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 t

Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medici

Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and pat

Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the res

Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statisti