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| Wednesday,
November 15 |
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| Opening
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| 08:30-09:00 |
REGISTRATION
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| 09:00-09:10 |
Opening
Kyungsoo
Park, Chair, Organizing Committee |
| 09:10-09:15 |
Welcoming
address
Min Soo
Park, Director, Clinical Trials
Center, Severance Hospital |
| 09:15-09:20 |
Congratulatory
address
Hoon
Sang Chi, CEO/President, Yonsei
University Health Care System |
| 09:20-09:40 |
Introduction
to Modeling & Simulation
in Drug Development
Kyungsoo
Park |
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| Session
1: Concepts in clinical pharmacology |
| Chairmen |
Terry
Blaschke & Hyung-Keun Roh |
| 09:40-10:05 |
Prediction
of pharmacokinetic profile in
pediatric patients from data
in adults for intravenous beta-lactam
antibiotics
Yoshitaka
Yano, Kyoto University, Japan |
| 10:05-10:30 |
Detection
and prediction of drug safety
Takahiko
Tanigawa, Bayer Yakuhin, Ltd,
Japan |
| 10:30-10:55 |
BREAK |
| Chairmen |
Atsunori
Kaibara & Young Moon Chae
|
| 10:55-11:20 |
Talking
Technology to Nontechnoligical
Audience
Howard
Lee, UCSF, USA |
| 11:20-11:45 |
Looking
into the population analysis
of densely sampled pharmacokinetic
data
Dong-Seok
Yim, The Catholic University,
Korea |
| 11:45-12:10 |
Functional
Implication of Transporters
on Pharmacokinetics during Nitrosative
Stress
Suk-Jae
Chung, Seoul National University,
Korea |
| 12:10-13:40 |
LUNCH |
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| Session
2: Pharmacokinetic and pharmacodynamic
modeling |
| Chairmen |
Nick Holford
& Dongwoo Kang |
| 13:40-14:05 |
Modelling
of the glucose-insulin system
Mats
Karlsson, Uppsala University,
Sweden |
| 14:05-14:30 |
Application
of PPK modeling and simulation
to clinical development of
S-1, a DPD inhibitory fluoropyrimidine
Kenichiro
Yoshida, Taiho Pharmaceutical
Corp., Japan |
| 14:30-14:55 |
PK/PD
modeling for fexofenadine with
polysomsography
Young-Ran
Yoon, Kyungpook National University,
Korea |
| 14:55-15:20 |
Population
PK-PD Modeling of Clopidogrel
Kyun-Seop
Bae, University of Ulsan, Korea
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| 15:20-15:50 |
BREAK |
| Chairmen |
Mats Karlsson
& Suneel Gupta |
| 15:50-16:15 |
Simultaneous
versus sequential population
PK/PD modeling
Liping
Zhang, Bristol-Myers Squibb
Co., USA |
| 16:15-16:40 |
PK/PD
model building and validation
Takuya
Okagaki, Tanabe Seiyaku Co.,
Ltd, Japan |
| 16:40-17:05 |
Promises
and challenges: what lies ahead
for population modeling?
Paolo
Vicini, University of Washington,
USA |
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| Thursday,
November 16 |
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| Session
3: Optimization of dosage regimen
& clinical trial design |
| Chairmen |
Jaap Mandema
& Kyung Hwan KIM |
| 09:00-09:25 |
Modeling
and simulation approach for
study design of FK506 (tacrolimus)
in patients with ulcerative
colitis
Atsunori
Kaibara, Astellas Pharmaceutical
Corp., Japan |
| 09:25-09:50 |
Population
PK/PD analysis of compound X
to find appropriate dosage regimen
in clinical trial
Tomoo
Funaki, Otsuka Pharmaceutical
Corp., Japan |
| 09:50-10:15 |
Pharmacokinetic
and Pharmacodynamic Guided Product
Design
Suneel
Gupta, ALZA Corporation, USA
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| 10:15-10:40 |
Application
of adaptive design to enhance
clinical trial
Dongwoo
Kang, Pfizer, USA
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| 10:40-11:10 |
BREAK |
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| Session
4: Biomarkers and surrogate
endpoints |
| Chairmen |
Yusuke Tanigawara
& Sang-Goo Shin |
| 11:10-11:35 |
Antiretroviral
Drugs for HIV Infection: What
Allowed Surrogate Endpoints
to be Used for Approval?
Terry
Blaschke, Stanford University,
USA |
| 11:35-12:00 |
Application
of PK-PD modeling and clinical
trial simulation in drug development:
Example of PET imaging biomarkers
Kyung-Sang
Yu, Seoul National University,
Korea |
| 12:00-13:30 |
LUNCH |
| 13:30-14:30 |
POSTER
SESSION |
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Session
5: Modeling and simulation in
drug development, regulatory
decision and clinical applications
Chair: To be announced |
| Chairmen |
Carl Peck
& Yil-Seob LEE |
| 14:30-14:55 |
Importance
of PK/PD in Internationally
Harmonized Drug Development
Yusuke
Tanigawara, Keio University,
Japan |
| 14:55-15:20 |
Modeling
of Disease: The Time Course
of Depression
-- What Happens in Clinical
Trials?
Nick
Holford, University of Auckland,
New Zealand |
| 15:20-15:45 |
Impact
of non compliance on anticancer
oral drugs: in silico study
using PK-PD models with application
to continuous and categorical
biomarkers
Pascal
Girard, INSERM - EA 3738 Univ
Lyon I, France |
| 15:45-16:10 |
BREAK |
| Chairmen |
Pascal Girard
& Howard Lee |
| 16:10-16:35 |
Utility
of Monte Carlo Simulation in
Anti-infective Agent Development
Hui
Kimko, Johnson & Johnson,
USA |
| 16:35-17:00 |
Value
of model-based meta-analyses
for drug development and approval
Jaap
Mandema, Quantitative Solutions
Inc, USA |
| 17:00-17:25 |
Factors
Affecting Impacts of PKPD in
Drug Development & Regulation
Carl
Peck, UCSF, USA |
| 17:25-17:50 |
Round
table discussion |
| 17:50-18:00 |
Closure
Kyungsoo
Park |
| 18:30-20:30 |
FAREWELL
DINNER |
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