Program To Focus On Drug Products For Oral Inhalation And Nasal Delivery

Alexandria, VA -- April 23, 1999 -- The AAPS Workshop on Regulatory Issues Related to Drug Products for Oral Inhalation and Nasal Delivery will be held June 3-4, 1999, at the J.W. Marriott Hotel in Washington, DC. This workshop is co-sponsored with the Food and Drug Administration (FDA) and U.S. Pharmacopeia (USP).

The goals and objectives of this workshop include the following:

• Review FDA and USP approaches, as reflected in draft guidances and other documents, to assure quality of dosage forms intended for oral inhalation and nasal drug administration;
• Review and discuss CMC data for the dosage forms in the context of NDA and ANDA submissions;
• Review and discuss the types of in vivo and in vitro bioavailability and bioequivalence data used to characterize each of the dosage forms; and
• Consider compendial issues as they relate to quality aspects of oral inhalation and nasal drug delivery.

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Contact: Amy Miller
miller@aaps.org
703-518-8417
American Association of Pharmaceutical Scientists
22-Apr-1999