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...

INTRODUCTION A multisource drug product is a drug product that contains the same active drug substance in the same dosage form and is marketed by more than one pharmaceutical manufacturer.  Single-source drug products are drug products for which the patent has not yet expired or has certain exclusivities so that only one manufacturer can make it. Single-source drug products are usually brand-name (innovator) drug products. After the patent and other exclusivities for the brand-name drug expires, a pharmaceutical firm may manufacture a generic drug product that can be substituted for the branded drug product.   Since the formulation and method of manufacture of the drug product can affect the bioavailability and stability of the drug, the generic drug manufacturer must demonstrate that the generic drug product is bioequivalent and therapeutically equivalent to the brand-name drug product.   Drug product selection and generic drug product substitution are major respo...