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Balancing Expediency and Scientific Rigor in Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine Development

Kevin W Graepel1, Sonali Kochhar2,3, Ellen W Clayton4,5,6

  • 1Vanderbilt University School of Medicine, Nashville, Tennessee, USA.

The Journal of Infectious Diseases
|May 5, 2020
PubMed
Abstract

No abstract available in PubMed .

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Body: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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