View in EDS HTML Full Text PDF Full Text

Therapeutic Drug Monitoring of Biologics: Current Practice, Challenges and Opportunities - a Workshop Report.

Saved in:
Bibliographic Details
Title: Therapeutic Drug Monitoring of Biologics: Current Practice, Challenges and Opportunities - a Workshop Report.
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
Full text is not displayed to guests.
FullText Links:
  – Type: pdflink
Text:
  Availability: 1
Header DbId: mdl
DbLabel: MEDLINE Ultimate
An: 40087239
AccessLevel: 2
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: Therapeutic Drug Monitoring of Biologics: Current Practice, Challenges and Opportunities - a Workshop Report.
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AU" term="%22Shubow+S%22">Shubow S</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Gunsior+M%22">Gunsior M</searchLink>; Astria Therapeutics, Boston, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Rosenberg+A%22">Rosenberg A</searchLink>; Epivax, Inc., Providence, Rhode Island, USA.<br /><searchLink fieldCode="AU" term="%22Wang+YM%22">Wang YM</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Altepeter+T%22">Altepeter T</searchLink>; Division of Gastroenterology, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Guinn+D%22">Guinn D</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Rajabiabhari+M%22">Rajabiabhari M</searchLink>; Novartis BioMedical Research, Cambridge, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Kotarek+J%22">Kotarek J</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Mould+DR%22">Mould DR</searchLink>; Projections Research Inc., Phoenixville, Pennsylvania, USA.<br /><searchLink fieldCode="AU" term="%22Zhou+H%22">Zhou H</searchLink>; Jazz pharmaceuticals, Philadelphia, Pennsylvania, USA.<br /><searchLink fieldCode="AU" term="%22Cheifetz+AS%22">Cheifetz AS</searchLink>; Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Garces+S%22">Garces S</searchLink>; Bristol Myers Squibb, New York, New York, USA.<br /><searchLink fieldCode="AU" term="%22Chevalier+R%22">Chevalier R</searchLink>; Children's Mercy Kansas City, University of Missouri-Kansas City (UMKC), Kansas City, USA.<br /><searchLink fieldCode="AU" term="%22Gavan+S%22">Gavan S</searchLink>; Manchester Centre for Health Economics, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Trusheim+MR%22">Trusheim MR</searchLink>; Tufts Medical Center, NEWDIGS, Boston, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Rispens+T%22">Rispens T</searchLink>; Amsterdam institute for Immunology and Infectious diseases, Immunology, Amsterdam, Netherlands.<br /><searchLink fieldCode="AU" term="%22Bray+K%22">Bray K</searchLink>; ProciseDx, San Diego, California, USA.<br /><searchLink fieldCode="AU" term="%22Partridge+MA%22">Partridge MA</searchLink>; Regeneron Pharmaceuticals, Tarrytown, New York, USA. Michael.Partridge@regeneron.com.
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%22101223209%22">The AAPS journal</searchLink> [AAPS J] 2025 Mar 14; Vol. 27 (2), pp. 62. <i>Date of Electronic Publication: </i>2025 Mar 14.
– Name: TypePub
  Label: Publication Type
  Group: TypPub
  Data: Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
– Name: TitleSource
  Label: Journal Info
  Group: Src
  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22American+Association+of+Pharmaceutical+Scientists%22">American Association of Pharmaceutical Scientists </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101223209 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1550-7416 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2215507416%22">15507416 </searchLink><i>NLM ISO Abbreviation: </i>AAPS J <i>Subsets: </i>MEDLINE
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=40087239
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1208/s12248-025-01050-9
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        StartPage: 62
    Titles:
      – TitleFull: Therapeutic Drug Monitoring of Biologics: Current Practice, Challenges and Opportunities - a Workshop Report.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Shubow S
      – PersonEntity:
          Name:
            NameFull: Gunsior M
      – PersonEntity:
          Name:
            NameFull: Rosenberg A
      – PersonEntity:
          Name:
            NameFull: Wang YM
      – PersonEntity:
          Name:
            NameFull: Altepeter T
      – PersonEntity:
          Name:
            NameFull: Guinn D
      – PersonEntity:
          Name:
            NameFull: Rajabiabhari M
      – PersonEntity:
          Name:
            NameFull: Kotarek J
      – PersonEntity:
          Name:
            NameFull: Mould DR
      – PersonEntity:
          Name:
            NameFull: Zhou H
      – PersonEntity:
          Name:
            NameFull: Cheifetz AS
      – PersonEntity:
          Name:
            NameFull: Garces S
      – PersonEntity:
          Name:
            NameFull: Chevalier R
      – PersonEntity:
          Name:
            NameFull: Gavan S
      – PersonEntity:
          Name:
            NameFull: Trusheim MR
      – PersonEntity:
          Name:
            NameFull: Rispens T
      – PersonEntity:
          Name:
            NameFull: Bray K
      – PersonEntity:
          Name:
            NameFull: Partridge MA
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 14
              M: 03
              Text: 2025 Mar 14
              Type: published
              Y: 2025
          Identifiers:
            – Type: issn-electronic
              Value: 1550-7416
          Numbering:
            – Type: volume
              Value: 27
            – Type: issue
              Value: 2
          Titles:
            – TitleFull: The AAPS journal
              Type: main
ResultId 1