Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products

Respiratory Drug Delivery 2010 in conjunction with the Product Quality Research Institute (PQRI) took an in-depth look at the potential for pharmacokinetics to serve as the sole in vivo metric necessary to support a finding of bioequivalence (BE) between inhaled products.

A panel of experts from the pharmaceutical industry evaluated the current state of knowledge and identified gaps in information relating to the potential use of pharmacokinetics (PK) as the sole indicator of in vivo bioequivalence of locally acting OIPs. The strengths of the PK approach to detect differences in product performance compared with in vitro and PD/clinical studies were addressed.

Expert opinions on this controversial issue were originally presented on April 29 and the speakers were joined in debate by FDA experts for a short panel discussion at the end of the formal presentations.

Discussions on this topic continued on Friday April 30 in a PQRI coordinated Workshop and included case studies and a series of breakout sessions. Please visit for further details.

This presentation consists of a series of audio lectures and synchronized powerpoint slides. The duration of the full presentation is approximately 3 hours. 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 the Product Quality Research Institute.

Complimentary copies of advocacy articles for each of the individual discussions are available online and as an attachment within each presentation. Articles are also included in Respiratory Drug Delivery 2010 Proceedings.

Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products.

Dennis O'Connor, B.S.
Boehringer Ingelheim, Ridgefield, CT.

Evolution of Regulatory and Scientific Paradigms for Establishing Equivalence of Systemic Exposure from Orally Inhaled Drugs: Current Status and Possible Challenges.

Gur Jai Pal Singh, Ph.D.
Scientific Advisor, Corona, CA.

Demonstrating Bioequivalence using Pharmacokinetics: Theoretical Considerations Across Drug Classes.

Guenther Hochhaus, Ph.D.
University of Florida, Gainesville, FL.

The Clinical Utility of Pharmacokinetics in Demonstrating Bioequivalence of Locally Acting OIPs.

Peter T. Daley-Yates, Ph.D.
GlaxoSmithKline, Uxbridge, United Kingdom.

Aspects of Pharmacokinetic Study Design to Differentiate Between Different Orally Inhaled Drug Products.

Lars Borgstrom, Ph.D.
AstraZeneca, Lund, Sweden.

Application of the EU Guidelines for Pharmacokinetic Studies of Locally Acting Orally Inhaled Drug Products.

Sanjeeva Dissanayake, M.R.C.P.
Medicines and Healthcare Products Regulatory Agency (MHRA), London, United Kingdom.

Panel Discussion

RDD Online® prepared slides to help summarize the issues discussed during the Panel Discussion.

During the Panel Discussion at Respiratory Drug Delivery 2010, Michael Newhouse, Thomas Hofmann, Stephen Newman, Xian-Ming Zeng, Colin Scott and Hartmut Derendorf agreed to the inclusion of their questions and comments.