Description
Dose Finding in Drug Development provides a thorough examination of the statistical and clinical methodologies essential for determining safe and effective drug dosages. Authored by Ting N., this comprehensive resource addresses the challenges and complexities inherent in dose finding studies throughout the drug development process.
The book explores various dose-response relationships, adaptive designs, and modern statistical techniques used in clinical trials. It covers traditional approaches alongside contemporary methods such as continual reassessment models and model-based designs. Readers will gain practical insights into regulatory considerations, including FDA guidance and international standards for dose escalation and optimization.
Ideal for statisticians, clinical researchers, pharmaceutical scientists, and regulatory professionals, this text bridges the gap between theoretical concepts and real-world applications. The content emphasizes practical implementation while maintaining rigorous statistical foundations, making it an invaluable reference for anyone involved in drug development, clinical trial design, or regulatory affairs.
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