanceforindustry/ucm052180.pdf
25. Gustafson, DL, and Thamm, DH. 2010. Pharmacokinetic modeling of doxorubicin pharmacokinetics in dogs deficient in ABCB1 drug transporters. J Vet Intern Med, 24:579–586.
26. Ismail, MM, and El-Kattan, YA. 2004. Disposition kinetics of doxycycline in chickens naturally infected with Mycoplasma gallisepticum. Br Poult Sci, 45:550–556.
27. Jarvinen, A, Nykanen, S, Paasiniemi, L, Hirsjarvi-Lahti, T, and Mattila, J. 1995. Enteric coating reduces upper gastrointestinal adverse reactions to doxycycline. Clin Drug Invest, 10:323–327.
28. Lacey, LF, Keene, ON, Pritchard, JF, and Bye, A. 1997. Common noncompartmental pharmacokinetic variables:are they normally or log-normally distributed? J Biopharm Stat. 7,:171–178.
29. Li, M, Liu, W, Huang, X, and Zeng, Z. 2011. Residual elimination of long-acting doxycline hydrochloride injection in swine. Chin J Vet Sci, 31:227–236. (in Chinese)
30. Michel, G, Mosser, J, and Olle, J. 1984. Pharmacokinetics and tissue localization of doxycycline polyphosphate and doxycycline hydrochloride in the rat. Eur J Drug Metab Pharmacokinet, 9:149–153.
31. Milch, RA, Rall, DP, and Tobie, JE. 1967. Bone localization of the tetracyclines. J Natl Cancer Inst, 19:87–91.
32. Nielsen, P, and Gyrd-Hansen, N. 1996. Bioavailability of oxytetracycline, tetracycline and chlortetracycline after oral administration to fed and fasted pigs. J Vet Pharmacol Ther, 19:305–311.
33. Nouws, JF, Smulders, A, and Rappalini, M. 1990. A comparative study on irritation and residue aspects of five oxytetracycline formulations administered intramuscularly to calves, pigs and sheep. Vet Q, 12:129–138.
34. Ole-Mapenay, IM, and Mitema, ES. 1995. Some pharmacokinetic parameters of doxycycline in east African goats after intramuscular administration of a long-acting formulation. Vet Res Commun, 19:425–432.
35. Riond, JL, and Riviere, JE. 1988. Pharmacology and toxicology of doxycycline. Vet Hum Toxicol, 30(5):431–443.
36. Riond, JL, and Riviere, JE. 1990. Pharmacokinetics and metabolic inertness of doxycycline in young pigs. Am J Vet Res, 51:1271–1275.
37. Santos, MD, Vermeersch, H, Remon, JP, Schelkens, M, De Backer, P, Van Bree, HJ, Ducatelle, R, and Haesebrouck, F. 1996. Pharmacokinetics and bioavailability of doxycycline in turkeys. J Vet Pharmacol Ther, 19:274–280.
38. Segelnick, SL, and Weinberg, MA. 2008. Recognizing doxycycline-induced esophageal ulcers in dental practice:a case report and review. J Am Dent Assoc, 139:581–585.
39. Shaw, DH, and Rubin, SI. 1986. Pharmacologic activity of doxycycline. J Am Vet Med Assoc, 189:808–810.
40. Shin, BS, Hong, SH, Bulitta, JB, Lee, JB, Hwang, SW, Kim, HJ, Yang, SD, Yoon, HS, Kim, DJ, Lee, BM. 2009. Physiologically based pharmacokinetics of zearalenone. J Toxicol Environ Health A, 72:1395–1405.
41. Thomas, RS, Lytle, WE, Keefe, TJ, Constan, AA, and Yang, RS. 1996. Incorporating Monte Carlo simulation into physiologically based pharmacokinetic models using advanced continuous simulation language (ACSL):a computational method. Fundam Appl Toxicol, 31:19–28.
42. Vargas-Estrada, D, Gracia-Mora, J, and Sumano, H. 2008. Pharmacokinetic study of an injectable long-acting parenteral formulation of doxycycline hyclate in calves. Res Vet Sci, 84:477–482.
43. Vargas-Estrada, D, Gutierrez, L, Juarez-Rodriguez, I, and Sumano, H. 2008. Pharmacokinetics of doxycycline and tissue concentrations of an experimental long-acting parenteral formulation of doxycycline in Wistar rats. Arzneimittelforschung, 58:310–315.
44. Verdel, BM, Souverein, PC, Meyboom, RHB, Kardaun, SH, Leufkens, HGM, and Egberts, ACG. 2009. Risk of drug-induced photosensitivity:focus on spectroscopic and molecular characteristics. Pharmacoepidemiol Drug Saf, 18:602–609.
45. Wang, JH, Cao, JY, Zai, KY, Li, X, and Zeng, LG. 2008. Pharmacokinetics and residues of doxycycline hydrochloride in pigs. Chin J Vet Sci, 28:1313–1320. (in Chinese)
46. Wilson, RC, Kemp, DT, Kitzman, JV, and Goetsch, DD. 1988. Pharmacokinetics of doxycycline in dogs. Can J Vet Res, 52:12–14.
47. Yuan, LG, Luo, XY, Zhu, LX, Wang, R, and Liu, YH. 2011. A physiologically based pharmacokinetic model for valnemulin in rats and extrapolation to pigs. J Vet Pharmacol Ther, 34:224–231.
48. Ziv, G, and Sulman, FG. 1974. Analysis of pharmacokinetic properties of nine tetracyline analogs in dairy-cows and ewes. Am J Vet Res, 35:1197–1201.