Bioequivalence/Bioavailability Studies

Bioavailability of drug is to measure its extent of absorption (percentage) in the systemic circulation when given through non-intravenous routes of administration (e.g., orally).

The bioequivalence study is conducted to assess the therapeutic equivalence between two drug product which may have a different placebo (excipients). The bioequivalence study evaluates clinical differences in the bioavailability of two distinct drug product.

Pharmacokinetic Evaluation

During the Bioequivalence study, pharmacokinetic parameters are assessed which is the indirect method to check bioavailability of drugs starting from absorption in the body until its excretion. The final assessment reveals the therapeutic index and the optimal dose of the drug.

Pharmacodynamic Evaluation

The pharmacodynamic method is the direct way of conducting bioequivalence study to assess the physiologic and biochemical impact of drug product on a living organism. The pharmacodynamic study is divided into uses two methods for bioequivalence evaluation, therapeutic, and acute pharmacological response. In the therapeutic evaluation, assessment is done for the relationship between the clinical response when the drug concentration moves to the site of action (or reacts to the symptoms it intends to cure). In the acute pharmacological evaluation, the impact of the drug dosage and concentration on ECG, pupil diameter, EEG, etc., are tested and measured.