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.
Author(s): J. Venitz, W. Sittner
Edition: 1
Year: 2006
Language: English
Pages: 222
Contents......Page 10
1 Extrapolation of Preclinical Data into Clinical Reality – Translational Science......Page 16
2 Smarter Candidate Selection – Utilizing Microdosing in Exploratory Clinical Studies......Page 21
3 The Applications of Biomarkers in Early Clinical Drug Development to Improve Decision-Making Processes......Page 42
4 Using Exposure – Response and Biomarkers to Streamline Early Drug Development......Page 59
5 Experiences with Dose Finding in Patients in Early Drug Development: The Use of Biomarkers in Early Decision Making......Page 76
6 Genotype and Phenotype Relationship in Drug Metabolism......Page 91
7 Clinical Trials in Elderly Patients......Page 111
8 Dose Finding in Pediatric Patients......Page 120
9 Integration of Pediatric Aspects into the General Drug Development Process......Page 131
10 Current Stumbling Blocks in Oncology Drug Development......Page 143
11 Exploratory IND: A New Regulatory Strategy for Early Clinical Drug Development in the United States......Page 158
12 Ethnic Aspects of Cancer Trials in Asia......Page 171
13 Evaluation of the Effect on Cardiac Repolarization (QTc Interval) of Oncologic Drugs......Page 176
14 The Role of PET Scanning in Determining Pharmacoselective Doses in Oncology Drug Development......Page 190
15 Biometrical Aspects of Drug Development......Page 199
16 Preventing Postmarketing Changes in Recommended Doses and Marketing Withdrawals......Page 212
Previous Volumes Published in This Series......Page 220
