Stephen Chestnut

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Chestnut is a Principal Scientist in the Analytical Research and Development Group at Pfizer Inc. Worldwide Research and Development at the Groton, CT, site. He received his bachelor of science from Pennsylvania State University in 1989. Chesnut joined Pfizer in 1997 and is a Lead Project Analyst on several late-stage drug substance development programs. In his role supporting drug-substance synthetic-route development, Chesnut performs chromatographic method development utilizing quality by design principles and assesses the performance of these methods using the analytical target profile criteria. He is a member of the Pfizer Separations Science Network as well as the Analytical R&D Quality by Design Steering Group at Pfizer.

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Technical
Defining the Analytical Target Profile

Analytical target profile criteria for judging the quality of results generated by analytical methods are framed in an optimization paradigm by illustrating the ATP criteria as a loss function. In the case where specifications are based on quality arguments and process capability, a probability-defined loss function is useful for providing a direct measurement of risk for making incorrect...