Contributing Authors: Stan Altan, J&J Pharmaceutical R&D; Jim Bergum, Bristol-Myers Squibb Company; Lori Pfahler, Merck & Co.; Edith Senderak, Merck and Co;  Shanthi Sethuraman, Lilly Reserach Laboratories; and  Kim Erland Vukovinsky, Pfizer. All authors are members of the PhRMA CMC SET.

The US Food and Drug Administration’s quality initiative for the 21st century seeks a new paradigm for pharmaceutical assessment. Design space and the statistics used in its development play an important role. The first in a three-part series, this article provides concise answers to frequently asked questions related to the statistical aspects of determining a design space as part of current quality-by-design initiatives. In parts II and III, the authors offer statistical tools used in experimental planning and strategy, as well as methods for evaluating the resulting design space and representing it graphically.

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