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Bayesian Designs for Phase I-II Clinical Trials
Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At …
Analyzing Longitudinal Clinical Trial Data
Analyzing Longitudinal Clinical Trial Data: A Practical Guide provides practical and easy to implement approaches for bringing the latest theory on analysis of longitudinal …
Statistical Testing Strategies in the Health Sciences
Statistical Testing Strategies in the Health Sciences provides a compendium of statistical approaches for decision making, ranging from graphical methods and classical procedures …
Cancer Clinical Trials
Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in …
Medical Biostatistics
Encyclopedic in breadth, yet practical and concise, Medical Biostatistics, Fourth Edition focuses on the statistical aspects ofmedicine with a medical perspective, showing the …
Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing
The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing …
Clinical Trial Data Analysis Using R and SAS
Review of the First Edition"The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of …
Dynamical Biostatistical Models
Dynamical Biostatistical Models presents statistical models and methods for the analysis of longitudinal data. The book focuses on models for analyzing repeated measures of …
Statistical Topics in Health Economics and Outcomes Research
With ever-rising healthcare costs, evidence generation through Health Economics and Outcomes Research (HEOR) plays an increasingly important role in decision-making about the …
Data and Safety Monitoring Committees in Clinical Trials
Praise for the first edition:"Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this …
How to Be Successful as a Consulting Biostatistician in Industry
This book provides guidance to the statisticians in industry on the non-technical “soft” skills that one needs to have in order to be successful as a statistician from the first …
Statistical Methods for Immunogenicity Assessment
Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and …