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*This PQRI Workshop will include a series of case studies using the PK approach followed by breakout sessions with focused discussions on selected topics.
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| Objectives |
| To evaluate the current state of knowledge and identify 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 will be addressed. |
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| 8.15 a.m. |
Introduction |
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Moderator: Myra Herrle, Ph.D., R.Ph.
Novartis Pharmaceuticals |
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| 8.30 a.m. |
Salmeterol / Fluticasone Propionate Diskus® versus Salmeterol / Fluticasone Propionate RPID® |
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Peter Daley-Yates, Ph.D.
GlaxoSmithKline, Uxbridge, United Kingdom |
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| 8.55 a.m. |
Formoterol Certihaler® versus Formoterol Aerolizer® |
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Beverley Patterson, Ph.D.
Novartis Pharmaceuticals, Horsham, United Kingdom |
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| 9.20 a.m. |
Salbutamol (INN) MDI versus Salbutamol Originator MDI. |
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Anders Fugslang, Ph.D.
Aeropharm GmbH |
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| 9.45 a.m. |
Panel Discussion |
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| 10.00 a.m. |
Coffee break |
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| 10.30 a.m. |
Breakout Sessions |
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Meeting participants may select and attend one of four breakout sessions indicated below |
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Session 1: PK and Lung Deposition
Facilitators:
Gunther Hochhaus, Ph.D.
University of Florida
Sau Lee, Ph.D.
Food and Drug Administration
Stephen P. Newman, Ph.D.
Scientific Consultant
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Session 2: PK and In Vitro Assessment
Facilitators:
Wallace P. Adams,
Food and Drug Administration
Martin Oliver, R.Ph.
Vectura Limited
Guirag Poochikian, Ph.D.
Scientific Consultant
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Session 3: PK and PD Relationships
Facilitators:
Hartmut Derendorf, Ph.D.
University of Florida
Murray Ducharne, Pharm.D.
Cetero Research
Sandra Suarez-Sharp, Ph.D.
Food and Drug Administration
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Session 4: Effective PK Study Design
Facilitators:
John Davis, Ph.D.
Pfizer
Partha Roy, Ph.D. and Bing, Li, Ph.D.
Food and Drug Administration
Tushar Shah, M.D.
Teva Pharmaceuticals
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| 12.00 Noon |
Lunch |
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| 1.00 p.m. |
Breakout Sessions |
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Breakout sessions will be repeated and facilitators will be asked to include feedback from earlier sessions.
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Repeat of Session 1: PK and Lung Deposition |
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Repeat of Session 2: PK and In Vitro Assessment |
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Repeat of Session 3: PK and PD Relationships |
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Repeat of Session 4: Effective PK Study Designs |
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| 2.30 p.m. |
Coffee Break |
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| 3.30 p.m. |
Review of Breakout Sessions |
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| 4.30 p.m. |
Panel Discussion |
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| 5.00 p.m. |
Closing Remarks |
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