A Bayesian noninferiority approach to evaluation of bridging studies

Journal of Biopharmaceutical Statistics

Volumn 14, Issue 2, 2004, Pages 291-300

  Liu, Jen Pei ^a,c   Hsueh, Hueymiin ^b   Hsiao, Chin Fu ^c  

^a NATIONAL CHENG KUNG UNIVERSITY   (Taiwan)

^b NATIONAL CHENGCHI UNIVERSITY   (Taiwan)

^c NATIONAL HEALTH RESEARCH INSTITUTES   (Taiwan)

Author keywords

Bridging study; Empirical Bayes; Extrapolation; Noninferiority

Indexed keywords

ARTICLE; BAYES THEOREM; BRIDGING STUDY; CLINICAL TRIAL; DATA ANALYSIS; DRUG DOSE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG INFORMATION; DRUG SAFETY; NONINFERIORITY TRIAL; PHASE 4 CLINICAL TRIAL; PRIORITY JOURNAL; SAMPLE SIZE;

BAYES THEOREM; CLINICAL TRIALS; MODELS, THEORETICAL; SAMPLE SIZE;

EID: 2642561923     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-120037180     Document Type: Article

References (7)

1. Chow, S. C., Shao, J., Hu, O. Y. P. (2002). Assessing sensitivity and similarity in bridging studies. J. Biopharm. Statist. 12:385-400.
2. ICH, International Conference on Harmonisation. (1998). Tripartite Guidance E5 Ethnic Factors in the Acceptability of Foreign Data, The U.S. Federal Register 83:31790-31796.
3. Liu, J. P., Chow, S. C. (2002). Bridging studies for clinical development. J. Biopharm. Statist. 12:357-369.
4. Liu, J. P., Hsiao, C.-F., Hsueh, H.-M. (2002a). Bayesian approach to evaluation of bridging studies. J. Biopharm. Statist. 12:401-408.
5. Liu, J. P., Hsueh, H.-M., Chen, J. J. (2002b). Sample size requirement for evaluation of bridging evidence. Biometrical J. 44:969-981.
6. 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.
7. Simon (1999). Bayesian design and analysis of active control trials. Biometrics 55:484-487.