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Implementing a tiered approach to bioanalytical method validation for large-molecule ligand-binding assay methods in pharmacokinetic assessments.
Watson, Rebecca G; Clements-Egan, Adrienne; Schantz, Allen; Ware, Mark; Wu, Bonnie; Yang, Tong-Yuan; Shankar, Gopi; Marini, Joseph C.
Affiliation
  • Watson RG; Biologics Development Sciences, Janssen BioTherapeutics, Janssen R&D, LLC, 1400 McKean Road, PO Box 776, Spring House, PA 19477, USA.
  • Clements-Egan A; Biologics Development Sciences, Janssen BioTherapeutics, Janssen R&D, LLC, 1400 McKean Road, PO Box 776, Spring House, PA 19477, USA.
  • Schantz A; Biologics Development Sciences, Janssen BioTherapeutics, Janssen R&D, LLC, 1400 McKean Road, PO Box 776, Spring House, PA 19477, USA.
  • Ware M; Biologics Development Sciences, Janssen BioTherapeutics, Janssen R&D, LLC, 1400 McKean Road, PO Box 776, Spring House, PA 19477, USA.
  • Wu B; Biologics Development Sciences, Janssen BioTherapeutics, Janssen R&D, LLC, 1400 McKean Road, PO Box 776, Spring House, PA 19477, USA.
  • Yang TY; Biologics Development Sciences, Janssen BioTherapeutics, Janssen R&D, LLC, 1400 McKean Road, PO Box 776, Spring House, PA 19477, USA.
  • Shankar G; Biologics Development Sciences, Janssen BioTherapeutics, Janssen R&D, LLC, 1400 McKean Road, PO Box 776, Spring House, PA 19477, USA.
  • Marini JC; Biologics Development Sciences, Janssen BioTherapeutics, Janssen R&D, LLC, 1400 McKean Road, PO Box 776, Spring House, PA 19477, USA.
Bioanalysis ; 9(18): 1407-1422, 2017 Sep.
Article in En | MEDLINE | ID: mdl-28920457
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Chemistry Techniques, Analytical Type of study: Prognostic_studies Limits: Humans Language: En Journal: Bioanalysis Year: 2017 Type: Article Affiliation country: United States
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Chemistry Techniques, Analytical Type of study: Prognostic_studies Limits: Humans Language: En Journal: Bioanalysis Year: 2017 Type: Article Affiliation country: United States