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Is Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays?

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Author information

Authors and Affiliations

  1. BioAgilytix Labs, 2300 Englert Drive, Durham, NC, 27713, USA

    Amanda Hays

  2. Boston Pharmaceuticals, Cambridge, MA, USA

    Lakshmi Amaravadi

  3. Pharmacadence Analytical Services, Hatfield, PA, USA

    Carmen Fernandez-Metzler

  4. Pfizer Inc., Cambridge, MA, USA

    Lindsay King

  5. Ionis Pharmaceuticals, Carlsbad, CA, USA

    Joel Mathews

  6. Passage Bio, Inc., Philadelphia, PA, USA

    Yan Ni & Karen Quadrini

  7. Bristol Myers Squibb, Princeton, NJ, USA

    Chunyan Tinder & Jianing Zeng

  8. Merck & Co. Inc., Rahway, NJ, USA

    Faye Vazvaei

Authors
  1. Amanda Hays
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  2. Lakshmi Amaravadi
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The authors contributed equally in writing, reviewing, and editing this manuscript.

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Correspondence to Amanda Hays.

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The authors are employed by and receive compensation from their affiliations that are listed in this manuscript. The authors have no other relevant affiliations or financial involvements with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.

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Hays, A., Amaravadi, L., Fernandez-Metzler, C. et al. Is Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays?. AAPS J 24, 65 (2022). https://doi.org/10.1208/s12248-022-00708-y

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