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Impact of Switching on Pharmacokinetics of Therapeutic Biologics and Interchangeability Assessment-A Simulation Study.
Ji, Ping; Ren, Yupeng; Li, Liang; Schrieber, Sarah J; Pisal, Dipak; Hallett, William; Wang, Yaning; Sahajwalla, Chandrahas G.
Affiliation
  • Ji P; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Ren Y; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Li L; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Schrieber SJ; Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Pisal D; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Hallett W; Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Wang Y; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Sahajwalla CG; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
J Clin Pharmacol ; 62(1): 36-45, 2022 01.
Article in En | MEDLINE | ID: mdl-34411322
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biological Products Type of study: Prognostic_studies Limits: Humans Language: En Journal: J Clin Pharmacol Year: 2022 Document type: Article Affiliation country: United States Country of publication: United kingdom
Fulltext
Add to My VHL
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biological Products Type of study: Prognostic_studies Limits: Humans Language: En Journal: J Clin Pharmacol Year: 2022 Document type: Article Affiliation country: United States Country of publication: United kingdom