Bioequivalence and Bioavailability Forum

❝ According to the guideline, …

❝ […] if two formulation are both intravenous formulation, should I call is absolute BA study or relative BA study? 

Bioequivalence studies are generally not required if the test product is to be administered as an aqueous intravenous solution containing the same active substance as the currently approved product. However, if any excipients interact with the drug substance (e.g. complex formation), or otherwise affect the disposition of the drug substance, a bioequivalence study is required unless both products contain the same excipients in very similar quantity and it can be adequately justified that any difference in quantity does not affect the pharmacokinetics of the active substance.

• <nitpick>
  • »Bioequivalence study« is a misnomer. Bioequivalence is the desired result of a comparative biovailability study.
    Only Health Canada consistently uses ‘comparative BA’. See also the funky footnote in this article.
• </nitpick>