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. |
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| 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 |
| ISSN: | 2168-4804 |
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| DOI: | 10.1007/s43441-025-00763-5 |
