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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

Hyperglycemia in Extremely- Low-Birth-Weight Infants

Meetze, William, Bowsher, Ronald, Compton, Joyce, Moorehead, Helen

Journal:

Biology of the Neonate

Year:

1998

Language:

english

File:

PDF, 299 KB

english, 1998

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

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

5

A sensitive immunoradiometric assay for the quantification of murine monoclonal antibodies in human serum

John M. Apathy, Ronald R. Bowsher

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Year:

1989

Language:

english

File:

PDF, 578 KB

english, 1989

6

Application of size-exclusion chromatography in the investigation of the in vitro stability of proinsulin and its cleaved metabolites in human serum and plasma

Ronald R. Bowsher, Paula F. Santa

Journal:

Journal of Chromatography B

Year:

2009

Language:

english

File:

PDF, 443 KB

english, 2009

7

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

8

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

9

Insights in the application of research-grade diagnostic kits for biomarker assessments in support of clinical drug development: Bioanalysis of circulating concentrations of soluble receptor activator of nuclear factor κB ligand

Ronald R. Bowsher, Jeffrey M. Sailstad

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Year:

2008

Language:

english

File:

PDF, 670 KB

english, 2008

10

A 3D gantry single photon emission tomograph with hemispherical coverage for dedicated breast imaging

Martin P Tornai, James E Bowsher, Caryl N Archer, Jörg Peter, Ronald J Jaszczak, Lawrence R MacDonald, Bradley E Patt, Jan S Iwanczyk

Journal:

Nuclear Instruments and Methods in Physics Research Section A: Accelerators, Spectrometers, Detectors and Associated Equipment

Year:

2003

Language:

english

File:

PDF, 563 KB

english, 2003

11

An immunoadsorption strategy to produce specific antisera against analogs of human proteins: development of sensitive and specific radioimmunoassays for two analogs of human leptin

Patricia Brown-Augsburger, Michael Masnyk, Paula Santa, Ronald L Gingerich, Ronald R Bowsher

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Year:

2000

Language:

english

File:

PDF, 146 KB

english, 2000

12

A sensitive chemiluminescent enzyme immunoassay for the bioanalysis of carboxyl-terminal B-chain analogues of human insulin

Ying Cao, Wendell C. Smith, Ronald R. Bowsher

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Year:

2001

Language:

english

File:

PDF, 149 KB

english, 2001

13

The effect of hypertonic saline administration or stalk transection on histamine and histamine N-methyltransferase in the rat posterior pituitary

Kenneth M. Verburg, Ronald R. Bowsher, Robert L. Zerbe, David P. Henry

Journal:

Inflammation Research

Year:

1986

Language:

english

File:

PDF, 395 KB

english, 1986

14

Phase I and pharmacokinetic study of LY309887: a specific inhibitor of purine biosynthesis

Daniel R. Budman, Robert Johnson, Barbara Barile, Ronald R. Bowsher, Vincent Vinciguerra, Steven L. Allen, Jonathan Kolitz, Steven C. Ernest, Willi Kreis, Peter Zervos, Jackie Walling

Journal:

Cancer Chemotherapy and Pharmacology

Year:

2001

Language:

english

File:

PDF, 131 KB

english, 2001

15

Method Validation and Measurement of Biomarkers in Nonclinical and Clinical Samples in Drug Development: A Conference Report

Jean W. Lee, Russ S. Weiner, Jeff M. Sailstad, Ronald R. Bowsher, Dean W. Knuth, Peter J. O’Brien, Jean L. Fourcroy, Rakesh Dixit, Lini Pandite, Robert G. Pietrusko, Holly D. Soares, Valerie Quarmby,

Journal:

Pharmaceutical Research

Year:

2005

Language:

english

File:

PDF, 142 KB

english, 2005

16

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

Year:

2005

Language:

english

File:

PDF, 195 KB

english, 2005

17

[Lys(B28), Pro(B29)]-human insulin: Effect of injection time on postprandial glycemia

Howey, Daniel C., Bowsher, Ronald R., Brunelle, Rocco L., Rowe, Howard M., Santa, Paula F., Downing-Shelton, Joyce, Woodworth, James R.

Journal:

Clinical Pharmacology & Therapeutics

Year:

1995

Language:

english

File:

PDF, 1.34 MB

english, 1995

18

Decarboxylation of p-Tyrosine: A Potential Source of p-Tyramine in Mammalian Tissues

Ronald R. Bowsher, David P. Henry

Journal:

Journal of Neurochemistry

Year:

1983

Language:

english

File:

PDF, 1.06 MB

english, 1983

19

A radioimmunoassay for LY315902, an analog of glucagon-like insulinotropic peptide, and its application in the study of canine pharmacokinetics

James Z. Chou, Gary D. Place, David G. Waters, Jeffrey A. Kirkwood, Ronald R. Bowsher

Journal:

Journal of Pharmaceutical Sciences

Year:

1997

Language:

english

File:

PDF, 130 KB

english, 1997

20

Pharmacokinetic and glucodynamic comparisons of recombinant and animal-source glucagon after IV, IM, and SC injection in healthy volunteers

Casey J. Graf, James R. Woodworth, Mary E. Seger, John H. Holcombe, Ronald R. Bowsher, Renee Lynch

Journal:

Journal of Pharmaceutical Sciences

Year:

1999

Language:

english

File:

PDF, 71 KB

english, 1999

21

Workshop on Bioanalytical Methods Validation for Macromolecules: Summary Report

Krys J. Miller, Ronald R. Bowsher, Abbie Celniker, Jacqueline Gibbons, Shalini Gupta, Jean W. Lee, Steve J. Swanson, Wendell C. Smith, Russell S. Weiner, Daan J. A. Crommelin, Ira Das, Binodh S. DeSil

Journal:

Pharmaceutical Research

Year:

2001

Language:

english

File:

PDF, 146 KB

english, 2001

22

A radioenzymatic assay for para-tyramine and para-octopamine

James W. Van Huysse, Ronald R. Bowsher, L.R. Willis, David P. Henry

Journal:

Biochemical Medicine and Metabolic Biology

Year:

1988

Language:

english

File:

PDF, 719 KB

english, 1988

23

Development of a novel radioimmunoassay to detect autoantibodies to amyloid beta peptides in the presence of a cross-reactive therapeutic antibody

John H. Sloan, Bradley J. Ackermann, Mark O’Dell, Ronald R. Bowsher, Robert A. Dean, Robert J. Konrad

Journal:

Journal of Pharmaceutical and Biomedical Analysis

Year:

2011

Language:

english

File:

PDF, 318 KB

english, 2011

24

Dopamine in rat adrenal glomerulosa

J. Howard Pratt, Deborah A. Turner, Ronald R. Bowsher, David P. Henry

Journal:

Year:

1987

Language:

english

File:

PDF, 307 KB

english, 1987

25

Conversion of p-tyrosine to p-tyramine in the isolated perfused rat kidney: Modulation by perfusate concentrations of p-tyrosine

Michael E. Brier, Ronald R. Bowsher, Philip R. Mayer, David P. Henry

Journal:

Year:

1991

Language:

english

File:

PDF, 416 KB

english, 1991

26

A sensitive radioenzymatic assay for the simultaneous determination of salsolinol and dopamine

Robert A. Dean, David P. Henry, Ronald R. Bowsher, Robert B. Forney

Journal:

Year:

1980

Language:

english

File:

PDF, 618 KB

english, 1980

27

Brain SPECT Simulation Using Half-Cone-Beam Collimation and Single-Revolution Helical-Path Acquisition

Ter-Antonyan, Ruben, Jaszczak, Ronald J., Bowsher, James E., Greer, Kim L., Metzler, Scott D.

Journal:

IEEE Transactions on Nuclear Science

Year:

2007

Language:

english

File:

PDF, 1.14 MB

english, 2007

28

Quantitative Evaluation of Half-Cone-Beam Scan Paths in Triple-Camera Brain SPECT

Ter-Antonyan, Ruben, Jaszczak, Ronald J., Bowsher, James E., Greer, Kim L., Metzler, Scott D.

Journal:

IEEE Transactions on Nuclear Science

Year:

2008

Language:

english

File:

PDF, 1.93 MB

english, 2008

29

[IEEE 2007 IEEE Nuclear Science Symposium Conference Record - Honolulu, HI, USA (2007.10.26-2007.11.3)] 2007 IEEE Nuclear Science Symposium Conference Record - Half-cone-beam data sufficiency in triple-camera SPECT

Ter-Antonyan, Ruben, Jaszczak, Ronald J., Bowsher, James E., Greer, Kim L., Metzler, Scott D.

Year:

2007

Language:

english

File:

PDF, 1023 KB

english, 2007

30

Insights in regulated bioanalysis of human insulin and insulin analogs by immunoanalytical methods

Bowsher, Ronald R, Nowatzke, William L

Journal:

Year:

2011

Language:

english

File:

PDF, 929 KB

english, 2011

31

[IEEE 2008 IEEE Nuclear Science Symposium and Medical Imaging conference (2008 NSS/MIC) - Dresden, Germany (2008.10.19-2008.10.25)] 2008 IEEE Nuclear Science Symposium Conference Record - High sensitivity collimators for brain SPECT

Ter-Antonyan, Ruben, Bowsher, James E., Greer, Kim L., Metzler, Scott D., Jaszczak, Ronald J.

Year:

2008

Language:

english

File:

PDF, 5.06 MB

english, 2008

32

Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments

Marini, Joseph C., Anderson, Michael, Cai, Xiao-Yan, Chappell, John, Coffey, Todd, Gouty, Dominique, Kasinath, Aparna, Koppenburg, Vera, Oldfield, Philip, Rebarchak, Shannon, Bowsher, Ronald R.

Journal:

The AAPS Journal

Year:

2014

Language:

english

File:

PDF, 1.76 MB

english, 2014

33

Relating Glucose Clamp Profiles to Reduction of Blood Glucose After Insulin Administration

Woodworth, James R., Howey, Daniel C., Bowsher, Ronald R., Brunelle, Rocco L.

Journal:

Diabetes Technology & Therapeutics

Year:

2004

Language:

english

File:

PDF, 171 KB

english, 2004

34

Fialuridine Accumulates in DNA of Dogs, Monkeys, and Rats Following Long-Term Oral Administration

Frank C. Richardson, Jeffery A. Engelhardt and Ronald R. Bowsher

Journal:

Proceedings of the National Academy of Sciences

Year:

1994

Language:

english

File:

PDF, 1014 KB

english, 1994

35

Using DTA and DTAARRAY Variables and Programming in WinNonlin ASCII Models to Streamline User-Defined Calculation and Data Analysis

Shen, Jun, Li, Shuanglian, Bowsher, Ronald R., Vick, Andrew

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 207 KB

english, 2015

36

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

37

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

38

Measurement of Insulin-Like Growth Factor-II in Physiological Fluids and Tissues. I. An Improved Extraction Procedure and Radioimmunoassay for Human and Rat Fluids*

BOWSHER, RONALD R., LEE, WEI-HUA, APATHY, JOHN M., O’BRIEN, PETER J., FERGUSON, ALBERT L., HENRY, DAVID P.

Journal:

Year:

1991

Language:

english

File:

PDF, 1.20 MB

english, 1991

39

Relation of Race, Age, and Sex Hormone Differences to Serum Leptin Concentrations in Children and Adolescents

Ambrosius, Walter T., Compton, Joyce A., Bowsher, Ronald R., Pratt, J. Howard

Journal:

Hormone Research

Year:

1998

Language:

english

File:

PDF, 222 KB

english, 1998

40

Application of commercial research-grade biomarker assays in drug development: is it time to create ‘pharmaceutical-grade’ kits?

Bowsher, Ronald R, Nowatzke, William, Sailstad, Jeffrey M, Khan, Masood U

Journal:

Year:

2012

Language:

english

File:

PDF, 1.37 MB

english, 2012

41

The development, optimization and validation of an ELISA bioanalytical method for the determination of Cetuximab in human serum

Hantash, Jamil, Smidt, Mary, Bowsher, Ronald R.

Journal:

Analytical Methods

Year:

2009

Language:

english

File:

PDF, 538 KB

english, 2009

42

Erratic Oscillatory Characteristics of Plasma Insulin Concentrations in Patients with Insulinoma: Mechanism for Unpredictable Hypoglycemia 1

Berman, Nancy, Genter, Pauline, Chou, Hsu-Fang, Cortez, Colleen, Bowsher, Ronald, Ipp, Eli

Journal:

Journal of Clinical Endocrinology & Metabolism

Year:

1997

Language:

english

File:

PDF, 301 KB

english, 1997

43

Unique challenges of providing bioanalytical support for biological therapeutic pharmacokinetic programs

Nowatzke, William L, Rogers, Kathryn, Wells, Edward, Bowsher, Ronald R, Ray, Chad, Unger, Steve

Journal:

Year:

2011

Language:

english

File:

PDF, 1.20 MB

english, 2011

44

Systematic analytical validation of commercial kits for the determination of novel biomarkers for clinical drug development

Nowatzke, William, Cole, Thomas G, Bowsher, Ronald R

Journal:

Year:

2010

Language:

english

File:

PDF, 825 KB

english, 2010

45

[IEEE 2006 IEEE Nuclear Science Symposium Conference Record - San Diego, CA, USA (2006.10.29-2006.11.1)] 2006 IEEE Nuclear Science Symposium Conference Record - Helical-Path, Half-Cone-Beam Acquisition for SPECT Brain Imaging

Jaszczak, Ronald J., Greer, Kim L., Bowsher, James E., Metzler, Scott D., Ter-Antonyan, Ruben, Bobkov, Konstantin V.

Year:

2006

Language:

english

File:

PDF, 851 KB

english, 2006

46

[IEEE 2007 IEEE Nuclear Science Symposium Conference Record - Honolulu, HI, USA (2007.10.26-2007.11.3)] 2007 IEEE Nuclear Science Symposium Conference Record - Quantitative evaluation of Half-Cone-Beam data acquisition trajectories in triple- camera brain SPECT

Ter-Antonyan, Ruben, Jaszczak, Ronald J., Bowsher, James E., Greer, Kim L., Metzler, Scott D.

Year:

2007

Language:

english

File:

PDF, 1.52 MB

english, 2007

47

[IEEE 2006 IEEE Nuclear Science Symposium Conference Record - San Diego, CA, USA (2006.10.29-2006.11.1)] 2006 IEEE Nuclear Science Symposium Conference Record - Pinhole Trajectories for SPECT Imaging of the Breast, Axilla, and Upper Chest

Bowsher, James E., Roper, Justin R., Peter, Joerg, Jaszczak, Ronald J.

Year:

2006

Language:

english

File:

PDF, 262 KB

english, 2006

48

SPIE Proceedings [SPIE San Diego '92 - San Diego, CA (Sunday 19 July 1992)] Neural and Stochastic Methods in Image and Signal Processing - Segmentation and analysis of emission-computed-tomography images

Johnson, Valen E., Bowsher, James E., Qian, Jiang, Jaszczak, Ronald J., Chen, Su-Shing

Year:

1992

Language:

english

File:

PDF, 273 KB

english, 1992

49

Interview with Dr Bowsher

Bowsher, Ronald R

Journal:

Year:

2013

Language:

english

File:

PDF, 448 KB

english, 2013

50

The interaction of norepinephrine excretion with blood pressure and race in children

Pratt, J Howard, Manatunga, Amita K., Bowsher, Ronald R., Henry, David P.

Journal:

Journal of Hypertension

Year:

1992

File:

PDF, 333 KB

1992