In March 1999, a workshop with the title, "Challenges in the Design and Evaluation of Bioequivalence," will be held in Frankfurt Germany under the cosponsorship of AAPS and APV (International Association of Pharmaceutical Technology, the leading German-based association for pharmaceutical sciences) in cooperation with CRS, EUFEPS and the FDA. This workshop is intended to provide a forum for discussion of current thinking in the FDA and the European regulatory authorities and industry with respect to the requirements for the design and evaluation of bioequivalence studies for solid oral dosage forms. The first day, March 8th, will be devoted to challenges in study design. Issues such as highly variable drugs, contribution of metabolites, use of pharmacodynamic parameters, individual bioequivalence and food interactions will be discussed by leading experts on these subjects including FDA representatives. The second day will focus on study evaluation, and will include presentation and discussion of the latest methods for evaluating studies. A highlight of the second day will be the presentation of case studies from industry, with an open forum discussion of the problems presented and how they might be solved. The third day will be devoted to a discussion of regulatory perspectives, beginning with a presentation of the new FDA BA/BE Guidance. Harmonization of regulations and local concerns will be discussed by representatives of key European organizations such as European Medicines Evaluation Agency, EUFEPS, the German regulatory authorities (BfARM) and issues specific to developing countries will be highlighted by Ms. Maria Santiago from the Bureau of Food and Drugs in the Philippines.

The workshop Committee consists of Jennifer Dressman (APV, University of Frankfurt), Henning Blume (EUFEPS, SocraTec). Jose Morals(EMEA, University of Lisbon), and Vinod Shah (FDA). We look forward to providing a forum for the participants to deepen their understanding of issues important to bioequivalence and to a lively discussion of the case studies and regulatory aspects of bioequivalence studies.