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This is a great book that provides both basic theories and practical aspects of developing solid products. It is an "all-in-one" book covering all essential topics including preformulation, biopharmaceutics, formulation and process, scale-up and all the way to regulatory submission of drug product. The book also contains many useful references and good case studies. Its content is organized logically...
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This book integrates all relevant aspects for the development of solid pharmaceutical products for human use. It covers in depth the entire spectrum of solid product development from preformulation, formulation, process development and validation, clinical study, regulatory registration, intellectual property, and product life cycle management. It discusses and presents the science supporting the routine...
This book is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with:
Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms
Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies
New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development
The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards
It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter
A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies