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Volumn 3, Issue , 2010, Pages 17-28

Safety Assessment of Pharmaceuticals

Author keywords

Carcinogenicity studies; Drug safety testing; EMA; FDA; Genotoxicity; Immunotoxicity; Juvenile toxicity studies; Local tolerance; MHLW; Mutagenicity; Nonclinical tests; Pharmacodynamics; Pharmacokinetics; Regulatory requirements; Repeat dose toxicity studies; Reproductive and developmental toxicity studies; Safety pharmacology; Single dose studies; Toxicokinetics

Indexed keywords


EID: 79953024930     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-0-08-046884-6.00303-1     Document Type: Chapter
Times cited : (5)

References (22)
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    • ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)
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    • (1995) Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals (S2A)
  • 12
    • 85012844720 scopus 로고    scopus 로고
    • ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)
    • Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals (S2B) 1997, ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use).
    • (1997) Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals (S2B)
  • 13
    • 85012815707 scopus 로고    scopus 로고
    • ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)
    • Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) 1998, ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use).
    • (1998) Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)
  • 15
    • 85012830873 scopus 로고    scopus 로고
    • ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)
    • Safety Pharmacology Studies for Human Pharmaceuticals (S7A) 2000, ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use).
    • (2000) Safety Pharmacology Studies for Human Pharmaceuticals (S7A)
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    • ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)
    • Immunotoxicity Studies for Human Pharmaceuticals S8 2006, ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use).
    • (2006) Immunotoxicity Studies for Human Pharmaceuticals S8
  • 17
    • 85012840063 scopus 로고    scopus 로고
    • ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)
    • Dose Selection for Carcinogenicity Studies of Pharmaceuticals & Limit Dose S1C(R2) 2008, ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use).
    • (2008) Dose Selection for Carcinogenicity Studies of Pharmaceuticals & Limit Dose S1C(R2)
  • 19
    • 85012836263 scopus 로고    scopus 로고
    • Pharmaceutical Administration and Regulations in Japan
    • English Regulatory Information Task Force,Japan
    • PMA (Pharmaceutical Manufacturers Association). Pharmaceutical Administration and Regulations in Japan. Information in English on Japan Regulatory Affairs. English Regulatory Information Task Force, Japan, 2007.
    • (2007) Information in English on Japan Regulatory Affairs


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.