Walsh Gary Скачать все книги 3 Количество книг

Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

With its focus on industrial pharmaceutical research, written by international experts from the industry, this book fills in a gap in the existing literature. It reflects the combination of such pharmaceutical interests as drug delivery, drug targeting, quality and safety management, drug approval and regulation, patenting issues and biotechnology fundamentals. Thus it provides practitioners in pharmaceutical biotechnology with all the relevant information from the shelf. The first part offers a comprehensive survey and review of the rapidly increasing array of biopharmaceuticals derived from the molecular biological approaches now widely available. This is followed by an extra section devoted to the very critical patenting and drug regulation issues. The whole is rounded off by detailed monographs of biotechnologically developed drugs that are already on the market. With a foreword of by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at the Massachusetts Institute of Technology. In 2002, he received the Charles Stark Draper Prize, the highest recognition for an engineer. Professor Langer is member of all three national academies – the Institute of Medicine, the National Academy of Engineering, and the National Academy of Sciences: «The book attempts to provide a balanced view of the biotechnological industry and the number of experts from industry sharing their knowledge and experience with the audience gives the book an outstanding value. All contributors provide with each chapter an up-to-date review on key topics in pharmaceutical biotechnology. This work is not only a valuable tool for the industrial expert but also for all pharmacists and scientists from related areas who wish to work with biotech drugs.»

Proteins Biochemistry and Biotechnology 2e is a definitive source of information for all those interested in protein science, and particularly the commercial production and isolation of specific proteins, and their subsequent utilization for applied purposes in industry and medicine. Fully updated throughout with new or fundamentally revised sections on proteomics as, bioinformatics, protein glycosylation and engineering, well as sections detailing advances in upstream processing and newer protein applications such as enzyme-based biofuel production this new edition has an increased focus on biochemistry to ensure the balance between biochemisty and biotechnology, enhanced with numerous case studies. This second edition is an invaluable text for undergraduates of biochemistry and biotechnology but will also be relevant to students of microbiology, molecular biology, bioinformatics and any branch of the biomedical sciences who require a broad overview of the various medical, diagnostic and industrial uses of proteins. • Provides a comprehensive overview of all aspects of protein biochemisty and protein biotechnology • Includes numerous case studies • Increased focus on protein biochemistry to ensure balance between biochemisty and biotechnology • Includes new section focusing on proteomics as well as sections detailing protein function and enzyme-based biofuel production "With the potential of a standard reference source on the topic, any molecular biotechnologist will profit greatly from having this excellent book. « (Engineering in Life Sciences, 2004; Vol 5; No. 5) “Few texts would be considered competitors, and none compare favorably.» (Biochemistry and Molecular Education, July/August 2002) «…The book is well written, making it informative and easy to read…» (The Biochemist, June 2002)