毒性試験計画書及び報告書の共通テンプレートを用いることによる試験実施の効率性向上

DOI

書誌事項

タイトル別名
  • Supporting Efficiencies in Nonclinical Toxicology Studies Through Common Templates

抄録

<p> BioCelerate is a non-profit consortium of pharmaceutical companies in US, EU and Japan. Our projects publicly released a Nonclinical Common Protocol Template for repeat-dose toxicology studies in November 2019, and through efforts to evolve synergistic processes, a companion Nonclinical Common Report Template in November 2020. Benefits to using these common templates for sponsors and CROs may include 1) productivity (time/effort/resources) optimization in drafting these documents for each study, 2) improve overall study quality by decreasing errors due to unfamiliarity with protocol/report layout, 3) simpler management of multiple studies, and 4) streamlined review of toxicology study reports by worldwide regulatory agencies. Importantly, in preparation for the future digitized state of information exchange in toxicologic research, widespread adoption of these common templates will provide a consistent substrate with which to transition these documents into electronic format. For both common templates, streamlined layout and process instructions were defined where large variations in preferences existed. For template development, public feedback periods and webinars were held to collect stakeholder feedback. Specific to the protocol template, most stakeholders reported using multiple templates and experienced problems associated with inconsistency, inefficiencies, and reduced study execution quality. For the associated report template, the BioCelerate team collaborated with reviewers from the US FDA and subsequently hosted an open webinar to gather input from stakeholders. </p>

収録刊行物

詳細情報 詳細情報について

  • CRID
    1390007536268950016
  • NII論文ID
    130008073791
  • DOI
    10.14869/toxpt.48.1.0_p-78
  • 本文言語コード
    ja
  • データソース種別
    • JaLC
    • CiNii Articles
  • 抄録ライセンスフラグ
    使用不可

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