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Effect of the Similarity of Formulations and Excipients of Approved Generic Drug Products on In Vivo Bioequivalence for Putative Biopharmaceutics Classification System Class III Drugs.
Ren, Ping; Chan, Theresa; Yang, Wen-Cheng; Frost, Mitchell; Wang, Yan; Luke, Markham; Kim, Myong-Jin; Lionberger, Robert; Zhang, Yi.
Affiliation
  • Ren P; Division of Therapeutic Performance I, Division of Therapeutic Performance II, Immediate Office, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
  • Chan T; Division of Therapeutic Performance I, Division of Therapeutic Performance II, Immediate Office, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
  • Yang WC; Division of Therapeutic Performance I, Division of Therapeutic Performance II, Immediate Office, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
  • Frost M; Division of Therapeutic Performance I, Division of Therapeutic Performance II, Immediate Office, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
  • Wang Y; Division of Therapeutic Performance I, Division of Therapeutic Performance II, Immediate Office, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
  • Luke M; Division of Therapeutic Performance I, Division of Therapeutic Performance II, Immediate Office, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
  • Kim MJ; Division of Therapeutic Performance I, Division of Therapeutic Performance II, Immediate Office, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
  • Lionberger R; Division of Therapeutic Performance I, Division of Therapeutic Performance II, Immediate Office, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
  • Zhang Y; Division of Therapeutic Performance I, Division of Therapeutic Performance II, Immediate Office, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
Pharmaceutics ; 15(9)2023 Sep 21.
Article in En | MEDLINE | ID: mdl-37765334
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Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Qualitative_research Language: En Journal: Pharmaceutics Year: 2023 Document type: Article Affiliation country: Estados Unidos
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Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Qualitative_research Language: En Journal: Pharmaceutics Year: 2023 Document type: Article Affiliation country: Estados Unidos