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

artículo científico publicado el 1 de diciembre de 2010

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

artículo científico publicado el 21 de marzo de 2011

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

artículo científico publicado en 2008

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

artículo científico publicado en 2003

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

artículo científico publicado en 2008

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

artículo científico publicado el 1 de octubre de 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

artículo científico publicado en 2015

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

artículo científico publicado en 2016

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

artículo científico publicado en 2015

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

artículo científico publicado el 1 de enero de 2012

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

artículo científico publicado en 2015

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

artículo científico publicado en 2009

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

artículo científico publicado en 2014

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

artículo científico publicado en 2016

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

artículo científico publicado en 2019

Transthyretin aggregation under partially denaturing conditions is a downhill polymerization

artículo científico publicado en 2004

Understanding and Mitigating Impact of Immunogenicity on Pharmacokinetic Assays ⬇️

artículo científico publicado el 1 de agosto de 2011

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