Finally, in many cases, process understanding is best achieved through proper statistical analysis of the data. The statistical
tools that are widely used in research and development are equally useful in the CMC setting. The statistical link between
sample size and reliability creates an incentive, rather than a disincentive, for collecting more data.
Laura Foust* is a research scientist at Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, tel. 317.276.3007, fax
Myron Diener is an industrial development scientist at sanofi-aventis. Mary Ann Gorko is a principal statistician at AstraZeneca Pharmaceuticals LP. Jeff Hofer is a principal research scientist at Eli Lilly and Company. Greg Larner is a statistics manager at Pfizer Scientific and Laboratory Services. David LeBlond is a principal research statistician at Abbott. Jerry Lewis is a senior principal biostatistician scientist at Wyeth Biotech. Dennis Sandell is an associate principal scientist at AstraZeneca. Tim Schofield is senior director, nonclinical statistics, at Merck Research Laboratories. Kimberly Erland Vukovinsky is director, nonclinical statistics, at Pfizer. Ed Warner is director, statistical services, at Schering Plough Global Quality. All authors are members of the PhRMA CM&C Statistics
*To whom all correspondence should be addressed.
Submitted: Jan 31, 2007. Accepted:Feb. 26, 2007
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