Böcker av Harry Yang

Intended to be a single source of information, this book covers a wide range of topics on the changing landscape of drug R&D, emerging applications of big data, AI and machine learning in drug development, and the build of robust data science organizations to drive biopharmaceutical digital transformations.

A critical issue in the development of biologics, immunogenicity can cause early termination or limited use of the products if not managed well. This book shows how to use robust statistical methods for detecting, quantifying, assessing, and mitigating immunogenicity risk. Along with covering regulatory requirements, the authors discuss statisti

This book concerns use of real world data (RWD) and real world evidence (RWE) to aid drug development across product cycle. RWD are healthcare data that are collected outside the constraints of conventual controlled randomized trials (CRTs); whereas RWE is the knowledge derived from aggregation and analysis of RWD.