Can we Move Towards Harmonized Requirements for Bioequivalence of Inhalers?

Peter Byron and a panel of distinguished scientists that included Richard Ahrens (University of Iowa), Badrul Chowdhury (FDA), John Hall (Quintiles / John Hall Consulting), Caroline Vanneste (Health Canada), Gaetano Brambilla (Chiesi) and Richard Malley (GlaxoSmithKline) were recorded on April 19 in Paris, France during RDD Europe 2007.

Dr. Byron's presentation (click here to view the advocacy article published in the RDD Europe 2007 Proceedings) and the ensuing discussion sought to provide a broad perspective on the scientific, regional and global challenges of achieving and demonstrating bioequivalence between pulmonary drug delivery devices and formulations. The discussion covered topics such as the appropriateness of using reference listed products and useful biological endpoints to define bioequivalence.

This 1 hour electronic presentation has been made possible by the generous support of Pfizer and will be of interest to scientists and regulatory affairs professionals.

RDD Europe 2007 Panel Discussion.
Can we Move Towards Harmonized Requirements for Bioequivalence of Inhalers?
Peter R. Byron, Ph.D.
Virginia Commonwealth University, Richmond, VA.

During the Panel Discussion at RDD Europe 2007, Martin Oliver (Vectura), Mark Everard (Sheffield Children's Hospital), Paul Atkins (Oriel Therapeutics), Gur Jai Pal Singh (Watson Labs) and Martin Grosvenor (AstraZeneca) agreed to the inclusion of their questions and comments.

Discussion Format:

• This discussion is presented as a series of audio lectures and synchronized powerpoint slides which were recorded and edited from RDD Europe 2007. It is possible to watch all, or only segments of, the presentation as time permits. The duration of the full presentation is approximately 1 hour.
• For your convenience, the RDD Online editorial team has added slides which summarize the issues discussed during the Q&A session with the audience.

Related References :

• At RDD Europe 2007, the discussion was preceded with presentations by Richard Ahrens, Badrul Chowdhury, John Hall, Caroline Vanneste, Gaetano Brambilla and Richard Malley. These talks are not available as audio presentations but corresponding written articles are available in the RDD Europe 2007 proceedings. The articles are available online to subscribers of RDD Online. Non-subscribers can get immediate online access for $35 per article.