Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations

Douglas M. Fast1, Marian Kelley2, C. T. Viswanathan3, J O'Shaughnessy3, Shang‐Ying P. King4, Archana Chaudhary5, Russell Weiner6, Anthony J. DeStefano7, Daniel Tang8
1Pharmacokinetics, Dynamics, and Metabolism, Pfizer Inc., MS-8118D-2061, Eastern Point Road, Groton, 06340, Connecticut, USA
2MKelley Consulting LLC, West Chester, Pennsylvania, USA
3Division of Scientific Investigations, Office of Compliance, CDER, US Food and Drug Administration, Silver Spring, Maryland, USA
4QPS LLC, Newark, Delaware, USA
5Lilly Research Laboratory, Indianapolis, Indiana, USA
6Bristol-Myers-Squibb, Lawrenceville, New Jersey, USA
7US Pharmacopeia, Rockville, Maryland, USA
8Shanghai ChemPartner Co. Ltd., Shanghai, China

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