* For continuity throughout the series, Figures and Tables are numbered in succession. Figure 1 and Table I appeared in Part
I of this article series. Figures 2–8 and Table II appeared in Part II.
** "Factor" is synonymous with "x," input, variable. A process parameter can be a factor as can an input material. For simplicity
and consistency, "factor" is used throughout the paper. "Response" is synonymous with "y" and output. Here, "response" is
either the critical quality attribute (CQA) or the surrogate for the CQA. For consistency, "response" is used throughout the
See Part I of this article series
The authors wish to thank Raymond Buck, statistical consultant; Rick Burdick, Amgen; Dave Christopher, Schering-Plough; Peter
Lindskoug, AstraZeneca; Tim Schofield and Greg Stockdale, GSK; and Ed Warner, Schering-Plough, for their advice and assistance
with this article.
Stan Altan is a senior research fellow at Johnson & Johnson Pharmaceutical R&D in Raritan, NJ. James Bergum is associate director of nonclinical biostatistics at Bristol-Myers Squibb Company in New Brunswick, NJ. Lori Pfahler is associate director, and Edith Senderak is associate director, scientific staff, both at Merck and Co. in West Point, PA. Shanthi Sethuraman is director of chemical product R&D at Lilly Research Laboratories in Indianapolis. Kim Erland Vukovinsky* is director of nonlinical statistics at Pfizer, MS 8200-3150, Eastern Point Rd., Groton, CT 06340, tel. 860.715.0916, email@example.com
. At the time of this writing, all authors were members of the Pharmaceutical Research and Manufacturers of America (PhRMA)
Chemistry, Manufacturing, and Controls Statistics Experts Team (SET).
*To whom all correspondence should be addressed.
Submitted: Jan. 12, 2010. Accepted: Jan. 27, 2010.
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34 (7) 66–70 (2010).
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