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Pharmaceutical QbD with Design of Experiments
Statistical Tools and Applications in Drug Delivery Systems
- 1st Edition - June 1, 2025
- Editors: Khushwant Yadav, Piyush Verma
- Language: English
- Hardback ISBN:9 7 8 - 0 - 4 4 3 - 2 9 2 0 8 - 8
- eBook ISBN:9 7 8 - 0 - 4 4 3 - 2 9 2 0 9 - 5
"Pharmaceutical QbD with Design of Experiments" offers comprehensive coverage of the best practices in pharmaceutical manufacturing. With a focus on design of experiments,… Read more
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Request a sales quote"Pharmaceutical QbD with Design of Experiments" 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
• 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
Pharmaceutical manufacturing professionals, pharmaceutical scientists, and drug delivery researchers.
Section-I Basics on QbD Chapter 1 - Quality by Design (QbD) Concept Chapter 2 - Benefits and Importance of QbD in Pharmaceutical Dosage Forms Chapter 3 - QbD Approach for Pharmaceutical Dosage Forms Chapter 4 - Case Studies on QbD Implementation in Pharmaceutical Dosage Forms Chapter 5 - Challenges and Limitations of QbD Implementation Chapter 6 - Future Perspectives and Emerging Trends in QbD for Dosage Forms Chapter 7 - Pharmaceutical Formulation by Design Section-II Basic Statistics for Design of Experiment Chapter 8 - Basic definitions & concepts in statistics useful in DoE Chapter 9 - Response surface methodology: Basics Chapter 10 - Basics of Factorial Designing and DoE Chapter 11 - Response Surface Modelling Section-III Application of QbD for Development of Dosage Form Design of Conventional Formulations Chapter 12 - Solid Dosage Forms: Chapter 13 - Liquid Dosage Forms: Chapter 14 - Semisolid Dosage Forms: Chapter 15 - Parenteral Dosage Forms: Chapter 16 - Inhalation Dosage Forms: Chapter 18 - Nasal Dosage Forms: Chapter 19 - Topical and Transdermal Dosage Forms: Chapter 20 - Ophthalmic Dosage Forms: Chapter 21 - Rectal and Vaginal Dosage Forms: Section-IV Application of QbD for Development of Dosage Form Design of Novel Drug Delivery Systems including Nano and Micro drug delivery systems Chapter 22 - Nano vesicular systems Chapter 23 - Polymeric micro and nano particles Chapter 24 - Dendrimers Chapter 25 - Carbon based novel drug delivery systems Chapter 26 - Microemulsions and Nanoemulsions Chapter 27 - Microneedles Chapter 28 - Bioengineered and bio mimicking drug delivery systems Chapter 29 - Nanofibers Chapter 30 - Gel-based Formulations Section-V Application of QbD for optimization of pharmaceutical processes and equipment used in the formulation of Novel drug delivery systems Chapter 31 - Freeze Drying Chapter 32 - Spray Drying Chapter 33 - High pressure homogenization Chapter 34 - 3-D Printing Chapter 35 - Electrospinning
- No. of pages: 875
- Language: English
- Edition: 1
- Published: June 1, 2025
- Imprint: Academic Press
- Hardback ISBN: 9780443292088
- eBook ISBN: 9780443292095
KY
Khushwant Yadav
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).
Affiliations and expertise
SVKM’s NMIMSPV
Piyush Verma
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.
Affiliations and expertise
SVKM’s NMIMS