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  <front>
    <journal-meta>
      <journal-id journal-id-type="iso-abbrev">Pharmacophore</journal-id>
      <journal-id journal-id-type="publisher-id">pharmacophorejournal.com</journal-id>
      <journal-id journal-id-type="publisher-id">Pharmacophore</journal-id>
      <journal-title-group>
        <journal-title>Pharmacophore</journal-title>
      </journal-title-group>
      <issn pub-type="epub">2229-5402</issn>
    </journal-meta>
    <article-meta>
      <article-id pub-id-type="publisher-id">pharmacophorejournal.com-6933</article-id>
      <article-id pub-id-type="doi">10.51847/2PDeVVb1Uu</article-id>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Original research</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>The Model Evidence Dossier for Traceable, Adaptive, and Change-Controlled Artificial Intelligence in Pharmaceutical Development</article-title>
      </title-group>
                    <contrib-group>
                      <contrib contrib-type="author">
              <name>
                <surname>Ramirez</surname>
                <given-names>Carlos</given-names>
              </name>
                              <xref rid="aff1" ref-type="aff">1</xref>
                                                            <xref rid="cor1" ref-type="corresp" />
                          </contrib>
                      <contrib contrib-type="author">
              <name>
                <surname>Torres</surname>
                <given-names>Elena</given-names>
              </name>
                              <xref rid="aff2" ref-type="aff">2</xref>
                                        </contrib>
                      <contrib contrib-type="author">
              <name>
                <surname>Ortega</surname>
                <given-names>Pablo</given-names>
              </name>
                              <xref rid="aff1" ref-type="aff">1</xref>
                                        </contrib>
                      <contrib contrib-type="author">
              <name>
                <surname>Mendes</surname>
                <given-names>Sofia</given-names>
              </name>
                              <xref rid="aff3" ref-type="aff">3</xref>
                                        </contrib>
                  </contrib-group>
                  <aff id="aff1">
            <label>1</label>Department of Model Evidence Dossier and AI Traceability, Faculty of Pharmacy, University of Barcelona, Barcelona, Spain.
          </aff>
                  <aff id="aff2">
            <label>2</label>Department of Adaptive AI and Change Control, Faculty of Pharmaceutical Sciences, University of Lisbon, Lisbon, Portugal.
          </aff>
                  <aff id="aff3">
            <label>3</label>Department of Evidence-Based AI Governance in Pharma, Faculty of Pharmacy, University of Porto, Porto, Portugal.
          </aff>
                          <author-notes>
            <corresp id="cor1">
              <bold>Address for correspondence:</bold> Prof. Wael Abu Dayyih, Department of
              Pharmaceutical Chemistry, Faculty of Pharmacy, Mutah University, Al-Karak 61710, Jordan.
                              E-mail: <email xlink:href="carlos.ramirez@ub.edu">carlos.ramirez@ub.edu</email>
                          </corresp>
          </author-notes>
                    <pub-date pub-type="epub">
        <day>28</day>
        <month>08</month>
        <year>2026</year>
      </pub-date>
      <volume>17</volume>
      <issue>4</issue>
      <fpage>26</fpage>
      <lpage>37</lpage>
      <permissions>
        <copyright-statement>
          Copyright: &#x000a9; 2026 Pharmacophore
        </copyright-statement>
        <copyright-year>2026</copyright-year>
        <license>
          <ali:license_ref xmlns:ali="http://www.niso.org/schemas/ali/1.0/"
            specific-use="textmining" content-type="ccbyncsalicense">
            https://creativecommons.org/licenses/by-nc-sa/4.0/</ali:license_ref>
          <license-p>This is an open access journal, and articles are distributed under the terms of
            the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows
            others to remix, tweak, and build upon the work non-commercially, as long as appropriate
            credit is given and the new creations are licensed under the identical terms.</license-p>
        </license>
      </permissions>
      <abstract>
        <title>A<sc>BSTRACT</sc></title>
        <p>Artificial intelligence models increasingly participate in pharmaceutical activities in which data, scientific assumptions, software dependencies, intended uses, and decision consequences evolve over time. Conventional model reports are usually static: they describe a model at development or publication but rarely preserve the relationships among model version, data provenance, validation scope, uncertainty, limitations, human approvals, subsequent changes, and continuing performance. This creates an evidentiary gap when models are retrained, transferred between development stages, exposed to altered data distributions, or incorporated into decisions different from those originally evaluated. This article proposes the Model Evidence Dossier, a living, version-bound, and queryable evidence-governance architecture for artificial intelligence in pharmaceutical development. The dossier organizes model identity, intended use, data lineage and suitability, technical configuration, validation evidence, uncertainty characterization, known limitations, monitoring signals, change-impact assessments, requalification decisions, and human challenge records as connected evidence objects. Its central principle is that no isolated performance measure can establish pharmaceutical usefulness, scientific validity, continuing fitness, or acceptable reliance. Instead, each claim must remain traceable to the model version, data state, decision context, assessment method, responsible actor, and boundary conditions that support it. The architecture distinguishes monitoring from authorization, updating from requalification, confidence from calibrated uncertainty, data accessibility from suitability, and predictive performance from experimental or clinical confirmation. The proposed dossier is conceptual rather than empirically validated and does not constitute a regulatory submission, deployment protocol, or universal evidence standard. Its value will depend on future ontology development, prospective evaluation, organizational integration, and evidence that dossier use improves scientific review, change control, and pharmaceutical decision quality.</p>
      </abstract>
      <kwd-group>
                <kwd>Artificial intelligence governance</kwd>
                <kwd>Pharmaceutical development</kwd>
                <kwd>Model provenance</kwd>
                <kwd>Change control</kwd>
                <kwd>Lifecycle monitoring</kwd>
                <kwd>Validation evidence</kwd>
              </kwd-group>
    </article-meta>
  </front>
</article>