AAPS WORKSHOP TO ADDRESS REGULATORY ISSUES
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.
For more information on this workshop, including a complete preliminary program, registration fees, and accommodations, visit AAPS Online at
www.aaps.org/edumeet/ornasdeliv/index.html.
For additional information about AAPS, please visit AAPS Online at www.aaps.org. You may find this and past news releases on AAPS' Online News Room at
www.aaps.org/sciaffairs/news.html.
AAPS is a professional, scientific society of more than 10,000 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.
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