Ebook: Appropriate Dose Selection — How to Optimize Clinical Drug Development

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 exposure–response 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.

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Optimal dose individualization has become more important in improving clinical efficacy and safety. This is due in part to 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 exposure-response evaluation throughout all phases of drug development can quantitatively integrate clinical pharmacology knowledge. It can also provide early proof of concept, and help in rational dose selection and rational drug product labeling for clinical use.

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Optimal dose individualization has become more important in improving clinical efficacy and safety. This is due in part to 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 exposure-response evaluation throughout all phases of drug development can quantitatively integrate clinical pharmacology knowledge. It can also provide early proof of concept, and help in rational dose selection and rational drug product labeling for clinical use.

Content:
Front Matter....Pages I-XVI
Extrapolation of Preclinical Data into Clinical Reality — Translational Science....Pages 1-5
Smarter Candidate Selection — Utilizing Microdosing in Exploratory Clinical Studies....Pages 7-27
The Applications of Biomarkers in Early Clinical Drug Development to Improve Decision-Making Processes....Pages 29-45
Using Exposure — Response and Biomarkers to Streamline Early Drug Development....Pages 47-63
Experiences with Dose Finding in Patients in Early Drug Development: The Use of Biomarkers in Early Decision Making....Pages 65-79
Genotype and Phenotype Relationship in Drug Metabolism....Pages 81-100
Clinical Trials in Elderly Patients....Pages 101-109
Dose Finding in Pediatric Patients....Pages 111-121
Integration of Pediatric Aspects into the General Drug Development Process....Pages 123-134
Current Stumbling Blocks in Oncology Drug Development....Pages 135-149
Exploratory IND: A New Regulatory Strategy for Early Clinical Drug Development in the United States....Pages 151-163
Ethnic Aspects of Cancer Trials in Asia....Pages 165-169
Evaluation of the Effect on Cardiac Repolarization (QTc Interval) of Oncologic Drugs....Pages 171-184
The Role of PET Scanning in Determining Pharmacoselective Doses in Oncology Drug Development....Pages 185-193
Biometrical Aspects of Drug Development....Pages 195-207
Preventing Postmarketing Changes in Recommended Doses and Marketing Withdrawals....Pages 209-216
Back Matter....Pages 217-221

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Optimal dose individualization has become more important in improving clinical efficacy and safety. This is due in part to 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 exposure-response evaluation throughout all phases of drug development can quantitatively integrate clinical pharmacology knowledge. It can also provide early proof of concept, and help in rational dose selection and rational drug product labeling for clinical use.

Content:
Front Matter....Pages I-XVI
Extrapolation of Preclinical Data into Clinical Reality — Translational Science....Pages 1-5
Smarter Candidate Selection — Utilizing Microdosing in Exploratory Clinical Studies....Pages 7-27
The Applications of Biomarkers in Early Clinical Drug Development to Improve Decision-Making Processes....Pages 29-45
Using Exposure — Response and Biomarkers to Streamline Early Drug Development....Pages 47-63
Experiences with Dose Finding in Patients in Early Drug Development: The Use of Biomarkers in Early Decision Making....Pages 65-79
Genotype and Phenotype Relationship in Drug Metabolism....Pages 81-100
Clinical Trials in Elderly Patients....Pages 101-109
Dose Finding in Pediatric Patients....Pages 111-121
Integration of Pediatric Aspects into the General Drug Development Process....Pages 123-134
Current Stumbling Blocks in Oncology Drug Development....Pages 135-149
Exploratory IND: A New Regulatory Strategy for Early Clinical Drug Development in the United States....Pages 151-163
Ethnic Aspects of Cancer Trials in Asia....Pages 165-169
Evaluation of the Effect on Cardiac Repolarization (QTc Interval) of Oncologic Drugs....Pages 171-184
The Role of PET Scanning in Determining Pharmacoselective Doses in Oncology Drug Development....Pages 185-193
Biometrical Aspects of Drug Development....Pages 195-207
Preventing Postmarketing Changes in Recommended Doses and Marketing Withdrawals....Pages 209-216
Back Matter....Pages 217-221
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