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 process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A comprehensive resource, it combines in-depth explanations of advanced statistical methods with real-life case studies that illustrate practical applications of these methods in QbD implementation.

part |2 pages

Section I Background

chapter 1|18 pages

Quality by Design in Biopharmaceuticals

part |2 pages

Section II Analytical Method

chapter 2|28 pages

Analytical Method Validation

chapter 3|30 pages

Parallelism Testing of Bioassay

chapter 4|32 pages

Validation of Method Linearity

part |2 pages

Section III Process Development

chapter 5|28 pages

Residual Host Cell DNA Risk Assessment

chapter 6|18 pages

Evaluations of Viral Clearance

chapter 7|32 pages

Bioburden Testing and Control

chapter 8|30 pages

Process Validation

part |2 pages

Section IV Manufacturing

chapter 9|28 pages


chapter 10|26 pages

Environmental Monitoring

chapter 11|34 pages

Stability Design and Analysis