Abstract

This chapter describes pharmacological and clinical measurements related to bioavailability testing in man. There are several clinical and pharmacological considerations that are extremely useful, if not essential, in the design and interpretation of effective bioavailability studies and standards. They include: (1) The use of clinical dose response data to establish the clinical significance of differences in bioavailability and set clinically acceptable limits for bioavailability differences, (2) the use of clinical or pharmacological response data to measure bioavailability differences in place of blood level data, (3) the use of pharmacologic and clinical information to determine whether parent drug and/or metabolites should be measured in bioavailability blood level studies, and to design optimum dosage forms, and (4) the use of data on the effect of variables associated with clinical use of the drug to determine the most suitable experimental protocol. The types of data required and the information gained from each of these considerations are quite different. The chapter discusses each of these four categories.

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