Overview

The ballooning body of research devoted to hyaluronan (HA) reflects its enormous potential for various medical applications. There have been many successes of varying degrees in the development of medical products based on HA, but also some setbacks. While there is obviously ample information available on the chemistry and various properties of this macromolecule, Practical Aspects of Hyaluronan Based Medical Products is the first book devoted to systematically applying this knowledge to product development. Based on the author's extensive experience working with HA, this book explores in detail the chemistry, composition, formulation, testing, safety, effectiveness, quality control, and regulatory approval of HA medical products. It begins with a survey of the historical development and recent products based on hyaluronan. Subsequent chapters detail the rheological properties of the molecule and explore the chemical principles and methods forming the technical basis of product development, illustrated by more than 50 figures of chemical structures, reaction schemes, and rheological properties. Individual chapters then consider standards, tests, and analytical methods; safety of HA-based products for their indicated applications; and clinical performance, mechanism of action, and product characteristics. Practical Aspects of Hyaluronan Based Medical Products surveys FDA review documents as well as peer-reviewed journal articles to identify the elements essential to successful product development, namely, understanding the critical issues in the regulatory path and linking clinical performance of the products to their original design.

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9781322621197

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