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Hybrid Frequentist/Bayesian Power and Bayesian Power in Planning Clinical Trials provides a practical introduction to unconditional approaches to planning randomised clinical …
The subject of this book is applied Bayesian methods for chemistry, manufacturing, and control (CMC) studies in the biopharmaceutical industry. The book has multiple authors from …
Real-world evidence is defined as evidence generated from real-world data outside randomized controlled trials. As scientific discoveries and methodologies continue to advance, …
Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States …
In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition that affects fewer than 200,000 persons. For the approval of "orphan" drug …
Bayesian adaptive designs provide a critical approach to improve the efficiency and success of drug development that has been embraced by the US Food and Drug Administration (FDA). …