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Quantifying factors for the success of stratified medicine.
Published in:
2011
By:
- Trusheim, Mark R.;
- Burgess, Breon;
- Hu, Sean Xinghua;
- Long, Theresa;
- Averbuch, Steven D.;
- Flynn, Aiden A.;
- Lieftucht, Alfons;
- Mazumder, Abhijit;
- Milloy, Judy;
- Shaw, Peter M.;
- Swank, David;
- Wang, Jian;
- Berndt, Ernst R.;
- Goodsaid, Federico;
- Palmer, Michael C.
Publication type:
journal article
Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact.
Published in:
2010
By:
- Goodsaid, Federico M.;
- Amur, Shashi;
- Aubrecht, Jiri;
- Burczynski, Michael E.;
- Carl, Kevin;
- Catalano, Jennifer;
- Charlab, Rosane;
- Close, Sandra;
- Cornu-Artis, Catherine;
- Essioux, Laurent;
- Fornace, Albert J.;
- Hinman, Lois;
- Huixiao Hong;
- Hunt, Ian;
- Jacobson-Kram, David;
- Jawaid, Ansar;
- Laurie, David;
- Lesko, Lawrence;
- Heng-Hong Li;
- Lindpaintner, Klaus
Publication type:
review
Recommendations for the development of rare disease drugs using the accelerated approval pathway and for qualifying biomarkers as primary endpoints.
Published in:
Orphanet Journal of Rare Diseases, 2015, v. 10, n. 1, p. 1, doi. 10.1186/s13023-014-0195-4
By:
- Kakkis, Emil D.;
- O'Donovan, Mary;
- Gerald Cox;
- Hayes, Mark;
- Goodsaid, Federico;
- Tandon, P. K.;
- Furlong, Pat;
- Boynton, Susan;
- Bozic, Mladen;
- Orfali, May;
- Thornton, Mark
Publication type:
Article
Recommendations for the development of rare disease drugs using the accelerated approval pathway and for qualifying biomarkers as primary endpoints.
Published in:
2015
By:
- Kakkis, Emil D;
- O'Donovan, Mary;
- Cox, Gerald;
- Hayes, Mark;
- Goodsaid, Federico;
- Tandon, P K;
- Furlong, Pat;
- Boynton, Susan;
- Bozic, Mladen;
- Orfali, May;
- Thornton, Mark
Publication type:
journal article
Study of the mechanism of action of Blarcamesine (ANAVEX®2‐73): Whole blood transcriptomics analysis identifies treatment impact on compensatory pathways by restoring key neurodegenerative pathways functionality, including Alzheimer's disease pathway
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2023, v. 19, p. 1, doi. 10.1002/alz.059024
By:
- Williams, Coralie;
- Kindermans, Martin;
- Parmentier, Frédéric;
- Goodsaid, Federico;
- Hammond, Edward;
- Missling, Christopher U;
- Afshar, Mohammad
Publication type:
Article
DT‐01‐05: SYSTEMATIC PROCESSING OF FULL GENOMIC ANALYSIS OF THE ANAVEX<sup>®</sup>2‐73 PHASE 2A ALZHEIMER'S DISEASE STUDY IDENTIFIES BIOMARKERS ENABLING A PRECISION MEDICINE APPROACH.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2018, v. 14, p. P1666, doi. 10.1016/j.jalz.2018.07.007
By:
- Hampel, Harald;
- Afshar, Mohammad;
- Parmentier, Frédéric;
- Williams, Coralie;
- Etcheto, Adrien;
- Goodsaid, Federico;
- Fadiran, Emmanuel O.;
- Missling, Christopher U.
Publication type:
Article
P4‐206: FULL GENOMIC ANALYSIS OF ANAVEX<sup>®</sup>2‐73 PHASE 2A ALZHEIMER'S DISEASE STUDY IDENTIFIES BIOMARKERS ENABLING TARGETED THERAPY AND A PRECISION MEDICINE APPROACH.
Published in:
Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2018, v. 14, p. P1519, doi. 10.1016/j.jalz.2018.07.027
By:
- Hampel, Harald;
- Afshar, Mohammad;
- Parmentier, Frédéric;
- Williams, Coralie;
- Etcheto, Adrien;
- Goodsaid, Federico;
- Fadiran, Emmanuel O.;
- Missling, Christopher U.
Publication type:
Article
The MicroArray Quality Control (MAQC)-II study of common practices for the development and validation of microarray-based predictive models.
Published in:
Nature Biotechnology, 2010, v. 28, n. 8, p. 827, doi. 10.1038/nbt.1665
By:
- Shi, Leming;
- Campbell, Gregory;
- Jones, Wendell D;
- Campagne, Fabien;
- Wen, Zhining;
- Walker, Stephen J;
- Su, Zhenqiang;
- Chu, Tzu-Ming;
- Goodsaid, Federico M;
- Pusztai, Lajos;
- Shaughnessy, John D;
- Oberthuer, André;
- Thomas, Russell S;
- Paules, Richard S;
- Fielden, Mark;
- Barlogie, Bart;
- Chen, Weijie;
- Du, Pan;
- Fischer, Matthias;
- Furlanello, Cesare
Publication type:
Article
Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium.
Published in:
Nature Biotechnology, 2010, v. 28, n. 5, p. 455, doi. 10.1038/nbt.1625
By:
- Dieterle, Frank;
- Sistare, Frank;
- Goodsaid, Federico;
- Papaluca, Marisa;
- Ozer, Josef S.;
- Webb, Craig P.;
- Baer, William;
- Senagore, Anthony;
- Schipper, Matthew J.;
- Vonderscher, Jacky;
- Sultana, Stefan;
- Gerhold, David L.;
- Phillips, Jonathan A.;
- Maurer, Gérard;
- Carl, Kevin;
- Laurie, David;
- Harpur, Ernie;
- Sonee, Manisha;
- Ennulat, Daniela;
- Holder, Dan
Publication type:
Article
Evolution of biomarker qualification at the health authorities.
Published in:
2010
By:
- Goodsaid, Federico;
- Papaluca, Marisa
Publication type:
Opinion
Towards consensus practices to qualify safety biomarkers for use in early drug development.
Published in:
Nature Biotechnology, 2010, v. 28, n. 5, p. 446, doi. 10.1038/nbt.1634
By:
- Sistare, Frank D.;
- Dieterle, Frank;
- Troth, Sean;
- Holder, Daniel J.;
- Gerhold, David;
- Andrews-Cleavenger, Dina;
- Baer, William;
- Betton, Graham;
- Bounous, Denise;
- Carl, Kevin;
- Collins, Nathaniel;
- Goering, Peter;
- Goodsaid, Federico;
- Yi-Zhong Gu;
- Guilpin, Valerie;
- Harpur, Ernie;
- Hassan, Alita;
- Jacobson-Kram, David;
- Kasper, Peter;
- Laurie, David
Publication type:
Article
Rat toxicogenomic study reveals analytical consistency across microarray platforms.
Published in:
Nature Biotechnology, 2006, v. 24, p. 1162, doi. 10.1038/nbt1238
By:
- Lei Guo;
- Lobenhofer, Edward K.;
- Wang, Charles;
- Shippy, Richard;
- Harris, Stephen C.;
- Lu Zhang;
- Nan Mei;
- Tao Chen;
- Herman, Damir;
- Goodsaid, Federico M.;
- Hurban, Patrick;
- Phillips, Kenneth L.;
- Jun Xu;
- Xutao Deng;
- Sun, Yongming Andrew;
- Weida Tong;
- Yvonne P.Dragan;
- Leming Shi
Publication type:
Article
The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements.
Published in:
Nature Biotechnology, 2006, v. 24, p. 1151, doi. 10.1038/nbt1239
By:
- Shi, Leming;
- Reid, Laura H.;
- Jones, Wendell D.;
- Shippy, Richard;
- Warrington, Janet A.;
- Baker, Shawn C.;
- Collins, Patrick J.;
- de Longueville, Francoise;
- Kawasaki, Ernest S.;
- Kathleen Y.Lee;
- Yuling Luo;
- Sun, Yongming Andrew;
- Willey, James C.;
- Setterquist, Robert A.;
- Fischer, Gavin M.;
- Tong, Weida;
- Dragan, Yvonne P.;
- Dix, David J.;
- Frueh, Felix W.;
- Goodsaid, Federico M.
Publication type:
Article
The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements.
Published in:
Nature Biotechnology, 2006, v. 24, n. 9, p. 1151, doi. 10.1038/nbt1239
By:
- Shi, Leming;
- Reid, Laura H.;
- Jones, Wendell D.;
- Shippy, Richard;
- Warrington, Janet A.;
- Baker, Shawn C.;
- Collins, Patrick J.;
- de Longueville, Francoise;
- Kawasaki, Ernest S.;
- Lee, Kathleen Y.;
- Luo, Yuling;
- Sun, Yongming Andrew;
- Willey, James C.;
- Setterquist, Robert A.;
- Fischer, Gavin M.;
- Tong, Weida;
- Dragan, Yvonne P.;
- Dix, David J.;
- Frueh, Felix W.;
- Goodsaid, Federico M.
Publication type:
Article
Rat toxicogenomic study reveals analytical consistency across microarray platforms.
Published in:
Nature Biotechnology, 2006, v. 24, n. 9, p. 1162, doi. 10.1038/nbt1238
By:
- Guo, Lei;
- Lobenhofer, Edward K.;
- Wang, Charles;
- Shippy, Richard;
- Harris, Stephen C.;
- Zhang, Lu;
- Mei, Nan;
- Chen, Tao;
- Herman, Damir;
- Goodsaid, Federico M.;
- Hurban, Patrick;
- Phillips, Kenneth L.;
- Xu, Jun;
- Deng, Xutao;
- Sun, Yongming Andrew;
- Tong, Weida;
- Dragan, Yvonne P.;
- Shi, Leming
Publication type:
Article
The External RNA Controls Consortium: a progress report.
Published in:
Nature Methods, 2005, v. 2, n. 10, p. 731, doi. 10.1038/nmeth1005-731
By:
- Baker, Shawn C.;
- Bauer, Steven R.;
- Beyer, Richard P.;
- Brenton, James D.;
- Bromley, Bud;
- Burrill, John;
- Causton, Helen;
- Conley, Michael P.;
- Elespuru, Rosalie;
- Fero, Michael;
- Foy, Carole;
- Fuscoe, James;
- Xiaolian Gao;
- Gerhold, David Lee;
- Gilles, Patrick;
- Goodsaid, Federico;
- Xu Guo;
- Hackett, Joe;
- Hockett, Richard D.;
- Ikonomi, Pranvera
Publication type:
Article
Erratum to: Translational Biomarkers: from Preclinical to Clinical a Report of 2009 AAPS/ACCP Biomarker Workshop.
Published in:
2011
By:
- Bai, Jane;
- Bell, Robert;
- Buckman, ShaAvhree;
- Burckart, Gilbert;
- Eichler, Hans-Georg;
- Fang, Kenneth;
- Goodsaid, Federico;
- Jusko, William;
- Lesko, Lawrence;
- Meibohm, Bernd;
- Patterson, Scott;
- Puig, Oscar;
- Smerage, Jeffrey;
- Snider, Barbara;
- Wagner, John;
- Wang, Jingsong;
- Walton, Marc;
- Weiner, Russell
Publication type:
Correction Notice
Translational Biomarkers: from Preclinical to Clinical a Report of 2009 AAPS/ACCP Biomarker Workshop.
Published in:
2011
By:
- Bai, Jane;
- Bell, Robert;
- Buckman, ShaAvhree;
- Burckart, Gilbert;
- Eichler, Hans-Georg;
- Fang, Kenneth;
- Goodsaid, Federico;
- Jusko, William;
- Lesko, Lawrence;
- Meibohm, Bernd;
- Patterson, Scott;
- Puig, Oscar;
- Smerage, Jeffrey;
- Snider, Barbara;
- Wagner, John;
- Wang, Jingsong;
- Walton, Marc;
- Weiner, Russell
Publication type:
Report
A robust targeted sequencing approach for low input and variable quality DNA from clinical samples.
Published in:
NPJ Genomic Medicine, 2018, v. 3, n. 1, p. N.PAG, doi. 10.1038/s41525-017-0041-4
By:
- So, Austin P.;
- Vilborg, Anna;
- Bouhlal, Yosr;
- Koehler, Ryan T.;
- Grimes, Susan M.;
- Pouliot, Yannick;
- Mendoza, Daniel;
- Ziegle, Janet;
- Stein, Jason;
- Goodsaid, Federico;
- Lucero, Michael Y.;
- De La Vega, Francisco M.;
- Ji, Hanlee P.
Publication type:
Article
The balance of reproducibility, sensitivity, and specificity of lists of differentially expressed genes in microarray studies.
Published in:
BMC Bioinformatics, 2008, v. 9, p. 1, doi. 10.1186/1471-2105-9-S9-S10
By:
- Leming Shi;
- Jones, Wendell D.;
- Jensen, Roderick V.;
- Harris, Stephen C.;
- Perkins, Roger G.;
- Goodsaid, Federico M.;
- Lei Guo;
- Croner, Lisa J.;
- Boysen, Cecilie;
- Hong Fang;
- Feng Qian;
- Amur, Shashi;
- Wenjun Bao;
- Barbacioru, Catalin C.;
- Bertholet, Vincent;
- Cao, Xiaoxi Megan;
- Tzu-Ming Chu;
- Collins, Patrick J.;
- Xiao-hui Fan;
- Frueh, Felix W.
Publication type:
Article
Cross-platform comparability of microarray technology: Intra-platform consistency and appropriate data analysis procedures are essential.
Published in:
BMC Bioinformatics, 2005, v. 6, p. S12, doi. 10.1186/1471-2105-6-S2-S12
By:
- Shi, Leming;
- Tong, Weida;
- Fang, Hong;
- Scherf, Uwe;
- Han, Jing;
- Puri, Raj K.;
- Frueh, Felix W.;
- Goodsaid, Federico M.;
- Guo, Lei;
- Su, Zhenqiang;
- Han, Tao;
- Fuscoe, James C.;
- Xu, Z. Alex;
- Patterson, Tucker A.;
- Hong, Huixiao;
- Xie, Qian;
- Perkins, Roger G.;
- Chen, James J.;
- Casciano, Daniel A.
Publication type:
Article
Microarray scanner calibration curves: characteristics and implications.
Published in:
BMC Bioinformatics, 2005, v. 6, p. S11, doi. 10.1186/1471-2105-6-S2-S11
By:
- Shi, Leming;
- Tong, Weida;
- Su, Zhenqiang;
- Han, Tao;
- Han, Jing;
- Puri, Raj K.;
- Fang, Hong;
- Frueh, Felix W.;
- Goodsaid, Federico M.;
- Guo, Lei;
- Branham, William S.;
- Chen, James J.;
- Xu, Z. Alex;
- Harris, Stephen C.;
- Hong, Huixiao;
- Xie, Qian;
- Perkins, Roger G.;
- Fuscoe, James C.
Publication type:
Article
Implementing the U.S. FDA guidance on pharmacogenomic data submissionsThis article is a US Government work and, as such, is in the public domain in the United States of America.Views expressed in this manuscript are those of the authors and not necessarily those of the U.S. Food and Drug Administration.
Published in:
Environmental & Molecular Mutagenesis, 2007, v. 48, n. 5, p. 354, doi. 10.1002/em.20294
By:
- Federico Goodsaid;
- Felix W. Frueh
Publication type:
Article
Assessment of the sensitivity of the computational programs DEREK, TOPKAT, and MCASE in the prediction of the genotoxicity of pharmaceutical molecules.
Published in:
Environmental & Molecular Mutagenesis, 2004, v. 43, n. 3, p. 143
By:
- Ronald D. Snyder;
- Greg S. Pearl;
- George Mandakas;
- Wai Nang Choy;
- Federico Goodsaid;
- I.Y. Rosenblum
Publication type:
Article
Translational Medicine and the Value of Biomarker Qualification.
Published in:
Science Translational Medicine, 2010, v. 2, n. 47, p. 1, doi. 10.1126/scitranslmed.3001040
By:
- Goodsaid, Federico M.;
- Mendrick, Donna L.
Publication type:
Article
Modulation of Clopidogrel Pharmacodynamic Response.
Published in:
Pharmacotherapy, 2008, v. 28, n. 12, p. 1423, doi. 10.1592/phco.28.12.1423
By:
- Goodsaid, Federico M.
Publication type:
Article
A precisionmedicine 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.
Published in:
Alzheimer's & Dementia: Translational Research & Clinical Interventions, 2020, v. 6, n. 1, p. 1, doi. 10.1002/trc2.12013
By:
- Hampel, Harald;
- Williams, Coralie;
- Etcheto, Adrien;
- Goodsaid, Federico;
- Parmentier, Frédéric;
- Sallantin, Jean;
- Kaufmann, Walter E.;
- Missling, Christopher U.;
- Afshar, Mohammad
Publication type:
Article
The Labyrinth of Product Development and Regulatory Approvals in Liquid Biopsy Diagnostics.
Published in:
CTS: Clinical & Translational Science, 2019, v. 12, n. 5, p. 431, doi. 10.1111/cts.12657
By:
- Goodsaid, Federico M.
Publication type:
Article
Regulatory landscapes for biomarkers and diagnostic tests: Qualification, approval, and role in clinical practice.
Published in:
Experimental Biology & Medicine, 2018, v. 243, n. 3, p. 256, doi. 10.1177/1535370217739629
By:
- Mattes, William B.;
- Goodsaid, Federico
Publication type:
Article
Biomarkers in Peripheral Blood Associated with Vascular Injury in Sprague-Dawley Rats Treated with the Phosphodiesterase IV Inhibitors SCH 351591 or SCH 534385.
Published in:
Toxicologic Pathology, 2008, v. 36, n. 6, p. 840, doi. 10.1177/0192623308322310
By:
- WEAVER, JAMES L.;
- SNYDER, RONALD;
- KNAPTON, ALAN;
- HERMAN, EUGENE H.;
- HONCHEL, RONALD;
- MILLER, TERRY;
- ESPANDIARI, PARVANEH;
- SMITH, ROGER;
- YI-ZHONG GU;
- GOODSAID, FEDERICO M.;
- ROSENBLUM, IRWIN Y.;
- SISTARE, FRANK D.;
- JUN ZHANG;
- HANIG, JOSEPH
Publication type:
Article
Histopathology of Vascular Injury in Sprague-Dawley Rats Treated with Phosphodiesterase IV Inhibitor SCH 351591 or SCH 534385.
Published in:
Toxicologic Pathology, 2008, v. 36, n. 6, p. 827, doi. 10.1177/0192623308322308
By:
- JUN ZHANG;
- SNYDER, RONALD D.;
- HERMAN, EUGENE H.;
- KNAPTON, ALAN;
- HONCHEL, RONALD;
- MILLER, TERRY;
- ESPANDIARI, PARVANEH;
- GOODSAID, FEDERICO M.;
- ROSENBLUM, IRWIN Y.;
- HANIG, JOSEPH P.;
- SISTARE, FRANK D.;
- WEAVER, JAMES L.
Publication type:
Article
Quantitative real time polymerase chain reaction in drug development.
Published in:
Drug Development Research, 2004, v. 62, n. 2, p. 151, doi. 10.1002/ddr.10378
By:
- Federico Goodsaid
Publication type:
Article
Grand Rounds in Proteomics at the FDA White Oak, Silver Spring, MD, USA, April 3, 2007.
Published in:
Proteomics - Clinical Applications, 2007, v. 1, n. 12, p. 1526, doi. 10.1002/prca.200700575
By:
- Goodsaid, Federico;
- Bandow, Julia Elisabeth;
- Mischak, Harald
Publication type:
Article

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