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Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...

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ヴァルマス氏はE-biomedの提案を擁護し,推進する準備を進めている.

E Marshall

    Science (New York, N.Y.)
    |July 17, 1999
    PubMed
    まとめ

    No abstract available in PubMed .

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