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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AAPS is a professional, scientific society of more than 9,000 members employed in academia, industry, government and other research institutes worldwide. Founded in 1986, AAPS aims to advance science through the open exchange of scientific knowledge, serve as an information resource, and contribute to human health through pharmaceutical research and development.