Publications by authors named "M E Furness"

Article Synopsis
  • FDA has identified that completing stability data is a major challenge for applicants seeking expedited New Drug Applications (NDAs).
  • MARS (Modeling Approaches to Reimagine Stability) has been proposed to help predict retest periods and expiration dates for drugs based on limited real-time stability data.
  • A study analyzed MARS data from various regulatory submissions and demonstrated its effectiveness in determining tentative shelf-lives, helping to ensure faster access to important medications for patients in need.
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Companion diagnostics (CDx) are essential to the practice of precision medicine. Next-generation sequencing is an increasingly important tool in the development of CDx. However, for CDx to be deployed, many different biopharma industry sectors need to collaborate.

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A 3-year-old Standardbred gelding with a history of pyrexia, persistent hemorrhage from the oral cavity, and a large, soft swelling at the junction of the caudal aspect of the mandibular rami and proximal neck was evaluated. The horse had neutropenia and anemia, with atypical granulated cells in a blood smear. Additional tests confirmed acute myeloid leukemia with basophilic differentiation, which has been reported in humans, cats, dogs, and cattle but not horses.

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Congenica (Cambridge, UK) is a world leading developer of genome-based discovery and diagnostic technologies. The UK company is a spin-out from the Wellcome Trust Sanger Institute (Cambridge, UK) and was founded by scientists and clinicians at the leading edge of genomic analysis. Congenica's Sapientia™ technology platform allows whole-genome sequence analysis to be easily interpreted and presented within a clinically actionable diagnostic report.

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Porcine epidemic diarrhea virus was first diagnosed in Ontario in January of 2014. An outbreak investigation was conducted and it was hypothesized that feed containing spray-dried porcine plasma contaminated with the virus was a risk factor in the introduction and spread of the disease in Ontario.

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