From The
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Expert perspectives focused on the latest bioanalytical topic & trends

Is ISR Needed For Biomarker Assays?

Incurred sample reanalysis (ISR) is a well-established measure for the reproducibility of pharmacokinetic (PK) assays and commonly conducted in regulated studies. ISR was established in PK assays to address sources irreproducibility observed in study data that could be attributed to back conversion of unstable metabolites, matrix effects, recovery issues, sample inhomogeneity and undocumented technical errors. In addition, the value of ISR is notably in the fact that validation of PK

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Difference Between Biobetters and Biosimilars

According to research compiled by Reports and Data, in 2018 the global biologics market was valued at over $250 million, but is projected to reach an estimated $625 million by the end of 2026 with an 11.9% compound annual growth rate (CAGR). Biologics are medications made up of proteins, sugars, or DNA, and oftentimes are a complex combination of these materials and by-products. Biologics can also be composed of living

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Scientist working in exploratory biomarker testing

Webinar Sneak Peek: Exploratory Biomarker Testing—to Qualify or Validate the Assay?

Biomarkers are endogenous molecules with much individual variability, and there is still not yet one clear and concise guidance for biomarker validation – so there are still questions around what it takes to sufficiently validate the performance characteristics of a biomarker assay to ensure it can properly establish the value of the target biomarker as a qualified DDT.

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|Bioanalytical scientist deciding between 510K Approved Assays and RUO Assays

510K Approved Assays vs. RUO Assays: Which Best Support Clinical Trial Biomarker Studies?

The answer to the question is “it depends”. Commonly a combination of 510K approved kits (in Europe known as assays that need to follow IVD-directive 2017/746) and research use only (RUO) kits are used to support the biomarker analysis needed in clinical trials because both types of assays have different strengths and limitations. To select the appropriate kit requires an understanding of these pros and cons in the context of the intended study the assay must support.

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ProteinSimple Ella™ Platform

Platform Spotlight: ProteinSimple Ella™ for Accurate and Reproducible Multiplex Biomarker Analysis

When assessing biomarkers for multifactorial diseases, we ideally want to assess multiple analytes in the same experiment. That is where the value of multiplex biomarker analysis comes in – but this method also inherently creates potential challenges with cross-reactivity. We discuss how the ProteinSimple Ella platform enables multiplexing with excellent assay reproducibility, and how it can benefit studies with low sample volumes.

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A Dose of Pharma and Biotech News: February 13, 2019

We find it critical to stay on top of the latest industry developments to inform our own work and help our customers best address emerging bioanalytical challenges and opportunities; we’ve compiled some of our favorite recent industry articles of interest to share with you.

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