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Volumn 35, Issue 1, 2001, Pages 285-291

Safety evaluation for new drug approval in Korea

Author keywords

Korea; New drug approval; Toxicity guidelines

Indexed keywords

NEW DRUG;

EID: 0035095216     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150103500133     Document Type: Review
Times cited : (2)

References (6)
  • 1
    • 0005756494 scopus 로고    scopus 로고
    • Pharmaceutical Affairs Law (Law No. 5959, revised on March 31, 1999)
  • 2
    • 0005714284 scopus 로고    scopus 로고
    • Enforcement Regulation of the Law (Ministry of Health and Welfare Ordinance No. 92, revised on January 6, 1999)
  • 3
    • 0005697409 scopus 로고    scopus 로고
    • Guidelines for Application Form for Approval (Notification) of Manufacturer and Manufacture (Import) of Drugs (Korea Food and Drug Administration Notification No. 1998-129, revised on December 31, 1998)
  • 4
    • 0005663243 scopus 로고    scopus 로고
    • Regulation for Evaluation on Safety and Efficacy of Drugs (Korea Food and Drug Administration Notification No. 1999-60, revised on December 22, 1999)
  • 5
    • 0005662341 scopus 로고    scopus 로고
    • Guidelines for Toxicity Studies of Drugs (Korea Food and Drug Administration Notification No. 1999-61, revised on December 22, 1999)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.