Search Results - "Bowsher, R. R."

Standardization of Insulin Immunoassays: Report of the American Diabetes Association Workgroup by Marcovina, Santica, Bowsher, Ronald R, Miller, W. Greg, Staten, Myrlene, Myers, Gary, Caudill, Samuel P, Campbell, Scott E, Steffes, Michael W, Insulin Standardization Workgroup

“…Circulating insulin concentration in serum or plasma provides important information for the estimation of insulin secretion and insulin resistance. Currently,…”
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Sensitive assay design for detection of anti-drug antibodies to biotherapeutics that lack an immunoglobulin Fc domain by Johnson, Derrick, Simmons, Erica, Abdeen, Sanofar, Kinne, Adam, Parmer, Elijah, Rinker, Sherri, Thystrup, Jennifer, Ramaswamy, Swarna, Bowsher, Ronald R.

“…Today the evaluation of unwanted immunogenicity is a key component in the clinical safety evaluation of new biotherapeutic drugs and macromolecular delivery…”
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Clinical Immunogenicity of DaxibotulinumtoxinA for Injection in Glabellar Lines: Pooled Data from the SAKURA Phase 3 Trials by Gallagher, Conor J, Bowsher, Ronald R, Clancy, Amanda, Dover, Jeffrey S, Humphrey, Shannon, Liu, Yan, Prawdzik, Gregg

“…DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A product containing daxibotulinumtoxinA with a stabilizing excipient peptide…”
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Metabolic and immunologic effects of insulin lispro in gestational diabetes by L Jovanovic, S Ilic, D J Pettitt, K Hugo, M Gutierrez, R R Bowsher, E J Bastyr, 3rd

“…Metabolic and immunologic effects of insulin lispro in gestational diabetes. L Jovanovic , S Ilic , D J Pettitt , K Hugo , M Gutierrez , R R Bowsher and E J…”
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Evidence of free and bound leptin in human circulation. Studies in lean and obese subjects and during short-term fasting by Sinha, M K, Opentanova, I, Ohannesian, J P, Kolaczynski, J W, Heiman, M L, Hale, J, Becker, G W, Bowsher, R R, Stephens, T W, Caro, J F

“…Little is known about leptin's interaction with other circulating proteins which could be important for its biological effects. Sephadex G-100 gel filtration…”
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Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies by Sun, Bin, Sengupta, Nilanjan, Rao, Anita, Donnelly, Charles, Waichale, Vinit, Roy, Arnab Sinha, Ramaswamy, Shilpa, Pathak, Divya, Bowsher, Ronald R, Raiter, Yaron, Aubonnet, Patrick, Barve, Abhijit

“…MYL-1501D is a proposed biosimilar to insulin glargine. The noninferiority of MYL-1501D was demonstrated in patients with type 1 diabetes and type 2 diabetes…”
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Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective by Findlay, J.W.A., Smith, W.C., Lee, J.W., Nordblom, G.D., Das, I., DeSilva, B.S., Khan, M.N., Bowsher, R.R.

“…Immunoassays are bioanalytical methods in which quantitation of the analyte depends on the reaction of an antigen (analyte) and an antibody. Although…”
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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 by 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.

“…For biosimilar drug development, it is critical to demonstrate similar physiochemical characteristics, efficacy, and safety of the biosimilar product compared…”
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A bridging assay for detection and characterization of anti-drug antibodies to dostarlimab, a new anti-PD-1 therapeutic monoclonal antibody by Patterson, Marilyn, Beausang, Lee Anne, Rup, Bonita, Bowsher, Ronald R., Krug, Kim, Melhem, Murad, Lu, Sharon

“…Dostarlimab (JEMPERLI) is a humanized anti-programmed death 1 (PD-1) immunoglobulin (Ig)G4-kappa monoclonal antibody that binds to the PD-1 receptor and…”
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[Lys(B28), Pro(B29)]-human insulin. A rapidly absorbed analogue of human insulin by Howey, D. C., Bowsher, R. R., Brunelle, R. L., Woodworth, J. R.

“…[Lys(B28), Pro(B29)]-human insulin. A rapidly absorbed analogue of human insulin. D C Howey , R R Bowsher , R L Brunelle and J R Woodworth Lilly Laboratory for…”
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Development, validation, and implementation of a multiplex immunoassay for the simultaneous determination of five cytokines in human serum by Ray, Chad A., Bowsher, Ronald R., Smith, Wendell C., Devanarayan, Viswanath, Willey, Mark B., Brandt, John T., Dean, Robert A.

“…Quantification of biomarkers can provide important information about the safety and efficacy of candidate drugs. Unfortunately, limited sample volume and…”
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Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report by Lee, Jean W, Weiner, Russ S, Sailstad, Jeff M, Bowsher, Ronald R, Knuth, Dean W, O'Brien, Peter J, Fourcroy, Jean L, Dixit, Rakesh, Pandite, Lini, Pietrusko, Robert G, Soares, Holly D, Quarmby, Valerie, Vesterqvist, Ole L, Potter, David M, Witliff, James L, Fritche, Herbert A, O'Leary, Timothy, Perlee, Lorah, Kadam, Sunil, Wagner, John A

“…Biomarkers are increasingly used in drug development to aid scientific and clinical decisions regarding the progress of candidate and marketed therapeutics…”
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[Lys(B28), Pro(B29)]-human insulin : a rapidly absorbed analogue of human insulin by HOWEY, D. C, BOWSHER, R. R, BRUNELLE, R. L, WOODWORTH, J. R

“…[Lys(B28, Pro(B29)]-human insulin (LYSPRO) is an insulin analogue in which the natural amino acid sequence of the B-chain at positions 28 and 29 is inverted…”
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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? by Bowsher, Ronald R., Devanarayan, Viswanath

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Workshop on bioanalytical methods validation for macromolecules: summary report by Miller, K J, Bowsher, R R, Celniker, A, Gibbons, J, Gupta, S, Lee, J W, Swanson, S J, Smith, W C, Weiner, R S

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Recommendations for Systematic Statistical Computation of Immunogenicity Cut Points by Devanarayan, Viswanath, Smith, Wendell C., Brunelle, Rocco L., Seger, Mary E., Krug, Kim, Bowsher, Ronald R.

“…Today, the assessment of immunogenicity is integral in nonclinical and clinical testing of new biotherapeutics and biosimilars. A key component in the…”
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Biosynthetic human proinsulin. Review of chemistry, in vitro and in vivo receptor binding, animal and human pharmacology studies, and clinical trial experience by GALLOWAY, J. A, HOOPER, S. A, SPRADLIN, C. T, HOWEY, D. C, FRANK, B. H, BOWSHER, R. R, ANDERSON, J. H

“…Biosynthetic human proinsulin. Review of chemistry, in vitro and in vivo receptor binding, animal and human pharmacology studies, and clinical trial…”
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Purification, characterization and identification of rat brain cytosolic tyrosine transaminase as glutamine Transaminase-K by Bowsher, Ronald R., Henry, David P.

“…The current study was undertaken to investigate the spectrum of tyrosine transaminases enzymes in a cytosolic fraction of rat brain and to specifically purify…”
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Capillary mediated vitrification is a novel technique that enables storage of antibody critical reagents at ambient temperature: Impact on binding, structure, and laboratory sustainability by Shank-Retzlaff, Mary, Abdeen, Sanofar J., Bronsart, Laura, Cieslak, Alyssa N., Cruse, James K., Kinne, Adam S., Mohanty, Pravansu, Parmer, Elijah S., Radford, Shari, Bowsher, Ronald R.

“…Antibodies and antibody conjugates are essential components of life science research, but their inherent instability necessitates cold storage or…”
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Application of size-exclusion chromatography in the investigation of the in vitro stability of proinsulin and its cleaved metabolites in human serum and plasma by Bowsher, Ronald R., Santa, Paula F.

“…To help ensure reliability of proinsulin measurements and define the optimal matrix for conducting routine bioanalysis of this prognostic biomarker, we…”
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