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EPA uncertainty factor workshop

Scientific basis for uncertainty factors used to establish occupational exposure limits for pharmaceutical active ingredients

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Pages 590-613 | Published online: 02 Dec 2008

References

  • Agius , R. 1989 . Occupational exposure limits for therapeutic substances . Ann. Occup. Hyg. , 33 : 555 – 562 .
  • Allen , B.C. , Kavlock , R.J. , Kimmel , C.A. and Faustman , E.M. 1994 . Comparison of generic benchmark dose estimates with no observed adverse effect levels . Fund. Appl. Toxicol. , 23 ( 4 ) : 487 – 495 .
  • Babhair , S.A. , Tariq , M. and Abdullah , M.E. 1990 . Comparison of intravenous and nasal bioavailability of clonidine in rodents . Res. Commun. Chem. Pathol. Pharmacol. , 67 ( 2 ) : 241 – 248 .
  • Barnes , D.G. and Dourson , M. 1988 . Reference Dose (RfD): Description and use in health risk assessments . Regul. Toxicol. Pharmacol. , 8 : 471 – 486 .
  • Bates , T.R. and Gibaldi , M. 1970 . “ Gastrointestinal absorption of drugs. ” . In Current Concepts in the Pharmaceutical Sciences: Biopharmaceutics , Edited by: Swarbrick , J. 58 – 99 . Philadelphia : Lea 8c Febiger .
  • Brown , R.A. Jr. and Schanker , L.S. 1983 . Absorption of aerosolized drugs from the rat lung . Drug Metabol. Disp. , 11 ( 4 ) : 355 – 360 .
  • Calabrese , E.J. 1985 . Uncertainty factors and interindividual variation . Regul. Toxicol. Pharmacol. , 5 : 190 – 196 .
  • Calabrese , E.J. , Beck , B.D. and Chappell , W.R. 1992 . Does the animal‐to‐human uncertainty factor incorporate interspecies differences in surface area? . Regul. Toxicol. Pharmacol. , 15 : 172 – 179 .
  • Calabrese , E.J. and Gilbert , C.E. 1993 . Lack of total independence of uncertainty factors (UFs): implications for the size of the total uncertainty factor . Regul. Toxicol. Pharmacol. , 17 ( 1 ) : 44 – 51 .
  • Cicmanec , J.L. , Poirier , K.A. and Dourson , M.L. 1994 . A non‐cancer quantitative risk assessment for Aroclor 1016 . The Toxicologist , 14 ( 1 ) : 402
  • Clewell , H.J. and Anderson , M.E. 1994 . Physiologically‐based pharmacokinetic modeling and bioactivation of xenobiotics . J. Toxicol. Indust. Health , 10 ( 1/2 ) : 1 – 24 .
  • Conolly , R.B. and Anderson , M.E. 1991 . Biologically based pharmacodynamic models: Tools for toxicological research and risk assessment . Annu. Rev. Pharmacol. Toxicol. , 31 : 503 – 523 .
  • Crump , K.S. 1984 . A new method for determining allowable daily intakes . Fund. Appl. Toxicol. , 4 : 854 – 871 .
  • Dahl , A.R. and Hadley , W.M. 1991 . Nasal cavity enzymes involved in xenobiotic metabolism: Effects on the toxicity of inhalants . Crit. Rev. Toxicol. , 21 ( 5 ) : 345 – 372 .
  • Davidson , I.W.F. , Parker , J.C. and Beliles , R.P. 1986 . Biological basis for extrapolation across mammalian species . Regul. Toxicol. Pharmacol. , 6 : 211 – 237 .
  • Dollery , C.T. , Davies , D.S. and Conolly , M.E. 1971 . Differences in the metabolism of drugs depending upon their routes of administration . Ann. N. Y. Acad. Sci. , 179 : 108 – 114 .
  • Dourson , M.L. and Stara , J.F. 1983 . Regulatory history and experimental support of uncertainty (safety) factors . Regul. Toxicol. Pharmacol. , 3 : 224 – 238 .
  • Frantz , S.W. , Beatty , P.W. , English , J.C. , Hundley , S.G. and Wilson , A.G.E. 1994 . The use of pharmacokinetics as an interpretive and predictive tool in chemical toxicology testing and risk assessment: A position paper on the appropriate use of pharmacokinetics in chemical toxicology . Regul. Toxicol. Pharmacol. , 19 : 317 – 337 .
  • Gad , S.C. 1994 . Routes in toxicology: An overview . J. Amer. Coll. Toxicol. , 13 ( 1 ) : 34 – 39 .
  • Galer , D.M. , Leung , H.W. , Sussman , R.G. and Trzos , R.J. 1992 . Scientific and practical considerations for the development of occupational exposure limits (OELs) for chemical substances . Regul. Toxicol. Pharmacol. , 15 : 291 – 306 .
  • Goddard , M.J. and Krewski , D. 1992 . Interspecies extrapolation of toxicity data . Risk Anal. , 12 ( 2 ) : 315 – 317 .
  • Harkema , J.R. 1991 . Comparative aspects of nasal airway anatomy: Relevance to inhalation toxicology . Toxicol. Pathol. , 19 ( 4 ) : 321 – 336 . Part 1,
  • Hattis , D. and Burmaster , D.E. 1994 . Assessment of variability and uncertainty distributions for practical risk analyses . Risk Anal. , 14 ( 5 ) : 713 – 730 .
  • 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 .
  • IPCS (International Programme on Chemical Safety) . 1994 . “ Assessing human health risks of chemicals: The derivation of guidance values for health‐based exposure limits ” . In Environmental Health Criteria 170 , Geneva : World Health Organization .
  • Jarabek , A.M. 1994 . Inhalation RfC methodology: Dosimetric adjustments and dose‐response estimation of noncancer toxicity in the upper respiratory tract . Inhal. Toxicol. , 6 (suppl) : 301 – 325 .
  • Johannsen , F.R. 1990 . Risk assessment of carcinogenic and noncarcinogenic chemicals . Crit. Rev. Toxicol. , 20 ( 5 ) : 341 – 368 .
  • Kadry , A.M. , Skowronski , G.A. and Abdel‐Rahman , M.S. 1995 . Evaluation of the use of uncertainty factors in deriving RfDs for some chlorinated compounds . J. Toxicol. Env. Health , 44 : 83 – 95 .
  • Kimmel , C.A. 1990 . Quantitative approaches to human risk assessment for noncancer health effects . Neurotoxicol. , 11 ( 2 ) : 189 – 198 .
  • Krasovskii , G.N. 1976 . Extrapolation of experimental data from animals to man . Environ. Health Persp. , 13 : 51 – 58 .
  • Lehman , A.J. and Fitzhugh , O.G. 1954 . 100‐Fold margin of safety . Assoc. Food Drug Off. U. S. Q. Bull. , 18 : 33 – 35 .
  • Lewis , S.C. , Lynch , J.R. and Nikiforov , A. I. 1990 . A new approach to deriving community exposure guidelines from “no‐observed‐adverse‐effect levels.” . Regul. Toxicol. Pharmacol. , 11 : 314 – 330 .
  • Lewis , S.C. 1993 . Reducing uncertainty with adjustment factors. In: Improvements in quantitative noncancer risk assessment (A symposium overview) . Fund. Appl. Toxicol. , 20 : 1 – 14 .
  • Lewis , S.C. and Nessel , C.S. 1994 . Extrapolating subchronic test results to estimate chronic no‐observed‐adverse‐effect levels: Factors of 10 are larger than necessary . The Toxicologist , 14 ( 1 ) : 401
  • Lu , F.C. 1988 . Acceptable Daily Intake: Inception, evolution and application . Regul. Toxicol. Pharmacol. , 8 : 45 – 60 .
  • McClellan , R.O. 1994 . A commentary on the NRC report “Science and Judgment in Risk Assessment.” . Regul. Toxicol. Pharmacol. , 20 : S142 – S168 .
  • McNamara , B.P. 1976 . “ Concepts in health evaluation of commercial and industrial chemicals. ” . In New Concepts in Safety Evaluation , Edited by: Mehlman , M.A. , Shapiro , R.E. and Blumenthal , H. 61 – 140 . Washington, DC : Hemisphere .
  • Mordenti , J. and Chappell , W. 1989 . “ The use of interspecies scaling in toxicokinetics. ” . In Toxicokinetics and New Drug Development , Edited by: Yacobi , A. , Skelly , J.P. and Batra , V. K. 42 – 96 . New York : Pergamon Press .
  • Naumann , B.D. , Sargent , E.V. , Starkman , B.S. , Fraser , W.J. , Becker , G.T. and Kirk , G.D. 1996 . Performance‐based exposure control limits for pharmaceutical active ingredients . Am. Ind Hyg. Assoc. J. , 57 : 33 – 42 .
  • Patton , J.S. and Platz , R.M. 1992 . Pulmonary delivery of peptides and proteins for systemic action . Adv. Drug Deliv. Rev. , 8 : 179 – 196 .
  • PDR . 1995 . Physicians Desk Reference, , 49th Edition , 1490 – 1658 . Montvale : Medical Economics Data Production Company .
  • Pepelko , W.E. and Withey , J.R. 1985 . Methods for route‐to‐route extrapolation of dose . Toxicol. Indust. Health , 1 ( 4 ) : 153 – 175 .
  • Peters‐Volleberg , G.W.M. , De Waal , E.J. and Van Der Laan , J.W. 1994 . Interspecies extrapolation in safety evaluation of human medicines in the Netherlands (1990–1992): Practical considerations . Regul. Toxicol. Pharmacol. , 20 : 248 – 258 .
  • Renwick , A.G. 1991 . Safety factors and establishment of acceptable daily intakes . Food Additives and Contaminants , 8 ( 2 ) : 135 – 150 .
  • Renwick , A.G. 1993 . Data‐derived safety factors for the evaluation of food additives and environmental contaminants . Food Additives and Contaminants , 10 ( 3 ) : 275 – 305 .
  • Sargent , E.V. and Kirk , G.D. 1988 . Establishing airborne exposure control limits in the pharmaceutical industry . Am. Ind Hyg. Assoc. J. , 49 ( 6 ) : 309 – 313 .
  • Schanker , L.S. 1978 . Drug absorption from the lung . Biochem. Pharmacol. , 27 : 381 – 385 .
  • Schlesinger , R.B. 1985 . Comparitive deposition of inhaled aerosols in experimental animals and humans: A review . J. Toxicol. Environ. Health , 15 : 197 – 214 .
  • Shand , D.G. , Nuckolls , E.M. and Oates , J.A. 1970 . Plasma propranolol levels in adults with observations in four children . Clin. Pharmacol. Therap. , 11 : 112 – 120 .
  • Travis , C.C. and Morris , J.M. 1992 . On the use of 0.75 as an interspecies scaling factor . Risk Anal. , 12 ( 2 ) : 311 – 313 .
  • Truhaut , R. 1991 . The concept of the acceptable daily intake: An historical review . Food Additives and Contaminants , 8 ( 2 ) : 151 – 162 .
  • Vbisin , E.M. , Ruthsatz , M. , Collins , J.M. and Hoyle , P.C. 1990 . Extrapolation of animal toxicity to humans: Interspecies comparisons in drug development . Regul. Toxicol. Pharmacol. , 12 : 107 – 116 .
  • Watanabe , K. , Bois , F.Y. and Zeise , L. 1992 . Interspecies extrapolation: A reexamination of acute toxiciry data . Risk Anal. , 12 ( 2 ) : 301 – 310 .
  • Weil , C.S. and McCollister , D.D. 1963 . Relationship between short‐ and long‐term feeding studies in designing an effective toxicity test . Agr. Food Chem. , 11 ( 6 ) : 486 – 491 .
  • Weil , C.S. 1972 . Statistics vs. safety factors and scientific judgment in the evaluation of safety for man . Toxicol. Appl. Pharmacol. , 21 : 454 – 463 .
  • Welling , P.G. 1986 . “ Dosage routes, bioavailability, and clinical efficacy. ” . In Pharmacokinetics: Regulatory, Industrial, and Academic Perspectives , Edited by: Welling , P.G. and Tse , F.L.S. 97 – 157 . New York : Marcel Dekker, Inc. .
  • Woutersen , R.A. , Til , H.P. and Feron , V.J. 1984 . Sub‐acute versus sub‐chronic oral toxiciry study in rats: Comparative study of 82 compounds . J. Appl. Toxicol. , 4 ( 5 ) : 277 – 280 .
  • Zielhuis , R.L. and van der Kreek , F.W. 1979 . The use of a safety factor in setting health based permissible levels for occupational exposure . Int. Arch. Occup. Environ. Health , 42 : 191 – 201 .
  • To whom reprints requests should be addressed; Merck 8c Co., Inc., One Merck Drive, WS2F‐45, Whitehouse Station, NJ 08889–0100

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