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Volumn 190, Issue 3, 2009, Pages 243-247

EMS in Viracept-The course of events in 2007 and 2008 from the non-clinical safety point of view

Author keywords

Ethyl methanesulfonate; Nelfinavir mesilate; Patient exposure risk; Regulatory interaction; Viracept

Indexed keywords

ANTINEOPLASTIC AGENT; ANTIRETROVIRUS AGENT; MESYLIC ACID ETHYL ESTER; NELFINAVIR; RITONAVIR;

EID: 70350151197     PISSN: 03784274     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.toxlet.2009.02.005     Document Type: Article
Times cited : (36)

References (9)
  • 3
    • 77953314802 scopus 로고    scopus 로고
    • London, September 20, Doc. Ref, EMEA/CHMP/492059/2007;
    • CHMP, 2007c. Assessment Report for Viracept. London, September 20, 2007; Doc. Ref.: EMEA/CHMP/492059/2007; http://www.emea.europa.eu.
    • (2007) Assessment Report for Viracept
  • 5
    • 70350146440 scopus 로고    scopus 로고
    • CMDh, 2008. Coordination Group for Mutual Recognition and Decentralized Procedures, human. Request to assess the risk of occurrence of contamination with mesilate esters and related compounds in pharmaceuticals. London, February 27, 2008; Doc. Ref.: EMEA/CMDh/98694/2008; http://www.hma.eu/uploads/media/CMDh_Press_Release_February_08.pdf.
    • CMDh, 2008. Coordination Group for Mutual Recognition and Decentralized Procedures, human. Request to assess the risk of occurrence of contamination with mesilate esters and related compounds in pharmaceuticals. London, February 27, 2008; Doc. Ref.: EMEA/CMDh/98694/2008; http://www.hma.eu/uploads/media/CMDh_Press_Release_February_08.pdf.
  • 6
    • 34248577471 scopus 로고    scopus 로고
    • Mechanistic influences for mutation induction curves after exposure to DNA-reactive carcinogens
    • Doak S.H., Jenkins G.J., Johnson G.E., Quick E., Parry E.M., and Parry J.M. Mechanistic influences for mutation induction curves after exposure to DNA-reactive carcinogens. Cancer Res. 15 (2007) 3904-3911
    • (2007) Cancer Res. , vol.15 , pp. 3904-3911
    • Doak, S.H.1    Jenkins, G.J.2    Johnson, G.E.3    Quick, E.4    Parry, E.M.5    Parry, J.M.6
  • 8
    • 69449094260 scopus 로고    scopus 로고
    • Elevated ethyl methanesulfonate (EMS) in Nelfinavir mesylate (Viracept, Roche): Animal studies confirm toxicity threshold and absence of risk to patients
    • Mexico City, August 7, Poster LBPE1157
    • Müller, L., Gocke, E., Larson, P., Lave, T., Pfister, T., 2008. Elevated ethyl methanesulfonate (EMS) in Nelfinavir mesylate (Viracept, Roche): animal studies confirm toxicity threshold and absence of risk to patients. World AIDS Conference, Mexico City, August 7, 2008, Poster LBPE1157.
    • (2008) World AIDS Conference
    • Müller, L.1    Gocke, E.2    Larson, P.3    Lave, T.4    Pfister, T.5
  • 9
    • 69549149576 scopus 로고    scopus 로고
    • Ethyl methanesulfonate toxicity in Viracept-a comprehensive human risk assessment based on threshold data for genotoxicity
    • Müller L., Gocke E., Lave T., and Pfister T. Ethyl methanesulfonate toxicity in Viracept-a comprehensive human risk assessment based on threshold data for genotoxicity. Toxicol. Lett. 190 (2009) 317-329
    • (2009) Toxicol. Lett. , vol.190 , pp. 317-329
    • Müller, L.1    Gocke, E.2    Lave, T.3    Pfister, T.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.