Updated all-in-one guide to understanding the science, development and manufacture of bio-based therapeuticsBiopharmaceuticals: Biochemistry and Biotechnology is a unique resource on biopharmaceuticals that serves as a comprehensive introduction to both the biopharmaceutical industry and its role within the global pharmaceutical industry. This new edition incorporates all major advances from the past 20 years, including the development of biosimilars, bisp...

Medical Product Regulatory AffairsHands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to marketBased on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. ...

Biopharmaceuticals, the term for genetically engineered therapeutic proteins, monoclonal antibodies, and nucleic acid-based products, have become an increasing part of the pharmaceutical armament. While this category of drugs accounts for approximately 25% of all new drugs coming to market, very few references exist that review these commercially a

Carefully crafted to provide tightly focused and authoritative information, the Directory of Therapeutic Enzymes covers all approved therapeutic enzymes currently used in medicine. Written mainly by industry experts, the book includes information sourced directly from the company that developed or manufactured the product. It explores major

Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these su...

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 proc...

The latest edition of this highly acclaimed textbook, provides a comprehensive and up-to-date overview of the science and medical applications of biopharmaceutical products. Biopharmaceuticals refers to pharmaceutical substances derived from biological sources, and increasingly, it is synonymous with 'newer' pharmaceutical substances derived from genetic engineering or hybridoma technology.This superbly written review of the important areas of investigation in the field, covers dru...

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 manufactur...

In this book, we look at the fundamental biology of the human cell from the outside in. While genes and mutations define our cells and how they function, this volume focuses on the biology of the cell rather than on the nuts and bolts of molecular biology. As a result, the book focuses primarily on protein function in normal and diseased states. The volume reveals how cells are constructed and how they are organized so they work effectively. In each case this understanding is related back ...

This fourth edition of the best-selling textbook, Human Genetics and Genomics, clearly explains the key principles needed by medical and health sciences students, from the basis of molecular genetics, to clinical applications used in the treatment of both rare and common conditions.A newly expanded Part 1, Basic Principles of Human Genetics, focuses on introducing the reader to key concepts such as Mendelian principles, DNA replication and gene expression. Part 2, Genetics...

This concise overview of the fundamental concepts of cancer biology is ideal for those with little or no background in the field. A summary of global cancer patterns introduces students to the general principles of how cancers arise and the risk factors involved. By focusing on fundamental examples of the signalling pathways within cells, the functional effects of DNA damage are explained. Later chapters then build on this foundation to provide a comprehensive summary of the major signalli...

You'll never find an easier, more efficient, and more focused way to ace biochemistry and biochemistry-related questions on the USMLE and course examinations than the USMLE Road Map. Designed to provide maximum learning in minimum time, this fully updated USMLE Road Map offers a concise, creative, and well-illustrated approach to mastering biochemistry.