"The confluence of big data, AI, and machine learning has led to a paradigm shift in how innovative medicines are developed and healthcare delivered. To fully capitalize on these technological advances, it is essential to systematically harness data from diverse sources and leve…
The confluence of big data, artificial intelligence (AI), and machine learning (ML) has led to a paradigm shift in how innovative medicines are developed and healthcare delivered. To fully capitalize on these technological advances, it is essential to systematically harness data…
Cover -- Half Title -- Title Page -- Copyright Page -- Table of Contents -- Preface -- Section I: Background -- 1: Quality by Design in Biopharmaceuticals -- 1.1 Introduction -- 1.2 Evolving Regulatory Environment -- 1.3 Bioprocess Development -- 1.3.1 Upstream Process -- 1.3.2 …
Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is th…
Provides a single source of information on statistical concepts, principles, methods, and strategies for detection, quanification, assessment, and control of immunogenicity.
Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is th…
