Shashi G. Amur: search on Z-Library

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1

Pharmacogenomic Biomarker Information in Drug Labels Approved by the United States Food and Drug Administration: Prevalence of Related Drug Use

Dr. Felix W. Frueh, Dr. Shashi Amur, Dr. Padmaja Mummaneni, Dr. Robert S. Epstein, Dr. Ronald E. Aubert, Dr. Teresa M. DeLuca, Dr. Robert R. Verbrugge, Dr. Gilbert J. Burckart, Dr. Lawrence J. Lesko

Journal:

Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy

Year:

2008

Language:

english

File:

PDF, 83 KB

english, 2008

2

Update on the clinical pharmacogenomics of organ transplantation

Burckart, Gilbert J, Amur, Shashi

Journal:

Pharmacogenomics

Year:

2010

Language:

english

File:

PDF, 592 KB

english, 2010

3

2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies’ inputs)

Neubert, Hendrik, Song, An, Lee, Anita, Wei, Cong, Duggan, Jeff, Xu, Keyang, Woolf, Eric, Evans, Chris, Palandra, Joe, Laterza, Omar, Amur, Shashi, Berger, Isabella, Bustard, Mark, Cancilla, Mark, Che

Journal:

Year:

2017

Language:

english

File:

PDF, 988 KB

english, 2017

4

Meta-analysis of microarray data using a pathway-based approach identifies a 37-gene expression signature for systemic lupus erythematosus in human peripheral blood mononuclear cells

Dhivya Arasappan, Weida Tong, Padmaja Mummaneni, Hong Fang, Shashi Amur

Journal:

Year:

2011

Language:

english

File:

PDF, 1.04 MB

english, 2011

5

Investigations on myelinogenesis in vitro: A study of the critical period at which thyroid hormone exerts its maximum regulatory effect on the developmental experession of two myelin associated markers in cultured brain cells from embryonic mice

Gouri Shanker, Shashi G. Amur, Ronald A. Pieringer

Journal:

Neurochemical Research

Year:

1985

Language:

english

File:

PDF, 484 KB

english, 1985

6

5β-Reductase and other Androgen-Metabolizing Enzymes in Primary Cultures of Developing Zebra Finch Telencephalon

Barney A. Schlinger, Shashi Amur-Umarjee, Anthony T. Campagnoni, Arthur P. Arnold

Journal:

Journal of Neuroendocrinology

Year:

1995

Language:

english

File:

PDF, 683 KB

english, 1995

7

Regulation of Myelin Basic Protein (Arginine) Methyltransferase by Thyroid Hormone in Myelinogenic Cultures of Cells Dissociated from Embryonic Mouse Brain

Shashi G. Amur, Gouri Shanker, Ronald A. Pieringer

Journal:

Journal of Neurochemistry

Year:

1984

Language:

english

File:

PDF, 500 KB

english, 1984

8

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

9

Successes Achieved and Challenges Ahead in Translating Biomarkers into Clinical Applications

Greg Tesch, Shashi Amur, John T. Schousboe, Jeffrey N. Siegel, Lawrence J. Lesko, Jane P. F. Bai

Journal:

The AAPS Journal

Year:

2010

Language:

english

File:

PDF, 186 KB

english, 2010

10

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

11

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

12

Sex differences and genomics in autoimmune diseases

Shashi Amur, Ameeta Parekh, Padmaja Mummaneni

Journal:

Journal of Autoimmunity

Year:

2012

Language:

english

File:

PDF, 229 KB

english, 2012

13

Posttranscriptional Events in the Expression of Myelin Protein Genes

ANTHONY T. CAMPAGNONI, JOSEPH M. VERDI, A. NEIL VERITY, SHASHI AMUR-UMARJEE

Journal:

Annals of the New York Academy of Sciences

Year:

1990

Language:

english

File:

PDF, 599 KB

english, 1990

14

Posttranscriptional Regulation of Myelin Protein Gene Expression

ANTHONY T. CAMPAGNONI, JOSEPH M. VERDI, A. NEIL VERITY, SHASHI AMUR-UMARJEE, SUJATHA BYRAVAN

Journal:

Annals of the New York Academy of Sciences

Year:

1991

Language:

english

File:

PDF, 812 KB

english, 1991

15

Response-guided telaprevir therapy in prior relapsers? The role of bridging data from treatment-naïve and experienced subjects

Liu, Jiang, Jadhav, Pravin R., Amur, Shashi, Fleischer, Russell, Hammerstrom, Thomas, Lewis, Linda, Naeger, Lisa, O'Rear, Jule, Pacanowski, Michael, Robertson, Sarah, Seo, Shirley, Soon, Greg, Birnkra

Journal:

Year:

2013

Language:

english

File:

PDF, 549 KB

english, 2013

16

Pharmacogenomics of HIV Therapy: Summary of a Workshop Sponsored by the National Institute of Allergy and Infectious Diseases

Haas, David W., Kuritzkes, Daniel R., Ritchie, Marylyn D., Amur, Shashi, Gage, Brian F., Maartens, Gary, Masys, Dan, Fellay, Jacques, Phillips, Elizabeth, Ribaudo, Heather J., Freedberg, Kenneth A., P

Journal:

HIV Clinical Trials

Year:

2011

Language:

english

File:

PDF, 196 KB

english, 2011

17

Allopurinol pharmacogenetics: assessment of potential clinical usefulness

Zineh, Issam, Mummaneni, Padmaja, Lyndly, Jenna, Amur, Shashi, La Grenade, Lois A, Chang, Stephen H, Rogers, Hobart, Pacanowski, Michael A

Journal:

Pharmacogenomics

Year:

2011

Language:

english

File:

PDF, 634 KB

english, 2011

18

Pharmacogenomics and adverse drug reactions

Amur, Shashi, Zineh, Issam, Abernethy, Darrell R, Huang, Shiew-Mei, Lesko, Lawrence J

Journal:

Personalized Medicine

Year:

2010

Language:

english

File:

PDF, 566 KB

english, 2010

19

New Genetic Discoveries and Treatment for Hepatitis C

Journal:

JAMA The Journal of the American Medical Association

Year:

2012

Language:

english

File:

PDF, 90 KB

english, 2012

20

Biomarkers for the Development of New Medications for Cocaine Dependence

Bough, Kristopher J, Amur, Shashi, Lao, Guifang, Hemby, Scott E, Tannu, Nilesh S, Kampman, Kyle M, Schmitz, Joy M, Martinez, Diana, Merchant, Kalpana M, Green, Charles, Sharma, Jyoti, Dougherty, Anne

Journal:

Neuropsychopharmacology

Year:

2014

Language:

english

File:

PDF, 866 KB

english, 2014

21

The Path from Biomarker Discovery to Regulatory Qualification || Contributors

Year:

2013

Language:

english

File:

PDF, 27 KB

english, 2013

22

The Path from Biomarker Discovery to Regulatory Qualification || Path to Regulatory Qualification Program Development

Year:

2013

Language:

english

File:

PDF, 71 KB

english, 2013

23

Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective

Amur, Shashi, Frueh, Felix W, Lesko, Lawrence J, Huang, Shiew-Mei

Journal:

Biomarkers in Medicine

Year:

2008

Language:

english

File:

PDF, 570 KB

english, 2008

24

Building a roadmap to biomarker qualification: challenges and opportunities

Amur, Shashi G, Sanyal, Sarmistha, Chakravarty, Aloka G, Noone, Marianne H, Kaiser, James, McCune, Susan, Buckman-Garner, ShaAvhree Y

Journal:

Biomarkers in Medicine

Year:

2015

Language:

english

File:

PDF, 1.14 MB

english, 2015

25

Boceprevir dosing for late responders and null responders: The role of bridging data between treatment-naïve and -experienced subjects

Florian, Jeffry, Jadhav, Pravin R., Amur, Shashi, Ayala, Ruben, Harrington, Patrick, Mishra, Poonam, O'Rear, Jules, Pacanowski, Michael, Robertson, Sarah, Singer, Mary, Soon, Greg, Zeng, Wen, Murray,

Journal:

Year:

2013

Language:

english

File:

PDF, 607 KB

english, 2013

26

Molecular and immunohistochemical characterization of the onset and resolution of human renal allograft ischemia-reperfusion injury

Hoffmann, Steven C., Kampen, Robert L., Amur, Shashi, Sharaf, Muhammad A., Kleiner, David E., Hunter, Keith, John Swanson, S., Hale, Douglas A., Mannon, Roslyn B., Blair, Patrick J., Kirk, Allan D.

Journal:

Transplantation Journal

Year:

2002

Language:

english

File:

PDF, 1.15 MB

english, 2002

27

The FDA in the 21st Century

Stockbridge, Norman, Miller, Kristen, Amur, Shashi, Hillebrenner, Matthew, Zuckerman, Bram, Fiuzat, Mona, Califf, Robert M.

Journal:

Journal of the American College of Cardiology: Heart Failure

Year:

2017

Language:

english

File:

PDF, 373 KB

english, 2017

28

Patient-Centered Therapy Development for Myotonic Dystrophy

Hesterlee, Sharon, Amur, Shashi, Bain, Lisa J., Carulli, John, Clarke, Sarah, Day, John W., Gagnon, Cynthia, Hagerman, Katharine, Heatwole, Chad, Johnson, Nicholas E., Moxley, Richard, Patel, Nikunj,

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2017

Language:

english

File:

PDF, 149 KB

english, 2017

29

Evaluating the Use of KIM-1 in Drug Development and Research Following FDA Qualification

Chen, Ru, Sanyal, Sarmistha, Thompson, Aliza, Ix, Joachim H., Haskins, Kylie, Muldowney, Laurie, Amur, Shashi

Journal:

Clinical Pharmacology & Therapeutics

Year:

2018

Language:

english

File:

PDF, 489 KB

english, 2018

30

2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 – PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies’ inputs on bioanalysis, biomarkers and immunogenicity)

Neubert, Hendrik, Olah, Timothy, Lee, Anita, Fraser, Stephanie, Dodge, Robert, Laterza, Omar, Szapacs, Matthew, Alley, Stephen C, Saad, Ola M, Amur, Shashi, Chen, Linzhi, Cherry, Elana, Cho, Seongeun

Journal:

Year:

2018

Language:

english

File:

PDF, 713 KB

english, 2018

31

Current Status and Future Opportunities in Lung Precision Medicine Research with a Focus on Biomarkers. An American Thoracic Society/National Heart, Lung, and Blood Institute Research Statement

Wu, Ann Chen, Kiley, James P., Noel, Patricia J., Amur, Shashi, Burchard, Esteban G., Clancy, John P., Galanter, Joshua, Inada, Maki, Jones, Tiffanie K., Kropski, Jonathan A., Loyd, James E., Nogee, L

Journal:

American Journal of Respiratory and Critical Care Medicine

Year:

2018

Language:

english

File:

PDF, 734 KB

english, 2018

32

The Reproducibility of Lists of Differentially Expressed Genes in Microarray Studies

Shi, Leming, Jones, Wendell, Jensen, Roderick, Harris, Stephen, Perkins, Roger, Goodsaid, Federico, Guo, Lei, Croner, Lisa, Boysen, Cecilie, Fang, Hong, Amur, Shashi, Bao, Wenjun, Barbacioru, Catalin,

Journal:

Bioentrepreneur

Year:

2007

Language:

english

File:

PDF, 2.09 MB

english, 2007

33

The Reproducibility of Lists of Differentially Expressed Genes in Microarray Studies

Shi, Leming, Jones, Wendell, Jensen, Roderick, Harris, Stephen, Perkins, Roger, Goodsaid, Federico, Guo, Lei, Croner, Lisa, Boysen, Cecilie, Fang, Hong, Amur, Shashi, Bao, Wenjun, Barbacioru, Catalin,

Journal:

Nature Precedings

Year:

2007

Language:

english

File:

PDF, 2.09 MB

english, 2007

34

The Reproducibility of Lists of Differentially Expressed Genes in Microarray Studies

Shi, Leming, Jones, Wendell, Jensen, Roderick, Harris, Stephen, Perkins, Roger, Goodsaid, Federico, Guo, Lei, Croner, Lisa, Boysen, Cecilie, Fang, Hong, Amur, Shashi, Bao, Wenjun, Barbacioru, Catalin,

Journal:

Nature Precedings

Year:

2007

File:

PDF, 2.09 MB

2007

35

The Reproducibility of Lists of Differentially Expressed Genes in Microarray Studies

Shi, Leming, Jones, Wendell, Jensen, Roderick, Harris, Stephen, Perkins, Roger, Goodsaid, Federico, Guo, Lei, Croner, Lisa, Boysen, Cecilie, Fang, Hong, Amur, Shashi, Bao, Wenjun, Barbacioru, Catalin,

Journal:

Bioentrepreneur

Year:

2007

File:

PDF, 2.09 MB

2007

36

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

Piccoli, Steven, Mehta, Devangi, Vitaliti, Alessandra, Allinson, John, Amur, Shashi, Eck, Steve, Green, Cherie, Hedrick, Michael, Hopper, Shirley, Ji, Allena, Joyce, Alison, Litwin, Virginia, Maher, K

Journal:

Year:

2019

File:

PDF, 743 KB

2019