
PSTC
News & Events
- March 20, 2021
- March 19, 2021
- January 19, 2021
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May 14, 2020
Serum Glutamate Dehydrogenase Activity Enables Early Detection of Liver Injury in Subjects with Underlying Muscle Impairments
King, Amy C. Porter, Jane Owens, et al. “Serum Glutamate Dehydrogenase Activity Enables Early Detection of Liver Injury in Subjects with Underlying Muscle Impairments.” PloS One 15, no. 5 (2020): e0229753. https://doi.org/10.1371/journal.pone.0229753.
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June 11, 2019
Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices
Brad Ackermann, Eli Lilly; John Allinson, Immunologix Laboratories; Mark Arnold, Covance;Shashi Amur, U.S. FDA; Jiri Aubrecht, Takeda; Amanda Baker, Ventana Medical Systems, Inc.; Robert Becker, U.S. FDA; ShaAvrée Buckman-Garner, U.S. FDA; Jennifer Burkey, Critical Path Institute; Martha Donoghue, U.S. FDA; Carmen Fernandez-Metzler, PharmaCadence; Fabio Garofolo, Angelini; Russ Grant, LabCorp; Huidong Gu, Bristol-Myers Squibb; Vinita Gupta, Exelixis; Steve Gutman, Kylie Haskins, U.S. FDA; Illumina; John Kadavil, U.S. FDA; Yan Mao, Boehringer Ingelheim; Nicholas King, Critical Path Institute; Omar Laterza, Merck; Jean Lee, BioQualQuan; Steve Lowes, Q2 Solutions; Vasum Peiris, U.S. FDA; Steven P. Piccoli, GlaxoSmithKline; Mark Rose, CHDI; Afshin Safavi, BioAgilytix; John Michael Sauer, Critical Path Institute; Shelli Schomaker, (retired); Rick Steenwyk, Pfizer (retired); Lauren Stevenson, Immunologix Laboratories; Meena Subramanyam, Takeda; Matt Szapacs, GlaxoSmithKline; Faye Vazvei, Merck; Sue Jane Wang, U.S. FDA; Jianing Zeng, Bristol-Myers Squibb;