Therapeutic Drug Monitoring of Biologics: Current Practice, Challenges and Opportunities - a Workshop Report.
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| Title: | Therapeutic Drug Monitoring of Biologics: Current Practice, Challenges and Opportunities - a Workshop Report. |
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| Authors: | Shubow S; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Gunsior M; Astria Therapeutics, Boston, Massachusetts, USA., Rosenberg A; Epivax, Inc., Providence, Rhode Island, USA., Wang YM; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Altepeter T; Division of Gastroenterology, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Guinn D; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Rajabiabhari M; Novartis BioMedical Research, Cambridge, Massachusetts, USA., Kotarek J; Office of Health Technology 7, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, USA., Mould DR; Projections Research Inc., Phoenixville, Pennsylvania, USA., Zhou H; Jazz pharmaceuticals, Philadelphia, Pennsylvania, USA., Cheifetz AS; Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA., Garces S; Bristol Myers Squibb, New York, New York, USA., Chevalier R; Children's Mercy Kansas City, University of Missouri-Kansas City (UMKC), Kansas City, USA., Gavan S; Manchester Centre for Health Economics, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, United Kingdom., Trusheim MR; Tufts Medical Center, NEWDIGS, Boston, Massachusetts, USA., Rispens T; Amsterdam institute for Immunology and Infectious diseases, Immunology, Amsterdam, Netherlands., Bray K; ProciseDx, San Diego, California, USA., Partridge MA; Regeneron Pharmaceuticals, Tarrytown, New York, USA. Michael.Partridge@regeneron.com. |
| Source: | The AAPS journal [AAPS J] 2025 Mar 14; Vol. 27 (2), pp. 62. Date of Electronic Publication: 2025 Mar 14. |
| Publication Type: | Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S. |
| Journal Info: | Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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| ISSN: | 1550-7416 |
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| DOI: | 10.1208/s12248-025-01050-9 |
