How to Optimize Clinical Drug Development
by J. Venitz
Appropriate Dose Selection reviews innovative methods, tools and examples of rational drug development strategies, particularly for novel oncological agents.
Contents
- 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 Withdrawls
Index