Literature DB >> 12492102

Bioavailability and bioequivalence requirements: abbreviated applications. Final Rule.

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Abstract

The Food and Drug Administration (FDA) is amending its regulations on bioavailability and bioequivalence and on the content and format of an abbreviated application to reflect current FDA policy and to correct certain typographical and inadvertent errors. This action is intended to improve the accuracy and clarity of the regulations.

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Year:  2002        PMID： 12492102

Source DB:  PubMed          Journal:  Fed Regist        ISSN： 0097-6326


  3 in total

1.  Bioequivalence of sitagliptin/metformin fixed-dose combination tablets and concomitant administration of sitagliptin and metformin in healthy adult subjects: a randomized, open-label, crossover study.

Authors:  Elizabeth M Migoya; Jutta L Miller; Maria Gutierrez; Wei Zheng; Amy O Johnson-Levonas; Qi Liu; Catherine Z Matthews; John A Wagner; Keith M Gottesdiener
Journal:  Clin Drug Investig       Date:  2010       Impact factor: 2.859

2.  Non-technical skills in surgery during the COVID-19 pandemic: An observational study.

Authors:  James C Etheridge; Rachel Moyal-Smith; Yves Sonnay; Mary E Brindle; Tze Tein Yong; Hiang Khoon Tan; Christine Lim; Joaquim M Havens
Journal:  Int J Surg       Date:  2022-01-04       Impact factor: 13.400

3.  Pharmacokinetics of the P-gp Inhibitor Tariquidar in Rats After Intravenous, Oral, and Intraperitoneal Administration.

Authors:  Peter Matzneller; Manuel Kussmann; Sabine Eberl; Alexandra Maier-Salamon; Walter Jäger; Martin Bauer; Oliver Langer; Markus Zeitlinger; Wolfgang Poeppl
Journal:  Eur J Drug Metab Pharmacokinet       Date:  2018-10       Impact factor: 2.441
  3 in total

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