Appropriate Dose Selection - How to Optimize Clinical Drug Development [Paperback]

Optimal dose individualization has become more important in improving clinical efficacy and safety. This is due in part to the variability in drug response. Therefore, the role of optimal dose finding in early clinical drug development so as to maximize successful clinical use is emphasized. This book reviews innovative methods, tools and examples of rational drug development strategies, particularly for novel oncological agents.

Optimal dose individualization has become more important in improving clinical efficacy and safety, given the variability in drug response, e.g., due to concurrent illnesses or co-medications. Therefore, the role of optimal dose finding in early clinical drug development so as to maximize successful clinical use is emphasized. The continued use of biomarkers  based on the (known) pharmacology of the drug and/or biology of the underlying disease  along with exposureresponse evaluation throughout all phases of drug development can quantitatively integrate clinical pharmacology knowledge, provide early proof of concept, and help in rational dose selection and rational drug product labeling for clinical use.

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 Developmel3*