Description

The book provides a concise overview of the key principles in dose selection and optimization and demonstrates applicability to recent successful new drug applications.
Focuses on two key interfaces in new drug development: transition from preclinical to Phase I clinical development and transition from Phase IIA/IIB proof-of-concept to Phase IIB/III pivotal efficacy trials
Promotes innovative clinical trial designs that may allow for a more optimal strategy for dose selection
Covers procedures and best practices in biomarker validation and qualification
Considers the benefits of novel clinical trial designs in clinical pharmacology and experimental medicine
Analyzes the importance of dose optimization during Phase II/III