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Successful authorization of drugs requires mostly the proof of bioavailability requiring numerous studies in humans. Complementation of clinical testing by meaningful in vitro laboratory methods would speed up authorization procedures. An increasing number of poorly water-soluble drug substances used for oral administration and the limitations of the traditional procedures require ongoing research and development to link in vitro and in vivo performance testing. More than 80 scientists, mainly from the United States, Europe, and Japan, discussed the progress in this field starting with the human physiology and in vitro release testing to linking the two aspects by establishing relations or correlations between in vitro and in vivo. Regulatory authorities participated with the goal of integrating novel procedures in their decision-making process, not only to benefit patients but also to limit the burden on industry.

AAPS Workshop Report on Biorelevant In Vitro Performance Testing of Orally Administered Dosage Forms