메뉴 건너뛰기




Volumn 65, Issue 3, 2013, Pages 334-343

Target organ toxicities in studies conducted to support first time in man dosing: An analysis across species and therapy areas

Author keywords

Candidate drugs; First time in man; Pre clinical studies; Target organ toxicities; Toxicity profile

Indexed keywords

NEW DRUG;

EID: 84875256110     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2013.02.002     Document Type: Article
Times cited : (37)

References (19)
  • 1
    • 44649157645 scopus 로고    scopus 로고
    • Safety evaluation to support first-in-man investigations II: toxicology studies
    • Baldrick P. Safety evaluation to support first-in-man investigations II: toxicology studies. Regul. Toxicol. Pharmacol. 2008, 51:237-243.
    • (2008) Regul. Toxicol. Pharmacol. , vol.51 , pp. 237-243
    • Baldrick, P.1
  • 2
    • 0030993661 scopus 로고    scopus 로고
    • Hepatotoxicity in drug development: detection, significance and solutions
    • Ballet F. Hepatotoxicity in drug development: detection, significance and solutions. J. Hepatol. 1997, 26(Suppl. 2):26-36.
    • (1997) J. Hepatol. , vol.26 , Issue.SUPPL. 2 , pp. 26-36
    • Ballet, F.1
  • 4
    • 84875266955 scopus 로고    scopus 로고
    • FDA Guidance for Industry, Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. (last accessed 09 November 2012).
    • FDA Guidance for Industry, 2005. Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. (last accessed 09 November 2012). http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078932.pdf.
    • (2005)
  • 5
    • 1642282158 scopus 로고    scopus 로고
    • First dose of potential new medicines to humans: how animals help
    • Greaves P., Williams A., Eve M. First dose of potential new medicines to humans: how animals help. Nat. Rev. Drug Discovery 2004, 3:226-236.
    • (2004) Nat. Rev. Drug Discovery , vol.3 , pp. 226-236
    • Greaves, P.1    Williams, A.2    Eve, M.3
  • 7
    • 33645014406 scopus 로고    scopus 로고
    • Review of the effects of anti-angiogenic compounds on the epiphyseal growth plate
    • Hall A., Westwood F., Wadsworth P. Review of the effects of anti-angiogenic compounds on the epiphyseal growth plate. Toxicol. Pathol. 2006, 34:131-147.
    • (2006) Toxicol. Pathol. , vol.34 , pp. 131-147
    • Hall, A.1    Westwood, F.2    Wadsworth, P.3
  • 9
    • 0019823046 scopus 로고
    • Target organ toxicity
    • Heywood R. Target organ toxicity. Toxicol. Lett. 1981, 8:349-358.
    • (1981) Toxicol. Lett. , vol.8 , pp. 349-358
    • Heywood, R.1
  • 10
    • 84875245629 scopus 로고    scopus 로고
    • ICH Guideline M3(R2), Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. (last accessed 09 November 2012).
    • ICH Guideline M3(R2), 2009. Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. (last accessed 09 November 2012). http://www.ich.org/products/guidelines/multidisciplinary/article/multidisciplinary-guidelines.html.
    • (2009)
  • 11
    • 84875253867 scopus 로고    scopus 로고
    • ICH Guideline S9, Nonclinical Evaluation for Anticancer Pharmaceuticals. (last accessed 09 November 2012).
    • ICH Guideline S9, 2009. Nonclinical Evaluation for Anticancer Pharmaceuticals. (last accessed 09 November 2012). http://www.ich.org/products/guidelines/safety/article/safety-guidelines.html.
    • (2009)
  • 12
    • 34547656228 scopus 로고    scopus 로고
    • The application of discovery toxicology and pathology towards the design of safer pharmaceutical lead candidates
    • Kramer J., Sagartz J., Morris D. The application of discovery toxicology and pathology towards the design of safer pharmaceutical lead candidates. Nat. Rev. Drug Discovery 2007, 6:636-649.
    • (2007) Nat. Rev. Drug Discovery , vol.6 , pp. 636-649
    • Kramer, J.1    Sagartz, J.2    Morris, D.3
  • 16
    • 77949374323 scopus 로고    scopus 로고
    • Regulatory aspects of oncology drug safety evaluation: past practice, current issues, and the challenge of new drugs
    • Rosenfeldt H., Kropp T., Benson K., Ricci S., McGuinn D., Verbois L. Regulatory aspects of oncology drug safety evaluation: past practice, current issues, and the challenge of new drugs. Toxicol. Appl. Pharmacol. 2010, 243:125-133.
    • (2010) Toxicol. Appl. Pharmacol. , vol.243 , pp. 125-133
    • Rosenfeldt, H.1    Kropp, T.2    Benson, K.3    Ricci, S.4    McGuinn, D.5    Verbois, L.6
  • 18
    • 77949663359 scopus 로고    scopus 로고
    • Information needed to conduct first-in-human oncology trials in the United States: a view from a former FDA medical reviewer
    • Senderowicz A.M. Information needed to conduct first-in-human oncology trials in the United States: a view from a former FDA medical reviewer. Clin. Cancer Res. 2010, 16:1719-1725.
    • (2010) Clin. Cancer Res. , vol.16 , pp. 1719-1725
    • Senderowicz, A.M.1
  • 19
    • 0037261333 scopus 로고    scopus 로고
    • The common marmoset (Callithrix jacchus) as a model in toxicology
    • Zühlke U., Weinbauer G. The common marmoset (Callithrix jacchus) as a model in toxicology. Toxicol. Pathol. 2003, 31:123-127.
    • (2003) Toxicol. Pathol. , vol.31 , pp. 123-127
    • Zühlke, U.1    Weinbauer, G.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.