Bioavailability and Bioequivalence Assessment

Bioavailability is referred to as the extent and rate to which the active drug ingredient or active moiety from the drug product is absorbed and becomes available at the site of drug action.

Bioequivalence studies conducted either during the development of the drug or after its marketing will be presented or discussed: Bioequivalence of highly variable drugs with the associated problem of widening the acceptance range or alternative solutions. Bioequivalence for investigating the food effect. Bioequivalence in special population such as children, non-Caucasian population. Bioequivalence based on in vitro data or literature. New approaches in bioequivalence interpretation. Bioequivalence and analytical methods which are not sensitive or specific enough.

  • Strategies for the bioequivalence assessment of topical dosage forms
  • Bioequivalence approaches for transdermal dosage forms
  • Bioequivalence assessment of respiratory dosage forms
  • Evaluation of highly variable drugs and drug products
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