News & Events
- September 13, 2019
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August 14, 2019
Conrado et al. 2019 Towards Regulatory Endorsement
Towards regulatory endorsement of drug development tools to promote the application of model-informed drug development in Duchenne muscular dystrophy.... -
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;
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February 23, 2019
Investigating the Value of Urine Volume, Creatinine, and Cystatin C for Urinary Biomarkers Normalization for Drug Development Studies
Adedeji, Adeyemi O., Tony Pourmohamad, Yafei Chen, Jennifer Burkey, Catherine J. Betts, Susan J. Bickerton, Manisha Sonee, and James E. McDuffie. “Investigating the Value of Urine Volume, Creatinine, and Cystatin C for Urinary Biomarkers Normalization for Drug Development Studies.” International Journal of Toxicology 38, no. 1 (February 2019): 12–22.
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February 16, 2019
Recommendations for the Design of Therapeutic Trials for Neonatal Seizures
Janet S. Soul, Ronit Pressler, Marilee Allen, Geraldine Boylan, Heike Rabe, Ron Portman, Pollyanna Hardy, Sarah Zohar, Klaus Romero, Brian Tseng, Varsha Bhatt-Mehta, Cecil Hahn, Scott Denne, Stephane Auvin, Alexander Vinks, John Lantos, Neil Marlow and Jonathan M. Davis for the International Neonatal Consortium.