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Principles and Practice of Pharmaceutical Medicine: Third Edition
Volumn , Issue , 2010, Pages 68-78
Nonclinical Toxicology

(1)  Reno, Frederick a  

a NONE
Author keywords

Active pharmaceutical ingredient (API); Consideration of regulatory strategy; Considerations related to the clinical development plan; Initial nonclinical considerations; New Drug Application (NDA); Nonclinical Toxicology; The Computer Assisted NDA (CANDA); The International Conference on Harmonization (ICH); Toxicological support for Phase II and III studies; Toxicological support pre IND and for Phase I clinical studies
Indexed keywords

EID: 84859223533     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781444325263.ch7     Document Type: Chapter
Times cited : (1)
References (9)
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    • Reproductive toxicology: current and future directions
    • Hoyer PB. Reproductive toxicology: current and future directions. Biochem Pharmacol 2001; 62:1557-1564.
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    • Hoyer, P.B.1
  • 3
    • 0035147462 scopus 로고    scopus 로고
    • In vitro carcinogenicity testing: present and future perspectives in pharmaceutical development
    • Kowalski LA. In vitro carcinogenicity testing: present and future perspectives in pharmaceutical development. Cure Opin Drug Discov Devel 2001; 4:29-35.
    • (2001) Cure Opin Drug Discov Devel. , vol.4 , pp. 29-35
    • Kowalski, L.A.1
  • 4
    • 0026504422 scopus 로고
    • Opportunities for integration of pharmacokinetics, Pharmacodynamics, and toxicokinetics in rational drug development
    • Peck CC, Barr WH, Benet LZ, et al. Opportunities for integration of pharmacokinetics, Pharmacodynamics, and toxicokinetics in rational drug development. Clin Pharmacol Ther 1992; 51:465-473.
    • (1992) Clin Pharmacol Ther. , vol.51 , pp. 465-473
    • Peck, C.C.1    Barr, W.H.2    Benet, L.Z.3
  • 5
    • 84886108221 scopus 로고    scopus 로고
    • In Comprehensive Toxicology Toxicological Testing and Evaluation Williams PD, Hottendorf GH (eds) Elsevier: London, UK
    • Reno FE. Carcinogenicity studies. In Comprehensive Toxicology Vol 2: Toxicological Testing and Evaluation, Williams PD, Hottendorf GH (eds). Elsevier: London, UK, 1997, 121-131.
    • (1997) Carcinogenicity studies , vol.2
    • Reno, F.E.1
  • 6
    • 0022602925 scopus 로고
    • Comparison of Multiple parameters of rodent carcinogenicity and in vitro genetic toxicity
    • Tennant RW, Stasiewicz S, Spalding JW. Comparison of Multiple parameters of rodent carcinogenicity and in vitro genetic toxicity Environ Mutagen 1986;8:205-227.
    • (1986) Environ Mutagen. , vol.8 , pp. 205-227
    • Tennant, R.W.1    Stasiewicz, S.2    Spalding, J.W.3
  • 7
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    • Issues with biotechnology products in toxicologic pathology
    • Terrell TG, Green JD. Issues with biotechnology products in toxicologic pathology. Toxicol Pathol 1994; 22:187-193.
    • (1994) Toxicol Pathol. , vol.22 , pp. 187-193
    • Terrell, T.G.1    Green, J.D.2
  • 8
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    • Extrapolation of animal toxicity to humans: interspecies comparisons in drug development
    • Voisin EM, Ruthsatz M, Collins JM, Hoyle PC. Extrapolation of animal toxicity to humans: interspecies comparisons in drug development. Regulat Toxicol Pharmacol 1990; 12:107-116.
    • (1990) Regulat Toxicol Pharmacol. , vol.12 , pp. 107-116
    • Voisin, E.M.1    Ruthsatz, M.2    Collins, J.M.3    Hoyle, P..C.4

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.