Literature DB >> 10339051

Bioavailability and bioequivalence requirements; abbreviated applications; proposed revisions--FDA. Proposed rule.

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Abstract

The Food and Drug Administration (FDA) is proposing to revise 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:  1998        PMID: 10339051

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


  4 in total

1.  Atenolol quantification in human plasma by high-performance liquid chromatography: application to bioequivalence study.

Authors:  Luis Renato Pires de Abreu; Silvana Aparecida Calafatti de Castro; José Pedrazzoli
Journal:  AAPS PharmSci       Date:  2003

2.  Evaluation of Bioequivalence of Two Long-Acting 20% Oxytetracycline Formulations in Pigs.

Authors:  Zhixin Lei; Qianying Liu; Bing Yang; Saeed Ahmed; Jincheng Xiong; Tingting Song; Pin Chen; Jiyue Cao; Qigai He
Journal:  Front Vet Sci       Date:  2017-05-01

Review 3.  Thyroxine and treatment of hypothyroidism: seven decades of experience.

Authors:  Roselyn Cristelle I Mateo; James V Hennessey
Journal:  Endocrine       Date:  2019-07-18       Impact factor: 3.633

4.  Evaluation of Marbofloxacin in Beagle Dogs After Oral Dosing: Preclinical Safety Evaluation and Comparative Pharmacokinetics of Two Different Tablets.

Authors:  Zhixin Lei; Qianying Liu; Bing Yang; Haseeb Khaliq; Saeed Ahmed; Bowen Fan; Jiyue Cao; Qigai He
Journal:  Front Pharmacol       Date:  2018-04-10       Impact factor: 5.810

  4 in total

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