메뉴 건너뛰기




Volumn 58, Issue 3, 2010, Pages 354-359

The value of acute toxicity studies to support the clinical management of overdose and poisoning: A cross-discipline consensus

Author keywords

Acute toxicity; Animal; Chemicals; ICH M3; Overdose; Pharmaceuticals; Poisoning; Preclinical; Safety

Indexed keywords

AGRICULTURAL CHEMICAL; CHEMICAL AGENT; COSMETIC; DOMESTIC CHEMICAL; DRUG; ILLICIT DRUG; INDUSTRIAL CHEMICAL; RECREATIONAL DRUG; VETERINARY DRUG;

EID: 79959495804     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2010.07.003     Document Type: Article
Times cited : (20)

References (22)
  • 2
    • 85054115522 scopus 로고    scopus 로고
    • CDER, Center for Drug Evaluation and Research (CDER) Guidance for Industry, August 1996. Single Dose Acute Toxicity Testing for Pharmaceuticals
    • CDER, Center for Drug Evaluation and Research (CDER) Guidance for Industry, August 1996. Single Dose Acute Toxicity Testing for Pharmaceuticals, Pt. 1.
    • , Issue.PART. 1
  • 3
    • 85054108474 scopus 로고    scopus 로고
    • Challenging the Regulatory Requirement for Acute Toxicity Studies in the Development of New Medicines: A Workshop Report. NC3Rs.
    • Chapman, K., Robinson, S., 2007. Challenging the Regulatory Requirement for Acute Toxicity Studies in the Development of New Medicines: A Workshop Report. NC3Rs.
    • (2007)
    • Chapman, K.1    Robinson, S.2
  • 5
    • 85054117349 scopus 로고    scopus 로고
    • EC, 2003. Commission Directive 2003/63/EC of the 25th June 2003 amending directive 2001/83/EC of the European parliament and of the council on the community code relating to medicinal products for human use, Annex I. Off. J. Eur. Union L159
    • EC, 2003. Commission Directive 2003/63/EC of the 25th June 2003 amending directive 2001/83/EC of the European parliament and of the council on the community code relating to medicinal products for human use, Annex I. Off. J. Eur. Union L159, 46-94.
  • 6
    • 85054109473 scopus 로고    scopus 로고
    • Response to Peter and colleagues. Re: is there a relationship between the WHO hazard classification of organophosphate pesticide and outcomes in suicidal human poisoning with commercial organophosphate formulations?
    • author reply
    • Eddleston, M., 2010. Response to Peter and colleagues. Re: is there a relationship between the WHO hazard classification of organophosphate pesticide and outcomes in suicidal human poisoning with commercial organophosphate formulations? Regul. Toxicol. Pharmacol. 57. 338; author reply 339-340.
    • (2010) Regul. Toxicol. Pharmacol. , vol.57 , pp. 339-340
    • Eddleston, M.1
  • 8
    • 40349083695 scopus 로고    scopus 로고
    • The global distribution of fatal pesticide self-poisoning: systematic review
    • Gunnell, D., Eddleston, M., Phillips, M.R., Konradsen, F., 2007. The global distribution of fatal pesticide self-poisoning: systematic review. BMC Public Health 7, 357.
    • (2007) BMC Public Health , vol.7 , pp. 357
    • Gunnell, D.1    Eddleston, M.2    Phillips, M.R.3    Konradsen, F.4
  • 9
    • 85054106437 scopus 로고    scopus 로고
    • ICCVAM-NICEATM. Report on the ICCVAM-NICEATM/ECVAM/JACVAM Scientific Workshop on Acute Chemical Safety Testing: Advancing in vitro Approaches and Humane Endpoints for Systemic Toxicity Evaluations. National Institute of Environmental Health Sciences, Research Triangle Park, NC.
    • ICCVAM-NICEATM. Report on the ICCVAM-NICEATM/ECVAM/JACVAM Scientific Workshop on Acute Chemical Safety Testing: Advancing in vitro Approaches and Humane Endpoints for Systemic Toxicity Evaluations. National Institute of Environmental Health Sciences, Research Triangle Park, NC. 2009
    • (2009)
  • 10
    • 85054110463 scopus 로고    scopus 로고
    • ICH. Guidelines for New Drug Registration with Harmonized Tripartite Guidelines.
    • ICH. Guidelines for New Drug Registration with Harmonized Tripartite Guidelines. 1999
    • (1999)
  • 11
    • 85054116162 scopus 로고    scopus 로고
    • ICH, 2009. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3(R2). Recommended for Adoption at Step 4 of the ICH Process on June 11
    • ICH, 2009. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3(R2). Recommended for Adoption at Step 4 of the ICH Process on June 11, 2009.
    • (2009)
  • 12
    • 0021048099 scopus 로고
    • A new approach to practical acute toxicity testing
    • Lorke, D., 1983. A new approach to practical acute toxicity testing. Arch. Toxicol. 54, 275-287.
    • (1983) Arch. Toxicol. , vol.54 , pp. 275-287
    • Lorke, D.1
  • 13
    • 85054113021 scopus 로고    scopus 로고
    • OECD. Test Guideline 420: Acute Oral Toxicity - Fixed Dose Procedure. OECD Guidelines for the Testing of Chemicals.
    • OECD. Test Guideline 420: Acute Oral Toxicity - Fixed Dose Procedure. OECD Guidelines for the Testing of Chemicals. 2001
    • (2001)
  • 14
    • 77951978455 scopus 로고    scopus 로고
    • Is there a relationship between the WHO hazard classification of organophosphate pesticide and outcomes in suicidal human poisoning with commercial organophosphate formulations? Regul
    • Peter, J.V., Jerobin, J., Nair, A., Bennett, A., 2010. Is there a relationship between the WHO hazard classification of organophosphate pesticide and outcomes in suicidal human poisoning with commercial organophosphate formulations? Regul. Toxicol. Pharmacol. 57, 99-102.
    • (2010) Toxicol. Pharmacol. , vol.57 , pp. 99-102
    • Peter, J.V.1    Jerobin, J.2    Nair, A.3    Bennett, A.4
  • 15
    • 79951915515 scopus 로고    scopus 로고
    • A statistical evaluation of the effects of gender differences in assessment of acute inhalation toxicity
    • doi:10.1177/0960327110370982.
    • Price, C., Stallard, N., Creton, S., Indans, I., Guest, R., Griffiths, D., Edwards, P., 2010. A statistical evaluation of the effects of gender differences in assessment of acute inhalation toxicity. Hum. Exp. Toxicol. doi:10.1177/0960327110370982.
    • (2010) Hum. Exp. Toxicol.
    • Price, C.1    Stallard, N.2    Creton, S.3    Indans, I.4    Guest, R.5    Griffiths, D.6    Edwards, P.7
  • 16
    • 69249231966 scopus 로고    scopus 로고
    • Are acute toxicity studies required to support overdose for new medicines?
    • Robinson, S., Chapman, K., 2009. Are acute toxicity studies required to support overdose for new medicines? Regul. Toxicol. Pharmacol. 55, 110.
    • (2009) Regul. Toxicol. Pharmacol. , vol.55 , pp. 110
    • Robinson, S.1    Chapman, K.2
  • 18
    • 85054112377 scopus 로고    scopus 로고
    • Acute organophosphorus and carbamate insecticide poisoning in Switzerland
    • Schmid, T., Wilks, M.F., Kupferschmidt, H., 2003. Acute organophosphorus and carbamate insecticide poisoning in Switzerland. Clin. Toxicol. 41, 525.
    • (2003) Clin. Toxicol. , vol.41 , pp. 525
    • Schmid, T.1    Wilks, M.F.2    Kupferschmidt, H.3
  • 19
    • 77955168444 scopus 로고    scopus 로고
    • Cross-sector review of drivers and available 3Rs approaches for acute systemic toxicity testing
    • Seidle, T., Robinson, S., Holmes, T., Creton, S., Prieto, P., Scheel, J., Chlebus, M., 2010. Cross-sector review of drivers and available 3Rs approaches for acute systemic toxicity testing. Toxicol. Sci. 116, 382-396.
    • (2010) Toxicol. Sci. , vol.116 , pp. 382-396
    • Seidle, T.1    Robinson, S.2    Holmes, T.3    Creton, S.4    Prieto, P.5    Scheel, J.6    Chlebus, M.7
  • 20
    • 79951929965 scopus 로고    scopus 로고
    • A new sighting study for the fixed concentration procedure to allow for gender differences
    • doi:10.1177/0960327110370983.
    • Stallard, N., Price, C., Creton, S., Indans, I., Guest, R., Griffiths, D., Edwards, P., 2010. A new sighting study for the fixed concentration procedure to allow for gender differences. Hum. Exp. Toxicol. doi:10.1177/0960327110370983.
    • (2010) Hum. Exp. Toxicol.
    • Stallard, N.1    Price, C.2    Creton, S.3    Indans, I.4    Guest, R.5    Griffiths, D.6    Edwards, P.7
  • 21
    • 85054109517 scopus 로고    scopus 로고
    • UN, 2009. Globally Harmonized System of Classification and Labelling of Chemicals (GHS): Third revised edition. United Nations, New York, Geneva.
    • UN, 2009. Globally Harmonized System of Classification and Labelling of Chemicals (GHS): Third revised edition. United Nations, New York, Geneva.
  • 22
    • 0019391510 scopus 로고
    • Significance of the LD50-test for the toxicological evaluation of chemical substances
    • Zbinden, G., Flury-Roversi, M., 1981. Significance of the LD50-test for the toxicological evaluation of chemical substances. Arch. Toxicol. 47, 77-99.
    • (1981) Arch. Toxicol. , vol.47 , pp. 77-99
    • Zbinden, G.1    Flury-Roversi, M.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.