Special Forum on Quality by Design (QbD):
What Type of In Vitro - In Vivo Correlations are feasible?

Respiratory Drug Delivery 2008 featured two panel discussions. This is the first which focused on Quality by Design (QbD).

Peter Byron and a panel of distinguished scientists that included Richard Ahrens (University of Iowa), Badrul Chowdhury (FDA), Prasad Peri (FDA), Terence Tougas (Boehringer Ingelheim), Omar Usmani (Imperial College, London), and Marjolein Weda (NIPH Netherlands) were recorded on May 13 in Scottsdale, Arizona.

Dr. Byron's presentation and the ensuing discussion focused on QbD and sought to discuss the possibility of using clinical data correlated with in vitro measurements (IVIVCs) to rationally set in vitro specifications for an inhaled product during development.

At Respiratory Drug Delivery 2008, the discussion was preceded with presentations by Marjolein Weda, Omar Usmani, Richard Ahrens and Terrence Tougas (Session 4: QbD: Defining the Quality Attributes of Orally Inhaled Drug Products). These talks are not available as audio presentations but corresponding articles are available online and in the Respiratory Drug Delivery 2008 proceedings.

This presentation consists of an audio lecture and synchronized powerpoint slides. The duration of the full presentation is approximately 75 minutes. It is possible to watch all, or only segments of, the presentation as time permits. This presentation has been made possible by the generous support of Respiratory Drug Delivery and Virginia Commonweath University's Medical College of Virginia Foundation and will be of interest to scientists and regulatory affairs professionals.

A complimentary copy of the advocacy article is available online and as an attachment within the presentation. The article is also included in Respiratory Drug Delivery 2008 Proceedings.