Autor: LLC, Gaithersburg, Maryland, USA) Yang Harry (MedImmune

The premise of Quality by Design (Qb D) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-o …

Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manuf …

The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologies. The theoretical development, coupled with advanc …

Develop Effective Immunogenicity Risk Mitigation Strategies Immunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. …

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 regulatory expectations …

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 regulatory expectations …

The premise of Quality by Design (Qb D) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-o …

Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manuf …