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List of works by Joleen T White

2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance ⬇️

scientific article published on 01 December 2010

Biodistribution and pharmacodynamics of recombinant human alpha-l-iduronidase (rhIDU) in mucopolysaccharidosis type I-affected cats following multiple intrathecal administrations ⬇️

scientific article published on March 21, 2011

Comparison of neutralizing antibody assays for receptor binding and enzyme activity of the enzyme replacement therapeutic Naglazyme (galsulfase).

scientific article published on 16 August 2008

D18G transthyretin is monomeric, aggregation prone, and not detectable in plasma and cerebrospinal fluid: a prescription for central nervous system amyloidosis?

scientific article

Development, validation, and clinical implementation of an assay to measure total antibody response to naglazyme (galsulfase)

scientific article

Free And Total Biotherapeutic Evaluation in Chromatographic Assays: Interference From Targets And Immunogenicity ⬇️

scientific article published on October 1, 2012

Immunogenicity Risk Assessment for PEGylated Therapeutics

scientific article published on 28 January 2020

Immunogenicity evaluation strategy for a second-generation therapeutic, PEG-IFN-β-1a

scientific article published on 6 November 2015

Incidence, characterization, and clinical impact analysis of peginterferon beta1a immunogenicity in patients with multiple sclerosis in the ADVANCE trial

scientific article published on 10 March 2016

Incurred sample reproducibility and stability assessment in a cell-based drug concentration assay

scientific article

Intrathecal recombinant human 4-sulfatase reduces accumulation of glycosaminoglycans in dura of mucopolysaccharidosis VI cats ⬇️

scientific article published on January 1, 2012

Pharmacokinetics and pharmacodynamics of peginterferon beta-1a in patients with relapsing-remitting multiple sclerosis in the randomized ADVANCE study

scientific article

R104H may suppress transthyretin amyloidogenesis by thermodynamic stabilization, but not by the kinetic mechanism characterizing T119 interallelic trans-suppression

Repeated intrathecal injections of recombinant human 4-sulphatase remove dural storage in mature mucopolysaccharidosis VI cats primed with a short-course tolerisation regimen

scientific article published on 13 October 2009

Stability: recommendation for best practices and harmonization from the Global Bioanalysis Consortium Harmonization Team

scientific article

Strategies for method comparison when changes in the immunogenicity method are needed within a clinical program

scientific article published on 28 April 2020

Strategies to Determine Assay Format for the Assessment of Neutralizing Antibody Responses to Biotherapeutics

scientific article

Time-Varying Clearance and Impact of Disease State on the Pharmacokinetics of Avelumab in Merkel Cell Carcinoma and Urothelial Carcinoma

scientific article published on 25 April 2019

Transthyretin aggregation under partially denaturing conditions is a downhill polymerization

scientific article

Understanding and Mitigating Impact of Immunogenicity on Pharmacokinetic Assays ⬇️

scientific article published on 01 August 2011

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