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I n 1997, a workshop on the "Scientific Basis for and Applications of the Biophanllaceutics C lassification System and In Vitro-In Vivo Correlations" was held in Washington DC under the auspices ofCRS, AAPS and the FDA. A European version of this workshop, this time in cooperation with EUFEPS and APV (the International Organization for Pharmaceutical Technology) as well as CRS and the FDA, was held March 25-27 this year in Frankfurt, Germany. The three day workshop featured sessions on various aspects of the Biopharmaceutics Classification Scheme. Professor Henning Blume of the Gennan Central Laboratory (ZL) and Dr. Roger Williams of the FDA kicked off the workshop with an overview of internationaJ bioequivalence standards and introduction to regulatory standards for drug product qualiry from the standpoint of the FDA. The following three sessions were devoted to the basic bunding stones of the BCS, namely gastrointestinal variables, membrane permeabiLity, and solubi li ry and drug dissolution. Of particular interest in terms of gastrointestinal variables were d,e dara presented by Prof. Clive WIlson from the Universiry ofStrathclyde concerning diurnal effects on the movement of dosage forms intO and through the colon. Dr.Jiirgen Stein, from the Universiry of Frankfurt, discussed alterations in drug uptake associated with disease states, using inAammatory bowel disease, resected sma ll bowel patients and pancreatitis as case examples. The presentations on permeabiliry covered the whole spectrum of predictive and e'"l'erimental techniques, from theoretical predictions based on physical chemical data (Dr. van de vVaterbeemd, Pfizer, Lnc.) through to a presentation on how the various methods can be integrated into a practical approach to preclinical screening in the pharmaceutical in dustry (Dr. Phil Smith, SmithKJine Beecham). A particularly important point that was brought out by Prof. Per Artllrsson (University ofUppsala) and highlighted in the pursuant discussion by Dr. Ajaz Hussain (FDA) was the need for reference compounds when using cell culUlres for permeabiliry

dissolution technologies

"Biopharmacy is Back!"· Meeting Report: The Role of the Biopharmaceutics Classification System and In Vitro-In Vivo Correlations in the Approval of Oral Drug Products