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Volumn 40, Issue 1, 2012, Pages 40-54

Comparative Long-Term Preclinical Safety Evaluation of Two Glatiramoid Compounds (Glatiramer Acetate, Copaxone®, and TV-5010, Protiramer) in Rats and Monkeys

Author keywords

glatiramer acetate; glatiramoids; injection site; protiramer; toxicity

Indexed keywords

GLATIRAMER; PROTIRAMER; TV 5010; UNCLASSIFIED DRUG;

EID: 84856144463     PISSN: 01926233     EISSN: 15331601     Source Type: Journal    
DOI: 10.1177/0192623311424169     Document Type: Article
Times cited : (30)

References (31)
  • 1
    • 70449526305 scopus 로고    scopus 로고
    • Neuroprotection and neurogeneration in MS and its animal model EAE affected by glatiramer acetate
    • Arnon R. Aharoni R. (2009). Neuroprotection and neurogeneration in MS and its animal model EAE affected by glatiramer acetate. J Neural Transm 116, 1443–49.
    • (2009) J Neural Transm , vol.116 , pp. 1443-1449
    • Arnon, R.1    Aharoni, R.2
  • 2
    • 40349089507 scopus 로고    scopus 로고
    • Glatiramer acetate: evidence for a dual mechanism of action
    • Blanchette F. Neuhaus O. (2008). Glatiramer acetate: evidence for a dual mechanism of action. J Neurol 255(Suppl 1), 26–36.
    • (2008) J Neurol , vol.255 , Issue.1 , pp. 26-36
    • Blanchette, F.1    Neuhaus, O.2
  • 3
    • 48349139795 scopus 로고    scopus 로고
    • Microbiology and management of soft tissue and muscle infections
    • Brook I. (2008). Microbiology and management of soft tissue and muscle infections. Int J Surg, 6, 328–38.
    • (2008) Int J Surg , vol.6 , pp. 328-338
    • Brook, I.1
  • 4
    • 0024447217 scopus 로고
    • Effects of skin sensitization test wrapping on guinea pigs
    • Cushman J. R. Richter W. R. Duke J. T. (1989). Effects of skin sensitization test wrapping on guinea pigs. Contact Derm 21, 279–80.
    • (1989) Contact Derm , vol.21 , pp. 279-280
    • Cushman, J.R.1    Richter, W.R.2    Duke, J.T.3
  • 6
    • 0032695877 scopus 로고    scopus 로고
    • Localized lipoatrophy after glatiramer acetate injection in patients with remitting-relapsing multiple sclerosis
    • Drago F. Brusati C. Mancardi G. Murialdo A. Rebora A. (1999). Localized lipoatrophy after glatiramer acetate injection in patients with remitting-relapsing multiple sclerosis. Arch Dermatol 135, 1277–78.
    • (1999) Arch Dermatol , vol.135 , pp. 1277-1278
    • Drago, F.1    Brusati, C.2    Mancardi, G.3    Murialdo, A.4    Rebora, A.5
  • 8
    • 46649095807 scopus 로고    scopus 로고
    • Predictivity of animal studies for human injection site reactions with parenteral drug products
    • Engelhardt J. A. (2008). Predictivity of animal studies for human injection site reactions with parenteral drug products. Exp Toxicol Pathol 60, 323–27.
    • (2008) Exp Toxicol Pathol , vol.60 , pp. 323-327
    • Engelhardt, J.A.1
  • 9
    • 68849125049 scopus 로고    scopus 로고
    • A comparison of rat chronic progressive nephropathy with human renal disease-implications for human risk assessment
    • Hard G. C. Johnson K. J. Cohen S. M. (2009). A comparison of rat chronic progressive nephropathy with human renal disease-implications for human risk assessment. Crit Rev Toxicol 39, 332–46.
    • (2009) Crit Rev Toxicol , vol.39 , pp. 332-346
    • Hard, G.C.1    Johnson, K.J.2    Cohen, S.M.3
  • 10
    • 0035489110 scopus 로고    scopus 로고
    • Lipoatrophy associated with glatiramer acetate injections for the treatment of multiple sclerosis
    • Hwang L. Orengo I. (2001). Lipoatrophy associated with glatiramer acetate injections for the treatment of multiple sclerosis. Cutis 68, 287–88.
    • (2001) Cutis , vol.68 , pp. 287-288
    • Hwang, L.1    Orengo, I.2
  • 11
    • 77951267099 scopus 로고    scopus 로고
    • Glatiramer acetate and the glatiramoid class of immunomodulator drugs in multiple sclerosis: an update
    • Johnson K. P. (2010). Glatiramer acetate and the glatiramoid class of immunomodulator drugs in multiple sclerosis: an update. Exp Opin Drug Metab Toxicol, 6, 643–60.
    • (2010) Exp Opin Drug Metab Toxicol , vol.6 , pp. 643-660
    • Johnson, K.P.1
  • 12
    • 54049145078 scopus 로고    scopus 로고
    • Impact of warm compresses on local injection-site reactions with self-administered glatiramer acetate
    • Jolly H. Simpson K. Bishop B. Hunter H. Newell C. Denney D. Oleen-Burkey M. (2008). Impact of warm compresses on local injection-site reactions with self-administered glatiramer acetate. J Neurosci Nurs 40, 232–39.
    • (2008) J Neurosci Nurs , vol.40 , pp. 232-239
    • Jolly, H.1    Simpson, K.2    Bishop, B.3    Hunter, H.4    Newell, C.5    Denney, D.6    Oleen-Burkey, M.7
  • 14
    • 77955663455 scopus 로고    scopus 로고
    • Results of a phase I study in patients suffering from secondary-progressive multiple sclerosis demonstrating the safety of the amino acid copolymer PI-2301 and a possible induction of an anti-inflammatory cytokine response
    • Kovalchin J. Krieger J. Genova M. Collins K. Augustyniak M. Masci A. Hittinger T. Kuca B. Edan G. Braudeau C. Rimbert M. Patel U. Mascioli E. Zanelli E. (2010). Results of a phase I study in patients suffering from secondary-progressive multiple sclerosis demonstrating the safety of the amino acid copolymer PI-2301 and a possible induction of an anti-inflammatory cytokine response. J Neuroimmunol 225, 153–63.
    • (2010) J Neuroimmunol , vol.225 , pp. 153-163
    • Kovalchin, J.1    Krieger, J.2    Genova, M.3    Collins, K.4    Augustyniak, M.5    Masci, A.6    Hittinger, T.7    Kuca, B.8    Edan, G.9    Braudeau, C.10    Rimbert, M.11    Patel, U.12    Mascioli, E.13    Zanelli, E.14
  • 15
    • 10344225070 scopus 로고    scopus 로고
    • Strategies for managing the side effects of treatments for multiple sclerosis
    • Langer-Gould A. Moses H. H. Murray T. J. (2004). Strategies for managing the side effects of treatments for multiple sclerosis. Neurology, 63, S35–41.
    • (2004) Neurology , vol.63 , pp. S35-S41
    • Langer-Gould, A.1    Moses, H.H.2    Murray, T.J.3
  • 16
    • 72649090947 scopus 로고    scopus 로고
    • Glatiramer acetate for the treatment of multiple sclerosis: evidence for a dual anti-inflammatory and neuroprotective role
    • Liblau R. (2009). Glatiramer acetate for the treatment of multiple sclerosis: evidence for a dual anti-inflammatory and neuroprotective role. J Neurol Sci 287(Suppl 1), S17–23.
    • (2009) J Neurol Sci , vol.287 , Issue.1 , pp. S17-S23
    • Liblau, R.1
  • 18
    • 28944439315 scopus 로고    scopus 로고
    • Hemodynamic disorders, thromboembolic disease, and shock
    • Kumar, V., Abbas, A. K., A. K., Fausto, N., 7th ed., Saunders Elsevier, Philadelphia, PA
    • Mitchell R. N. (2004). Hemodynamic disorders, thromboembolic disease, and shock. In: Robbins and Cotran Pathologic Basis of Disease (Kumar V. Abbas A. K. A. K. Fausto N., eds.), 7th ed., pp. 119–44. Saunders Elsevier, Philadelphia, PA.
    • (2004) Robbins and Cotran Pathologic Basis of Disease , pp. 119-144
    • Mitchell, R.N.1
  • 19
    • 0026507223 scopus 로고
    • Possible pitfalls in rat extended dermal toxicity testing: an hepatic-ocular syndrome
    • Nyska A. Waner T. Wormser U. Gur E. Kuttin E. Dayan D. (1992). Possible pitfalls in rat extended dermal toxicity testing: an hepatic-ocular syndrome. Arch Toxicol 66, 339–46.
    • (1992) Arch Toxicol , vol.66 , pp. 339-346
    • Nyska, A.1    Waner, T.2    Wormser, U.3    Gur, E.4    Kuttin, E.5    Dayan, D.6
  • 20
    • 0029153126 scopus 로고
    • Liver lesions in rats associated with wrapping of the torso
    • Parker G. A. Gibson W. B. (1995). Liver lesions in rats associated with wrapping of the torso. Toxicol Pathol 23, 507–12.
    • (1995) Toxicol Pathol , vol.23 , pp. 507-512
    • Parker, G.A.1    Gibson, W.B.2
  • 21
    • 0142087834 scopus 로고    scopus 로고
    • Delayed drug hypersensitivity reactions
    • Pichler W. J. (2003). Delayed drug hypersensitivity reactions. Ann Intern Med 139, 683–93.
    • (2003) Ann Intern Med , vol.139 , pp. 683-693
    • Pichler, W.J.1
  • 23
    • 34250784647 scopus 로고    scopus 로고
    • Delayed drug hypersensitivity reactions—new concepts
    • Posadas S. J. Pichler W. J. (2007). Delayed drug hypersensitivity reactions—new concepts. Clin Exp Allergy 37, 989–99.
    • (2007) Clin Exp Allergy , vol.37 , pp. 989-999
    • Posadas, S.J.1    Pichler, W.J.2
  • 25
    • 34447529095 scopus 로고    scopus 로고
    • Glatiramer acetate: mechanisms of action in multiple sclerosis
    • Schrempf W. Ziemssen T. (2007). Glatiramer acetate: mechanisms of action in multiple sclerosis. Autoimmun Rev 6, 469–75.
    • (2007) Autoimmun Rev , vol.6 , pp. 469-475
    • Schrempf, W.1    Ziemssen, T.2
  • 26
    • 0036186057 scopus 로고    scopus 로고
    • Qualitative and quantitative analysis of nonneoplastic lesions in toxicology studies
    • Shackelford C. Long G. Wolf J. Okerberg C. Herbert R. (2002). Qualitative and quantitative analysis of nonneoplastic lesions in toxicology studies. Toxicol Pathol 30, 93–96.
    • (2002) Toxicol Pathol , vol.30 , pp. 93-96
    • Shackelford, C.1    Long, G.2    Wolf, J.3    Okerberg, C.4    Herbert, R.5
  • 27
    • 33750844575 scopus 로고    scopus 로고
    • Localized panniculitis secondary to subcutaneous glatiramer acetate injections for the treatment of multiple sclerosis: a clinicopathologic and immunohistochemical study
    • Soares Almeida L. M. Requena L. Kutzner H. Angulo J. de Sa J. Pignatelli J. (2006). Localized panniculitis secondary to subcutaneous glatiramer acetate injections for the treatment of multiple sclerosis: a clinicopathologic and immunohistochemical study. J Am Acad Dermatol 55, 968–74.
    • (2006) J Am Acad Dermatol , vol.55 , pp. 968-974
    • Soares Almeida, L.M.1    Requena, L.2    Kutzner, H.3    Angulo, J.4    de Sa, J.5    Pignatelli, J.6
  • 28
    • 10644241482 scopus 로고    scopus 로고
    • Localized panniculitis and subsequent lipoatrophy with subcutaneous glatiramer acetate (Copaxone) injection for the treatment of multiple sclerosis
    • Soos N. Shakery K. Mrowietz U. (2004). Localized panniculitis and subsequent lipoatrophy with subcutaneous glatiramer acetate (Copaxone) injection for the treatment of multiple sclerosis. Am J Clin Dermatol 5, 357–59.
    • (2004) Am J Clin Dermatol , vol.5 , pp. 357-359
    • Soos, N.1    Shakery, K.2    Mrowietz, U.3
  • 29
    • 78650955431 scopus 로고    scopus 로고
    • Glatiramer acetate for treatment of MS: regulatory B cells join the cast of players
    • Van Kaer L. (2011). Glatiramer acetate for treatment of MS: regulatory B cells join the cast of players. Exp Neurol 227, 19–23.
    • (2011) Exp Neurol , vol.227 , pp. 19-23
    • Van Kaer, L.1
  • 31
    • 34848885871 scopus 로고    scopus 로고
    • Mechanism of action of glatiramer acetate in treatment of multiple sclerosis
    • Weber M. S. Hohlfeld R. Zamvil S. S. (2007). Mechanism of action of glatiramer acetate in treatment of multiple sclerosis. Neurotherapeutics 4, 647–53.
    • (2007) Neurotherapeutics , vol.4 , pp. 647-653
    • Weber, M.S.1    Hohlfeld, R.2    Zamvil, S.S.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.