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Integration of Biorelevant Pediatric Dissolution Methodology into PBPK Modeling to Predict In Vivo Performance and Bioequivalence of Generic Drugs in Pediatric Populations: a Carbamazepine Case Study.
Pawar, Gopal; Wu, Fang; Zhao, Liang; Fang, Lanyan; Burckart, Gilbert J; Feng, Kairui; Mousa, Youssef M; Al Shoyaib, Abdullah; Jones, Marie-Christine; Batchelor, Hannah K.
Afiliación
  • Pawar G; School of Pharmacy, Institute of Clinical Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK. G.Pawar@bham.ac.uk.
  • Wu F; Division of Quantitative Methods and Modelling, Office of Research and Standard, Office of Generic Drug Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, 20993, USA. Fang.Wu@fda.hhs.gov.
  • Zhao L; Division of Quantitative Methods and Modelling, Office of Research and Standard, Office of Generic Drug Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
  • Fang L; Division of Quantitative Methods and Modelling, Office of Research and Standard, Office of Generic Drug Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
  • Burckart GJ; Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
  • Feng K; Division of Quantitative Methods and Modelling, Office of Research and Standard, Office of Generic Drug Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
  • Mousa YM; Division of Quantitative Methods and Modelling, Office of Research and Standard, Office of Generic Drug Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
  • Al Shoyaib A; Division of Quantitative Methods and Modelling, Office of Research and Standard, Office of Generic Drug Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
  • Jones MC; School of Pharmacy, Institute of Clinical Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
  • Batchelor HK; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow, G4 0RE, UK. Hannah.batchelor@strath.ac.uk.
AAPS J ; 25(4): 67, 2023 06 29.
Article en En | MEDLINE | ID: mdl-37386339
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Benzodiazepinas / Medicamentos Genéricos Tipo de estudio: Prognostic_studies / Risk_factors_studies Límite: Adult / Child / Humans Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2023 Tipo del documento: Article País de afiliación: Reino Unido Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Benzodiazepinas / Medicamentos Genéricos Tipo de estudio: Prognostic_studies / Risk_factors_studies Límite: Adult / Child / Humans Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2023 Tipo del documento: Article País de afiliación: Reino Unido Pais de publicación: Estados Unidos