A Bayesian approach to the ICH Q8 definition of design space

Journal of Biopharmaceutical Statistics

Volumn 18, Issue 5, 2008, Pages 959-975

  Peterson, John J ^a,b  

^a GLAXOSMITHKLINE   (United States)

^b UP 4315 ^*  (United States)

Author keywords

Posterior predictive distribution; Process capability; Reliability; Response surface methodology; Robust parameter design

Indexed keywords

GLUCOSE;

ANIMAL CELL; ARTICLE; BAYES THEOREM; BIOREACTOR; CELL COUNT; CELL VIABILITY; CHO CELL; DESIGN SPACE; DRUG INDUSTRY; DRUG MANUFACTURE; GOOD MANUFACTURING PRACTICE; MULTIVARIATE ANALYSIS; NONHUMAN; PH; PREDICTION; PRIORITY JOURNAL; PROBABILITY; PROCESS DESIGN; RELIABILITY; STATISTICAL ANALYSIS; TEMPERATURE;

BAYES THEOREM; BIOTECHNOLOGY; CHEMISTRY, PHARMACEUTICAL; DRUG INDUSTRY; GUIDELINES AS TOPIC; INTERNATIONAL COOPERATION; RESEARCH DESIGN;

EID: 51649119587     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400802278197     Document Type: Article

References (21)

1. Chen, M.-H., Shao, Q.-M., Ibrahim, J. G. (2000). Monte Carlo Methods in Bayesian Computation. New York: Springer-Verlag.
2. Congdon, P. (2006). Bayesian Statistical Modeling. 2nd ed. West Sussex, UK: John Wiley & Sons, Ltd.
3. Gelman, A., Carlin, J., Stern, H., Rubin, D. (2004). Bayesian Data Analysis. 2nd ed. Boca Raton, FL: CRC Press/Chapman and Hall.
4. Griffiths, W. E. (2003). Bayesian inference in the seemingly unrelated regressions model. In: Giles, D. E. A., ed. Computer-Aided Econometrics. New York: Marcel Dekker, pp. 263-290.
5. Griffiths, W. E., Skeels, C. L., Chotikapanich, D. (2002). Sample size requirements for estimation in SUR models. In: Ullah, A., Wan, A., Chaturvedi, A., eds. Handbook of Applied Econometrics and Statistical Inference. New York: Marcel Dekker, pp. 575-590.
6. Harrington, E. C. (1965). The desirability function. Industrial Quality Control 21:494-498.
7. Hothorn, T., Bretz, F., Genz, A. (2001). On multivariate t and Gauss probabilities in R. R News 1:27-28.
8. Miró-Quesada, G., del Castillo, E., Peterson, J. J. (2004). A Bayesian approach for multiple response surface optimization in the presence of noise variables. J Appl Statist 31:251-270.
9. Moore, C. (2007). Design Space - An FDA Perspective. Presented at the 43rd Annual Meeting of the Drug Information Association, Atlanta, Georgia.
10. Peterson, J. J. (2004). A posterior predictive approach to multiple response surface optimization. Journal of Quality Technology 36:139-153.
11. Peterson, J. J. (2007). Chapter 10: A review of Bayesian reliability approaches to multiple response surface optimization. In: Colosimo, B. M., del Castillo, E., eds. Bayesian Statistics for Process Monitoring, Control, and Optimization. Chapman and Hall/CRC Press Inc., pp. 269-290.
12. Peterson, J. J., Miró-Quesada, G., del Castillo, E. (2008). A Bayesian reliability approach to multiple response optimization with seemingly unrelated regression models. Quality Technology and Quantitative Management (in press).
13. Press, S. J. (2003). Subjective and Objective Bayesian Statistics. 2nd ed. Hoboken, NJ: John Wiley & Sons Inc.
14. Rajagopal, R., del Castillo, E. (2005). Model-robust process optimization using Bayesian model averaging. Technometrics 47:152-163.
15. Rajagopal, R., del Castillo, E., Peterson, J. J. (2005). Model and distribution-robust process optimization with noise factors. Journal of Quality Technology 37:210-222.
16. Robinson, T., Borror, C., Myers, R. (2004). Robust parameter design: A review. Quality and Reliability Engineering International 20:81-101.
17. Rowe, D. B. (2003). Multivariate Bayesian Statistics. Boca Raton, FL: Chapman & Hall/CRC.
18. Schafer, J. L., Yucel, R. M. (2002). Computational strategies for multivariate linear mixed-effects models with missing values. Journal of Computational and Graphical Statistics 11:437-457.
19. Schneider, R., Huhn, G., Cini, P. (2006). Aligning PAT, validation, and post-validation process improvement. Process Analytical Technology Insider Magazine, April issue.
20. StatSoft, Inc. (2003). STATISTICA (data analysis software system), version 6. http://www.statsoft.com.
21. Stockdale, G., Cheng, A. (2008). Finding design space and a reliable operating region using a multivariate Bayesian approach with experimental design. Quality Technology and Quantitative Management (in press).