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The effect of food vehicles on in vitro performance of pantoprazole sodium delayed release sprinkle formulation.
Wu, Kai-Wei; Zheng, Kai; Tian, Li; Xia, Li; Hwang, Sung-Yong; Nwakama, Patrick E; Sun, Wei-Jhe; Kim, Myong-Jin; Tampal, Nilufer; Xu, Xiaoming; Boyce, Heather; Feng, Xin.
Afiliação
  • Wu KW; Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, United States.
  • Zheng K; Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, United States.
  • Tian L; Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, United States.
  • Xia L; Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, United States.
  • Hwang SY; Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, United States.
  • Nwakama PE; Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, United States.
  • Sun WJ; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, United States.
  • Kim MJ; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, United States.
  • Tampal N; Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, United States.
  • Xu X; Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, United States.
  • Boyce H; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, United States.
  • Feng X; Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, United States. Electronic address: Xin.feng1@fda.hhs.gov.
Int J Pharm ; 635: 122737, 2023 Mar 25.
Article em En | MEDLINE | ID: mdl-36801362
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Excipientes / Alimentos Idioma: En Ano de publicação: 2023 Tipo de documento: Article
Texto completo
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PubMed Links
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Excipientes / Alimentos Idioma: En Ano de publicação: 2023 Tipo de documento: Article