John-Michael Sauer
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Explore the profile of John-Michael Sauer including associated specialties, affiliations and a list of published articles.
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49
Citations
730
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Recent Articles
1.
Waikar S, Mogg R, Baker A, Frendl G, Topper M, Adler S, et al.
Clin Pharmacol Ther
. 2025 Jan;
PMID: 39754474
Two observational studies were conducted to support an initiative to qualify translational kidney safety biomarkers as clinical drug development tools that identify tubular injury prior to changes in estimated glomerular...
2.
Sarntivijai S, Blomberg N, Lauer K, Briggs K, Steger-Hartmann T, van der Lei J, et al.
F1000Res
. 2022 May;
11.
PMID: 35602243
Integrative drug safety research in translational health informatics has rapidly evolved and included data that are drawn in from many resources, combining diverse data that are either reused from (curated)...
3.
Hendrix S, Mogg R, Wang S, Chakravarty A, Romero K, Dickson S, et al.
Biomark Med
. 2021 May;
15(9):669-684.
PMID: 34037457
Qualification of a biomarker for use in a medical product development program requires a statistical strategy that aligns available evidence with the proposed context of use (COU), identifies any data...
4.
Spurney C, Ascheim D, Charnas L, Cripe L, Hor K, King N, et al.
Open Heart
. 2021 Mar;
8(1).
PMID: 33762424
Cardiac disease is now the leading cause of death in Duchenne muscular dystrophy (DMD). Clinical evaluations over time have demonstrated asymptomatic cardiac troponin elevations and acute elevations are associated with...
5.
Sauer J, Porter A
Exp Biol Med (Maywood)
. 2021 Mar;
246(22):2391-2398.
PMID: 33757340
Safety biomarkers are important drug development tools, both preclinically and clinically. It is a straightforward process to correlate the performance of nonclinical safety biomarkers with histopathology, and ideally, the biomarker...
6.
Porter A, Aubrecht J, Birch C, Braun J, Cuff C, Dasgupta S, et al.
Inflamm Bowel Dis
. 2020 Aug;
26(10):1498-1508.
PMID: 32840322
Background: Currently, 2 coprimary end points are used by health authorities to determine the effectiveness of therapeutic interventions in patients with Crohn's disease (CD): symptomatic remission (patient-reported outcome assessment) and...
7.
Schomaker S, Potter D, Warner R, Larkindale J, King N, Porter A, et al.
PLoS One
. 2020 May;
15(5):e0229753.
PMID: 32407333
Serum activities of alanine and aspartate aminotransferases (ALT and AST) are used as gold standard biomarkers for the diagnosis of hepatocellular injury. Since ALT and AST lack liver specificity, the...
8.
Church R, Kullak-Ublick G, Aubrecht J, Bonkovsky H, Chalasani N, Fontana R, et al.
Hepatology
. 2018 Jan;
69(2):760-773.
PMID: 29357190
Current blood biomarkers are suboptimal in detecting drug-induced liver injury (DILI) and predicting its outcome. We sought to characterize the natural variabilty and performance characteristics of 14 promising DILI biomarker...
9.
Sauer J, Porter A
Exp Biol Med (Maywood)
. 2017 Nov;
243(3):222-227.
PMID: 29171289
Biomarkers are ubiquitously used within drug development programs in both nonclinical species and in humans to assess safety and efficacy of novel compounds. To routinely apply such novel biomarkers with...
10.
Leptak C, Menetski J, Wagner J, Aubrecht J, Brady L, Brumfield M, et al.
Sci Transl Med
. 2017 Nov;
9(417).
PMID: 29167393
Biomarkers can facilitate all aspects of the drug development process. However, biomarker qualification-the use of a biomarker that is accepted by the U.S. Food and Drug Administration-needs a clear, predictable...