James Morgado

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Morgado received his bachelor of science from the University of South Florida in 1994. He joined Pfizer Inc. in 1995 as a lab scientist in the quality division, focusing on the redevelopment and validation of commercial methods and methodologies to support patent protection. In 1998, Morgado joined Pfizer Central Research Analytical R&D, where he is currently a Principal Scientist. He is the key analytical analyst for several oncology candidates, including Enlyta (Axitinib) and Xtandi. For the last several years his focus has been on the development of chromatographic methodologies to support late-stage drug development employing quality by design principles as appropriate.

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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...