Devanarayan, Viswanath: search on Z-Library

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1

Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs

Civoli, Francesca, Kasinath, Aparna, Cai, Xiao-Yan, Wadhwa, Meenu, Exley, Andrew, Oldfield, Philip, Alvandkouhi, Safa, Schaffar, Gregor, Chappell, John, Bowsher, Ronald, Devanarayan, Viswanath, Marini

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 302 KB

2020

2

Human SPF45, a Splicing Factor, Has Limited Expression in Normal Tissues, Is Overexpressed in Many Tumors, and Can Confer a Multidrug-Resistant Phenotype to Cells

Janardhan Sampath, Pandy R. Long, Robert L. Shepard, Xiaoling Xia, Viswanath Devanarayan, George E. Sandusky, William L. Perry III, Anne H. Dantzig, Mark Williamson, Mark Rolfe, Robert E. Moore

Journal:

The American Journal of Pathology

Year:

2003

Language:

english

File:

PDF, 734 KB

english, 2003

3

Recommendations for Systematic Statistical Computation of Immunogenicity Cut Points

Devanarayan, Viswanath, Smith, Wendell C., Brunelle, Rocco L., Seger, Mary E., Krug, Kim, Bowsher, Ronald R.

Journal:

The AAPS Journal

Year:

2017

Language:

english

File:

PDF, 1.51 MB

english, 2017

4

Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development

Jani, Darshana, Allinson, John, Berisha, Flora, Cowan, Kyra J., Devanarayan, Viswanath, Gleason, Carol, Jeromin, Andreas, Keller, Steve, Khan, Masood U., Nowatzke, Bill, Rhyne, Paul, Stephen, Laurie

Journal:

The AAPS Journal

Year:

2016

Language:

english

File:

PDF, 760 KB

english, 2016

5

Are Lessons Learned in Setting Cut Points for Detection of Anti-Drug Antibodies Also Useful in Serology Assays for Robust Detection of SARS-CoV-2 Reactive Antibodies?

Bowsher, Ronald R., Devanarayan, Viswanath

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 237 KB

2020

6

The quintessence of immunogenicity reporting for biotherapeutics

Shankar, Gopi, Arkin, Steven, Devanarayan, Viswanath, Kromminga, Arno, Quarmby, Valerie, Richards, Susan, Subramanyam, Meena, Swanson, Steven

Journal:

Nature Biotechnology

Year:

2015

Language:

english

File:

PDF, 641 KB

english, 2015

7

Confirmatory reanalysis of incurred bioanalytical samples

Mario L. Rocci, Viswanath Devanarayan, David B. Haughey, Paula Jardieu

Journal:

The AAPS Journal

Year:

2007

Language:

english

File:

PDF, 527 KB

english, 2007

8

Evaluation of the plasma proteomics data from the ADNI database for Alzheimer's disease-state classification and prediction of 12-month progression from MCI to AD

Devanarayan, Viswanath, Simon, Adam

Journal:

Alzheimer's & Dementia

Year:

2011

Language:

english

File:

PDF, 48 KB

english, 2011

9

Optimization of analytical and pre-analytical variables associated with an ex vivo cytokine secretion assay

Chad A. Ray, Carmen Dumaual, Mark Willey, Jeffrey Fill, Peter J. O’Brien, Ian Gourley, Viswanath Devanarayan, Robert J. Konrad

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Year:

2006

Language:

english

File:

PDF, 234 KB

english, 2006

10

Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products

Eugen Koren, Holly W. Smith, Elizabeth Shores, Gopi Shankar, Deborah Finco-Kent, Bonita Rup, Yu-Chen Barrett, Viswanath Devanarayan, Boris Gorovits, Shalini Gupta, Thomas Parish, Valerie Quarmby, Mich

Journal:

Journal of Immunological Methods

Year:

2008

Language:

english

File:

PDF, 327 KB

english, 2008

11

Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products

Gopi Shankar, Viswanath Devanarayan, Lakshmi Amaravadi, Yu Chen Barrett, Ronald Bowsher, Deborah Finco-Kent, Michele Fiscella, Boris Gorovits, Susan Kirschner, Michael Moxness, Thomas Parish, Valerie

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Year:

2008

Language:

english

File:

PDF, 581 KB

english, 2008

12

IDENTIFICATION AND EVALUATION OF A NOVEL CSF PEPTIDE SIGNATURE THAT IS USEFUL FOR BOTH ALZHEIMER’S DISEASE STATE CLASSIFICATION AND FOR PREDICTING FUTURE DISEASE PROGRESSION

Llano, Daniel, Bundela, Saurabh, Mudar, Raksha, Devanarayan, Viswanath

Journal:

Alzheimer's & Dementia

Year:

2016

Language:

english

File:

PDF, 50 KB

english, 2016

13

Enhancement of the ADAS-Cog using tree-based multivariate analysis: Prediction of conversion from mild cognitive impairment to Alzheimer's disease using the ADNI dataset

Llano, Daniel A., Laforet, Genevieve A., Devanarayan, Viswanath

Journal:

Alzheimer's & Dementia

Year:

2010

Language:

english

File:

PDF, 44 KB

english, 2010

14

Intelligent and effective informatic deconvolution of “Big Data” and its future impact on the quantitative nature of neurodegenerative disease therapy

Maudsley, Stuart, Devanarayan, Viswanath, Martin, Bronwen, Geerts, Hugo

Journal:

Alzheimer's & Dementia

Year:

2018

Language:

english

File:

PDF, 1.68 MB

english, 2018

15

VGF in Cerebrospinal Fluid Combined With Conventional Biomarkers Enhances Prediction of Conversion From MCI to AD

Llano, Daniel A., Devanarayan, Priya, Devanarayan, Viswanath

Journal:

Alzheimer Disease & Associated Disorders

Year:

2019

File:

PDF, 242 KB

2019

16

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3 – LBA, biomarkers and immunogenicity)

Amaravadi, Lakshmi, Song, An, Myler, Heather, Thway, Theingi, Kirshner, Susan, Devanarayan, Viswanath, Ni, Yan G, Garofolo, Fabio, Birnboeck, Herbert, Richards, Susan, Gupta, Shalini, Luo, Linlin, Kin

Journal:

Year:

2015

Language:

english

File:

PDF, 962 KB

english, 2015

17

Estimating a Nonlinear Function of a Normal Mean

Leonard A. Stefanski, Steven J. Novick and Viswanath Devanarayan

Journal:

Year:

2005

Language:

english

File:

PDF, 515 KB

english, 2005

18

Cerebrospinal Fluid Cytokine Dynamics Differ Between Alzheimer Disease Patients and Elderly Controls

Llano, Daniel A., Li, Jinhe, Waring, Jeffrey F., Ellis, Teresa, Devanarayan, Viswanath, Witte, David G., Lenz, Robert A.

Journal:

Alzheimer Disease & Associated Disorders

Year:

2012

Language:

english

File:

PDF, 446 KB

english, 2012

19

The path to regulatory qualification of cerebrospinal fluid biomarkers as enrichment tools in clinical trials of patients with early Alzheimer’s disease: For the coalition against major diseases

Vanderstichele, Hugo Marcel, Stephenson, Diane, Shaw, Leslie M., Carrillo, Maria, Umek, Robert, Rajapakse, Hemaka, Luthman, Johan, Soares, Holly, Gordon, Mark Forrest, Devanarayan, Viswanath, Genius,

Journal:

Alzheimer's & Dementia

Year:

2015

Language:

english

File:

PDF, 149 KB

english, 2015

20

Empirical simulation extrapolation for measurement error models with replicate measurements

Viswanath Devanarayan, Leonard A. Stefanski

Journal:

Statistics & Probability Letters

Year:

2002

Language:

english

File:

PDF, 102 KB

english, 2002

21

Recommendations for adaptation and validation of commercial kits for biomarker quantification in drug development

Khan, Masood U, Bowsher, Ronald R, Cameron, Mark, Devanarayan, Viswanath, Keller, Steve, King, Lindsay, Lee, Jean, Morimoto, Alyssa, Rhyne, Paul, Stephen, Laurie, Wu, Yuling, Wyant, Timothy, Lachno, D

Journal:

Year:

2015

Language:

english

File:

PDF, 994 KB

english, 2015

22

Evaluation of Plasma Proteomic Data for Alzheimer Disease State Classification and for the Prediction of Progression From Mild Cognitive Impairment to Alzheimer Disease

Llano, Daniel A., Devanarayan, Viswanath, Simon, Adam J.

Journal:

Alzheimer Disease & Associated Disorders

Year:

2013

Language:

english

File:

PDF, 452 KB

english, 2013

23

Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated Environment

Kelley, Marian, Stevenson, Lauren, Golob, Michaela, Devanarayan, Viswanath, Pedras-Vasconcelos, Joao, Staack, Roland F., Jenkins, Rand, Booth, Brian, Wakshull, Eric, Bowsher, Ronald, Rock, Marie, Duda

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 155 KB

english, 2015

24

Comparison of RNA-seq and microarray-based models for clinical endpoint prediction

Zhang, Wenqian, Yu, Ying, Hertwig, Falk, Thierry-Mieg, Jean, Zhang, Wenwei, Thierry-Mieg, Danielle, Wang, Jian, Furlanello, Cesare, Devanarayan, Viswanath, Cheng, Jie, Deng, Youping, Hero, Barbara, Ho

Journal:

Year:

2015

Language:

english

File:

PDF, 1.54 MB

english, 2015

25

Effect of growth hormone secretagogue LY444711 on IGF-1, growth hormone, and cortisol levels in beagle dogs after one and seven daily oral doses

David E. Seyler, Jeffrey A. Dodge, John J. Osborne, Karen L. Cox, Devanarayan Viswanath, Anita F. Wilmot, M. Joni Keaton, Mark L. Heiman, Henry U. Bryant, Gordon B. Cutler Jr.

Journal:

Drug Development Research

Year:

2000

Language:

english

File:

PDF, 140 KB

english, 2000

26

DISCOVERING ALZHEIMER’S DISEASE NETWORKS IN ACCELERATING MEDICINES PARTNERSHIP – ALZHEIMER’S DISEASE DATASETS

Srivastava, Gyan P., Ravikumar, Brinda, Bi, Yingtao, Mishra, Smriti, Das, Amit, Shah, Mohammad I., Kamaraj, Balu, Bhattacharyya, Amitava, Philip, Philge, Devanarayan, Viswanath, Bannon, Anthony W., Da

Journal:

Alzheimer's & Dementia

Year:

2019

Language:

english

File:

PDF, 238 KB

english, 2019

27

Development, validation, and implementation of a multiplex immunoassay for the simultaneous determination of five cytokines in human serum

Chad A. Ray, Ronald R. Bowsher, Wendell C. Smith, Viswanath Devanarayan, Mark B. Willey, John T. Brandt, Robert A. Dean

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Year:

2005

Language:

english

File:

PDF, 342 KB

english, 2005

28

Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics

Shalini Gupta, Viswanath Devanarayan, Deborah Finco, George R. Gunn III, Susan Kirshner, Susan Richards, Bonita Rup, An Song, Meena Subramanyam

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Year:

2011

Language:

english

File:

PDF, 301 KB

english, 2011

29

Patient subgroup identification for clinical drug development

Huang, Xin, Sun, Yan, Trow, Paul, Chatterjee, Saptarshi, Chakravartty, Arunava, Tian, Lu, Devanarayan, Viswanath

Journal:

Statistics in Medicine

Year:

2017

Language:

english

File:

PDF, 725 KB

english, 2017

30

Decrease in age-adjusted cerebrospinal fluid β-secretase activity in Alzheimer's subjects

Guoxin Wu, Sethu Sankaranarayanan, Kate Tugusheva, Jason Kahana, Guy Seabrook, Xiao-ping Shi, Elizabeth King, Viswanath Devanarayan, Jacquelynn J. Cook, Adam J. Simon

Journal:

Clinical Biochemistry

Year:

2008

Language:

english

File:

PDF, 1.01 MB

english, 2008

31

Screening for New Biomarkers for Subcortical Vascular Dementia and Alzheimer’s Disease

Öhrfelt, Annika, Andreasson, Ulf, Simon, Adam, Zetterberg, Henrik, Edman, Åke, Potter, William, Holder, Daniel, Devanarayan, Viswanath, Seeburger, Jeffrey, Smith, A. David, Blennow, Kaj, Wallin, Ander

Journal:

Dementia and Geriatric Cognitive Disorders Extra

Year:

2011

Language:

english

File:

PDF, 1.44 MB

english, 2011

32

A hidden Markov model-based algorithm for identifying tumour subtype using array CGH data

Ke Zhang, Yi Yang, Viswanath Devanarayan, Linglin Xie, Youping Deng, Sens Donald

Journal:

Year:

2011

Language:

english

File:

PDF, 644 KB

english, 2011

33

IMPACT OF ANALYTICAL BIAS AND IMPRECISION OF CSF BIOMARKERS ON THEIR CLINICAL DIAGNOSTIC PERFORMANCE FOR AD DIAGNOSIS

Vanderstichele, Hugo, Vanderstichele, Hugo, Devanarayan, Viswanath, Shaw, Leslie, Jeromin, Andreas, Coart, Els, Engelborghs, Sebastiaan

Journal:

Alzheimer's & Dementia

Year:

2014

Language:

english

File:

PDF, 54 KB

english, 2014

34

META-ANALYSIS OF HETEROGENEOUS NETWORKS TO CONSTRUCT DE-NOVO META-NETWORKS FOR TARGET IDENTIFICATION IN ALZHEIMER’S DISEASE

Srivastava, Gyan P., Devanarayan, Viswanath

Journal:

Alzheimer's & Dementia

Year:

2018

Language:

english

File:

PDF, 120 KB

english, 2018

35

P2-165: A multi-analyte panel of six CSF biomarkers classifies AD and control in pathologically confirmed Alzheimer subjects within the OPTIMA cohort

Adam J. Simon, Viswanath Devanarayan, Jeff Seeburger, Wesley Tanaka, Derek Chappell, Michael Tanen, Mary Flynn, Karen Snyder, Guy Seabrook, Mark Shearman, Elizabeth King, Catharine Joachim, A. David S

Journal:

Alzheimer's & Dementia

Year:

2006

Language:

english

File:

PDF, 57 KB

english, 2006

36

Stability of Aβ and tau levels in human cerebrospinal fluid

Li, Jinhe, Llano, Daniel, Ellis, Teresa, Devanarayan, Viswanath, Gopalakrishnan, Murali, Lenz, Robert, Waring, Jeffrey F.

Journal:

Alzheimer's & Dementia

Year:

2010

Language:

english

File:

PDF, 62 KB

english, 2010

37

From big data to smart data in Alzheimer's disease. The brain health modeling initiative to foster actionable knowledge

Geerts, Hugo, Dacks, Penny A., Devanarayan, Viswanath, Haas, Magali, Khatchaturian, Zaven, Gordon, Mark Forrest, Maudsley, Stuart, Romero, Klaus, Stephenson, Diane

Journal:

Alzheimer's & Dementia

Year:

2016

Language:

english

File:

PDF, 1.47 MB

english, 2016

38

DISCOVERING ALZHEIMER’S DISEASE NETWORKS IN ACCELERATING MEDICINES PARTNERSHIP – ALZHEIMER’S DISEASE DATASETS

Srivastava, Gyan P., Ravikumar, Brinda, Bi, Yingtao, Mishra, Smriti, Das, Amit, Shah, Mohammad I., Kamaraj, Balu, Bhattacharyya, Amitava, Philip, Philge, Devanarayan, Viswanath, Bannon, Anthony W., Da

Journal:

Alzheimer's & Dementia

Year:

2019

File:

PDF, 238 KB

2019

39

Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement

Jean W. Lee, Viswanath Devanarayan, Yu Chen Barrett, Russell Weiner, John Allinson, Scott Fountain, Stephen Keller, Ira Weinryb, Marie Green, Larry Duan, James A. Rogers, Robert Millham, Peter J. O'Br

Journal:

Pharmaceutical Research

Year:

2006

Language:

english

File:

PDF, 520 KB

english, 2006

40

A very early induction of major vault protein accompanied by increased drug resistance in U-937 cells

Yi Hu, Andrew G. Stephen, Jin Cao, Lee R. Tanzer, Christopher A. Slapak, Steadman D. Harrison, Viswanath Devanarayan, Anne H. Dantzig, James J. Starling, Leonard H. Rome, Robert E. Moore

Journal:

International Journal of Cancer

Year:

2002

Language:

english

File:

PDF, 216 KB

english, 2002

41

Identification of Distinct Plasma Biomarker Signatures in Patients with Rapid and Slow Declining Forms of COPD

Devanarayan, Viswanath, Scholand, Mary-Beth, Hoidal, John, Leppert, Mark F., Crackower, Michael A., O'Neill, Gary P., Gervais, Francois G.

Journal:

COPD Journal of Chronic Obstructive Pulmonary Disease

Year:

2010

Language:

english

File:

PDF, 357 KB

english, 2010

42

Identification of protein changes in CSF from Alzheimer subjects using global profiling analysis

Waring, Jeffrey F., Halbert, Donald, Cassar, Steven, Groebe, Duncan, Devanarayan, Viswanath, Ellis, Teresa, Li, Jinhe

Journal:

Alzheimer's & Dementia

Year:

2009

Language:

english

File:

PDF, 41 KB

english, 2009

43

Derivation of a New ADAS-cog Composite Using Tree-based Multivariate Analysis

Llano, Daniel A., Laforet, Genevieve, Devanarayan, Viswanath

Journal:

Alzheimer Disease & Associated Disorders

Year:

2011

Language:

english

File:

PDF, 460 KB

english, 2011

44

Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products

Anthony R Mire-Sluis, Yu Chen Barrett, Viswanath Devanarayan, Eugen Koren, Hank Liu, Mauricio Maia, Thomas Parish, George Scott, Gopi Shankar, Elizabeth Shores, Steven J Swanson, Gary Taniguchi, Danie

Journal:

Journal of Immunological Methods

Year:

2004

Language:

english

File:

PDF, 373 KB

english, 2004

45

A multivariate predictive modeling approach reveals a novel CSF peptide signature for both Alzheimer's Disease state classification and for predicting future disease progression

Llano, Daniel A., Bundela, Saurabh, Mudar, Raksha A., Devanarayan, Viswanath, Chen, Kewei

Journal:

Year:

2017

Language:

english

File:

PDF, 2.60 MB

english, 2017

46

Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles

Goodman, Joanne, Cowen, Simon, Devanarayan, Viswanath, Egging, David, Emrich, Thomas, Golob, Michaela, Kramer, Daniel, McNally, Jim, Munday, James, Nelson, Robert, Pedras-Vasconcelos, João A, Piironen

Journal:

Year:

2018

Language:

english

File:

PDF, 222 KB

english, 2018

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