Knowledge of Pharma

BIOEQUIVALENCE: It‘s commonly observed that there are several formulations of the same drug, in the same dose, in similar dosage form and meant to be given by the same route. in order to ensure clinical performance of such drug products, bioequivalence studies should be performed. TYPES  OF  EQUIVALENCE Chemical Equivalence:  When 2 or more drug products contain the same labeled chemical substance as an active ingredient in the same amount.  Pharmaceutical Equivalence:  When two or more drug products are identical in strength, quality, purity, content uniformity, disintegration and dissolution characteristics; they may however differ in excipients.  Bioequivalence:  A relative term which denotes that the drug substance in two or more dosage forms, reaches the systemic circulation at the same relative rate and to the same relative extent i.e., their plasma concentration time profiles will be identical without significant statistic...

METHODS  FOR  ASSESSING  BIOAVAILABILITY: Direct and indirect methods may be used to assess drug bioavailability. The in-vivo bioavailability of a drug product is demonstrated by the rate and extent of drug absorption, as determined by comparison of measured parameters, eg, concentration of the active drug ingredient in the blood, cumulative urinary excretion rates, or pharmacological effects.  For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action. The design of the bioavailability study depends on the objectives of the study, the ability to analyze the drug (and metabolites) in biological fluids, the pharmacodynamics of the drug substance, the route of drug administration, and the nature of the drug product.  Pharmacokinetic and/or pharmacodynamic paramet...