Average Reviews:
(More customer reviews)This book addresses a wide range of subjects of solid product development with impressive breadth and depth. It contains various theories, technologies, approaches, methodologies, requirements and practice necessary to the whole development cycle of solid dosage forms for NCE's, line-extension or generic products. I found that many important topics that used to be dealt with in books published separately in this one book, such as, discovery support/preformulation, product and process development, characterization and scale-up, biopharmaceutics and pharmacokinetics, regulation and even intellectual property.
Written by many experts from various institutions, each chapter has its unique content and style, yet they are rationally laid out and nicely tied together. Most of the chapters provide helpful case studies or examples. Thus, I consider this book a solid dosage form "bible" for those who conduct research or develop oral products.
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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
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