Bioavailability and bioequivalence

Extract Bioavailability (F) Bioavailability is defined as the proportion of an administered dose of a drug that reaches the systemic circulation, normally expressed as a percentage. For IV administered drugs, the bioavailability is 100%. For oral drugs, only a proportion of the drug will reach the systemic circulation due to incomplete absorption and/or first pass metabolism. Absolute bioavailability compares the bioavailability of an IV administered drug to the bioavailability of a non-IV administered drug. Relative bioavailability compares the bioavailability of two non-IV administered drugs (e.g. tablet vs. oral solution). Generic medicinal products The activity of a drug is determined by its chemical concentration at the site of action. This may be the drug itself or an active metabolite. Rather than repeat the evidence for safety and efficacy of an innovator drug, generics abridge to these data with proof that the new formulation has the same bioavailability of the active as the innovator product....