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Author Details

Federico Goodsaid
1974
67
29
PMIDPaper TitleJournal TitlePublished Year
32318621A precision medicine framework using artificial intelligence for the identification and confirmation of genomic biomarkers of response to an Alzheimer's disease therapy: Analysis of the blarcamesine (ANAVEX2-73) Phase 2a clinical study.Alzheimers Dement (N Y)2020
31162800The Labyrinth of Product Development and Regulatory Approvals in Liquid Biopsy Diagnostics.Clinical and Translational Science2019
29110507Regulatory landscapes for biomarkers and diagnostic tests: Qualification, approval, and role in clinical practice.Experimental Biology and Medicine2018
29354287A robust targeted sequencing approach for low input and variable quality DNA from clinical samples.NPJ Genom Med2018
25757705Recommendations for the development of rare disease drugs using the accelerated approval pathway and for qualifying biomarkers as primary endpoints.Orphanet Journal of Rare Diseases2015
23961847The current status of biomarkers for predicting toxicity.Expert Opin Drug Metab Toxicol2013
22471322Challenges of biomarkers in drug discovery and development.Expert Opinion on Drug Discovery2012
22970228Technical reproducibility of genotyping SNP arrays used in genome-wide association studies.PLoS One2012
22037040Quantifying factors for the success of stratified medicine.Nature Reviews Drug Discovery2011
23484625Qualifying biomarkers for use in drug development: a US Food and Drug Administration overview.Expert Opinion on Medical Diagnostics2011
21448748Translational biomarkers: from preclinical to clinical a report of 2009 AAPS/ACCP Biomarker Workshop.AAPS J2011
20406066Molecular biomarkers: a US FDA effort.Biomark Med2010
20676074The MicroArray Quality Control (MAQC)-II study of common practices for the development and validation of microarray-based predictive models.Nat Biotechnol2010
20676072Assessment of variability in GWAS with CRLMM genotyping algorithm on WTCCC coronary artery disease.Pharmacogenomics J2010
20676071Batch effects in the BRLMM genotype calling algorithm influence GWAS results for the Affymetrix 500K array.Pharmacogenomics J2010
20676070Variability in GWAS analysis: the impact of genotype calling algorithm inconsistencies.Pharmacogenomics J2010
20811041Translational medicine and the value of biomarker qualification.Science Translational Medicine2010
20514070Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact.Nat Rev Drug Discov2010
20458315Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium.Nature Biotechnology2010
20458314Towards consensus practices to qualify safety biomarkers for use in early drug development.Nature Biotechnology2010
20458312Evolution of biomarker qualification at the health authorities.Nature Biotechnology2010
20368714Assessing sources of inconsistencies in genotypes and their effects on genome-wide association studies with HapMap samples.Pharmacogenomics J2010
20407457The Critical Path Institute's approach to precompetitive sharing and advancing regulatory science.Clinical Pharmacology and Therapeutics2010
19958096Development of an undergraduate pharmacogenomics curriculum.Pharmacogenomics2009
19710639Novel biomarkers of acute kidney toxicity.Clinical Pharmacology and Therapeutics2009
19102722Drug-diagnostic codevelopment strategies: FDA and industry dialog at the 4th FDA/DIA/PhRMA/PWG/BIO Pharmacogenomics Workshop.Pharmacogenomics2009
18776163Histopathology of vascular injury in Sprague-Dawley rats treated with phosphodiesterase IV inhibitor SCH 351591 or SCH 534385.Toxicologic Pathology2008
19025421Modulation of clopidogrel pharmacodynamic response.Pharmacotherapy2008
18093264Qualification of biomarkers for drug development in organ transplantation.Am J Transplant2008
18280028Strategic paths for biomarker qualification.Toxicology2008
18793455The balance of reproducibility, sensitivity, and specificity of lists of differentially expressed genes in microarray studies.BMC Bioinformatics2008
18776166Biomarkers in peripheral blood associated with vascular injury in Sprague-Dawley rats treated with the phosphodiesterase IV inhibitors SCH 351591 or SCH 534385.Toxicologic Pathology2008
18447634The first RSBI (ISA-TAB) workshop: "can a simple format work for complex studies?".OMICS2008
18802418The next steps for genomic medicine: challenges and opportunities for the developing world.Nat Rev Genet2008
17259954The experience with voluntary genomic data submissions at the FDA and a vision for the future of the voluntary data submission program.Clinical Pharmacology and Therapeutics2007
24980840The Predictive Safety Testing Consortium: A synthesis of the goals, challenges and accomplishments of the Critical Path.Drug Discovery Today: Technologies2007
24980714Questions and answers about the Pilot Process for Biomarker Qualification at the FDA.Drug Discovery Today: Technologies2007
24980713An integrated bioinformatics infrastructure essential for advancing pharmacogenomics and personalized medicine in the context of the FDA's Critical Path Initiative.Drug Discov Today Technol2007
21136652Grand rounds in proteomics at the FDA white oak, silver spring, MD, USA, april 3, 2007.Proteomics - Clinical Applications2007
17567848Implementing the U.S. FDA guidance on pharmacogenomic data submissions.Environmental and Molecular Mutagenesis2007
17408233Biomarker qualification pilot process at the US Food and Drug Administration.AAPS Journal2007
16886901Process map proposal for the validation of genomic biomarkers.Pharmacogenomics2006
20021001Application of pharmacogenomics in clinical pharmacology.Toxicol Mech Methods2006
20020998Gaining Confidence on Molecular Classification through Consensus Modeling and Validation.Toxicol Mech Methods2006
16964229The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements.Nat Biotechnol2006
16964225Evaluation of DNA microarray results with quantitative gene expression platforms.Nat Biotechnol2006
17061323Rat toxicogenomic study reveals analytical consistency across microarray platforms.Nat Biotechnol2006
16179916The External RNA Controls Consortium: a progress report.Nat Methods2005
16041391The need for education in pharmacogenomics: a regulatory perspective.Pharmacogenomics J2005
16026597Cross-platform comparability of microarray technology: intra-platform consistency and appropriate data analysis procedures are essential.BMC Bioinformatics2005
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National Center for Toxicological Research
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National Center for Toxicological Research (NCTR)
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SAS Institute
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University of New Mexico
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Department of Bioinformatics and Clinical Systems
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Department of Pharmaceutics, University of Florida
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Bruno Kessler Foundation
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Virginia Tech
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Fondazione Bruno Kessler
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Pte. Ltd.
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