Research ArticleTechnology/Application
A Risk Index and Data Display for Process Performance in the Pharmaceutical Industry
Bert Gunter, Daniel Coleman, Aaron Goerke, Theo Koulis, Jens Lamerz and Yiming Peng
PDA Journal of Pharmaceutical Science and Technology March 2018, 72 (2) 188-198; DOI: https://doi.org/10.5731/pdajpst.2017.008177
Bert Gunter
1Retired, formerly Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA;
Daniel Coleman
2Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA;
Aaron Goerke
3Global Manufacturing Science and Technology, F. Hoffmann-La Roche AG, Basel, Switzerland; and
Theo Koulis
2Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA;
Jens Lamerz
4Nonclinical Biostatistics, F. Hoffmann-La Roche AG, Basel, Switzerland
Yiming Peng
2Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA;

References
- 1.↵ICH Harmonized Tripartite Guideline, Pharmaceutical Development Q8(R2), current step 4 version dated August 2009.
- 2.↵
- Kotz S.,
- Johnson N. L.
- 3.↵
- Hyndman R. J.,
- Fan Y.
- 4.↵
- Tukey J. W.
- 5.↵
- Montgomery D. C.
- 6.↵
- Gunter B. H.
- 7.↵
- Somerville S. E.,
- Montgomery D. C.
- 8.↵
- Vannman K.,
- Albing M.
- 9.↵
- Clements J. A.
- 10.↵
- Pal S.
- 11.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 2
March/April 2018
A Risk Index and Data Display for Process Performance in the Pharmaceutical Industry
Bert Gunter, Daniel Coleman, Aaron Goerke, Theo Koulis, Jens Lamerz, Yiming Peng
PDA Journal of Pharmaceutical Science and Technology Mar 2018, 72 (2) 188-198; DOI: 10.5731/pdajpst.2017.008177
Jump to section
- Article
- Abstract
- 1. Introduction and Context
- 2. Rpk Objectives
- 3. Some Basics On Statistical Quantiles
- 4. Rpk Definition and Interpretation
- 5. Product A—How To “Read” the Data Display (Figure 2)
- 6. Product B—Drilling Down (Figures 3 and 4)
- 7. Product C—Drilling Down (Figures 5 and 6)
- 8. FAQS
- 9. Summary
- Conflict of Interest Declaration
- Acknowledgments
- References
- Figures & Data
- References
- Info & Metrics
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