AAPS 25th Anniversary. Developing Science. Impacting health.

2009-03-03

PQRI Presents Bioequivalence Workshop

Focus to be on Locally Acting Orally Inhaled Drug Products

WHO:
The Product Quality Research Institute (PQRI) is a non-profit consortium of organizations working together to generate and share timely, relevant, and impactful information that advances drug product quality and development. The outcomes of PQRI will be focused on research projects whose results provide a continuing scientific basis for regulatory policy. PQRI has been in development since January of 1996, guided by a Steering Committee composed of representatives from its sponsoring organizations, including the American Association of Pharmaceutical Scientists (AAPS), Consumer Healthcare Products Association (CHPA), Parenteral Drug Association (PDA), U.S. Food and Drug Administration, Center for Drug Evaluation and Research (FDA/CDER), Health Canada (HC), International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS), International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) and United States Pharmacopeia (USP).

WHAT:
PQRI is pleased to present the Workshop on Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products. The two-day workshop will feature various presentations, as well as breakout sessions with focused discussions on selected topics. Topics to be discussed include biomarker strategies, imaging techniques and device design similarity. The event will also focus on in vitro approaches to demonstrating bioequivalence and in vivo approaches to establishing local delivery equivalence.

WHY:
The aim of this workshop is to develop a set of expert-derived scientific considerations for demonstrating bioequivalence that may be considered in the development of locally acting orally inhaled drug products, and in the preparation of regulatory guidances for NDAs, ANDAs, and post-approval changes.

WHEN:
March 9-10, 2009
Hyatt Regency Bethesda
Bethesda, MD

CONTACT:
For additional information about the workshop, and to register as press, visit http://www.pqri.org/workshops/index.asp. To set up an interview with a workshop speaker please contact Stacey May at 703-248-4740 or MayS@aaps.org.

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