Appropriate Dose Selection reviews innovative methods, tools and examples of rational drug development strategies, particularly for novel oncological agents.

Contents

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

Index

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ORDER NOW Appropriate Dose Selection How to Optimize Clinical Drug Development by J. Venitz 2007 • 216 pages • $98.00 + shipping Texas residents please add 6.75 % sales tax