Current status of clinical trials and GCP in the Republic of Korea

Drug Information Journal

Volumn 31, Issue 4, 1997, Pages 1079-1087

  Shin, Sang Goo ^a  

^a Seoul National University College of Medicine   (South Korea)

Author keywords

Clinical trial; Current status; Drug industry; ICH GCP; Investigator; IRB; Korean GCP; Medical institution; Monitoring; Survey; WHO GCP

Indexed keywords

CLINICAL TRIAL; CONFERENCE PAPER; DRUG APPROVAL; DRUG INDUSTRY; GOOD CLINICAL PRACTICE; PRIORITY JOURNAL; PROFESSIONAL STANDARD; QUALITY CONTROL; SOUTH KOREA;

EID: 0030664637     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159703100405     Document Type: Conference Paper

References (8)

1. Korean Good Clinical Practice Guidelines. Korean Ministry of Health and Welfare, August 1994.
2. Annual statistical report of Korean drug industries. Korean Pharmaceutical Manufacturer's Association; 1996.
3. Shin SG. Problems related to the clinical trials in Korea. / Kor Med Assoc. 1995;38:68CH586.
4. P radical manual of Korean GCP. Pharmaceutical Bureau Korean Ministry of Health and Welfare; August 1995.
5. GCP workshop; Practical guides for good clinical practices. KorJ Clin Pharmacol Ther. 1996;4:35-123.
6. Lee YS, Han EK, Kirn KS, Oh SJ. A survey on the preparation of Korean pharmaceutical companies for the implementation of GCP. Kor J Clin Pharmacol Ther. 1996;4:49-53.
7. Kirn JM, Kirn CJ, Kirn HK, Moon BW, Moon HL, Park BJ, Shin SG, Yang JH, Woo JH, Lee MS. Knowledge and attitude of clinicians on the clinical trials in Korea. Kor J Clin Pharmacol Ther. 1996;4:63-77.
8. Good Clinical Practice: Consolidated Guideline. ICH Harmonized Tripartite Guideline: E6; May 1996.