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Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective.
Liu, Qing; Absar, Mohammad; Saluja, Bhawana; Guo, Changning; Chowdhury, Badrul; Lionberger, Robert; Conner, Dale P; Li, Bing V.
Afiliación
  • Liu Q; Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Absar M; Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Saluja B; Office of Translational Research, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Guo C; Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Chowdhury B; Office of Translational Research, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Lionberger R; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Conner DP; Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Li BV; Respiratory, Inflammation and Autoimmunity, Medimmune, AstraZeneca Pharmaceuticals, Gaithersburg, Maryland, USA.
AAPS J ; 21(2): 14, 2019 01 07.
Article en En | MEDLINE | ID: mdl-30617594
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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Medicamentos Genéricos / Aprobación de Drogas / Furoato de Mometasona Tipo de estudio: Prognostic_studies País/Región como asunto: America do norte Idioma: En Revista: AAPS J Año: 2019 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Medicamentos Genéricos / Aprobación de Drogas / Furoato de Mometasona Tipo de estudio: Prognostic_studies País/Región como asunto: America do norte Idioma: En Revista: AAPS J Año: 2019 Tipo del documento: Article País de afiliación: Estados Unidos