Appropriate Dose Selection - How to Optimize Clinical Drug Development

Extrapolation of Preclinical Data into Clinical Reality — Translational Science.- Smarter Candidate Selection — Utilizing Microdosing in Exploratory Clinical Studies.- The Applications of Biomarkers in Early Clinical Drug Development to Improve Decision-Making Processes.- Using Exposure — Response and Biomarkers to Streamline Early Drug Development.- Experiences with Dose Finding in Patients in Early Drug Development: The Use of Biomarkers in Early Decision Making.- Genotype and Phenotype Relationship in Drug Metabolism.- Clinical Trials in Elderly Patients.- Dose Finding in Pediatric Patients.- Integration of Pediatric Aspects into the General Drug Development Process.- Current Stumbling Blocks in Oncology Drug Development.- Exploratory IND: A New Regulatory Strategy for Early Clinical Drug Development in the United States.- Ethnic Aspects of Cancer Trials in Asia.- Evaluation of the Effect on Cardiac Repolarization (QTc Interval) of Oncologic Drugs.- The Role of PET Scanning in Determining Pharmacoselective Doses in Oncology Drug Development.- Biometrical Aspects of Drug Development.- Preventing Postmarketing Changes in Recommended Doses and Marketing Withdrawals.