Guidance on the establishment of acceptable daily exposure limits (ADE) to support Risk-Based Manufacture of Pharmaceutical Products

Regulatory Toxicology and Pharmacology

Volumn 65, Issue 2, 2013, Pages 242-250

  Sargent, Edward V ^a,b   Faria, Ellen ^c   Pfister, Thomas ^d   Sussman, Robert G ^e  

^a UNIVERSITY OF MEDICINE AND DENTISTRY OF NEW JERSEY   (United States)

^b Strategic Innovative Solutions   (United States)

^c JOHNSON AND JOHNSON   (United States)

^d F HOFFMANN LA ROCHE LTD   (Switzerland)

^e SafeBridge Consultants Inc ^*  (United States)

Author keywords

Acceptable daily exposure; Active pharmaceutical ingredients; Cleaning validation; GmP

Indexed keywords

DRUG;

AREA UNDER THE CURVE; ARTICLE; BIOAVAILABILITY; CLEANING; DOCUMENTATION; DOSE RESPONSE; DRUG CLEARANCE; DRUG ELIMINATION; DRUG HALF LIFE; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; DRUG SURVEILLANCE PROGRAM; FACTORIAL ANALYSIS; HAZARD ASSESSMENT; HUMAN; OCCUPATIONAL EXPOSURE; OCCUPATIONAL SAFETY; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RISK ASSESSMENT; RISK MANAGEMENT; SPECIES DIFFERENCE; TOXICOLOGY; UNSPECIFIED SIDE EFFECT;

EID: 84872810678     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2012.12.007     Document Type: Article

References (44)

1. Barnes D.G., Dourson M. Reference dose (RfD): description and use in health risk assessments. Regul. Toxicol. Pharmacol. 1988, 8:471-486.
2. Castorina R., Woodruff T.J. Assessment of potential risk levels associated with US environmental protection agency reference values. Environ. Health Perspect. 2003, 111:1318-1325.
3. Crump K.S. A new method for determining allowable daily intakes. Fundam. Appl. Toxicol. 1984, 4:854-871.
4. Dolan D.G., Naumann B.D., Sargent E.V., Maier A., Dourson M. Application of the threshold of toxicological concerns concept to pharmaceutical manufacturing operations. Regul. Toxicol. Pharmacol. 2005, 43:1-9.
5. Dourson M.L., Felter S.P., Robinson D. Evaluation of science-based uncertainty factors in noncancer risk assessment. Regul. Toxicol. Pharmacol. 1996, 24:108-120.
6. Dourson M.L., Stara J.F. Regulatory history and experimental support of uncertainty (safety) factors. Regul. Toxicol. Pharmacol. 1983, 3:224-238.
7. ECHA (European Chemicals Agency), 2009. Guidance on the application of the CLP criteria. Available from:. http://echa.europa.eu.
8. ECHA, 2010. Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterization of dose [concentration]-response for human health, Version 2. Available from:. http://echa.europa.eu.
9. EMEA (European Medicines Agency), 2006. Guideline on the Limits of Genotoxic Impurities. Available from:. http://www.emea.europa.eu.
10. EMEA, 2005. Concept paper dealing with the need for updated GMP guidance concerning dedicated manufacturing facilities in the manufacture of certain medicinal products. Available from:. http://www.emea.europa.eu.
11. EPA, 2011. External review draft of data-derived extrapolation factors. Available from:. http://www.epa.gov/raf/DDEF/index.htm.
12. Fiori J.M., Meyerhoff R.D. Extending the threshold of regulation concept: de minimus limits for carcinogens and mutagens. Regul. Toxicol. Pharmacol. 2002, 35:209-216.
13. FDA (Food and Drug Administration), 2005. Guidance for Industry, Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research.
14. FDA, 2008. Draft Guidance for Industry Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches. Available from:. http://fda.gov/cder/guidance/7834dft.htm.
15. Galer D.L., Leung H.L., Sussman R.G., Trzos R.J. Scientific and practical considerations for the development of occupational exposure limits (OELs) for chemical substances. Regul. Toxicol. Pharmacol. 1992, 19:317-337.
16. Hattis D., Erdreich L., Ballew M. Human variability in susceptibility to toxic chemicals - a preliminary analysis of pharmaceutical data from normal volunteers. Risk Anal. 1987, 7:415-426.
17. ICH (International Conference on Harmonization), 1998. International Conference on Harmonization: Q3C (R3) Impurities: Residual Solvents. Step 5, Note for guidance on impurities: residual solvents, CPMP/ICH/283/95. Available from:. http://www.ich.org.
18. ICH, 2005. Quality Risk Management - Q9. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Available from:. http://www.ich.org.
19. IPCS (International Programme on Chemical Safety) Assessing human health risks of chemicals: the derivation of guidance values for health-based exposure limits. Environmental Health Criteria 170 1994, World Health Organization, Geneva, Switzerland.
20. IPCS Guidance document for the uses of data in development of chemical-specific adjustment factors (CSAFs) for interspecies differences and human variability in dose/concentration-response assessment 2001, World Health Organization, Geneva, Switzerland.
21. IPCS Chemical-specific adjustment factors for interspecies differences and human variability: guidance document for use of data in dose/concentration-response assessment 2005, World Health Organization, Geneva, Switzerland.
22. ISPE (International Society for Pharmaceutical Engineering) Risk-Based Manufacture of Pharmaceutical Products 2010, vol. 7. International Society for Pharmaceutical Engineering, Tampa, FL. first ed.
23. Jarabek A.M. Inhalation RfC methodology: dosimetric adjustments and dose-response estimation of noncancer toxicity in the upper respiratory tract. Inhal. Toxicol. 1994, 6(Suppl):301-325.
24. Johannsen F.R. Risk assessment of carcinogenic and noncarcinogenic chemicals. Crit. Rev. Toxicol. 1990, 20:341-368.
25. Kadry A.M., Skowronski G.A., Abdel-Rahman M.S. Evaluation of the use of uncertainty factors in deriving RfDs for some chlorinated compounds. J. Toxicol. Env. Health. 1995, 44:83-95.
26. Kroes R., Galli C., Munro I.C., Schilter B., Tran L.A., Walker R., Wurtzen G. Threshold of toxicological concern for chemical substances present in the diet: a practical tool for assessing the need for toxicity testing. Food Chem. Toxicol. 2000, 38:255-312.
27. Lehman A.J., Fitzhugh O.G. 100-Fold margin of safety. Assoc. Food Drug Off. U.S.Q. Bull. 1954, 13:51-58.
28. Lewis S.C., Lynch J.R., Nikiforov A.I. A new approach to deriving community exposure guidelines from "no-observed-adverse-effect levels". Regul. Toxicol. Pharmacol. 1990, 11:314-330.
29. Lu F.C. Acceptable daily intake: inception, evolution and application. Regul. Toxicol. Pharmacol. 1998, 8:45-60.
30. Meek B., Ohanian E., Renwick A., et al. Guidelines for application of chemical-specific adjustment factors in dose/concentration assessment. Comments Toxicol. 2001, 7:575-590.
31. Muller L., Mauthe R.J., Riley C.M., et al. A rationale for determining, testing and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity. Regul. Toxicol. Pharmacol. 2006, 44:198-211.
32. Munro I.C., Ford R.A., Kennepohl E., Sprenger J.G. Correlation of structural class with no observed-effect levels: a proposal for establishing a threshold of concern. Food Chem. Toxicol. 1996, 34:829-867.
33. NRC (National Research Council) Risk Assessment in the Federal Government: Managing the Process 1983, National Academy Press, Washington, DC.
34. Naumann B.D., Silverman K.C., Dixit R., Faria E.C., Sargent E.V. Case studies of categorical data-derived adjustment factors. Hum. Ecol. Risk Assess. 2001, 7:61-105.
35. Naumann B.D., Weideman P.A. Scientific basis for uncertainty factors used to establish occupational exposure limits for pharmaceutical active ingredients. Hum. Ecol. Risk Assess. 1995, 1:590-613.
36. Naumann B.D., Weideman P.A., Dixit R., Grossman S.J., Shen C.F., Sargent E.V. Use of toxicokinetic and toxicodynamic data to reduce uncertainties when setting occupational exposure limits for pharmaceuticals. Hum. Ecol. Risk Assess. 1997, 3:555-565.
37. Naumann B.D., Weideman P.A., Sarangapani R., Hu S.C., Dixit R., Sargent E.V. Investigations of the use of bioavailability data to adjust occupational exposure limits for active pharmaceutical ingredients. Toxicol. Sci. 2009, 112:196-210.
38. Renwick A.G. Data-derived safety factors for the evaluation of food additives and environmental contaminants. Food Addit. Contam. 1993, 10:275-305.
39. Sargent E.V., Kirk G.D. Establishing airborne exposure control limits in the pharmaceutical industry. Am. Ind. Hyg. Assoc. J. 1988, 49:303-313.
40. Sargent E.V., Naumann B.D., Dolan D.G., Faria E.C., Schulman L. The importance of human data in the establishment of occupational exposure limits. Hum. Ecol. Risk Assess. 2002, 8:805-822.
41. Sargent E.V. Biomarkers in occupational safety and health. Toxicologic Biomarkers 2006, Marcel Dekker, New York. A. DeCaprio (Ed.).
42. Sargent E.V., Naumann B.D., Schwartz C.S. Occupational toxicology testing. Toxicological Testing and Evaluation 2010, vol. 2. Elsevier Science Ltd., Oxford. second ed. C. McQueen (Ed.).
43. Silverman K.C., Naumann B.D., Holder D.J., Dixit R., Faria E.C., Sargent E.V., Gallo M.A. Establishing data-derived adjustment factors from published pharmaceutical clinical trial data. Hum. Ecol. Risk Assess. 1999, 5:1059-1089.
44. Sussman R.G., Sargent E.V., Davidson T.L. Dose response analysis in experimental toxicology and risk assessment. General and Applied Toxicology 2010, The Macmillan Press Ltd, United Kingdom. third ed. B. Ballantyne, T. Marrs, P. Turner (Eds.).