Assessment of the extrapolation of foreign clinical data for registration purposes

Drug Information Journal

Volumn 36, Issue 3, 2002, Pages 513-516

  Lin, Yeong Liang ^a   Chiou, Yi Jin ^a   Hsiao, Chia Ling ^a   Chern, Herng Der ^a   Chu, Mong Ling ^a  

^a Center for Drug Evaluation   (Taiwan)

Author keywords

Bridging study; Efficacy; Ethnic factors; Foreign; Safety

Indexed keywords

AGENTS ACTING ON THE EYE; ANTIBIOTIC AGENT; ANTITHROMBOCYTIC AGENT; INOTROPIC AGENT;

ARTICLE; ASIA; CLINICAL TRIAL; DATA ANALYSIS; ETHNIC DIFFERENCE; PHARMACODYNAMICS; PHARMACOKINETICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; REGISTRATION; TAIWAN;

EID: 0036379958     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150203600306     Document Type: Article

References (3)

1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: Ethnic Factors for the Acceptability of Foreign Clinical Data (E5). Geneva, Switzerland: ICH; 1998.
2. Naito C. Necessity and requirements of bridging studies and their present status in Japan. Int J. Clin Pharmacol Ther. 2000;38:80-86.
3. Hsiao ML. The current status of clinical trials and GCP in Taiwan. Drug Inf J. 1998;32:1203S-1207S