Federico Goodsaid

Federico Goodsaid

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Federico Goodsaid

Publications by authors named "Federico Goodsaid"

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The Labyrinth of Product Development and Regulatory Approvals in Liquid Biopsy Diagnostics.

Clin Transl Sci 2019 09 1;12(5):431-439. Epub 2019 Jul 1.

Regulatory Pathfinders, LLC, Pescadero, California, USA.

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http://dx.doi.org/10.1111/cts.12657DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6742934PMC
September 2019

Regulatory landscapes for biomarkers and diagnostic tests: Qualification, approval, and role in clinical practice.

Exp Biol Med (Maywood) 2018 02 7;243(3):256-261. Epub 2017 Nov 7.

2 Regulatory Pathfinders, Pescadero, CA 94060, USA.

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http://dx.doi.org/10.1177/1535370217739629DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5813865PMC
February 2018

The Predictive Safety Testing Consortium: A synthesis of the goals, challenges and accomplishments of the Critical Path.

Drug Discov Today Technol 2007 ;4(2):47-50

Critical Path Institute, Rockville, MD, USA.

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http://dx.doi.org/10.1016/j.ddtec.2007.10.010DOI Listing
July 2014

An integrated bioinformatics infrastructure essential for advancing pharmacogenomics and personalized medicine in the context of the FDA's Critical Path Initiative.

Drug Discov Today Technol 2007 ;4(1):3-8

Genomics Group, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, FDA, Rockville, MD, USA.

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http://dx.doi.org/10.1016/j.ddtec.2007.10.008DOI Listing
July 2014

Questions and answers about the Pilot Process for Biomarker Qualification at the FDA.

Drug Discov Today Technol 2007 ;4(1):9-11

Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA.

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http://dx.doi.org/10.1016/j.ddtec.2007.10.005DOI Listing
July 2014

The current status of biomarkers for predicting toxicity.

Expert Opin Drug Metab Toxicol 2013 Nov 21;9(11):1391-408. Epub 2013 Aug 21.

Drug Safety Research and Development, Pfizer, Inc. , Eastern Point Road, MS 8274 1260, Groton, CT 06340 , USA.

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http://dx.doi.org/10.1517/17425255.2013.827170DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3870154PMC
November 2013

Gaining Confidence on Molecular Classification through Consensus Modeling and Validation.

Toxicol Mech Methods 2006 ;16(2-3):59-68

Center for Toxicoinformatics, National Center for Toxicological Research (NCTR), U.S. Food and Drug Administration, Jefferson, AR, 72079, USA.

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http://dx.doi.org/10.1080/15376520600558259DOI Listing
October 2012

Application of pharmacogenomics in clinical pharmacology.

Toxicol Mech Methods 2006 ;16(2-3):89-99

Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1080/15376520600558333DOI Listing
October 2012

Challenges of biomarkers in drug discovery and development.

Expert Opin Drug Discov 2012 Jun 4;7(6):457-61. Epub 2012 Apr 4.

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http://dx.doi.org/10.1517/17460441.2012.679615DOI Listing
June 2012

Quantifying factors for the success of stratified medicine.

Nat Rev Drug Discov 2011 Oct 31;10(11):817-33. Epub 2011 Oct 31.

Massachusetts Institute of Technology, Sloan School of Management and Center for Biomedical Innovation, 100 Main Street, Cambridge, Massachusetts 02139, USA.

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http://dx.doi.org/10.1038/nrd3557DOI Listing
October 2011

Qualifying biomarkers for use in drug development: a US Food and Drug Administration overview.

Expert Opin Med Diagn 2011 Sep;5(5):369-74

Center for Drug Evaluation and Research, Office of Clinical Pharmacology, Office of Translational Sciences, Food and Drug Administration, 10903 New Hampshire Ave, Building 51, Room 3182, Silver Spring, MD 20993 USA +1 301 796 4756 ; +1 3018478720 ;

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http://www.tandfonline.com/doi/full/10.1517/17530059.2011.58
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http://dx.doi.org/10.1517/17530059.2011.588947DOI Listing
September 2011

Translational medicine and the value of biomarker qualification.

Sci Transl Med 2010 Sep;2(47):47ps44

Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Silver Spring, MD 20903, USA.

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http://dx.doi.org/10.1126/scitranslmed.3001040DOI Listing
September 2010

The MicroArray Quality Control (MAQC)-II study of common practices for the development and validation of microarray-based predictive models.

Authors:
Leming Shi Gregory Campbell Wendell D Jones Fabien Campagne Zhining Wen Stephen J Walker Zhenqiang Su Tzu-Ming Chu Federico M Goodsaid Lajos Pusztai John D Shaughnessy André Oberthuer Russell S Thomas Richard S Paules Mark Fielden Bart Barlogie Weijie Chen Pan Du Matthias Fischer Cesare Furlanello Brandon D Gallas Xijin Ge Dalila B Megherbi W Fraser Symmans May D Wang John Zhang Hans Bitter Benedikt Brors Pierre R Bushel Max Bylesjo Minjun Chen Jie Cheng Jing Cheng Jeff Chou Timothy S Davison Mauro Delorenzi Youping Deng Viswanath Devanarayan David J Dix Joaquin Dopazo Kevin C Dorff Fathi Elloumi Jianqing Fan Shicai Fan Xiaohui Fan Hong Fang Nina Gonzaludo Kenneth R Hess Huixiao Hong Jun Huan Rafael A Irizarry Richard Judson Dilafruz Juraeva Samir Lababidi Christophe G Lambert Li Li Yanen Li Zhen Li Simon M Lin Guozhen Liu Edward K Lobenhofer Jun Luo Wen Luo Matthew N McCall Yuri Nikolsky Gene A Pennello Roger G Perkins Reena Philip Vlad Popovici Nathan D Price Feng Qian Andreas Scherer Tieliu Shi Weiwei Shi Jaeyun Sung Danielle Thierry-Mieg Jean Thierry-Mieg Venkata Thodima Johan Trygg Lakshmi Vishnuvajjala Sue Jane Wang Jianping Wu Yichao Wu Qian Xie Waleed A Yousef Liang Zhang Xuegong Zhang Sheng Zhong Yiming Zhou Sheng Zhu Dhivya Arasappan Wenjun Bao Anne Bergstrom Lucas Frank Berthold Richard J Brennan Andreas Buness Jennifer G Catalano Chang Chang Rong Chen Yiyu Cheng Jian Cui Wendy Czika Francesca Demichelis Xutao Deng Damir Dosymbekov Roland Eils Yang Feng Jennifer Fostel Stephanie Fulmer-Smentek James C Fuscoe Laurent Gatto Weigong Ge Darlene R Goldstein Li Guo Donald N Halbert Jing Han Stephen C Harris Christos Hatzis Damir Herman Jianping Huang Roderick V Jensen Rui Jiang Charles D Johnson Giuseppe Jurman Yvonne Kahlert Sadik A Khuder Matthias Kohl Jianying Li Li Li Menglong Li Quan-Zhen Li Shao Li Zhiguang Li Jie Liu Ying Liu Zhichao Liu Lu Meng Manuel Madera Francisco Martinez-Murillo Ignacio Medina Joseph Meehan Kelci Miclaus Richard A Moffitt David Montaner Piali Mukherjee George J Mulligan Padraic Neville Tatiana Nikolskaya Baitang Ning Grier P Page Joel Parker R Mitchell Parry Xuejun Peng Ron L Peterson John H Phan Brian Quanz Yi Ren Samantha Riccadonna Alan H Roter Frank W Samuelson Martin M Schumacher Joseph D Shambaugh Qiang Shi Richard Shippy Shengzhu Si Aaron Smalter Christos Sotiriou Mat Soukup Frank Staedtler Guido Steiner Todd H Stokes Qinglan Sun Pei-Yi Tan Rong Tang Zivana Tezak Brett Thorn Marina Tsyganova Yaron Turpaz Silvia C Vega Roberto Visintainer Juergen von Frese Charles Wang Eric Wang Junwei Wang Wei Wang Frank Westermann James C Willey Matthew Woods Shujian Wu Nianqing Xiao Joshua Xu Lei Xu Lun Yang Xiao Zeng Jialu Zhang Li Zhang Min Zhang Chen Zhao Raj K Puri Uwe Scherf Weida Tong Russell D Wolfinger

Nat Biotechnol 2010 Aug 30;28(8):827-38. Epub 2010 Jul 30.

National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas, USA.

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http://dx.doi.org/10.1038/nbt.1665DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3315840PMC
August 2010

Evolution of biomarker qualification at the health authorities.

Nat Biotechnol 2010 May;28(5):441-3

Food and Drug Administration, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1038/nbt0510-441DOI Listing
May 2010

Molecular biomarkers: a US FDA effort.

Biomark Med 2010 Apr;4(2):215-25

Center for Toxicoinformatics, Division of Systems Toxicology, National Center for Toxicological Research, US FDA 3900 NCTR Road, Jefferson, AR, USA.

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http://dx.doi.org/10.2217/bmm.09.81DOI Listing
April 2010

Development of an undergraduate pharmacogenomics curriculum.

Pharmacogenomics 2009 Dec;10(12):1979-86

The George Washington University Medical Center, Ross Hall Room 660A, 2300 Eye Street, NW, Washington, DC 20037, USA.

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http://dx.doi.org/10.2217/pgs.09.145DOI Listing
December 2009

Drug-diagnostic codevelopment strategies: FDA and industry dialog at the 4th FDA/DIA/PhRMA/PWG/BIO Pharmacogenomics Workshop.

Pharmacogenomics 2009 Jan;10(1):127-36

Novartis Pharmaceuticals Corp, One Health Plaza, East Hanover, NJ 07939-1080, USA.

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http://dx.doi.org/10.2217/14622416.10.1.127DOI Listing
January 2009

Modulation of clopidogrel pharmacodynamic response.

Pharmacotherapy 2008 Dec;28(12):1423-4

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http://dx.doi.org/10.1592/phco.28.12.1423DOI Listing
December 2008

Histopathology of vascular injury in Sprague-Dawley rats treated with phosphodiesterase IV inhibitor SCH 351591 or SCH 534385.

Toxicol Pathol 2008 Oct 5;36(6):827-39. Epub 2008 Sep 5.

Division of Applied Pharmacology Research (HFD-910), Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, USA.

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http://dx.doi.org/10.1177/0192623308322308DOI Listing
October 2008

Biomarkers in peripheral blood associated with vascular injury in Sprague-Dawley rats treated with the phosphodiesterase IV inhibitors SCH 351591 or SCH 534385.

Toxicol Pathol 2008 Oct 5;36(6):840-9. Epub 2008 Sep 5.

Division of Applied Pharmacology Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, USA.

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http://dx.doi.org/10.1177/0192623308322310DOI Listing
October 2008

The next steps for genomic medicine: challenges and opportunities for the developing world.

Nat Rev Genet 2008 10;9 Suppl 1:S23-7

McLaughlin-Rotman Centre for Global Health, Program on Life Sciences, Ethics and Policy, University Health Network and University of Toronto, MaRS Centre, South Tower, Suite 406, 101 College Street, Toronto, Ontario M5G 1L7, Canada.

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http://dx.doi.org/10.1038/nrg2444DOI Listing
October 2008

Strategic paths for biomarker qualification.

Toxicology 2008 Mar 6;245(3):219-23. Epub 2008 Jan 6.

Genomics Group, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, FDA, MD 20903-0002, United States.

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http://dx.doi.org/10.1016/j.tox.2007.12.023DOI Listing
March 2008

Qualification of biomarkers for drug development in organ transplantation.

Am J Transplant 2008 Feb 18;8(2):267-70. Epub 2007 Dec 18.

School of Pharmacy, University of Southern California, Los Angeles, CA, USA.

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http://dx.doi.org/10.1111/j.1600-6143.2007.02063.xDOI Listing
February 2008

Grand rounds in proteomics at the FDA white oak, silver spring, MD, USA, april 3, 2007.

Proteomics Clin Appl 2007 Dec;1(12):1526-31

Genomics Group, U.S. Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1002/prca.200700575DOI Listing
December 2007

Implementing the U.S. FDA guidance on pharmacogenomic data submissions.

Environ Mol Mutagen 2007 Jun;48(5):354-8

Genomics Group, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20903-0002, USA.

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http://dx.doi.org/10.1002/em.20294DOI Listing
June 2007

Biomarker qualification pilot process at the US Food and Drug Administration.

AAPS J 2007 Mar 23;9(1):E105-8. Epub 2007 Mar 23.

Genomics Group, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20903-0002, USA.

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http://dx.doi.org/10.1208/aapsj0901010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2751298PMC
March 2007

Process map proposal for the validation of genomic biomarkers.

Pharmacogenomics 2006 Jul;7(5):773-82

US Food and Drug Administration, Genomics Group, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 21, Room 3663, Silver Spring, MD 20903-0002, USA.

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http://dx.doi.org/10.2217/14622416.7.5.773DOI Listing
July 2006

Microarray scanner calibration curves: characteristics and implications.

BMC Bioinformatics 2005 Jul 15;6 Suppl 2:S11. Epub 2005 Jul 15.

National Center for Toxicological Research, U.S. Food and Drug Administration, 3900 NCTR Road, Jefferson, Arkansas 72079, USA.

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http://dx.doi.org/10.1186/1471-2105-6-S2-S11DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1637029PMC
July 2005

Identification and measurement of genomic biomarkers of nephrotoxicity.

J Pharmacol Toxicol Methods 2004 May-Jun;49(3):183-6

Department of Genetic and Molecular Toxicology, Schering-Plough Research Institute, 144 Route 94, Lafayette, NJ 07871, USA.

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http://dx.doi.org/10.1016/j.vascn.2004.02.005DOI Listing
December 2004

QA/QC: challenges and pitfalls facing the microarray community and regulatory agencies.

Expert Rev Mol Diagn 2004 Nov;4(6):761-77

US Food and Drug Administration, Center for Toxicoinformatics, Division of Systems Toxicology, National Center for Toxicological Research, HFT-020, 3900 NCTR Road, Jefferson, AR 72079, USA.

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http://dx.doi.org/10.1586/14737159.4.6.761DOI Listing
November 2004

Quantitative gene expression analysis in a nonhuman primate model of antibiotic-induced nephrotoxicity.

Toxicol Appl Pharmacol 2004 Oct;200(1):16-26

Division of Drug Safety and Metabolism, Schering-Plough Research Institute, Lafayette, NJ 07848, USA.

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http://dx.doi.org/10.1016/j.taap.2004.02.001DOI Listing
October 2004

Regulation of gene expression by pegylated IFN-alpha2b and IFN-alpha2b in human peripheral blood mononuclear cells.

J Interferon Cytokine Res 2004 Aug;24(8):455-69

Department of Biotechnology, Schering-Plough Research Institute, Union, NJ 07083, USA.

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http://dx.doi.org/10.1089/1079990041689638DOI Listing
August 2004

Assessment of the sensitivity of the computational programs DEREK, TOPKAT, and MCASE in the prediction of the genotoxicity of pharmaceutical molecules.

Environ Mol Mutagen 2004 ;43(3):143-58

Department of Genetic and Molecular Toxicology, Schering-Plough Research Institute, Lafayette, New Jersey 07848, USA.

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http://dx.doi.org/10.1002/em.20013DOI Listing
June 2004

Quantitative PCR deconstruction of discrepancies between results reported by different hybridization platforms.

Environ Health Perspect 2004 Mar;112(4):456-60

Division of Drug Safety and Metabolism, Schering-Plough Research Institute, 144 Route 94, PO Box 32, Lafayette, NJ 07848, USA.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1241899PMC
http://dx.doi.org/10.1289/ehp.6695DOI Listing
March 2004

Genomic biomarkers of toxicity.

Curr Opin Drug Discov Devel 2003 Jan;6(1):41-9

Schering-Plough Research Institute, Department of Genetic and Molecular Toxicology, 144 Route 94, Lafayette, NJ 07871, USA.

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January 2003