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Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products: Summary of workshop.
Gong, Yuqing; Zhang, Peijue; Yoon, Miyoung; Zhu, Hao; Kohojkar, Ameya; Hooker, Andrew C; Ducharme, Murray P; Gobburu, Jogarao; Cellière, Géraldine; Gajjar, Parmesh; Li, Bing V; Velagapudi, Raja; Tsang, Yu Chung; Schwendeman, Anna; Polli, James; Fang, Lanyan; Lionberger, Robert; Zhao, Liang.
Afiliação
  • Gong Y; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zhang P; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Yoon M; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zhu H; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Kohojkar A; Regulatory Affairs, Teva Pharmaceuticals, Fairfield, New Jersey, USA.
  • Hooker AC; Department of Pharmacy, Uppsala University, Uppsala, Sweden.
  • Ducharme MP; Learn and Confirm Inc., St. Laurent, Quebec, Canada.
  • Gobburu J; Center for Translational Medicine, School of Pharmacy, University of Maryland, College Park, Maryland, USA.
  • Cellière G; Simulations Plus, Lixoft Division, Paris, France.
  • Gajjar P; Seda Pharmaceutical Development Services, Cheadle, UK.
  • Li BV; Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Velagapudi R; Sandoz Inc., East Hanover, New Jersey, USA.
  • Tsang YC; Apotex Inc., Toronto, Ontario, Canada.
  • Schwendeman A; Department of Pharmaceutical Sciences, Biointerfaces Institute, University of Michigan, Ann Arbor, Michigan, USA.
  • Polli J; Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, College Park, Maryland, USA.
  • Fang L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Lionberger R; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zhao L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
CPT Pharmacometrics Syst Pharmacol ; 12(5): 624-630, 2023 05.
Article em En | MEDLINE | ID: mdl-36710372
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Medicamentos Genéricos Idioma: En Ano de publicação: 2023 Tipo de documento: Article
Texto completo
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Medicamentos Genéricos Idioma: En Ano de publicação: 2023 Tipo de documento: Article