Association of Inhalation Toxicologists' (AIT) review of regulatory aspects for inhalation toxicology studies

Inhalation Toxicology

Volumn 25, Issue 2, 2013, Pages 84-90

  Jones, David R ^a   Baldrick, Paul ^b  

^a MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

^b UK   (United Kingdom)

Author keywords

Inhalation Toxicology Guidelines

Indexed keywords

ACT; ACUTE TOXICITY; CARCINOGENICITY; CHRONIC TOXICITY; CLASSIFICATION; GOOD LABORATORY PRACTICE; GOVERNMENT REGULATION; HUMAN; INHALATION; INTERNATIONAL COOPERATION; LC 50; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; SAFETY; TOXICITY TESTING;

ADMINISTRATION, INHALATION; ANIMALS; DRUG TOXICITY; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HUMANS; INTERNATIONAL COOPERATION; PHARMACEUTICAL PREPARATIONS; SOCIETIES, SCIENTIFIC; TOXICITY TESTS;

EID: 84873320155     PISSN: 08958378     EISSN: 10917691     Source Type: Journal    
DOI: 10.3109/08958378.2012.757400     Document Type: Review

References (46)

1. Arts JH, Muijser H, Jonker D, et al. (2008). Inhalation toxicity studies: OECD guidelines in relation to REACH and scientific developments. Exp Toxicol Pathol 60:125-33.
2. Bide RW, Armour SJ, Yee E. (2004). Estimation of human toxicity from animal inhalation toxicity data. Defence Research Establishment Suffield Ralston, Alberta, Canada. Suffield Report 67.
3. Chapman K, Creton S, Kupferschmidt H, et al. (2010). The value of acute toxicity studies to support the clinical management of overdose and poisoning: a cross-discipline consensus. Reg Tox Pharm 58:354-9.
4. Costa DL. (2008). Alternative test methods in inhalation toxicology: challenges and opportunities. Exp Toxicol Pathol 60:105-9.
5. Creton S. (2012). Refining acute inhalation toxicity testing: the fixed concentration procedure. Tox Sci 126:52-3.
6. Degeorge JJ, Ahn CH, Andrews PA, et al. (1997). Considerations for toxicology studies of respiratory drug products. Reg Tox Pharmacol 25:189-93. (Pubitemid 27220201)
7. EU. (2004a). Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP).
8. EU. (2004b). Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances.
9. GHS. (2009). Globally harmonized system of classification and labelling of chemicals (GHS). Third revised ed. United Nations. Available from: http://Live.unece.org/trans/danger/publi/ghs/ghs-rev03/03files-e.html [last accessed 2012]
10. ICH. (1995). Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals. ICH M3.
11. ICH. (1998). Non-clinical safety evaluation of biotechnology-derived pharmaceuticals. ICH S6.
12. ICH. (2000). Safety pharmacology studies for human pharmaceuticals. ICH S7A.
13. ICH. (2009). Non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals. ICH M3(R2).
14. ICH. (2011). ICH guideline M3 (R2) - Questions and Answers. London: European Medicines Agency.
15. Japanese Technical Requirements. (1997). Japanese technical requirements for new drug registration. Tokyo: Yakuja Nippon Ltd.
16. Notice to Applicants. (2003). Volume 2B - Medicinal products for human use. In: The rules governing medicinal products in the European Union. Luxembourg: Office for Official Publications of the European Communities.
17. OECD. (1981). ''Acute Inhalation Toxicity''. OECD, 403. [Online] Available from: http://www.oecd.org/dataoecd/17/48/1948354.pdf [last accessed 2012].
18. OECD. (1998). Series on principles of good laboratory practice and compliance monitoring number 1. OECD Principles on Good Laboratory Practice (as revised in 1997). [Online] Available from: http://www.oecd-ilibrary.org/ environment/oecd-principles-on-goodlaboratory-practice-9789264078536-en [last accessed 2012].
19. OECD. (2004). Acute inhalation toxicity - fixed concentration procedure - draft proposal for a new guideline. OECD, 433. [Online] Available from: http://www.oecd.org/dataoecd/63/7/32035886.pdf [last accessed 2012].
20. OECD. (2009a). Acute Inhalation Toxicity. OECD, 403. [Online] Available from: http://www.oecd-library.org/environment/test-o-acute-inhalation-toxicity- 9789264070608-en.
21. OECD. (2009b). Acute inhalation toxicity - acute toxic class method. OECD, 436. [Online] Available from: http://www.oecd-ilibrary.org/docserver/ download/fulltext/9743601e.pdf?expires-1314797362&id-id&accname- freeContent&checksum-105F0BC1EC404D041883B7D966F66627 [last accessed 2012].
22. OECD. (2009c). Subchronic inhalation toxicity: 28-day study. OECD, 412. [Online] Available from: http://www.oecd-ilibrary.org/docserver/download/ fulltext/9741201e.pdf?expires-1314797048&id-id&accname- freeContent&checksum-E72E064EB84CDC509004836A75CDEE1C [last accessed 2012].
23. OECD. (2009d). Subchronic inhalation toxicity: 90-day study. OECD, 413. [Online] Available from: http://www.oecd-ilibrary.org/environment/test-no-413- subchronic-inhalation-toxicity-90-day-study-9789264070806-en;jsessionid- d6z2kbd8vhca.delta [last accessed 2012].
24. OECD. (2009e). Guidance document on acute inhalation toxicity testing - series on testing and assessment number 39 [ENV/JM/MONO(2009)28]. [Online] Available from: http://iccvam.niehs.nih.gov/SuppDocs/FedDocs/OECD/OECD-GD39.pdf [last accessed 2012].
25. OECD. (2009f). Guidance document on histopathology for inhalation toxicity studies, supporting TG 412 (subacute inhalation toxicity: 28-day study) and TG 413 (subchronic inhalation toxicity: 90-day study) [ENV/JM/MONO(2010)16] . [Online] Available from: http://iccvam.niehs.nih.gov/SuppDocs/FedDocs/OECD/ OECD-GD125.pdf [last accessed 2012].
26. OECD. (2009g). Chronic Toxicity Studies. OECD, 452. [Online] Available from: http://www.oecd-ilibrary.org/environment/test-no-452-chronic-toxicity- studies-9789264071209-en [last accessed 2012].
27. OECD. (2009h). Combined chronic toxicity/carcinogenicity studies. OECD, 453. [Online] Available from: http://www.oecd-ilibrary.org/docserver/download/ fulltext/9745301e.pdf?expires-1314797901&id-id&accname- freeContent&checksum-AE80DD0DB1C40C9171B8A947554C105F [last accessed 2012].
28. OECD. (2009i). Carcinogenicity studies. OECD, 451. [Online] Available from: http://www.oecd-library.org/environment/test-no-451-carcinogenicity- studies-97892640701186-en [last accessed 2012].
29. Price C, Stallard N, Creton S, et al. (2011). A statistical evaluation of the effects of gender differences in assessment of acute inhalation toxicity. Hum Exp Tox 30:217-38.
30. Snipes MB. (1988). Species comparison for pulmonary retention of inhaled particles. In: McClellan RO, ed. Concepts in inhalation toxicology. Washington, DC: Hemisphere Publishing Co., 193-227.
31. Snipes MB, McClellan RO, Mauderly JL, Wolff RK. (1989). Retention patterns for inhaled particles in the lung: comparisons between laboratory animals and humans for chronic exposures. Health Phys 57:69-77.
32. Stallard N, Price C, Creton S, et al. (2011). A new sighting study for the fixed concentration procedure to allow for gender differences. Hum Exp Tox 30:239-49.
33. Texas Commission on Environmental Quality (TCEQ). (2006). Guidelines to develop effects screening levels, reference values, and unit risk factors. RG442.
34. Texas Commission on Environmental Quality (TCEQ). (2011). Proposed guidelines to develop inhalation and oral cancer and non-cancer toxicity factors. Chief Engineer's Office. [Online] Available from: http://www.tera.org/ peer/tceqesl/ [last accessed 2012].
35. US Environmental Protection Agency (US EPA). (1988). Hazard evaluation division standard evaluation procedure, inhalation toxicity testing. Office of Health and Environmental Assessment, Research Triangle Park, NC. EPA-540/09-88/101.
36. US Environmental Protection Agency (US EPA). (1991a). Guidelines for developmental toxicity risk assessment. Fed Regist 56:63798-826.
37. US Environmental Protection Agency (US EPA). (1991b). Integrated risk information system (IRIS). [Online]. Office of Health and Environmental Assessment, Washington, DC.
38. US Environmental Protection Agency (US EPA). (1992). Guidelines for exposure assessment. Fed Regist 57:22888-938.
39. US Environmental Protection Agency (US EPA). (1994a). Methods for derivation of inhalation reference doses. Environmental Criteria and Assessment Office, Office of Health and Environmental Assessment, Research Triangle Park, NC. EPA/600/8-90/066F.
40. US Environmental Protection Agency (US EPA). (1994b). Interim policy for particle size and limit concentration issues in inhalation toxicity studies. Office of Health and Environmental Assessment, Research Triangle Park, NC. Fed Regist Notice, 59:53799.
41. US Environmental Protection Agency (US EPA). (1996). Guidelines for reproductive toxicity risk assessment. Fed Regist 61:56274-322.
42. US Environmental Protection Agency (US EPA). (1998). Guidelines for neurotoxicity risk assessment. Fed Regist 63:26926-54.
43. US Environmental Protection Agency (US EPA). (2005). Guidelines for carcinogen risk assessment. Environmental Criteria and Assessment Office, Office of Health and Environmental Assessment, Research Triangle Park, NC. EPA/630/P-03/001F.
44. US Food and Drug Administration (US FDA). (1987). Guidelines for the format and content of the nonclinical pharmacology/toxicology section of an application. US Department of Health and Human Services - Food and Drug Administration Center for Drug Evaluation and Research. Guidance for Industry.
45. US Food and Drug Administration (US FDA). (1998). Guidance for industry - metered dose inhaler (MDI) and dry powder inhaler (DPI) drug products - chemistry, manufacturing, and controls documentation. Draft.
46. US Department of Health and Human Services - Food and Drug Administration Center for Drug Evaluation and Research (CDER). October 1998.