Bioavailability and generic prescribing

Abstract

Although oral drug bioinequivalence has been attributed to a number of causes (excipients, dosage form, variation in dissolution time, and aging) less is known about bioavailability problems of topical medications in ophthalmology. Factors that can alter drug absorption from solutions (pH, partition coefficient, container impurities, contact time, etc.) are noted, and cases in which bioavailability problems should be considered as causes of therapeutic failure are discussed. Various attitudes representing pharmaceutical companies, the federal government, pharmacists, consumers and physicians toward the related problems of bioinequivalence and generic prescribing are examined. Techniques for in vivo and in vitro drug testing and for establishing uniform conditions of drug manufacture and storage can contribute to identification and minimization of bioavailability problems. A rational program based on a combination of such techniques could, ultimately, lead to establishment of the terms "generic equivalency" and "therapeutic equivalency" as synonymous.