Bøger i Biotechnology: Pharmaceutical Aspects serien

The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops - the Stability Workshop and the Degradation Mechanism Workshop.

Protein pharmaceuticals form a fast-growing category in the arsenal of drugs. In the coming years, the patents on a number of the first-generation protein pharmaceuticals will expire, opening the door for the development of biogenerics into the market. However, it is very difficult to characterize these compounds so that the results can be replicated in a generic form. This volume details the nature of the different analytical techniques and how they are relevant for characterizing pharmaceutical proteins. In addition to serving the analytical chemist, this book is needed by the formulation scientist who is responsible for design and formulation of a pharmaceutical protein that can be monitored during production and over time. It also will be useful for students, fellows, and research scientists who are working in the academic world and in the pharmaceutical/biotechnology industry on basic aspects of proteins.

Prodrugs are substances administered in an inactive form that is then metabolized in the body in vivo into the active compound. The rationale behind administering prodrugs is to optimize absorption, distribution, metabolism, and excretion of these drugs. Since first described in the 1950s, prodrugs continue to be a fertile area of research. There are a number of small pharmaceutical/biotech companies dedicated to using prodrugs for the delivery of older but problematic drugs as well as to developing broad-based prodrug technologies for application to new and future drugs. These volumes represent a comprehensive guide to prodrugs and will guide the reader through the current status of the prodrug concept and its many applications and to highlight its many successes in overcoming formulation and delivery of problematic drugs.

This book arises from a workshop organized by the American Association of Pharmaceutical Scientists entitled "Optimizing the Drug-Like Properties of Leads in Drug Discovery," which took place in Parsippany, NJ in September 2004. The workshop focused on the optimization of the drug-like properties of leads in drug discovery.

This volume provides researchers with recent information on bioactivation reactions of drugs and toxicants. In other sections, focus is on recent applications of bioactivation research in pharmacology, toxicology, and environmental health sciences, where contributors demonstrate the integration of bioactivation research.

This is a well thought-out, highly practical text covering contemporary 'in vitro' techniques for drug absorption studies. Starting at the molecular level of investigation, it continues with cell monolayer models (both primary and cell lines) and culminates with in situ techniques as a final testing format.

The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops - the Stability Workshop and the Degradation Mechanism Workshop.

Solvent Systems and Their Selection in Pharmaceutics and Biopharmaceutics

Immunogenicity of Biopharmaceuticals is the first book to comprehensively address the potential of an immune response to biopharmaceuticals.

This volume provides researchers with recent information on bioactivation reactions of drugs and toxicants. In other sections, focus is on recent applications of bioactivation research in pharmacology, toxicology, and environmental health sciences, where contributors demonstrate the integration of bioactivation research.

This is a well thought-out, highly practical text covering contemporary 'in vitro' techniques for drug absorption studies. Starting at the molecular level of investigation, it continues with cell monolayer models (both primary and cell lines) and culminates with in situ techniques as a final testing format.

These volumes represent a comprehensive guide to prodrugs. They guide the reader through the current status of the prodrug concept and its many applications and highlight its many successes in overcoming formulation and delivery of problematic drugs.

This volume focuses on how to increase the efficiency of drug discovery and development. The volume details in silico, in vitro, and in vivo tools for prediction, measurement, and application of compound properties to select and improve potential drug candidates.

This volume provides an understanding of the development, manufacturing techniques, and requirements of monoclonal antibodies. Covering one of the fastest growing areas of drug development, readers will find an informative text that describes the parameters for a successful regulatory submission.

This book arises from a workshop organized by the American Association of Pharmaceutical Scientists entitled "Optimizing the Drug-Like Properties of Leads in Drug Discovery," which took place in Parsippany, NJ in September 2004. The workshop focused on the optimization of the drug-like properties of leads in drug discovery.

Immunogenicity of Biopharmaceuticals is the first book to comprehensively address the potential of an immune response to biopharmaceuticals.

This volume provides an understanding of the development, manufacturing techniques, and requirements of monoclonal antibodies. Covering one of the fastest growing areas of drug development, readers will find an informative text that describes the parameters for a successful regulatory submission.

The reader will be introduced to various aspects of the fundamentals of nanotechnology based drug delivery systems and the application of these systems for the delivery of small molecules, proteins, peptides, oligonucleotides and genes.