메뉴 건너뛰기




Volumn 40, Issue 6, 2004, Pages 907-913

Multi-species toxicology approaches for oncology drugs: The US perspective

Author keywords

Animals; Antineoplastic agents; Drug evaluation; Models; Pharmacology; Preclinical; Toxicology

Indexed keywords

ANTINEOPLASTIC AGENT; BORTEZOMIB; CYTOTOXIC AGENT; OLIGONUCLEOTIDE;

EID: 1942454387     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejca.2003.11.024     Document Type: Article
Times cited : (23)

References (40)
  • 1
    • 0036636580 scopus 로고    scopus 로고
    • Toxicity testing in the development of anticancer drugs
    • Double J. Toxicity testing in the development of anticancer drugs. Lancet Oncol. 3:2002;438-439.
    • (2002) Lancet Oncol. , vol.3 , pp. 438-439
    • Double, J.1
  • 2
    • 0035810147 scopus 로고    scopus 로고
    • Efficacy and safety of a specific inhibitor of BCR-ABL tyrosine kinase in chronic myeloid leukemia
    • Druker B.J., Talpaz M., Resta D.J., Peng B.et al. Efficacy and safety of a specific inhibitor of BCR-ABL tyrosine kinase in chronic myeloid leukemia. N. Engl. J. Med. 344:2001;1031-1037.
    • (2001) N. Engl. J. Med. , vol.344 , pp. 1031-1037
    • Druker, B.J.1    Talpaz, M.2    Resta, D.J.3    Peng, B.4
  • 3
    • 0035810142 scopus 로고    scopus 로고
    • Activity of a specific inhibitor of the BCR-ABL tyrosine kinase in the blast crisis of chronic myeloid leukemia and acute lymphoblastic leukemia with the Philadelphia Chromosome
    • Druker B.J., Sawyers C.L., Kantarjian H.et al. Activity of a specific inhibitor of the BCR-ABL tyrosine kinase in the blast crisis of chronic myeloid leukemia and acute lymphoblastic leukemia with the Philadelphia Chromosome. N. Engl. J. Med. 344:2001;1038-1042.
    • (2001) N. Engl. J. Med. , vol.344 , pp. 1038-1042
    • Druker, B.J.1    Sawyers, C.L.2    Kantarjian, H.3
  • 4
    • 1942438725 scopus 로고    scopus 로고
    • Gleevec™ prescribing information
    • Medical Economics Company, Montvale, NJ
    • Gleevec™ prescribing information. Physicians' Desk Reference, Medical Economics Company, Montvale, NJ, 2002, 2357-2360.
    • (2002) Physicians' Desk Reference , pp. 2357-2360
  • 5
    • 0034071688 scopus 로고    scopus 로고
    • A phase I trial of the farnesyl transferase inhibitor SCH66336: Evidence for biological and clinical activity
    • Adjei A.A., Erlichman C., Davis J.N.et al. A phase I trial of the farnesyl transferase inhibitor SCH66336. evidence for biological and clinical activity Cancer Res. 60:2000;1871-1877.
    • (2000) Cancer Res. , vol.60 , pp. 1871-1877
    • Adjei, A.A.1    Erlichman, C.2    Davis, J.N.3
  • 6
    • 18544412314 scopus 로고    scopus 로고
    • Phase I and pharmacokinetic study of farnesyl protein transferase inhibitor R115777 in advanced cancer
    • Zujewski J., Horak I.D., Bol C.J.et al. Phase I and pharmacokinetic study of farnesyl protein transferase inhibitor R115777 in advanced cancer. J. Clin. Oncol. 18:2000;927-941.
    • (2000) J. Clin. Oncol. , vol.18 , pp. 927-941
    • Zujewski, J.1    Horak, I.D.2    Bol, C.J.3
  • 8
    • 14444267319 scopus 로고    scopus 로고
    • Regulatory considerations for preclinical development of anticancer drugs
    • DeGeorge J.J., Ahn C., Andrews P.A.et al. Regulatory considerations for preclinical development of anticancer drugs. Cancer Chemother. Pharmacol. 41:1998;173-185.
    • (1998) Cancer Chemother. Pharmacol. , vol.41 , pp. 173-185
    • Degeorge, J.J.1    Ahn, C.2    Andrews, P.A.3
  • 9
    • 0028908050 scopus 로고
    • Revisions of general guidelines for the preclinical toxicology of new cytotoxic anticancer agents in Europe. The Cancer Research Campaign (CRC) Phase I/II Clinical Trials Committee and the European Organization for Research and Treatment of Cancer (EORTC) New Drug Development Office
    • Burtles S.S., Newell D.R., Henrar R.E., Connors T.A. Revisions of general guidelines for the preclinical toxicology of new cytotoxic anticancer agents in Europe. The Cancer Research Campaign (CRC) Phase I/II Clinical Trials Committee and the European Organization for Research and Treatment of Cancer (EORTC) New Drug Development Office. Eur. J. Cancer. 31:1995;408-410.
    • (1995) Eur. J. Cancer , vol.31 , pp. 408-410
    • Burtles, S.S.1    Newell, D.R.2    Henrar, R.E.3    Connors, T.A.4
  • 10
    • 0022572075 scopus 로고
    • Relation of preclinical toxicology to findings in early clinical trials
    • Grieshaber C.K., Marsoni S. Relation of preclinical toxicology to findings in early clinical trials. Cancer Treat. Rep. 70:1986;65-72.
    • (1986) Cancer Treat. Rep. , vol.70 , pp. 65-72
    • Grieshaber, C.K.1    Marsoni, S.2
  • 11
    • 0033771951 scopus 로고    scopus 로고
    • Concordance of the toxicity of pharmaceuticals in humans and in animals
    • Olson H., Betton G., Robinson D.et al. Concordance of the toxicity of pharmaceuticals in humans and in animals. Regul. Toxicol. Pharmacol. 32:2000;56-67.
    • (2000) Regul. Toxicol. Pharmacol. , vol.32 , pp. 56-67
    • Olson, H.1    Betton, G.2    Robinson, D.3
  • 12
    • 0027506349 scopus 로고
    • The use of the dog in toxicity tests on pharmaceutical compounds
    • Parkinson C., Grasso P. The use of the dog in toxicity tests on pharmaceutical compounds. Hum. Exp. Toxicol. 12:1993;99-109.
    • (1993) Hum. Exp. Toxicol. , vol.12 , pp. 99-109
    • Parkinson, C.1    Grasso, P.2
  • 13
    • 17744387700 scopus 로고    scopus 로고
    • Prospects for reducing and refining the use of dogs in the regulatory toxicity testing of pharmaceuticals
    • Broadhead C.L., Benton G., Combes R.et al. Prospects for reducing and refining the use of dogs in the regulatory toxicity testing of pharmaceuticals. Hum. Exp. Toxicol. 19:2000;440-447.
    • (2000) Hum. Exp. Toxicol. , vol.19 , pp. 440-447
    • Broadhead, C.L.1    Benton, G.2    Combes, R.3
  • 14
    • 0030886937 scopus 로고    scopus 로고
    • Managing the drug discovery/development interface
    • Kennedy T. Managing the drug discovery/development interface. Drug Discov. Today. 2:1997;436-444.
    • (1997) Drug Discov. Today , vol.2 , pp. 436-444
    • Kennedy, T.1
  • 15
    • 1942502952 scopus 로고
    • Agent-directed preclinical toxicology for new antineoplastic drugs
    • F.A. Valeriote, T.H. Corbett, & L.H. et al. Baker. Boston: Kluwer Academic Publishers
    • Grieshaber C.K. Agent-directed preclinical toxicology for new antineoplastic drugs. Valeriote F.A., Corbett T.H., Baker L.H.et al. Cytotoxic Anticancer Drugs: Models and Concepts for Drug Discovery and Development. 1992;247-260 Kluwer Academic Publishers, Boston.
    • (1992) Cytotoxic Anticancer Drugs: Models and Concepts for Drug Discovery and Development , pp. 247-260
    • Grieshaber, C.K.1
  • 16
    • 0000288599 scopus 로고    scopus 로고
    • Chapter 23, Safety testing of antitumor agents
    • P.D. Williams, & G.H. Hottendorf. Oxford, England: Elsevier Science Ltd
    • Tomaszewski J.E., Smith A.C. Chapter 23, Safety testing of antitumor agents. Williams P.D., Hottendorf G.H. Comprehensive Toxicology, Toxicity Testing and Evaluation, Vol. 2. 1997;299-309 Elsevier Science Ltd, Oxford, England.
    • (1997) Comprehensive Toxicology, Toxicity Testing and Evaluation, Vol. 2 , pp. 299-309
    • Tomaszewski, J.E.1    Smith, A.C.2
  • 17
    • 0345072162 scopus 로고    scopus 로고
    • Chapter 17, Relevance of preclinical pharmacology and toxicology to phase I trial extrapolation techniques. Relevance of animal toxicology
    • B.C. Baguley. San Diego, CA: Academic Press
    • Tomaszewski J.E., Smith A.C., Covey J.M., Donohue S.J., Rhie J.K., Schweikart K.M. Chapter 17, Relevance of preclinical pharmacology and toxicology to phase I trial extrapolation techniques. Relevance of animal toxicology. Baguley B.C. Anti-Cancer Drug Design. 2001;301-328 Academic Press, San Diego, CA.
    • (2001) Anti-Cancer Drug Design , pp. 301-328
    • Tomaszewski, J.E.1    Smith, A.C.2    Covey, J.M.3    Donohue, S.J.4    Rhie, J.K.5    Schweikart, K.M.6
  • 18
    • 0025273434 scopus 로고
    • General guidelines for the preclinical toxicology of new cytotoxic anticancer agents in Europe
    • Joint Steering Committee of the EORTC and CRC General guidelines for the preclinical toxicology of new cytotoxic anticancer agents in Europe. Eur. J. Cancer. 26:1990;411-414.
    • (1990) Eur. J. Cancer , vol.26 , pp. 411-414
  • 19
    • 0032748041 scopus 로고    scopus 로고
    • Evaluation of rodent-only toxicology for early clinical trials with novel cancer therapeutics
    • Newell D.R., Burtles S.S., Fox B.W., Jodrell D.I., Connors T.A. Evaluation of rodent-only toxicology for early clinical trials with novel cancer therapeutics. Br. J. Cancer. 81:1999;760-768.
    • (1999) Br. J. Cancer , vol.81 , pp. 760-768
    • Newell, D.R.1    Burtles, S.S.2    Fox, B.W.3    Jodrell, D.I.4    Connors, T.A.5
  • 20
    • 0029841357 scopus 로고    scopus 로고
    • Phase I trial design: Are new methodologies being put into practice?
    • Dent S.F., Eisenhauer E.A. Phase I trial design. are new methodologies being put into practice? Ann. Oncol. 7:1996;561-566.
    • (1996) Ann. Oncol. , vol.7 , pp. 561-566
    • Dent, S.F.1    Eisenhauer, E.A.2
  • 22
    • 0029793053 scopus 로고    scopus 로고
    • Workshop on phase I study design. Ninth NCI/EORTC New Drug Development Symposium, Amsterdam, March 12, 1996
    • Arbuck S.G. Workshop on phase I study design. Ninth NCI/EORTC New Drug Development Symposium, Amsterdam, March 12, 1996. Ann. Oncol. 7:1996;567-573.
    • (1996) Ann. Oncol. , vol.7 , pp. 567-573
    • Arbuck, S.G.1
  • 25
    • 0033152760 scopus 로고    scopus 로고
    • Proteasome inhibitors: A novel class of potent and effective antitumor agents
    • Adams J., Palombella V.J., Sausville E.A.et al. Proteasome inhibitors. a novel class of potent and effective antitumor agents Cancer Res. 59:1999;2615-2622.
    • (1999) Cancer Res. , vol.59 , pp. 2615-2622
    • Adams, J.1    Palombella, V.J.2    Sausville, E.A.3
  • 26
    • 0036181371 scopus 로고    scopus 로고
    • Development of the proteasome inhibitor PS-341
    • Adams J. Development of the proteasome inhibitor PS-341. Oncologist. 7:2002;9-16.
    • (2002) Oncologist , vol.7 , pp. 9-16
    • Adams, J.1
  • 27
    • 0031882946 scopus 로고    scopus 로고
    • Results of single and repeat dose studies of the oral matrix metalloproteinase inhibitor marimastat in healthy male volunteers
    • Millar A.W., Brown P.D., Moore J.et al. Results of single and repeat dose studies of the oral matrix metalloproteinase inhibitor marimastat in healthy male volunteers. Br. J. Clin. Pharmacol. 45:1998;21-26.
    • (1998) Br. J. Clin. Pharmacol. , vol.45 , pp. 21-26
    • Millar, A.W.1    Brown, P.D.2    Moore, J.3
  • 28
    • 0033012742 scopus 로고    scopus 로고
    • Preclinical development strategies for novel gene therapy products
    • Pilaro A.M., Serabian M.A. Preclinical development strategies for novel gene therapy products. Toxicol. Pathol. 27:1999;4-7.
    • (1999) Toxicol. Pathol. , vol.27 , pp. 4-7
    • Pilaro, A.M.1    Serabian, M.A.2
  • 30
    • 0027730199 scopus 로고
    • Regulatory considerations for evaluating the pharmacology and toxicology of antisense drugs
    • Black L.E., DeGeorge J.J., Cavagnaro J.A., Jordan A., Ahn C.H. Regulatory considerations for evaluating the pharmacology and toxicology of antisense drugs. Antisense Res. Dev. 3:1993;399-404.
    • (1993) Antisense Res. Dev. , vol.3 , pp. 399-404
    • Black, L.E.1    Degeorge, J.J.2    Cavagnaro, J.A.3    Jordan, A.4    Ahn, C.H.5
  • 31
    • 0028567504 scopus 로고
    • Regulatory considerations for oligonucleotide drugs: Updated recommendations for pharmacology and toxicology studies
    • Black L.E., Farrelly J.G., Cavagnaro J.A.et al. Regulatory considerations for oligonucleotide drugs. updated recommendations for pharmacology and toxicology studies Antisense Res. Dev. 4:1994;299-301.
    • (1994) Antisense Res. Dev. , vol.4 , pp. 299-301
    • Black, L.E.1    Farrelly, J.G.2    Cavagnaro, J.A.3
  • 34
    • 1942534752 scopus 로고
    • In vitro/in vivo bone marrow toxicity: Comparison of clinical and preclinical data for selected anticancer drugs
    • (abstr 2185)
    • Schweikart K.M., Parchment R., Osborn B.et al. In vitro/in vivo bone marrow toxicity. comparison of clinical and preclinical data for selected anticancer drugs Proc. Amer. Assoc. Cancer Res. 36:1995;367. (abstr 2185).
    • (1995) Proc. Amer. Assoc. Cancer Res. , vol.36 , pp. 367
    • Schweikart, K.M.1    Parchment, R.2    Osborn, B.3
  • 37
    • 1942438724 scopus 로고    scopus 로고
    • Success in predicting human maximum tolerated dose from in vitro data and mouse MTD
    • (abstr 1046).
    • Parchment R., Tomaszewski J., Schweikart K., LoRusso P. Success in predicting human maximum tolerated dose from in vitro data and mouse MTD. Proc. Amer. Assoc. Cancer Res. 43:2002;208-209. (abstr 1046).
    • (2002) Proc. Amer. Assoc. Cancer Res. , vol.43 , pp. 208-209
    • Parchment, R.1    Tomaszewski, J.2    Schweikart, K.3    Lorusso, P.4
  • 38
    • 10744231168 scopus 로고    scopus 로고
    • Application of the CFU-GM assay to predict acute drug-induced neutropenia: An international blind trial to validate a prediction model for the maximum tolerated dose (MTD) of myelosuppressive xenobiotics
    • Pessina A., Albella B., Bayo M.et al. Application of the CFU-GM assay to predict acute drug-induced neutropenia. an international blind trial to validate a prediction model for the maximum tolerated dose (MTD) of myelosuppressive xenobiotics Toxicol. Sci. 75:2003;355-367.
    • (2003) Toxicol. Sci. , vol.75 , pp. 355-367
    • Pessina, A.1    Albella, B.2    Bayo, M.3
  • 39
    • 0029067452 scopus 로고
    • In vivo cultivation of tumor cells in hollow fibers
    • Hollingshead M.G., Alley M.C., Camalier R.F.et al. In vivo cultivation of tumor cells in hollow fibers. Life Sci. 57:1995;131-141.
    • (1995) Life Sci. , vol.57 , pp. 131-141
    • Hollingshead, M.G.1    Alley, M.C.2    Camalier, R.F.3
  • 40
    • 0028864544 scopus 로고
    • In vivo drug screening applications of HIV-infected cells cultivated within hollow fibers in two physiologic compartments of mice
    • Hollingshead M., Roberson J., Decker W.et al. In vivo drug screening applications of HIV-infected cells cultivated within hollow fibers in two physiologic compartments of mice. Antiviral. Res. 28:1995;265-279.
    • (1995) Antiviral. Res. , vol.28 , pp. 265-279
    • Hollingshead, M.1    Roberson, J.2    Decker, W.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.