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Bioavailability & Bioequivalence Studies ? Pharmaceutical Importance

Pratibha Muntha

Pharmacokinetics has now emerged as an important part of drug development especially in the development of new drugs. The combined studies of Pharmacodynamics and pharmacokinetics present a thorough understanding on how the drug affects the body and how the body affects the drug. Bioavailability is the study of the rate and extent to which the active ingredient is absorbed from a dosage form and it is available at the required action site. Bioequivalence is that there should not be any significant difference in bioavailability between two products. Bioavailability (BA) and bioequivalence (BE) studies play a key role during the phase of drug development for both innovator drugs and generic drugs and thus have gained great attention over the past few decades. BE is used to introduce generic drugs of innovator drugs at a lower cost. So a thorough understanding of these BA/BE studies is required.