The field of pharmaceutical development is constantly evolving, with new technologies and methodologies being introduced to ensure the production of safe, effective, and high-quality pharmaceutical products. One such methodology that has gained significant attention in recent years is Quality by Design (QbD) and Analytical Quality by Design (AQbD). In their book, “Fundamentals and Applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in Pharmaceutical Development,” Marcia Cristina Breitkreitz and twenty-five experts from academia, the pharmaceutical industry, and Pharmacopeias worldwide provide a comprehensive and practical guide to understanding and implementing QbD and AQbD principles in the pharmaceutical industry.

The book starts by highlighting the motivation and urgent need for the implementation of the QbD framework in pharmaceutical development. It explains the major elements of QbD, including the Quality Target Product Profile (QTTP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and Critical Material Attributes (CMAs). The authors emphasize the importance of using multivariate methods of Design of Experiments (DOE) in QbD and provide a detailed discussion on the concept of life cycle and regulatory perspectives.

One of the key sections of the book is dedicated to DOE theory, ranging from screening to optimization designs. The authors explain the principles of DOE and provide practical examples to demonstrate its application in pharmaceutical development. Modelling and data treatment techniques are also discussed to help readers understand how to analyze and interpret the data obtained from DOE experiments.

The book also covers practical aspects of QbD and DOE for different dosage forms in pharmaceutical product and process development. It offers a practical guide on identifying the input process variables, material attributes, and intermediate and final quality attributes for various pharmaceutical processes. This comprehensive approach ensures that readers can apply QbD principles to their specific projects and understand their impact on product quality and process control.

In addition to QbD, the book delves into Analytical Quality by Design (AQbD), an essential aspect of pharmaceutical development. It covers topics such as risk analysis, the definition of Analytical Target Profile (ATP), and the Method Operable Design Region (MODR). The authors discuss the life cycle approach to AQbD and provide insights into the compendial and regulatory perspectives. The book also includes a detailed example of using the AQbD procedure to develop a new chromatographic method for the quality control of a pharmaceutical topical product.

Furthermore, the book explores advanced statistical approaches and DOE methods for extraction studies of bioactive compounds. This highlights the versatility and applicability of QbD and DOE principles beyond traditional pharmaceutical development.

With its comprehensive coverage and practical approach, “Fundamentals and Applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in Pharmaceutical Development” is an indispensable resource for pharmaceutical scientists, researchers, and professionals involved in drug development, quality control, and regulatory affairs. The book provides the necessary knowledge and tools to implement QbD and AQbD principles effectively, ensuring the production of safe and high-quality pharmaceutical products.

Order Your Copy Today!

If you are a pharmaceutical scientist, researcher, or professional looking to enhance your understanding and implementation of QbD and AQbD principles, “Fundamentals and Applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in Pharmaceutical Development” is the book for you. Order your copy today and delve into the world of QbD and AQbD to revolutionize your pharmaceutical development processes. Unlock the potential for safer, more effective, and higher quality pharmaceutical products by embracing the principles of QbD and AQbD.