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Scientific and regulatory activities initiated by the U.S. Food and drug administration to foster approvals of generic dry powder inhalers: Bioequivalence perspective.
Newman, Bryan; Babiskin, Andrew; Bielski, Elizabeth; Boc, Susan; Dhapare, Sneha; Fang, Lanyan; Feibus, Katharine; Kaviratna, Anubhav; Li, Bing V; Luke, Markham C; Ma, Tian; Spagnola, Michael; Walenga, Ross L; Wang, Zhong; Zhao, Liang; El-Gendy, Nashwa; Bertha, Craig M; Abd El-Shafy, Mohammed; Gaglani, Dhaval K.
Afiliación
  • Newman B; Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Babiskin A; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Bielski E; Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Boc S; Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Dhapare S; Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Fang L; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Feibus K; Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Kaviratna A; Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Li BV; Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Luke MC; Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Ma T; Division of Bioequivalence I, Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Spagnola M; Division of Clinical Safety and Surveillance, Office of Safety and Clinical Evaluation, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Walenga RL; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA. Electronic address: Ross.Walenga@fda.hhs.gov.
  • Wang Z; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zhao L; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • El-Gendy N; Division of Immediate and Modified Release Drug Products III, Office of Lifecycle Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Bertha CM; Division of New Drug Products II, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Abd El-Shafy M; Division of Immediate and Modified Release Drug Products III, Office of Lifecycle Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Gaglani DK; Division of Immediate and Modified Release Drug Products III, Office of Lifecycle Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Adv Drug Deliv Rev ; 190: 114526, 2022 11.
Article en En | MEDLINE | ID: mdl-36067967
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Medicamentos Genéricos / Inhaladores de Polvo Seco País/Región como asunto: America do norte Idioma: En Revista: Adv Drug Deliv Rev Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2022 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Base de datos: MEDLINE Asunto principal: Medicamentos Genéricos / Inhaladores de Polvo Seco País/Región como asunto: America do norte Idioma: En Revista: Adv Drug Deliv Rev Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2022 Tipo del documento: Article