DERMATOLOGICAL THERAPEUTIC PRODUCTS WORKSHOP - II Principles in the Establishment of Bioavailability and Bioequivalence of Dermatological Products December 3 - 5, 1991 ß Hyatt Regency Crystal City ß Arlington, VA An AAPS/FDA/industry co-sponsored second workshop is planned to consider solutions to those issues and problems identified in the first workshop held in March, 1990 on the principles and criteria involved in the establishment of bioavailability and bioequivalence of dermatological therapeutic products. In this serial workshop, emphasis will also be placed on the developmental process involving new formulations or new drugs including the optimization of drug delivery to the skin. The major objectives of the second workshop are: ß Review the accomplishments of the first workshop. ß Establish the principles and methods of assessment of bioavailability and bioequivalence of dermatological therapeutic products. ß Evaluate relationships amongst pharmacological activity, drag delivery and clinical efficacy. ß Propose criteria for the selection of promising formulations for clinical studies. ß Discuss quality contxol and other regulatory issues. The planning committee for this workshop consists of Distinguished Professor William I. Higuchi, Ph.D., (Co-Chair), Vinod P. Shah, Ph.D. (Co-Chair), Charan R. Behl, Ph.D. (Co-Chair and Coordinator), Jerome Skelly, Ph.D. (Advisor), A. Waseem Malick, Ph.D. (Advisor), Dinesh Sharma, Ph.D. (Advisor), Got&an L. Flynn, Ph.D., Boyd J. Poulsen, Ph.D., Howard I. Maibach, Ph.D., Gerald Krueger, Ph.D., Tsuneji Nagai, Ph.D., Russell O. Potts, Ph.D., Sergio Nacht, Ph.D., and Brian W. Barry, Ph.D. The format of the workshop provides ample opportunity for discussion. Also, audience participation is encouraged. For example, members of the audience will be encouraged to bring some data/information and present it at the workshop. Advance knowledge of such presentations is requested by the planning committee. At the end of the workshop, a summary report will be written and published. Registration materials are available from: •650 K•NG STREET ALEXANOR•A VIRGINIA 22314 2?4? ZO3 545 3000 FAX 703 684 7349 INDEX TO ADVERTISERS Croda, Inc. Kobo Products, Inc. Koster Keunen, Inc. Mona Industries Inc. Phillip Rockley Ltd. Robeco Chemicals, Inc. Rohm & Haas Company Strahl & Pitsch Inc. TWA