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title: "Evidence-Weighted Software Architecture for Integrative Natural Products and Biomarker Research: Design Principles, Scoring Semantics, Regulatory Positioning, and an Evaluation Protocol"
type: article
authors:
  - family-names: Schüller
    given-names: Thomas
    email: forschung@tschueller.com
    orcid: "https://orcid.org/0009-0003-9799-6747"
    affiliation: "Syntagma Forschung, Wien, Österreich"
version: "0.3"
date-released: "2026-09-04"
license: CC-BY-4.0
keywords:
  - evidence weighting
  - natural products
  - biomarkers
  - knowledge graph
  - provenance
  - reproducibility
  - software qualification
abstract: >-
  Design of a research platform joining natural products research with individual
  biomarker data in one evidence-weighted knowledge model. Version 0.3 withdraws the
  GRADE-adaptation claim of v0.1, states the record-level unit of analysis and the known
  defects of the multiplicative composition, adds a preregisterable calibration protocol
  with falsification criteria, adds a regulatory positioning covering MDR/IVDR software
  qualification, the AI Act as amended in 2026, GDPR Article 9 and the European Health
  Data Space timetable, and adds a four-stage evaluation and beta protocol. Twelve
  limitations are documented. No empirical calibration has been performed.