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1

Quantitative real time polymerase chain reaction in drug development

Federico Goodsaid

Journal:

Drug Development Research

Year:

2004

Language:

english

File:

PDF, 94 KB

english, 2004

2

Recommendations for the development of rare disease drugs using the accelerated approval pathway and for qualifying biomarkers as primary endpoints

Kakkis, Emil D, O’Donovan, Mary, Cox, Gerald, Hayes, Mark, Goodsaid, Federico, Tandon, PK, Furlong, Pat, Boynton, Susan, Bozic, Mladen, Orfali, May, Thornton, Mark

Journal:

Orphanet Journal of Rare Diseases

Year:

2015

Language:

english

File:

PDF, 628 KB

english, 2015

3

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

Ronald D. Snyder, Greg S. Pearl, George Mandakas, Wai Nang Choy, Federico Goodsaid, I.Y. Rosenblum

Journal:

Environmental and Molecular Mutagenesis

Year:

2004

Language:

english

File:

PDF, 121 KB

english, 2004

4

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

Federico Goodsaid, Felix W. Frueh

Journal:

Environmental and Molecular Mutagenesis

Year:

2007

Language:

english

File:

PDF, 257 KB

english, 2007

5

Grand Rounds in Proteomics at the FDA White Oak, Silver Spring, MD, USA, April 3, 2007

Federico Goodsaid, Julia Elisabeth Bandow, Harald Mischak

Journal:

PROTEOMICS - Clinical Applications

Year:

2007

Language:

english

File:

PDF, 332 KB

english, 2007

6

Membrane organization in soybean seeds during hydration

Victoria Seewaldt, David A. Priestley, A. Carl Leopold, Gerald W. Feigenson, Federico Goodsaid-Zalduondo

Journal:

Year:

1981

Language:

english

File:

PDF, 467 KB

english, 1981

7

Strategic paths for biomarker qualification

Federico M. Goodsaid, Felix W. Frueh, William Mattes

Journal:

Year:

2008

Language:

english

File:

PDF, 205 KB

english, 2008

8

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

Shi, Leming, Campbell, Gregory, Jones, Wendell D, Campagne, Fabien, Wen, Zhining, Walker, Stephen J, Su, Zhenqiang, Chu, Tzu-Ming, Goodsaid, Federico M, Pusztai, Lajos

Journal:

Nature Biotechnology

Year:

2010

Language:

english

File:

PDF, 1.12 MB

english, 2010

9

Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium

Dieterle, Frank, Sistare, Frank, Goodsaid, Federico, Papaluca, Marisa, Ozer, Josef S, Webb, Craig P, Baer, William, Senagore, Anthony, Schipper, Matthew J, Vonderscher, Jacky

Journal:

Nature Biotechnology

Year:

2010

Language:

english

File:

PDF, 293 KB

english, 2010

10

Evolution of biomarker qualification at the health authorities

Goodsaid, Federico, Papaluca, Marisa

Journal:

Nature Biotechnology

Year:

2010

Language:

english

File:

PDF, 314 KB

english, 2010

11

Rat toxicogenomic study reveals analytical consistency across microarray platforms

Guo, Lei, Lobenhofer, Edward K, Wang, Charles, Shippy, Richard, Harris, Stephen C, Zhang, Lu, Mei, Nan, Chen, Tao, Herman, Damir, Goodsaid, Federico M

Journal:

Nature Biotechnology

Year:

2006

Language:

english

File:

PDF, 534 KB

english, 2006

12

Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact

Goodsaid, Federico M., Amur, Shashi, Aubrecht, Jiri, Burczynski, Michael E., Carl, Kevin, Catalano, Jennifer, Charlab, Rosane, Close, Sandra, Cornu-Artis, Catherine, Essioux, Laurent

Journal:

Nature Reviews Drug Discovery

Year:

2010

Language:

english

File:

PDF, 592 KB

english, 2010

13

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

Hardy, Billie-Jo, Séguin, Béatrice, Goodsaid, Federico, Jimenez-Sanchez, Gerardo, Singer, Peter A., Daar, Abdallah S.

Journal:

Nature Reviews Genetics

Year:

2008

Language:

english

File:

PDF, 297 KB

english, 2008

14

Erratum to: Translational Biomarkers: from Preclinical to Clinical a Report of 2009 AAPS/ACCP Biomarker Workshop

Jane P. F. Bai, Robert Bell, ShaAvhree Buckman, Gilbert J. Burckart, Hans-Georg Eichler, Kenneth C. Fang, Federico M. Goodsaid, William J. Jusko, Lawrence L. Lesko, Bernd Meibohm, Scott D. Patterson,

Journal:

The AAPS Journal

Year:

2011

Language:

english

File:

PDF, 81 KB

english, 2011

15

Translational Biomarkers: from Preclinical to Clinical a Report of 2009 AAPS/ACCP Biomarker Workshop

Jane P. F. Bai, Robert Bell, ShaAvhree Buckman, Gilbert J. Burckart, Hans-Georg Eichler, Kenneth C. Fang, Federico M. Goodsaid, William J. Jusko, Lawrence L. Lesko, Bernd Meibohm, Scott D. Patterson,

Journal:

The AAPS Journal

Year:

2011

Language:

english

File:

PDF, 351 KB

english, 2011

16

Application of Pharmacogenomics in Clinical Pharmacology

Huang, Shiew-Mei, Goodsaid, Federico, Rahman, Atiqur, Frueh, Felix, Lesko, Lawrence J.

Journal:

Toxicology Mechanisms and Methods

Year:

2006

Language:

english

File:

PDF, 764 KB

english, 2006

17

Analysis of porphyrins and enzymes in porphyrin synthesis in Taenia solium cysticercus from man and pig

Carlos Larralde, Shigeru Sassa, Jane M. Vanderkooi, Henryk Koloczek, Juan Pedro Laclette, Federico Goodsaid, Edda Sciutto, Charles S. Owen

Journal:

Molecular and Biochemical Parasitology

Year:

1987

Language:

english

File:

PDF, 840 KB

english, 1987

18

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

John W. Davis II, Federico M. Goodsaid, Christopher M. Bral, Leslie A. Obert, George Mandakas, C.Edwin Garner II, Nathaniel D. Collins, Roger J. Smith, I.Y. Rosenblum

Journal:

Toxicology and Applied Pharmacology

Year:

2004

Language:

english

File:

PDF, 597 KB

english, 2004

19

Identification and measurement of genomic biomarkers of nephrotoxicity

Federico M Goodsaid

Journal:

Journal of Pharmacological and Toxicological Methods

Year:

2004

Language:

english

File:

PDF, 583 KB

english, 2004

20

Qualification of Biomarkers for Drug Development in Organ Transplantation

Gilbert J. Burckart, Shashi Amur, Federico M. Goodsaid, Lawrence J. Lesko, Felix W. Frueh, Shiew-Mei Huang, Marc W. Cavaille-Coll

Journal:

American Journal of Transplantation

Year:

2008

Language:

english

File:

PDF, 797 KB

english, 2008

21

Microarray scanner calibration curves: characteristics and implications

Leming Shi, Weida Tong, Zhenqiang Su, Tao Han, Jing Han, Raj K Puri, Hong Fang, Felix W Frueh, Federico M Goodsaid, Lei Guo, William S Branham, James J Chen, Z Alex Xu, Stephen C Harris, Huixiao Hong,

Journal:

BMC Bioinformatics

Year:

2005

Language:

english

File:

PDF, 1.80 MB

english, 2005

22

Cross-platform comparability of microarray technology: Intra-platform consistency and appropriate data analysis procedures are essential

Leming Shi, Weida Tong, Hong Fang, Uwe Scherf, Jing Han, Raj K Puri, Felix W Frueh, Federico M Goodsaid, Lei Guo, Zhenqiang Su, Tao Han, James C Fuscoe, Z Alex Xu, Tucker A Patterson, Huixiao Hong, Qi

Journal:

BMC Bioinformatics

Year:

2005

Language:

english

File:

PDF, 607 KB

english, 2005

23

The balance of reproducibility, sensitivity, and specificity of lists of differentially expressed genes in microarray studies

Leming Shi, Wendell D Jones, Roderick V Jensen, Stephen C Harris, Roger G Perkins, Federico M Goodsaid, Lei Guo, Lisa J Croner, Cecilie Boysen, Hong Fang, Feng Qian, Shashi Amur, Wenjun Bao, Catalin C

Journal:

BMC Bioinformatics

Year:

2008

Language:

english

File:

PDF, 1.32 MB

english, 2008

24

Modulation of Clopidogrel Pharmacodynamic Response

Federico M. Goodsaid

Journal:

Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy

Year:

2008

Language:

english

File:

PDF, 57 KB

english, 2008

25

Lateral diffusion of lipids and proteins in bilayer membranes

Winchil L.C. Vaz, Federico Goodsaid-Zalduondo, Ken Jacobson

Journal:

Year:

1984

Language:

english

File:

PDF, 996 KB

english, 1984

26

Biomarker qualification pilot process at the US Food and Drug Administration

Federico Goodsaid, Felix Frueh

Journal:

The AAPS Journal

Year:

2007

Language:

english

File:

PDF, 724 KB

english, 2007

27

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

Federico M. Goodsaid, Felix W. Frueh, William Mattes

Journal:

Drug Discovery Today: Technologies

Year:

2007

Language:

english

File:

PDF, 148 KB

english, 2007

28

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

Federico M. Goodsaid, Felix W. Frueh

Journal:

Drug Discovery Today: Technologies

Year:

2007

Language:

english

File:

PDF, 74 KB

english, 2007

29

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

Weida Tong, Stephen C. Harris, Hong Fang, Leming Shi, Roger Perkins, Federico Goodsaid, Felix W. Frueh

Journal:

Drug Discovery Today: Technologies

Year:

2007

Language:

english

File:

PDF, 1.20 MB

english, 2007

30

A Novel Method to Compensate for Different Amplification Efficiencies between Patient DNA Samples in Quantitative Real-Time PCR

Meijerink, Jules, Mandigers, Caroline, van de Locht, Louis, Tönnissen, Evelyn, Goodsaid, Federico, Raemaekers, John

Journal:

The Journal of Molecular Diagnostics

Year:

2001

Language:

english

File:

PDF, 125 KB

english, 2001

31

Toxicogenomics || Quantitative PCR Deconstruction of Discrepancies between Results Reported by Different Hybridization Platforms

Federico M. Goodsaid, Roger J. Smith and I. Y. Rosenblum

Journal:

Environmental Health Perspectives

Year:

2004

Language:

english

File:

PDF, 776 KB

english, 2004

32

Molecular biomarkers: a US FDA effort

Hong, Huixiao, Goodsaid, Federico, Shi, Leming, Tong, Weida

Journal:

Biomarkers in Medicine

Year:

2010

Language:

english

File:

PDF, 1.17 MB

english, 2010

33

Gaining Confidence on Molecular Classification through Consensus Modeling and Validation

Tong, Weida, Fang, Hong, Xie, Qian, Hong, Huixiao, Shi, Leming, Perkins, Roger, Scherf, Uwe, Goodsaid, Federico, Frueh, Felix

Journal:

Toxicology Mechanisms and Methods

Year:

2006

Language:

english

File:

PDF, 2.17 MB

english, 2006

34

Regulation of Gene Expression by Pegylated IFN- α 2b and IFN- α 2b in Human Peripheral Blood Mononuclear Cells

Brassard, Diana L., Delorenzo, Marc M., Cox, Stuart, Leaman, Douglas W., Sun, Yaping, Ding, Wei, Gavor, Sean, Spond, Jeffrey, Goodsaid, Federico, Bordens, Ronald, Grace, Michael J.

Journal:

Journal of Interferon & Cytokine Research

Year:

2004

Language:

english

File:

PDF, 2.73 MB

english, 2004

35

The First RSBI (ISA-TAB) Workshop: “Can a Simple Format Work for Complex Studies?”

Sansone, Susanna-Assunta, Rocca-Serra, Philippe, Brandizi, Marco, Brazma, Alvis, Field, Dawn, Fostel, Jennifer, Garrow, Andrew G., Gilbert, Jack, Goodsaid, Federico, Hardy, Nigel, Jones, Phil, Lister,

Journal:

Omics A Journal of Integrative Biology

Year:

2008

Language:

english

File:

PDF, 147 KB

english, 2008

36

Challenges of biomarkers in drug discovery and development

Goodsaid, Federico

Journal:

Expert Opinion on Drug Discovery

Year:

2012

Language:

english

File:

PDF, 192 KB

english, 2012

37

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

Shi, Leming, Tong, Weida, Goodsaid, Federico, Frueh, Felix W, Fang, Hong, Han, Tao, Fuscoe, James C, Casciano, Daniel A

Journal:

Expert Review of Molecular Diagnostics

Year:

2004

Language:

english

File:

PDF, 308 KB

english, 2004

38

Process map proposal for the validation of genomic biomarkers

Goodsaid, Federico, Frueh, Felix

Journal:

Pharmacogenomics

Year:

2006

Language:

english

File:

PDF, 219 KB

english, 2006

39

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

Woodcock, Janet, Buckman, ShaAvhree, Goodsaid, Federico, Walton, Marc K, Zineh, Issam

Journal:

Expert Opinion on Medical Diagnostics

Year:

2011

Language:

english

File:

PDF, 294 KB

english, 2011

40

The Path from Biomarker Discovery to Regulatory Qualification || Impact of Biomarker Qualification Regulatory Processes on the Critical Path for Drug Development

Goodsaid, Federico

Year:

2013

Language:

english

File:

PDF, 422 KB

english, 2013

41

Development of an undergraduate pharmacogenomics curriculum

O’Brien, Travis J, Goodsaid, Federico, Plack, Margaret, Harralson, Arthur, Harrouk, Wafa, Hales, Tim G, Mandel, H George, Perry, David C, Kennedy, Katherine, Sarvazyan, Narine, Chiappinelli, Vincent A

Journal:

Pharmacogenomics

Year:

2009

Language:

english

File:

PDF, 412 KB

english, 2009

42

The Path from Biomarker Discovery to Regulatory Qualification || The Tortuous Path From Development to Qualification of Biomarkers

Goodsaid, Federico

Year:

2013

Language:

english

File:

PDF, 34 KB

english, 2013

43

The Path from Biomarker Discovery to Regulatory Qualification || Preface

Goodsaid, Federico

Year:

2013

Language:

english

File:

PDF, 17 KB

english, 2013

44

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

Hinman, Lois, Spear, Brian, Tsuchihashi, Zenta, Kelly, James, Bross, Peter, Goodsaid, Federico, Kalush, Francis

Journal:

Pharmacogenomics

Year:

2009

Language:

english

File:

PDF, 408 KB

english, 2009

45

Porphyrin Content of the Cysticercus of Taenia solium

Carlos Larralde, Gustavo Martinez Zedillo, David Lagunoff, Russell Ludowyke, Rosa M. Montoya, Federico Goodsaid, Georges Dreyfus, Edda Sciutto, Tzipe Govezensky and Maria L. Diaz

Journal:

Journal of Parasitology

Year:

1986

Language:

english

File:

PDF, 1.29 MB

english, 1986

46

Membrane organization in soybean seeds during hydration

Victoria Seewaldt, David A. Priestley, A. Carl Leopold, Gerald W. Feigenson and Federico Goodsaid-Zalduondo

Journal:

Year:

1981

Language:

english

File:

PDF, 741 KB

english, 1981

47

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

Mattes, William B., Goodsaid, Federico

Journal:

Experimental Biology and Medicine

Year:

2017

Language:

english

File:

PDF, 107 KB

english, 2017

48

A robust targeted sequencing approach for low input and variable quality DNA from clinical samples

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, Fra

Journal:

npj Genomic Medicine

Year:

2018

Language:

english

File:

PDF, 920 KB

english, 2018

49

The labyrinth of product development and regulatory approvals in liquid biopsy diagnostics

Goodsaid, Federico M.

Journal:

Clinical and Translational Science

Year:

2019

Language:

english

File:

PDF, 412 KB

english, 2019

50

The labyrinth of product development and regulatory approvals in liquid biopsy diagnostics

Goodsaid, Federico M.

Journal:

Clinical and Translational Science

Year:

2019

File:

PDF, 412 KB

2019