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Developing Solid Oral Dosage Forms: Pharmaceutical Theory & Practice

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Developing Solid Oral Dosage Forms: Pharmaceutical Theory & Practice

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出版时间:2009年1月2日

I S B N:9780444532428

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内容简介

内容简介

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

作者简介

目录

Ch 1Solubility of Pharmaceutical Solids
Ch 2Crystalline and Amorphous Solids
Ch 3Analytical Techniques in Solid State Characterization
Ch 4Salt Screening and Selection: New Challenges and Considerations in the Modern Pharmaceutical R&D Paradigm
Ch 5Drug Stability and Stability Studies
Ch 6Excipient Compatibility
Ch 7Theory of Diffusion and Pharmaceutical Applications
Ch 8Particle, Powder and Compact Characterization
Ch 9Polymer Properties and Characterization
Ch 10Applied Statistics in Product Development
Ch 11Oral Absorption Basics: Pathways, Physicochemical and Biological Factors, and Methods of Study
Ch 12Oral Absorption Evaluation and Prediction
Ch 13Fundamentals of Dissolution
Ch 14Dissolution Testing of Solid Products
Ch 15Bioavailability and Bioequivalence
Ch 16In Vivo Evaluation of Dosage Form Performance
Ch 17In Vitro-In Vivo Correlations: Fundamentals, Applications and Development Considerations
Ch 18Integration of physical, chemical, mechanical and biopharmaceutical properties in solid oral dosage form development
Ch 19 Design and Development of Self-Emulsifying Drug Delivery Systems for Enhanced Oral Absorption of Poorly Soluble Compounds
Ch 20Rational Design of Oral Modified-Release Drug Delivery Systems
Ch 21Development of Modified-Releas Oral Dosage Forms
Ch 22Analytical Development and Validation for Solid Oral Dosage Forms
Ch 23Statistical Design and Analysis of Long Term Stabilty Studies for Drug Products
Ch 24Packaging selection for solid dosage forms
Ch 25 Clincial Supplies Manufacture
Ch 26Specification Setting and Manufacturing Process Control for Solid Oral Drug Products
Ch 27Scale-Up Of Pharmaceutical Manufacturing Operation of Solid Dosage Forms
Ch 28 Process Development, Optimization and Scale-Up: Powder Handling and Segregation Concerns
Ch 29Process Development and Scale-Up of Wet Granulation by High-Shear Process
Ch 30Development,Scale-Up and Optimization of Fluid-bed Granulation
Ch 31Development, Optimization and Scale-Up of Process Parameters: Roller Compaction
Ch 32Development, Optimization And Scale-Up Of Process Parameters: Compression
Ch 33Development, Optimization & Scale-Up of Process Parameters: Pan Coating
Ch 34Development, Optimization And Scale-Up Of Process Parameters: Wurster Coating
Ch 35Process Analytical Technology
Ch 36 The Product Development Process
Ch 37Product Registration and Drug Approval Process
Ch 38Modern Pharmaceutical Development Regulations
Ch 39Intellectual Property in Pharmaceutical Development
Ch 40Product Life-Cycle Management

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