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Original Articles

Kinetic and dynamic data of analgesics and NSAIDs drugs reduce 10X uncertainty factors

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Pages 567-578 | Published online: 02 Dec 2008

References

  • Advenier , C. , Roux , A. , Gobert , C. , Massias , P. , Varoquaux , O. and Flouvat , B. 1983 . Pharmacokinetics of ketoprofen in the elderly . Br. J. Pharmacol. , 16 : 65 – 70 .
  • Aw , T.Y. , Shan , X. , Sillau , A. H. and Jones , D.P. 1991 . Effect of chronic hypoxia on acetaminophen metabolism in the rat . Biochem. Pharmacol. , 42 ( 5 ) : 1029 – 1038 .
  • Barnes , D.G. and Dourson , M. 1988 . Reference dose (RfD): Description and use in health risk assessments . Regul. Toxicol. Pharmacol. , 8 : 471 – 486 .
  • Beaulac‐Baillargeon , L. and Rocheleau , S. 1994 . Paracetamol pharmacokinetics during the first trimester of human pregnancy . Eur. J. Clin. Pharmacol. , 46 : 451 – 454 .
  • Borzelleca , J.F. 1991 . Commentary on ‘Assessment of safety/risk of chemicals: inception and evolution of the ADI and dose‐response modeling procedures’ by Frank C. Lu and Robert L. Sielken, Jr. . Toxicol. Lett. , 59 : 1 – 4 .
  • Brunborg , G. , Holme , J.A. and Hongslo , J.K. 1995 . Inhibitory effects of paracetamol on DNA repair in mammalian cells . Mut. Res. , 342 : 157 – 170 .
  • Conolly , R.B. 1995 . Cancer and non‐cancer risk assessment not so different if you consider mechanisms . Toxicol , 102 : 179 – 188 .
  • Cuny , G. , Royer , R. J. , Mur , J. M. , Serot , J. M. , Faure , G. , Netter , P. , Maillard , A. and Penin , F. 1979 . Pharmacokinetics of salicylates in elderly . Geront. , 25 : 49 – 55 .
  • Dahlin , D.C. , Miwa , G.T. , Lu , A.Y.A. and Nelson , S.D. 1984 . N‐acetyl‐p‐ benzoquinone imine: a cytochrome P‐450 mediated oxidation product of acetaminophen . Proc. Natl. Acad. Sci. , 81 : 1327 – 1331 .
  • Dohi , M. , Sakata , Y. , Seki , J. , Namikawa , Y. , Fujisaki , J. , Tanaka , A. , Takasugi , H. , Motoyama , Y. and Yoshida , K. 1993 . The anti‐platelet actions of FR122047, a novel cyclooxygenase inhibitor . Eur. J. Pharmacol. , 243 : 179 – 184 .
  • Dourson , M.L. , Felter , S.P. and Robinson , D. 1996 . Evolution of science‐based uncertainty factors in noncancer risk assessment . Regul Toxicol Pharmacol. , 24 : 108 – 120 .
  • Dybing , E. , Holme , J.A. , Gordon , W.P. , Soderlund , E.J. , Dahlin , D.C. and Nelson , S.D. 1984 . Genotoxicity studies with paracetamol . Mut. Res. , 138 : 21 – 32 .
  • Foster , R. T. and Jamali , F. 1988 . Stereo selective pharmacokinetics of ketoprofen in the rat . Drug Metab. Dispos. , 16 ( 4 ) : 623 – 626 .
  • Fu , C. J. , Melethil , S. and Mason , W. D. 1991 . The pharmacokinetics of aspirin in rats and the effect of buffer . J. Pharmacokin. Biopharm. , 19 ( 2 ) : 157 – 173 .
  • Geisslinger , G. , Schuster , O. , Stock , K.‐P. , Loew , D. , Bach , G.L. and Brune , K. 1990 . Pharmacokinetics of S(+)‐ and (R)‐ ibuprofen in volunteers and first clinical experience of S(+)‐ ibuprofen in rheumatoid arthritis . Eur. J. Clin. Pharmacol , 38 : 493 – 497 .
  • Hattis , D. , Erdreich , L. and Ballew , M. 1987 . Human variability in susceptibility to toxic chemicals ‐ a preliminary analysis of pharmacokinetic data from normal volunteers . Risk Anal. , 7 ( 4 ) : 415 – 426 .
  • Holme , J.A. , Wirth , P.J. , Dybing , E. and Thorgeirson , S.S. 1982 . Cytotoxic effects of N‐ hydroxy paracetamol in suspensions of isolated rat hepatocytes . Acta Pharmacol. Toxicol. Copenh. , 51 : 87 – 95 .
  • Honglso , J.K. , Bjornstad , C. , Schwarze , P.E. and Holme , J.A. 1984 . Inhibition of replicative DNA synthesis in V79 Chinese hamster cells . Toxicol. In Vitro , 3 : 13 – 20 .
  • Hongslo , J.K. , Christensen , T. , Brunborg , G. , Bjornstad , C. and Home , J.A. 1988 . Genotoxic effects of paracetamol in V79 Chinese hamster cells . Mut. Res. , 204 : 333 – 341 .
  • IPCS (International Programme on Chemical Safety) . 1994 . Environmental Health Criteria No. 170: Assessing human health risks of chemicals: Derivation of guidance values for health‐based exposure limits , Geneva : World Health Organization .
  • Lehman , A.J. and Fitzhugh , O.G. 1954 . 100‐fold margin of safety . Q. Bull. Assoc. Food Drug Off. U. S. Q. Bull. , 18 : 33 – 35 .
  • Miners , J.O. , Penhall , R. , Robson , R.A. and Birkett , D.J. 1988 . Comparison of paracetamol metabolism in young adult and elderly males . Eur. J. Clin. Pharmacol. , 35 : 157 – 160 .
  • Naumann , B.D. and Weideman , P.A. 1995 . Scientific basis for uncertainty factors used to occupational exposure limits for pharmaceutical active ingredients . Human and Ecol. Risk Assess. , 1 ( 5 ) : 590 – 613 .
  • Osborne , N.J. , Tonkin , A.L. and Miners , J.O. 1991 . Interethnic differences in drug glucuronidation: A comparision of paracetamol metabolism in Caucasians and Chinese . Br. J. Clin. Pharmacol. , 32 : 765 – 767 .
  • PDR (Physicians’ Desk Reference) . 1988 . Orudis (ketoprofen), , 42nd. Edition 2288
  • Renwick , A. G. 1993 . Data‐derived safety factors for the evaluation of food additives and environmental contaminants . Food Addit. and Contam. , 10 ( 3 ) : 275 – 305 .
  • Roediger , W.E.W. and Millard , S. 1995 . Selective inhibition of fatty acid oxidation in colonocytes by ibuprofen: a cause of colitis . Gut. , 36 : 55 – 59 .
  • Rudy , A.C. , Knight , P.M. , Brater , D.C. and Hall , S.D. 1995 . Enantioselective disposition of ibuprofen in elderly persons with and without renal impairment . J. Pharmacol Exp. Ther. , 273 : 88 – 93 .
  • Runkel , R. , Chaplin , M. , Boost , G. , Segre , E. and Forchielli , E. 1972 . Absorption, distribution, metabolism and excretion of naproxen in various laboratory animals and human subjects . J. Pharm. Sci. , 61 : 703 – 708 .
  • Sargent , E. V. and Kirk , G. D. 1988 . Establishing airbone exposure control limits in the pharmaceutical industry . Am. Ind. Hyg. Assoc. J. , 49 ( 6 ) : 309 – 313 .
  • Satterwhite , J.H. and Boudinot , F. D. 1992 . Pharmacokinetics of ketoprofen in rats: Effects of age and dose . Biopharm. Drug Disposit. , 13 : 197 – 211 .
  • Scherkl , R. and Frey , H.‐H. 1987 . Pharmacokinetics of ibuprofen in the dog . J. Vet. Pharmacol Therap. , 10 : 261 – 265 .
  • Schwartz , C. 1995 . A semiquanitiative method for selection of safety factors in establishing OELs for pharmaceutical compounds . Human and Ecol Risk Assess. , 1 ( 5 ) : 527 – 543 .
  • Van Den Ouweland , FA. , Franssen , M.JAM. , Van De Putte , L.B.A. , Tan , Y. , Van Ginneken , C.A.M. and Gribnau , F.W.J. 1987 . Naproxen pharmacokinetics in patients with rheumatoid arthritis during active polyarticular inflammation . Br. J. Pharmacol. , 23 : 189 – 193 .
  • Wells , T. G. , Mortensen , M. E. , Dietrich , A. , Walson , P.D. , Blasier , D. and Kearns , G.L. 1994 . Comparison of the pharmacokinetics of naproxen tablets and suspension in childern . J. Clin. Pharmacol. , 34 : 30 – 33 .
  • To whom correspondence should be addressed: University of Medicine and Dentistry of New Jersey, New Jersey Medical School, 185 South Orange Avenue, Room 1–655, Newark, New Jersey 07103–2714; Tel: (973) 972–6568; Fax: (973) 972–4554

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