Binodh S. Desilva : rechercher sur Z-Library

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1

Current Challenges and Potential Opportunities for the Pharmaceutical Sciences to Make Global Impact: An FIP Perspective

Tucker, Geoffrey, DeSilva, Binodh, Dressman, Jennifer, Ito, Michiho, Kumamoto, Takuya, Mager, Don, Mahler, Hanns-Christian, Maitland-van der Zee, Anke H., Pauletti, Giovanni M., Sasaki, Hitoshi, Shah,

Journal:

Journal of Pharmaceutical Sciences

Année:

2016

Langue:

english

Fichier:

PDF, 345 KB

english, 2016

2

Assessment of Incurred Sample Reanalysis for Macromolecules to Evaluate Bioanalytical Method Robustness: Effects from Imprecision

Theingi M. Thway, Michael Eschenberg, Dominador Calamba, Chris Macaraeg, Mark Ma, Binodh DeSilva

Journal:

The AAPS Journal

Année:

2011

Langue:

english

Fichier:

PDF, 523 KB

english, 2011

3

Development and validation of an LC–MS/MS assay for the quantitation of a PEGylated anti-CD28 domain antibody in human serum: overcoming interference from antidrug antibodies and soluble target

Gong, Chao, Zeng, Jianing, Akinsanya, Billy, Jiang, Hao, Mora, Johanna, Chilewski, Shannon, Gambardella, Janice, Allentoff, Alban, Gleason, Carol, Aubry, Anne-Francoise, DeSilva, Binodh S, Arnold, Mar

Journal:

Année:

2014

Langue:

english

Fichier:

PDF, 1.47 MB

english, 2014

4

Development and validation of a functional cell-based neutralizing antibody assay for ipilimumab

Xu, Weifeng, Cummings, Jennifer, Sank, Michael, Juhel, Marina, Li, Xuefeng, Gleason, Carol, DeSilva, Binodh S, Dodge, Robert W, Pillutla, Renuka

Journal:

Année:

2018

Langue:

english

Fichier:

PDF, 1.06 MB

english, 2018

5

Strategies to minimize variability and bias associated with manual pipetting in ligand binding assays to assure data quality of protein therapeutic quantification

Kinnari Pandya, Chad A. Ray, Laura Brunner, Jin Wang, Jean W. Lee, Binodh DeSilva

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Année:

2010

Langue:

english

Fichier:

PDF, 314 KB

english, 2010

6

A strategy for improving comparability across sites for ligand binding assays measuring therapeutic proteins

Chad A. Ray, Lei Zhou, Jennifer Tsoi, Lennie Uy, Jessie Gu, Jennifer Malella, Danielle DeSimone, Han Gunn, Mark Ma, Jean Lee, Binodh DeSilva

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Année:

2010

Langue:

english

Fichier:

PDF, 204 KB

english, 2010

7

Innovative Use of LC-MS/MS for Simultaneous Quantitation of Neutralizing Antibody, Residual Drug, and Human Immunoglobulin G in Immunogenicity Assay Development

Jiang, Hao, Xu, Weifeng, Titsch, Craig A., Furlong, Michael T., Dodge, Robert, Voronin, Kimberly, Allentoff, Alban, Zeng, Jianing, Aubry, Anne-Françoise, DeSilva, Binodh S., Arnold, Mark E.

Journal:

Analytical Chemistry

Année:

2014

Langue:

english

Fichier:

PDF, 1.24 MB

english, 2014

8

Targeting an acid labile aspartyl–prolyl amide bond as a viable alternative to trypsin digestion to generate a surrogate peptide for LC–MS/MS analysis

Fung, Eliza N, Zambito, Frank, Haulenbeek, Jonathan, Piccoli, Steven P, Zhang, Yan, DeSilva, Binodh, Arnold, Mark, Kozhich, Alexander

Journal:

Année:

2014

Langue:

english

Fichier:

PDF, 1.43 MB

english, 2014

9

Development and characterization of a pre-treatment procedure to eliminate human monoclonal antibody therapeutic drug and matrix interference in cell-based functional neutralizing antibody assays

Xu, Weifeng, Jiang, Hao, Titsch, Craig, Haulenbeek, Jonathan R., Pillutla, Renuka C., Aubry, Anne-Françoise, DeSilva, Binodh S., Arnold, Mark E., Zeng, Jianing, Dodge, Robert W.

Journal:

Journal of Immunological Methods

Année:

2015

Langue:

english

Fichier:

PDF, 1.36 MB

english, 2015

10

Detection of drug specific circulating immune complexes from in vivo cynomolgus monkey serum samples

Pierog, Piotr, Krishna, Murli, Yamniuk, Aaron, Chauhan, Anil, DeSilva, Binodh

Journal:

Journal of Immunological Methods

Année:

2015

Langue:

english

Fichier:

PDF, 1.41 MB

english, 2015

11

Development and characterization of a free therapeutic ligand binding assay with assistance from kinetics modeling

Williams, LaKenya, Sank, Michael, Chimalakonda, Anjaneya, Ni, Yan, Saewert, Mark, DeSilva, Binodh, Pillutla, Renuka

Journal:

Journal of Immunological Methods

Année:

2015

Langue:

english

Fichier:

PDF, 615 KB

english, 2015

12

Development and Fit-for-Purpose Validation of a Soluble Human Programmed Death-1 Protein Assay

Ni, Yan G., Yuan, Xiling, Newitt, John A., Peterson, Jon E., Gleason, Carol R., Haulenbeek, Jonathan, Santockyte, Rasa, Lafont, Virginie, Marsilio, Frank, Neely, Robert J., DeSilva, Binodh, Piccoli, S

Journal:

The AAPS Journal

Année:

2015

Langue:

english

Fichier:

PDF, 545 KB

english, 2015

13

Addressing matrix effects in ligand-binding assays through the use of new reagents and technology

Chilewski, Shannon D, Mora, Johanna R, Gleason, Carol, DeSilva, Binodh

Journal:

Année:

2014

Langue:

english

Fichier:

PDF, 1.31 MB

english, 2014

14

The Journey to AAPS 2020: a Reflection from Strategic Planning to PharmSci 360

Polli, Joseph W., McCurdy, Christopher R., Wurster, Dale Eric, DeSilva, Binodh S., Bak, Annette, Bendayan, Reina, Meibohm, Bernd, Templeton, Allen C., Weiser, William

Journal:

The AAPS Journal

Année:

2019

Langue:

english

Fichier:

PDF, 717 KB

english, 2019

15

Experimental and statistical approaches in method cross-validation to support pharmacokinetic decisions

Theingi M. Thway, Mark Ma, Jean Lee, Bethlyn Sloey, Steven Yu, Yow-Ming C. Wang, Binodh DeSilva, Tom Graves

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Année:

2009

Langue:

english

Fichier:

PDF, 312 KB

english, 2009

16

Applications of a planar electrochemiluminescence platform to support regulated studies of macromolecules: Benefits and limitations in assay range

Theingi Thway, Chris Macaraeg, Dominador Calamba, Vimal Patel, Jennifer Tsoi, Mark Ma, Jean Lee, Binodh DeSilva

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Année:

2010

Langue:

english

Fichier:

PDF, 578 KB

english, 2010

17

Novel approaches using alkaline or acid/guanidine treatment to eliminate therapeutic antibody interference in the measurement of total target ligand

Hossein Salimi-Moosavi, Jean Lee, Binodh DeSilva, George Doellgast

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Année:

2010

Langue:

english

Fichier:

PDF, 620 KB

english, 2010

18

Bioanalytical Method Validation for Macromolecules in Support of Pharmacokinetic Studies

JoMarie Smolec, Binodh DeSilva, Wendell Smith, Russell Weiner, Marian Kelly, Ben Lee, Masood Khan, Richard Tacey, Howard Hill, Abbie Celniker, Vinod Shah, Ronald Bowsher, Anthony Mire-Sluis, John W. A

Journal:

Pharmaceutical Research

Année:

2005

Langue:

english

Fichier:

PDF, 195 KB

english, 2005

19

Application of multi-factorial design of experiments to successfully optimize immunoassays for robust measurements of therapeutic proteins

Chad A. Ray, Vimal Patel, Judy Shih, Chris Macaraeg, Yuling Wu, Theingi Thway, Mark Ma, Jean W. Lee, Binodh DeSilva

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Année:

2009

Langue:

english

Fichier:

PDF, 1.16 MB

english, 2009

20

Tartrate-resistant acid phosphatase (TRACP 5b): A biomarker of bone resorption rate in support of drug development: Modification, validation and application of the BoneTRAP® kit assay

Yuling Wu, Jean W. Lee, Lennie Uy, Bassam Abosaleem, Han Gunn, Mark Ma, Binodh DeSilva

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Année:

2009

Langue:

english

Fichier:

PDF, 855 KB

english, 2009

21

Development of a cell culture system to study antibody convection in tumors

Binodh S. Desilva, Tina L. Hendrickson, Elizabeth M. Topp

Journal:

Journal of Pharmaceutical Sciences

Année:

1997

Langue:

english

Fichier:

PDF, 297 KB

english, 1997

22

Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules

Binodh DeSilva, Wendell Smith, Russell Weiner, Marian Kelley, JoMarie Smolec, Ben Lee, Masood Khan, Richard Tacey, Howard Hill, Abbie Celniker

Journal:

Pharmaceutical Research

Année:

2003

Langue:

english

Fichier:

PDF, 155 KB

english, 2003

23

Catalytic antibodies for complex reactions

Binodh S. DeSilva, György Orosz, Kamal L. Egodage, Robert G. Carlson, Richard L. Schowen, George S. Wilson

Journal:

Applied Biochemistry and Biotechnology

Année:

2000

Langue:

english

Fichier:

PDF, 152 KB

english, 2000

24

“Fit-for-Purpose” Method Validation and Application of a Biomarker (C-terminal Telopeptides of Type 1 Collagen) in Denosumab Clinical Studies

Jin Wang, Jean Lee, Daniel Burns, David Doherty, Laura Brunner, Mark Peterson, Binodh DeSilva

Journal:

The AAPS Journal

Année:

2009

Langue:

english

Fichier:

PDF, 282 KB

english, 2009

25

Ligand-Binding Mass Spectrometry to Study Biotransformation of Fusion Protein Drugs and Guide Immunoassay Development: Strategic Approach and Application to Peptibodies Targeting the Thrombopoietin Receptor

Michael P. Hall, Colin Gegg, Kenneth Walker, Christopher Spahr, Robert Ortiz, Vimal Patel, Steven Yu, Liana Zhang, Hsieng Lu, Binodh DeSilva, Jean W. Lee

Journal:

The AAPS Journal

Année:

2010

Langue:

english

Fichier:

PDF, 314 KB

english, 2010

26

Solid phase synthesis of bifunctional antibodies

Binodh S. DeSilva, George S. Wilson

Journal:

Journal of Immunological Methods

Année:

1995

Langue:

english

Fichier:

PDF, 973 KB

english, 1995

27

Synthesis of Bifunctional Antibodies for Immunoassays

Binodh S. DeSilva, George S. Wilson

Journal:

Année:

2000

Langue:

english

Fichier:

PDF, 128 KB

english, 2000

28

Modified Aβ42 peptides as immunoassay calibrators improve the measurement of native Aβ42 peptides in clinical samples

Flora Berisha, Oitak (Allen) Wong, Claudio Mapelli, Mark Witmer, Robert Neely, Yan Zhang, Adam Simon, Binodh Desilva, Paul Rhyne

Journal:

Alzheimer's & Dementia

Année:

2012

Langue:

english

Fichier:

PDF, 59 KB

english, 2012

29

Key elements of bioanalytical method validation for macromolecules

Marian Kelley, Binodh DeSilva

Journal:

The AAPS Journal

Année:

2007

Langue:

english

Fichier:

PDF, 564 KB

english, 2007

30

Rapid development of multiple ‘fit-for-purpose’ assays on an automatic microfluidic system using a streamlined process in support of early biotherapeutics discovery programs

Liu, Rong, Pillutla, Renuka, DeSilva, Binodh, Zhang, Yan J

Journal:

Année:

2013

Langue:

english

Fichier:

PDF, 1.37 MB

english, 2013

31

Fit for purpose Clinical validation of a multiplex immunoassay for the measurement of Tau, p-Tau and Abeta 42

Berisha, Flora, Wong, Oitak (Allen), Neely, Robert, Gleason, Carol, Zhang, Yan, Desilva, Binodh, Rhyne, Paul

Journal:

Alzheimer's & Dementia

Année:

2011

Langue:

english

Fichier:

PDF, 49 KB

english, 2011

32

Bioanalytical Method Validation: Concepts, Expectations and Challenges in Small Molecule and Macromolecule—A Report of PITTCON 2013 Symposium

Bashaw, Edward D., DeSilva, Binodh, Rose, Mark J., Wang, Yow-Ming C., Shukla, Chinmay

Journal:

The AAPS Journal

Année:

2014

Langue:

english

Fichier:

PDF, 201 KB

english, 2014

33

Fully Validated LC-MS/MS Assay for the Simultaneous Quantitation of Coadministered Therapeutic Antibodies in Cynomolgus Monkey Serum

Jiang, Hao, Zeng, Jianing, Titsch, Craig, Voronin, Kimberly, Akinsanya, Billy, Luo, Linlin, Shen, Hongwu, Desai, Dharmesh D., Allentoff, Alban, Aubry, Anne-Françoise, DeSilva, Binodh S., Arnold, Mark

Journal:

Analytical Chemistry

Année:

2013

Langue:

english

Fichier:

PDF, 2.45 MB

english, 2013

34

Matrix interference in ligand-binding assays: challenge or solution?

DeSilva, Binodh, Garofolo, Fabio

Journal:

Année:

2014

Langue:

english

Fichier:

PDF, 667 KB

english, 2014

35

2013 White Paper on recent issues in bioanalysis: ‘ hybrid ’ – the best of LBA and LCMS

Stevenson, Lauren, Garofolo, Fabio, DeSilva, Binodh, Dumont, Isabelle, Martinez, Suzanne, Rocci, Mario, Amaravadi, Lakshmi, Brudny-Kloeppel, Margarete, Musuku, Adrien, Booth, Brian, Dicaire, Catherine

Journal:

Année:

2013

Langue:

english

Fichier:

PDF, 893 KB

english, 2013

36

2012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple Guidelines

DeSilva, Binodh, Garofolo, Fabio, Rocci, Mario, Martinez, Suzanne, Dumont, Isabelle, Landry, France, Dicaire, Catherine, Szekely-Klepser, Gabriella, Weiner, Russell, Arnold, Mark, Bansal, Surendra, Ba

Journal:

Année:

2012

Langue:

english

Fichier:

PDF, 649 KB

english, 2012

37

Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance

Booth, Brian, Arnold, Mark E., DeSilva, Binodh, Amaravadi, Lakshmi, Dudal, Sherri, Fluhler, Eric, Gorovits, Boris, Haidar, Sam H., Kadavil, John, Lowes, Steve, Nicholson, Robert, Rock, Marie, Skelly,

Journal:

The AAPS Journal

Année:

2015

Langue:

english

Fichier:

PDF, 261 KB

english, 2015

38

Bioanalytical method requirements and statistical considerations in incurred sample reanalysis for macromolecules

Thway, Theingi M, Macaraeg, Chris R, Calamba, Dominador, Brunner, Laura A, Eschenberg, Michael, Pourvasei, Ramak, Zhang, Liana, Ma, Mark, DeSilva, Binodh

Journal:

Année:

2010

Langue:

english

Fichier:

PDF, 1.30 MB

english, 2010

39

Introduction to the Proposals from the Global Bioanalysis Consortium Harmonization Team

Timmerman, Philip, Arnold, Mark, DeSilva, Binodh, Garofolo, Fabio, Golob, Michaela, van Amsterdam, Peter, Kudoh, Shinobu, Singhal, Puran, Tang, Daniel, Riccio, Maria Francesca, Barrientos, Rafael, Sav

Journal:

The AAPS Journal

Année:

2014

Langue:

english

Fichier:

PDF, 124 KB

english, 2014

40

Development and validation of a liquid chromatography tandem mass spectrometry assay for the quantitation of a protein therapeutic in cynomolgus monkey serum

Zhao, Yue, Liu, Guowen, Angeles, Aida, Hamuro, Lora L., Trouba, Kevin J., Wang, Bonnie, Pillutla, Renuka C., DeSilva, Binodh S., Arnold, Mark E., Shen, Jim X.

Journal:

Journal of Chromatography B

Année:

2015

Langue:

english

Fichier:

PDF, 540 KB

english, 2015

41

Anti-PEG antibody bioanalysis: a clinical case study with PEG-IFN-λ-1a and PEG-IFN-α2a in naive patients

Myler, Heather, Hruska, Matthew W, Srinivasan, Subasree, Cooney, Elizabeth, Kong, George, Dodge, Robert, Krishna, Murli, Zhu, Jie, Felix, Tonya, Gleason, Carol, Piccoli, Steven P, DeSilva, Binodh

Journal:

Année:

2015

Langue:

english

Fichier:

PDF, 1.02 MB

english, 2015

42

Development of a Generic Anti-PEG Antibody Assay Using BioScale’s Acoustic Membrane MicroParticle Technology

Dong, Huijin, Mora, Johanna R., Brockus, Catherine, Chilewski, Shannon D., Dodge, Robert, Merrifield, Colin, Dickerson, W. Matthew, DeSilva, Binodh

Journal:

The AAPS Journal

Année:

2015

Langue:

english

Fichier:

PDF, 832 KB

english, 2015

43

A generic template for automated bioanalytical ligand-binding assays using modular robotic scripts in support of discovery biotherapeutic programs

Duo, Jia, Dong, Huijin, DeSilva, Binodh, Zhang, Yan J

Journal:

Année:

2013

Langue:

english

Fichier:

PDF, 2.18 MB

english, 2013

44

Stability assessment in ligand-binding assays: a critical parameter for data integrity

Thway, Theingi M, DeSilva, Binodh

Journal:

Année:

2015

Langue:

english

Fichier:

PDF, 2.13 MB

english, 2015

45

Conference Report: US FDA/EMA harmonization of their bioanalytical guidance/guideline and activities of the Global Bioanalytical Consortium

Garofolo, Fabio, Michon, Josée, Leclaire, Virginie, Booth, Brian, Lowes, Stephen, Viswanathan, CT, Welink, Jan, Haidar, Sam, Teixeira, Leonardo de Souza, Tang, Daniel, Desilva, Binodh

Journal:

Année:

2012

Langue:

english

Fichier:

PDF, 311 KB

english, 2012

46

Bioanalysis of biomarkers for drug development

Fidock, Mark, DeSilva, Binodh

Journal:

Année:

2012

Langue:

english

Fichier:

PDF, 1.11 MB

english, 2012

47

Development and characterization of antibody reagents to assess anti-PEG IgG antibodies in clinical samples

Krishna, Murli, Palme, Holly, Duo, Jia, Lin, Zheng, Corbett, Martin, Dodge, Robert, Piccoli, Steven, Myler, Heather, Pillutla, Renuka, Desilva, Binodh

Journal:

Année:

2015

Langue:

english

Fichier:

PDF, 1.43 MB

english, 2015

48

Bioanalytical considerations in the comparability assessment of biotherapeutics

Lee, Jean W, Wang, Yow-Ming, Moxness, Michael, DeSilva, Binodh

Journal:

Année:

2011

Langue:

english

Fichier:

PDF, 535 KB

english, 2011

49

Accelerating Regulated Bioanalysis for Biotherapeutics: Case Examples Using a Microfluidic Ligand Binding Assay Platform

Liu, Rong, Hoffpauir, Brian, Chilewski, Shannon D, Gamberdella, Janice, Kavita, Uma, Duo, Jia, Gleason, Carol, Zhang, Yan, Pillutla, Renuka, DeSilva, Binodh, Hamuro, Lora

Journal:

The AAPS Journal

Année:

2017

Langue:

english

Fichier:

PDF, 663 KB

english, 2017

50

Characterization of labeled reagents in ligand-binding assays by a surface plasmon resonance biosensor

Duo, Jia, Bruno, JoAnne, Piccoli, Steven, DeSilva, Binodh, Zhang, Yan J

Journal:

Année:

2017

Langue:

english

Fichier:

PDF, 2.06 MB

english, 2017