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Volumn 102-103, Issue , 1998, Pages 551-555

The international harmonisation of guidelines in the future: A viewpoint from the industry

Author keywords

Future aims of ICH; ICH toxicology guidelines; Topics for harmonisation

Indexed keywords

CARCINOGENICITY; CONFERENCE PAPER; DRUG INDUSTRY; DRUG SAFETY; DRUG SCREENING; HUMAN; IMMUNOTOXICITY; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; STANDARDIZATION;

EID: 0032440865     PISSN: 03784274     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0378-4274(98)00264-1     Document Type: Conference Paper
Times cited : (3)

References (7)
  • 1
    • 0027466244 scopus 로고
    • Clinical pathology testing recommendations for non-clinical toxicity and safety studies
    • 20
    • AACC-DACC/ASVCP Joint Task Forcel992. Clinical pathology testing recommendations for non-clinical toxicity and safety studies. Toxicol. Pathol. 20/20, 539-543.
    • (1992) Toxicol. Pathol. , vol.20 , pp. 539-543
  • 2
    • 0030864216 scopus 로고    scopus 로고
    • Overview of the Fourth International Conference on Harmonization
    • Christian, M.S., 1997. Overview of the Fourth International Conference on Harmonization. Int. J. Toxicol. Pathol. 20, 659-668.
    • (1997) Int. J. Toxicol. Pathol. , vol.20 , pp. 659-668
    • Christian, M.S.1
  • 3
    • 78650063979 scopus 로고    scopus 로고
    • Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals
    • ICH Harmonised Tripartite Guideline, D'Arcy, P.F., Harron, D.W.G. (Eds.), Brussels 1997. Graystone Books Ltd, Antrim, N. Ireland
    • ICH Harmonised Tripartite Guideline, 1997. Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals. In: D'Arcy, P.F., Harron, D.W.G. (Eds.), Proceeding of the Fourth International Conference on Harmonisation, Brussels 1997. Graystone Books Ltd, Antrim, N. Ireland, pp. 1057-1066.
    • (1997) Proceeding of the Fourth International Conference on Harmonisation , pp. 1057-1066
  • 4
    • 0344935573 scopus 로고    scopus 로고
    • Testing for carcinogenicity of pharmaceuticals
    • ICH Harmonised Tripartite Guideline, D'Arcy, P.F., Harron, D.W.G. (Eds.), Brusssels 1997. Graystone Books Ltd, Antrim, N. Ireland
    • ICH Harmonised Tripartite Guideline, 1997. Testing for carcinogenicity of pharmaceuticals. In: D'Arcy, P.F., Harron, D.W.G. (Eds.), Proceedings of the Fourth International Conference on Harmonisation, Brusssels 1997. Graystone Books Ltd, Antrim, N. Ireland, pp. 949-958.
    • (1997) Proceedings of the Fourth International Conference on Harmonisation , pp. 949-958
  • 5
    • 0028802973 scopus 로고
    • Immunotoxicity testing and risk assessment: Summary of a 1994 Workshop
    • ILSI Health and Environmental Sciences Institute, 1126 Sixteenth Street, N.W, Washington, DC 20036, USA., 1995
    • Immunotoxicology Technical Committee 1995. ILSI Health and Environmental Sciences Institute, 1126 Sixteenth Street, N.W, Washington, DC 20036, USA., 1995. Immunotoxicity testing and risk assessment: summary of a 1994 Workshop. Food Chem. Toxicol. 35, 887-894.
    • (1995) Food Chem. Toxicol. , vol.35 , pp. 887-894
  • 6
    • 0037986193 scopus 로고
    • An international appraisal of the minimum duration of chronic animal toxicity studies
    • D'Arcy, P.F., Harron, D.W.G. (Eds.), Brussels Graystone Books Ltd, Antrim, N. Ireland
    • Lumley, C.E., Parkinson, C., Walker, S.R., 1992. An international appraisal of the minimum duration of chronic animal toxicity studies. In: D'Arcy, P.F., Harron, D.W.G. (Eds.), Proceedings of the First International Conference on Harmonisation, Brussels 1991. Graystone Books Ltd, Antrim, N. Ireland, pp. 236-248.
    • (1991) Proceedings of the First International Conference on Harmonisation , pp. 236-248
    • Lumley, C.E.1    Parkinson, C.2    Walker, S.R.3
  • 7
    • 0345366967 scopus 로고    scopus 로고
    • Use and impact of ICH guidelines in the pharmaceutical industry
    • D'Arcy, P.F., Harron, D.W.G. (Eds.), Brussels Graystone Books Ltd, Antrim, N. Ireland
    • Watanabe, A.W., 1998. Use and impact of ICH guidelines in the pharmaceutical industry. In: D'Arcy, P.F., Harron, D.W.G. (Eds.), Proceedings of the Fourth International Conference on Harmonisation, Brussels 1997. Graystone Books Ltd, Antrim, N. Ireland, pp. 34-42.
    • (1997) Proceedings of the Fourth International Conference on Harmonisation , pp. 34-42
    • Watanabe, A.W.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.