A two-stage design for bridging studies

Journal of Biopharmaceutical Statistics

Volumn 15, Issue 1, 2005, Pages 75-83

  Hsiao, Chin Fu ^a   Xu, Jia Zhen ^a   Liu, Jen Pei ^a,b  

^a NATIONAL HEALTH RESEARCH INSTITUTES   (Taiwan)

^b NATIONAL TAIWAN UNIVERSITY   (Taiwan)

Author keywords

Bridging study; Extrapolation; Similarity; Two stage design

Indexed keywords

UNCLASSIFIED DRUG;

ANALYTIC METHOD; ARTICLE; BRIDGING STUDY; DATA ANALYSIS; DRUG DOSAGE FORM; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG MARKETING; DRUG SAFETY; EVALUATION; MATHEMATICAL ANALYSIS; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROCESS DESIGN; SAMPLING; STATISTICAL SIGNIFICANCE; VALIDATION PROCESS;

CLINICAL TRIALS; HUMANS; MODELS, STATISTICAL; RESEARCH DESIGN; SAMPLE SIZE;

EID: 12344263150     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-200040836     Document Type: Article

References (8)

1. Chow, S. C., Shao, J., Hu, O. Y. P. (2002). Assessing sensitivity and similarity in bridging studies. J. Biopharm. Stat. 12:385-400.
2. Hsiao, C. F., Xu, J. Z., Liu, J. P. (2003). A group sequential approach to evaluation of bridging studies. J. Biopharm. Stat. 13:793-801.
3. ICH, International Conference on Harmonisation. (1998). Tripartite Guidance E5, Ethnic Factors in the Acceptability of Foreign Data. Washington, DC: The U.S. Federal Register, 83, pp. 31, 790-31, 796.
4. Liu, J. P., Chow, S. C. (2002). Bridging studies for clinical development. J. Biopharm. Stat. 12:357-369.
5. Liu, J. P., Hsueh, H.-M., Chen, J. J. (2002a). Sample size requirement for evaluation of bridging evidence. Biometr. J. 44:969-981.
6. Liu, J. P., Hsiao, C.-F., Hsueh, H.-M. (2002b). Bayesian approach to evaluation of bridging studies. J. Biopharm. Stat. 12:401-408.
7. Liu, J. P., Hsueh, H.-M., Hsiao, C.-F. (2004). Bayesian non-inferiority approach to evaluation of bridging studies. J. Biopharm. Stat. 14:290-300.
8. Shih, W. J. (2001). Clinical trials for drug registration in Asian-Pacific countries: Proposal for a new paradigm from a statistical perspective. Control. Clin. Trials 22:357-366.