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Thursday April 29, 2010
| 7.30 a.m. |
Continental Breakfast |
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Registration |
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| SESSION 9: |
Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products |
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Coordinated with Product Quality Research Institute (PQRI) |
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Chairperson: Dennis O'Connor, B.S., |
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| 8.30 a.m. |
Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products.
Dennis O'Connor, B.S.
Boehringer Ingelheim, Ridgefield, CT. |
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| 8.45 a.m. |
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. |
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| 9.15 a.m. |
Demonstrating Bioequivalence using Pharmacokinetics: Theoretical Considerations Across Drug Classes.
Guenther Hochhaus, Ph.D.,
University of Florida, Gainesville, FL. |
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| 9.45 a.m. |
The Clinical Utility of Pharmacokinetics in Demonstrating Bioequivalence of Locally Acting OIPs.
Peter T. Daley-Yates, Ph.D.,
GlaxoSmithKline, Uxbridge, United Kingdom. |
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| 10.15 a.m. |
Refreshments |
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| 10.45 a.m. |
Aspects of Pharmacokinetic Study Design to Differentiate Between Different Orally Inhaled Drug Products.
Lars Borgstrom, Ph.D.,
AstraZeneca, Lund, Sweden. |
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| 11.15 a.m. |
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. |
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| 11.45 a.m. |
Panel Discussion |
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| 12.15 p.m. |
Luncheon |
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Sponsored by ‘Our Platinum & Gold Sponsors’ |
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| SESSION 10: |
Regulatory Perspectives on Bioequivalence |
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Sponsor: Teva Pharmaceuticals
Moderator: Peter R. Byron, Ph.D. |
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| 1.30 p.m. |
A Lawyer's Perspective on the Approval and Legal Challenges for Topically Active Generic Inhalers.
Kurt R. Karst, J.D.,
Hyman, Phelps & McNamara, Washington, DC. |
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| 2.00 p.m. |
Regulatory Uncertainties in Bioequivalence: Exhaled Nitric Oxide as a Possible Efficacy Endpoint for Inhaled Corticosteroids.
Badrul A. Chowdhury, M.D., Ph.D.,
Food and Drug Administration, Silver Springs, MD. |
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| 2.30 p.m. |
Refreshments |
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| SESSION 11: |
MDIs and DPIs: Fundamental Pharmaceutics |
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Sponsor: Chiesi Farmaceutici
Moderator: Carsten Niederlaender, Ph.D. |
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| 3.00 p.m. |
Understanding the Power Requirements for Efficient Dispersion in Powder Inhalers: Comparing CFD Predictions and Experimental Measurements.
James A. Tibbatts, M.Eng.,
Concept Flow, Cambridge, United Kingdom. |
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| 3.30 p.m. |
Powder Rheology: A New Technique to Predict the Performance of Inhaled Powder Formulations.
Jag Shur, Ph.D.,
University of Bath, Bath, United Kingdom. |
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| 4.00 p.m. |
A Picture Tells a Thousand Words - Discovering Sites of Deposition, Cavitation and Gasket Deformation in MDIs using Improved High Speed Photography.
Darren J. Hodson, C.Eng.,
AstraZeneca, Loughborough, United Kingdom. |
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| 4.30 p.m. |
Modeling MDI Delivery: A Priori Predictions, Empirical Models and Experiments.
Stephen W. Stein, Ph.D.,
3M Drug Delivery Systems, St. Paul, MN. |
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| 5.00 p.m. |
End of Respiratory Drug Delivery 2010 |
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