Pharmaceutical QbD with Design of Experiments: Statistical Tools and Applications in Drug Delivery Systems

Khushwant Yadav · Piyush Verma

Feb 2026 · Academic Press

Ebook

875

Pages

Eligible

This book will become available on February 1, 2026. You will not be charged until it is released.

About this ebook

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

About the author

Dr. Khushwant Yadav has an experience of more than 19 years in both Industry and Academics. He has been a Research Scientist in Claris Lifesciences, Ahmedabad and Alembic Ltd., Vadodara. Dr. Yadav has completing AICTE-RPS project as Principal Investigator with a grant of Rupees 18 Lakhs. He has done collaborative research with National Institute for Research in Reproductive Health (NIRRH), ICMR Lab, Mumbai; Institute of Nuclear Medicine & Allied Sciences (INMAS), DRDO Lab, Delhi. His publications have been listed in 25 Hottest Articles by Elsevier, Most-Read Article by Parenteral Drug Association, USA, Most Viewed Article (Top 10) by AAPS, USA. He is recipient of Fellow of Institute of Chemists (India).

Mr. Piyush Verma is a seasoned professional, holding a Masters in Pharmacy specialized in Industrial Pharmacy from SPPSPTM, NMIMS, India, complemented by a master's degree in business administration. His research delves into Quality by Design, Design of Experiments, Novel Drug Delivery Systems, and topical drug delivery. Notably, Piyush is the driving force behind Velite Healthcare, a pioneering dermatology company in India, where he serves as the founding member and chief consultant. His work amalgamates scientific innovation with strategic leadership, making a significant impact in pharmaceuticals and healthcare.

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