BIO '99
INTERNATIONAL

PROGRAM


Wednesday, 29 September 1999

08.00 - 08.15 Opening
08.15 - 09.00 Plenary Lecture 1: Where are we now and where do we go next in terms of scientific basis of regulation of BA and BE?
R. Williams, USA
SESSION I International Reference Product
Moderators: J. Idänpään-Heikkilä, Switzerland and I.J. McGiveray, Canada
09.00 - 09.30 Current Status of the International Comparator (Reference) Product System
J. Idänpään-Heikkilä, Switzerland
09.30 - 10.00 Differences in Reference Products:
Dissolution and in Vivo Evidence
I.J. McGilveray, Canada
10.00 - 10.30 Coffee/Tea
10.30 - 11.00 Innovator Industry Perspective
M. Siewert, Germany
11.00 - 11.30 Generic Perspective
M. Spino, Canada
11.30 - 12.00 Regulatory Perspective
R. Patnaik, USA
12.00 - 13.00 Panel Discussion
13.00 - 14.00 Lunch
SESSION II New Initiatives in BA/BE
Moderators: L. Paalzow, Sweden and G. Amidon, USA
14.00 - 14.25 Basis of Individual Bioequivalence
R. Williams, USA
14.25 - 14.50 European Perspective on Individual Bioequivalence
T. Salmonson, Sweden
14.50 - 15.15 Realities and Implementation - Report of the International Workshop on IBE, Montreal, Canada (August 1999)
K.K. Midha, Canada
15.15 - 15.45 Coffee/Tea
15.45 - 16.10 Bioequivalence - Quality Parameter or Therapeutic Surrogate
L. Paalzow, Sweden
16.10 - 16.35 Dissolution Studies as Surrogate for Bioequivalence
G. Amidon, USA
16.35 - 17.00 Considerations in Drug Product Selection:
Quality and Performance
T. Foster, USA
17.00 - 18.00 Panel Discussion


Thursday, 30 September 1999

08.30 - 09.15 Plenary Lecture 2: Herbal Products - An Issue in Bioequivalence/Bioavailability Assessment
H.H. Blume, Germany
SESSION III Guidances Related to Bioavailability and Bioeequivalence
Moderators: M. Holz-Slomczyk, Germany and V. Shah, USA
09.15 - 09.40 When Bioequivalence Studies are not required
M. Holz-Slomczyk, Germany
09.40 - 10.05 US FDA General Guidance on Bioavailability and Bioequivalence
V.P. Shah, USA
10.05 - 10.30 CPMP Note for Guidance on Bioavailability and Bioequivalence
J. Morais, Portugal
10.30 - 10.55 Coffee/Tea
10.55 - 11.20 European Industry Perspective
Speaker to be announced
11.20 - 11.45 Japanese Guidance on Bioavailability and Bioequivalence
N. Aoyagi, Japan
11.45 - 12.45 Panel Discussion
12.45 - 14.00 Lunch
SESSION IV Bridging BA/BE and Therapeutic Equivalence
Moderators: L. Lesko, USA and M. Rowland, Great Britain
14.00 - 14.30 Permeability, Metabolism, Transporters and Systemic Exposure
L.Z. Benet, USA
14.30 - 15.00 Clinical Consequences in "Failed" Bioequivalence Studies
L. Lesko, USA
15.00 - 15.30 Coffee/Tea
15.30 - 16.00 Pharmacokinetic Basis for Immediate Release to Control Release Dosage Forms
A. Yacobi, USA
16.00 - 16.30 Pharmacodynamic Basis for Control Release Dosage Form and Immediate Release to Control Release Bridging Studies
M. Rowland, Great Britain
16.30 - 17.30 Panel Discussion


Friday, 1 October 1999

08.15 - 09.00 Plenary Lecture 3: Linking Pharmacology and Biopharmaceutics
D. Breimer, The Netherlands
SESSION V Linking Pharmacology and Biopharmaceutics
Moderators: D. Breimer, The Netherlands and V. Steinijans, Germany
09.00 - 09.30 Equivalence Concepts in Clinical Pharmacology
V. Steinijans, Germany
09.30 - 10.00 Equivalence in Disease States
G. Tucker, Great Britain
10.00 - 10.30 Coffee/Tea
10.30 - 11.00 Drug-drug Interaction - Industry Approach
R. Barbhaiya, USA
11.00 - 11.30 Equivalence in Special Populations (age, ethnic)
H. Ogata, Japan
11.30 - 12.00 Pharmacometrics - Modelling and Simulation
R. Gieschke, Switzerland
12.00 - 12.45 Panel Discussion
12.45 - 13.30 Lunch
SESSION VI Conference Conclusions
Moderators: R. Williams, USA and K.K. Midha, Canada
13.30 - 13.50 Session I
Rapporteur: I.J. McGilveray, Canada
13.50 - 14.10 Session II
Rapporteur: to be announced
14.10 - 14.30 Session III
Rapporteur: V.P. Shah, USA
14.30 - 14.50 Session IV
Rapporteur: L. Lesko, USA
14.50 - 15.10 Session V
Rapporteur: V. Steinijans, Germany
15.10 - 15.35 Closing Remarks

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