ABSTRACT
The Bio International ’89 conference developed consensus reports for three topics: rate of absorption in bioequivalence determinations, design and assessment of equivalence of highly variable drugs, and statistical analysis of bioequivalence data. Difference in regulatory approaches can be expected for drug products compared with products with a large therapeutic index because of the greater risk associated with inter-changeability of these products. During the 1980s a number of European regulatory agencies published guidances; and, in fact, the European Economic Community issued a directive concerning bioavailability. Areas of disagreement remain with modified-release dosage forms, e.g., whether clinical studies will be needed when changing from conventional definition of profile and how to deal with enteric-coated products. A conference in Barcelona in 1991 provided a further opportunity for regulatory agencies to discuss harmonization; to provide general definitions, statistical design, validation, and quality assurance advice; and to indicate under what circumstances bioavailability/bioequivalence studies would or would not be needed.
