Bøger af Sarfaraz K. (Therapeutic Proteins International Niazi

The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products.

Handbook of Biogeneric Therapeutic Proteins is the first book to offer extensive coverage of all aspects of generic and biosimilar biological products, from the scientific basis through the marketing issues. This practical book includes comprehensive information on establishing a manufacturing system and securing regulatory approval for biogeneric

This comprehensive bioprocessing textbook deals with the basic concepts, definitions, methods, and applications of the use of biological catalysts to deliver products of high value and utility, from alcohol to recombinant monoclonal antibodies to common day use fuel. It covers all modern aspects, including the means of processing that are required for drug processing to the use of biofuels, downstream bioprocessing, bioprocess design, and regulatory affairs, among many other cutting-edge topics. Applications and case studies are incorporated throughout.

Even very established companies have made mistakes when developing biosimilar products. For example, not appreciating future threats to intellectual property caused a biosimilar product development plan to fail after millions have been spent. Additional pitfalls include not anticipating the next line of improved products, better formulations, delivery systems and the possibility that the dosing and indications can themselves be patented. This two-volume set examines how to choose the right product to develop and how to meander around the legal fireworks and secure a viable commercial presence.

This comprehensive bioprocessing textbook deals with the basic concepts, definitions, methods, and applications of the use of biological catalysts to deliver products of high value and utility, from alcohol to recombinant monoclonal antibodies to common day use fuel. It covers all modern aspects, including the means of processing that are required for drug processing to the use of biofuels, downstream bioprocessing, bioprocess design, and regulatory affairs, among many other cutting-edge topics. Applications and case studies are incorporated throughout.

The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products.