Pharmaceutical QbD with Design of Experiments

Pharmaceutical QbD with Design of Experiments: Statistical Tools and Applications in Drug Delivery Systems offers comprehensive coverage of the best practices in pharmaceutical manufacturing. With a focus on design of experiments, examples, and case studies, this book is ideal for manufacturing researchers and industry professionals. The contents of the book cover all drug delivery systems and is structured in five parts. The first discusses the principles and basics of Quality by Design (QbD). Part two covers the foundational statistical principles and tools for the Design of Experiments (DoE). Section three is dedicated to the applications of QbD for conventional formulations. The next section provide ample coverage of applications to Novel Drug Delivery Systems (NDDS), including micro and nano-particles. The final section discusses extensively the application of QbD for optimization of pharmaceutical processes and equipment used in the formulation of NDDSs. Researchers in pharmaceutical manufacturing will benefit from the thorough statistical review in part two, while students in this field will gain practical insights the experienced chapter authors provide in case studies. Industry professionals can find solutions to their particular problems within the insights and strategies shared in this book.

• Covers multiple aspects of QbD such as risk assessment, experiment design, process optimization, analytical methodologies, and more
• Integrates real-life case studies for practical relevance and a deeper understanding of the subject matter
• Emphasizes the importance of implementing QbD principles in regulatory processes