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Regulatory, Translational, and Operational Considerations for the Incorporation of Biomarkers in Drug Development.

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Title: Regulatory, Translational, and Operational Considerations for the Incorporation of Biomarkers in Drug Development.
Authors: Hatcher H; Regulatory Consulting, Parexel International, 2520 Meridian Parkway, Durham, NC, 27713, USA., Stankeviciute S; Regulatory Consulting, Parexel International, 2520 Meridian Parkway, Durham, NC, 27713, USA., Learn C; Cell and Gene Therapy Center of Excellence, Parexel International, 2520 Meridian Parkway, Durham, NC, 27713, USA. chris.learn@parexel.com., Qu AX; Biomarkers and Genomic Medicine, Parexel International, 2520 Meridian Parkway, Durham, NC, 27713, USA.
Source: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2025 May; Vol. 59 (3), pp. 519-526. Date of Electronic Publication: 2025 Mar 08.
Publication Type: Journal Article; Review
Journal Info: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: <searchLink fieldCode="AU" term="%22Hatcher+H%22">Hatcher H</searchLink>; Regulatory Consulting, Parexel International, 2520 Meridian Parkway, Durham, NC, 27713, USA.<br /><searchLink fieldCode="AU" term="%22Stankeviciute+S%22">Stankeviciute S</searchLink>; Regulatory Consulting, Parexel International, 2520 Meridian Parkway, Durham, NC, 27713, USA.<br /><searchLink fieldCode="AU" term="%22Learn+C%22">Learn C</searchLink>; Cell and Gene Therapy Center of Excellence, Parexel International, 2520 Meridian Parkway, Durham, NC, 27713, USA. chris.learn@parexel.com.<br /><searchLink fieldCode="AU" term="%22Qu+AX%22">Qu AX</searchLink>; Biomarkers and Genomic Medicine, Parexel International, 2520 Meridian Parkway, Durham, NC, 27713, USA.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Springer+International+Publishing%22">Springer International Publishing </searchLink><i>Country of Publication: </i>Switzerland <i>NLM ID: </i>101597411 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2168-4804 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2221684790%22">21684790 </searchLink><i>NLM ISO Abbreviation: </i>Ther Innov Regul Sci <i>Subsets: </i>MEDLINE
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        Value: 10.1007/s43441-025-00763-5
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      – Code: eng
        Text: English
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        StartPage: 519
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      – TitleFull: Regulatory, Translational, and Operational Considerations for the Incorporation of Biomarkers in Drug Development.
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              Text: 2025 May
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              Y: 2025
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