Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms

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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 agenciesTABLE 25.2 Template for phase I clinical trials TABLE 25.3 The advantages and disadvantages of contracting versus in-house. computer technology and new methodologies in drug discovery and development, and process analytical technology (PAT) are among ... review/informed consent Investigator and site selection a—‹ Investigatora#39;s brochure a—‹ Sponsora€“investigator agreement Clinical supplyanbsp;...

Title:Developing Solid Oral Dosage Forms
Author:Yihong Qiu, Yisheng Chen, Geoff G.Z. Zhang, Lirong Liu, William Porter
Publisher:Academic Press - 2009-03-10


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