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Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory …
Statistical Testing Strategies in the Health Sciences provides a compendium of statistical approaches for decision making, ranging from graphical methods and classical procedures …
Encyclopedic in breadth, yet practical and concise, Medical Biostatistics, Fourth Edition focuses on the statistical aspects ofmedicine with a medical perspective, showing the …
Explore Important Tools for High-Quality Work in Pharmaceutical SafetyStatistical Methods for Drug Safety presents a wide variety of statistical approaches for analyzing …
Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both …
Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting …
As clinicians begin to realize the important role of dose-finding in the drug development process, there is an increasing openness to "novel" methods proposed in the past two …
Nonpharmacological treatments include a wide variety of treatments such as surgery, technical procedures, implantable and non-implantable devices, rehabilitation, psychotherapy, …
With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA’s recent draft guidance, a new edition of one of the first books on the …
The aim of this book is to equip biostatisticians and other quantitative scientists with the necessary skills, knowledge, and habits to collaborate effectively with clinicians in …