Research ArticleResearch
Setting Alert and Action Limits in the Presence of Significant Amount of Censoring in Data
Steven J. Novick, Wei Zhao and Harry Yang
PDA Journal of Pharmaceutical Science and Technology January 2017, 71 (1) 20-32; DOI: https://doi.org/10.5731/pdajpst.2016.006684
Steven J. Novick
MedImmune LLC, Gaithersburg, MD
Wei Zhao
MedImmune LLC, Gaithersburg, MD
Harry Yang
MedImmune LLC, Gaithersburg, MD

References
- 1.↵FDA Guidance for industry. Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice, (2004); http://www.fda.gov/downloads/Drugs/…/Guidances/ucm070342.pdf. Accessed 25 March 2016.
- 2.↵EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use—Annex 1 Manufacture of Sterile Medicinal Products (corrected version, 2008; http://ec.europa.eu/health/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf. Accessed 25 March 2016.
- 3.↵USP<1116> Microbiological Control and Monitoring of Aseptic Processing Environments, 2013. http://www.ccv.com.ve/SalasLimpias/USP_1116_USP_36_NF31S1.pdf. Accessed 25 March 2016.
- 4.↵
- Sutton S.
- 5.↵
- Wheeler D.
- 6.↵
- Yang H.,
- Zhao W.,
- O'Day T.,
- Fleming W.
- 7.↵
- Tobin J.
- 8.↵
- Davidian M.,
- Giltinan D. M.
- 9.↵
- Bates D. M.,
- DebRoy S.
- 10.↵
- Gelman A.,
- Carlin J.,
- Stern H.,
- Rubin D.
- 11.↵
- Harville D. A.
- 12.↵
- Liao C. T.,
- Lin T. Y.,
- Iyer H. K.
- 13.↵
- Efron B.,
- Tibshirani R. J.
- 14.↵
- Casella G.,
- Berger R. L.
- 15.↵
- Lunn D.,
- Spiegelhalter D.,
- Thomas A.,
- Best N.
- 16.↵
- Plummer M.
- 17.↵Stan Development Team, (2016). Stan Modeling Language Users Guide and Reference Manual, Version 2.9.0. http://mc-stan.org
- 18.↵SAS Institute Inc. SAS/STAT® 9.2 User's Guide, 2nd ed.; SAS Institute, Inc.: Cary, NC, 2009.
- 19.↵
- Royston J. P.
- 20.↵
- Royston P. A.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 1
January/February 2017
Setting Alert and Action Limits in the Presence of Significant Amount of Censoring in Data
Steven J. Novick, Wei Zhao, Harry Yang
PDA Journal of Pharmaceutical Science and Technology Jan 2017, 71 (1) 20-32; DOI: 10.5731/pdajpst.2016.006684
Jump to section
- Article
- Abstract
- 1. Introduction
- 2. Two-variance Component (2VC) Gaussian Model
- 3. Single-variance Component (1VC) Gaussian Model
- 4. Example Data Set
- 5. Simulation
- 6. Discussion
- Conflict of Interest Declaration
- Acknowledgments
- Appendix A1. STAN Computer Code for 2VC Gaussian Model
- Appendix A2. STAN Computer Code for 1VC Gaussian Model
- References
- Figures & Data
- References
- Info & Metrics
Related Articles
- No related articles found.
Cited By...
- No citing articles found.