During the last 25 years, there has been considerable interest in in vitro-in vivo relationships of oral dosage forms. The advantages are obvious in terms of cost, time, and safety. This paper considers the problems involved in establishing in vitro-in vivo relationships, the dimensions of the task, and the different perspectives that apply to in vitro-in vivo correlations. Two examples based on laboratory work on two compounds showing how in vitro data might be used to improve the efficiency and reduce the cost of dosage form development are included.
Twenty-one Code of Federal Regulations Parts 201 and 211, 1978. Amended March 1994.
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