Bioavailability & Bioequivalence

Bioavailability and bioequivalence studies play a important role during the drug development for both new drugs and generic drugs and thus have gained great attention over the past few decades. Bioavailability is the rate and extent to which the active moeity or is absorbed from the dosage form and is available at the required site of action. Relative bioavailability of drug after administered orally is compared with that of an oral standard of the same drug aqueous or non-aqueous solutions.  Absolute bioavailability It compares the bioavailability of the active drug administered through non intravenous routes such as after transdermal route, oral route, rectal route, sublingual route , subcutaneous route,  of administration and comparing the bioavailability of the same drug administered intravenously.

Bioequivalence studies are as vital concern in drug development process, which are required for small changes in drug products that develop during drug development to ensure that the dosage forms prove to be safe and effective. Moreover, bioequivalence has proven even more significant in case of drugs with narrow therapeutic index. Pharmaceutical equality indicates that the identical amount of a similar active substance(s), in the comparative measurements shape, for a similar route of administration additionally meeting the same or else practically identical standards.

  • First Pass Metabolism
  • Relative Bioavailability
  • Absolute Bioavailability
  • Therapeutic relevance
  • Pka and Pkd Models

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