Publications by authors named "Erin Muhlbradt"

The Tumor Combination Guide was created at the request of the U. S. Food and Drug Administration (FDA) by a Working Group of biopharmaceutical experts from international societies of toxicologic pathology, the Food and Drug Administration (FDA), and members of the Standard for Exchange of Nonclinical Data (SEND) initiative, to assist pharmacology/toxicology reviewers and biostatisticians in statistical analysis of nonclinical tumor data.

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Article Synopsis
  • Real-world data (RWD) and real-world evidence (RWE) are essential for clinical research and health care decisions, but they require well-defined and structured data for effective use.
  • The CDISC RWD Connect Initiative aims to tackle challenges in implementing CDISC data standards for RWD and seeks to provide necessary tools and guidance for easier adoption.
  • A qualitative Delphi survey involving 66 experts highlighted the need for RWD standardization, prioritizing electronic health records and observational study data to enhance data sharing and improve the quality of evidence.
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NKX3.1 is a tumor suppressor down-regulated in early prostate cancers. A SNP (rs2228013), which represents a polymorphic NKX3.

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