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会议将同时进行
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Preclinical Development 概要
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概要 |
展销前置会 |
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Catalog(PDF) ]
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第4回 临床前开发 - 临床安全性的预测改善方法
2008年3月26～28日
开幕议程:专题演讲（药剂安全性动向之共同议程）
毒性试验和预测的最新动向（药剂安全性动向之共同议程）
案例学习：临床前开发之成功和失败（药剂安全性动向之共同议程）
毒性经路 （临床前开发、药剂安全性动向、及癌的分子标靶之共同议程）
- 生物医药品的毒性试验的适切模型：从Tegenero所得之教训（药剂安全性动向之共同议程）
- 用于内部的决定和规范认可的双方之影像检测的选定(转译医学之共同议程)
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Keynote Session
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Improving R&D Productivity Through Better Preclinical
Decision Making and Science
B. Michael Silber, Ph.D., Senior Vice President and Head Safety
& Technical
Sciences (Preclinical Development), Roche Pharmaceuticals, LLC
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Toxicity Testing in the 21st Century: Opportunities for
Pharmaceutical Risk Assessment
Daniel Krewski, Ph.D., MHA, Professor and Director,
McLaughlin Centre for Population Health Risk Assessment,
University of Ottawa
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Highlighted Presentations
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From Publication to Practice: Interlaboratory Validation of Microarray and QPCR-based Signatures for Predicting Carcinogenicity in the Rat
Mark Fielden, Ph.D., DABT, Discovery and Investigative Safety, Non-Clinical Drug Safety, Roche Palo Alto LLC
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Mechanistic Cardiac Modeling: Concepts and Utility in
Drug Development
Anna Georgieva, Ph.D., Associate Director, Modeling & Simulation,
and Ruben Bibas, Ph.D., Biology Modeler, Modeling &
Simulation, Novartis Inc.
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Challenges of Doxercalciferol, a Prodrug of a Potent
Vitamin D Hormone
Joyce Knutson, Ph.D., Senior Director of Research, Bone Care
International
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Defining and Finding Relevant Animal Models:
The Evolution of 揜elevant丒During Development
Nancy Wehner, Ph.D., Senior Director, Non-clinical Safety
Evaluation, Elan Pharmaceuticals
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Predicting the Undesirable Pharmacodynamic Effects of
Small Molecules on Physiological Function: From the Brain to the Heart
Vivek Kadambi, Ph.D., Director of Drug Safety Evaluation,
Millennium Pharmaceuticals, Inc.
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Predicting Cardiac Toxicity with Adjuant Trastuzumab Therapy
Ellie Guardino, M.D., Ph.D., Assistant Professor of Medicine,
Breast Oncology, Stanford University
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Imaging Biomarkers in Early Clinical Development of
Novel Therapeutic Agents
Jeffrey L. Evelhoch, Ph.D., Executive Director, Medical Sciences,
Imaging, Amgen Inc.
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Session:
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Advances in Toxicity Testing and Prediction
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Case Studies: Successes and Failures in Preclinical Development
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Toxicity Pathways
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Finding the Relevant Model for Toxicity Testing
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Choosing an Imaging Modality
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Hot Topics This Year:
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Interlaboratory Validation of Signatures for Predicting
Carcinogenicity
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Mechanistic Cardiac Modeling and Utility in Drug
Development
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Defining and Finding Relevant Animal Models
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Advances in Liver Toxicity Testing
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Predicting Cytokine Storms from in Vitro Cell Based Models
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Translating Safety from Animals to FIH Studies of
Biologics
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