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Arun Sharma1, Vittorio Sebastiano2, Christopher T Scott3

  • 1Institute for Stem Cell Biology and Regenerative Medicine, Stanford University School of Medicine, Stanford, CA 94305, USA. Cardiovascular Institute, Stanford University School of Medicine, Stanford, CA 94305, USA.

Science (New York, N.Y.)
|November 7, 2015
PubMed
まとめ

No abstract available in PubMed .

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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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