A predictive bayesian approach to the design and analysis of bridging studies

Journal of Biopharmaceutical Statistics

Volumn 22, Issue 5, 2012, Pages 916-934

  Gould, A Lawrence ^a   Jin, Tian ^b   Zhang, Li Xin ^a   Wang, William W B ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b SHANGHAI UNIVERSITY   (China)

Author keywords

Consumer risk; Predictive distribution; Producer risk

Indexed keywords

ARTICLE; BAYES THEOREM; CLINICAL TRIAL; CONFIDENCE INTERVAL; DRUG RESEARCH; HUMAN; INFORMATION; INTERNAL CONSISTENCY; PREDICTION; PRIORITY JOURNAL; PROBABILITY; SAMPLE SIZE; STATISTICAL MODEL; STUDY DESIGN;

ALGORITHMS; BAYES THEOREM; CLINICAL TRIALS AS TOPIC; DATA INTERPRETATION, STATISTICAL; DRUG INDUSTRY; HUMANS; LIKELIHOOD FUNCTIONS; MODELS, STATISTICAL; MULTICENTER STUDIES AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; RISK; SAMPLE SIZE;

EID: 84866274217     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543406.2012.701579     Document Type: Article

References (9)

1. Carlin, B. P., Louis, T. A. (1998). Bayes and Empirical Bayes Methods for Data Analysis. Boca Raton, FL: CRC Press.
2. Hsiao, C. F., Xu, J. Z., Liu, J. P. (2005). A two-stage design for bridging studies. Journal of Biopharmaceutical Statistics 15: 75-83.
3. International Conference on Harmonization. (1998). Ethnic factors in the acceptability of foreign data. Federal Register 83: 31790-31796.
4. Lan, K. K. G., Soo, Y., Siu, C., Wang, M. (2005). The use of weighted z-tests in medical research. Journal of Biopharmaceutical Statistics 15: 625-639. (Pubitemid 40967304)
5. Liu, J. P., Hsiao, C. F., Hsueh, H. (2002). Bayesian approach to evaluation of bridging studies. Journal of Biopharmaceutical Statistics 12: 401-408. (Pubitemid 35332824)
6. Liu, J. P., Hsueh, H., Hsiao, C. F. (2004). A Bayesian noninferiority approach to evaluation of bridging studies. Journal of Biopharmaceutical Statistics 14: 291-300. (Pubitemid 38715782)
7. Lunn, D., Spiegelhalter, D., Thomas, A., Best, N. (2009). The BUGS project: Evolution, critique, and future directions (with discussion). Statistics in Medicine 28: 3049-3082.
8. Shih, W. J. (2001). Clinical trials for drug registrations in Asian-Pacific countries. Controlled Clinical Trials 22: 357-366.
9. Wright, T. D. (1986). A note on the construction of highest posterior density intervals. Applied Statistics 35: 49-53.