Dose Finding in Drug Development is based on discussion between the pharmaceutical manufacturer and the drug regulatory agency, and the label is a summary of results obtained from many scientific experiments.

Dose Finding in Drug Development introduces the drug development process, the design and the analysis of clinical trials.

Contents

1. Introduction and New Drug Development Process

• New Drug Development Process
• Nonclinical Development
• Premarketing Clinical Development
• Clinical Development Plan
• Postmarketing Clinical Development
• Concluding Remarks

2. Dose Finding Based on Preclinical Studies

• Parallel Line Assays
• Competitive Binding Assays
• Anti-infective Drugs
• Biological Substances
• Preclinical Toxicology Studies
• Extrapolating Dose from Animal to Human

3. Dose-Finding Studies in Phase I and Estimation of Maximally Tolerated Dose

• Basic Concepts
• General Considerations for FIH Studies
• Dose Selection
• Assessments
• Dose Selection for Phase II

4. Dose-Finding in Oncology--Nonparametric Methods

• Traditional or 3 + 3 Design
• Basic Properties of Group Up-and-Down Designs
• Designs that Use Random Sample Size: Escalation and A + B Designs
• Designs that Use Fixed Sample Size
• More Complex Dose-Finding Trails

5. Dose Finding in Oncology--Parametric Methods

• Escalation with Overdose Control Design
• Adjusting for Covariates
• Choice of Prior Distributions

6. Dose Response: Pharmacokinetic- Pharmacodynamic Approach

• Exposure Response
• Time Course of Response
• Pharmacokinetics
• Pharmacodynamics
• Delayed Effects and Response
• Cumulative Effects and Response
• Disease Progress
• Modeling Methods

7. General Considerations in Dose-Response Study Designs

• Issues Relating to Clinical Development Plan
• General Considerations for Designing Clinical Trials
• Design Considerations for Phase II Dose-Response Studies
• Number of Doses to be Tested
• Dose Allocation, Dose Spacing
• Optimal Designs

8. Clinical Trial Simulation--A Case Study Incorporating Efficacy and Tolerability Dose Response

• Clinical Development Project Background
• The Clinical Trial Simulation Project
• Simulation Results and Design Recommendations

9. Analysis of Dose-Response Studies-E_max Model

• Sensitivity of the E_max
• Similar Models
• A Mixed Effects E_max Model
• Examples

10. Analysis of Dose-Response Studies--Modeling Approaches

• Some Commonly Used Dose-Response Models
• Estimation of Target Doses
• Model Uncertainty and Model Selection
• Combining Modeling Techniques and Multiple Testing

11. Multiple Comparison Procedures in Dose Response Studies

• Identifying the Minimum Effective Dose
• Identifying the Maximum Safe Dose

12. Multiple Comparison Procedures in Dose Response Studies

• Identifying the Minimum Effective Dose
• Identifying the Maximum Safe Dose

13. Analysis of Dose-Response Relationship Based on Categorical Outcomes

• When the Response is Ordinal
• When the Response in Binary
• Multiple Comparisons

14. Power and Sample Size for Dose Response Studies

• General Approach to Power Calculation
• Multiple-Arm Dose Response Trial
• Phase I Oncology Dose Escalation Trial

Index

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