Immunotoxicity evaluation and guidelines for drug approval in Korea

Drug Information Journal

Volumn 34, Issue 1, 2000, Pages 25-32

  Kim, Young Ok ^a   Chung, Hyejoo ^a   Kil, Kwang Sup ^a   Park, Jae Hyun ^a   Kim, Dong Sup ^a   Cho, Dae Hyun ^b  

^a Korea Food and Drug Administration   (South Korea)

^b National Institute of Toxicological Research   (South Korea)

Author keywords

Immunotoxicity guidelines; Korea

Indexed keywords

ARTICLE; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; DRUG SCREENING; IMMUNOTOXICITY; KOREA; LAW; PRACTICE GUIDELINE; PRIORITY JOURNAL; REGULATORY MECHANISM; TOXICITY;

EID: 0034125845     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150003400103     Document Type: Article

References (5)

1. Pharmaceutical Affairs Law (Law No. 5959, revised on March 31, 1999).
2. Enforcement Regulation of the Law (Ministry of Health and Welfare Ordinance No. 92, revised on January 6, 1999).
3. 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. Regulation for Evaluation on Safety and Efficacy of Drugs (Korea Food and Drug Administration Notification No. 1999-13, revised on February 6, 1999).
5. Guidelines for Toxicity Studies of Drugs (Korea Food and Drug Administration Notification No. 1998-116, revised on December 3, 1998).