This dictionary defines various terms typically used in pharmaceutical medicine. A new, 4th edition includes adaptations of the text to the steadily increasing regulatory requirements, particularly in the area of genetics/gene therapy, product quality (e.g., protection against falsified medicines) and of product safety (pharmacovigilance). Further evolving areas that are covered by the 4th edition are typical “grey zones” (health effects often borderline to medicinal products) such as cosm...

The 4th edition of Drug Interactions in Infectious Diseases is being split into two separate volumes – “Mechanisms and Models of Drug Interactions” and “Antimicrobial Drug Interactions”.This volume, “Mechanisms and Models of Drug Interactions,” delivers a text that enhances clinical knowledge of the complex mechanisms, risks, and consequences of drug interactions associated with antimicrobials, infection, and inflammation. The book provides a comprehensive review of basic ...

The first contribution reviews the occurrence of xanthine alkaloids in the plant kingdom and the elucidation of the caffeine biosynthesis pathway, providing details of the N-methyltransferases, belonging to the motif B' methyltransferase family which catalyze three steps in the four step pathway leading from xanthosine to caffeine. The second contribution in this book provides a background on the molecule and related compounds and update knowledge on the most recent advances in Iboga alkal...

This book explores technological innovation in family firms, seeking to reconstruct the links between the heterogeneous dimensions of family businesses and their innovative behaviour. Building on and examining the traditional view of family firms as conservative, this book contributes to knowledge surrounding the puzzling role of family firms in technological innovation, with particular focus on the Italian pharmaceutical industry. The authors explore technological advances within the indu...

One of the main problems concerning therapeutic tools for the treatment of parasitic diseases, including leishmaniasis, is that some field parasites are naturally resistant to the classical drugs; additionally, current therapies may select parasites prone to be resistant to the applied drugs. These features are (at least partially) responsible for the disappointing persistence of the disease and resultant deaths worldwide. This book provides a comprehensive view of the pathology of the dis...

This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best pr...

This monograph is devoted to different aspects associated with citric acid, inorganic citrates and their aqueous and organic solutions. It includes information about properties, occurrence and technological applications of citric acid and inorganic citrates. Phase equilibria - melting, freezing, boiling, vapour pressures, solubilities of citric acid in water, organic solvents and ternary systems are presented, correlated, and analyzed. Dynamic properties - viscosities, diffusion coefficien...

The book covers theoretical background and methodology as well as all current applications of Quantitative Structure-Activity Relationships (QSAR). Written by an international group of recognized researchers, this edited volume discusses applications of QSAR in multiple disciplines such as chemistry, pharmacy, environmental and agricultural sciences addressing data gaps and modern regulatory requirements. Additionally, the applications of QSAR in food science and nanoscience have been incl...

The book focuses on the aqueous interface of biomolecules, a vital yet overlooked area of biophysical research. Most biological phenomena cannot be fully understood at the molecular level without considering interfacial behavior.The author presents conceptual advances in molecular biophysics that herald the advent of a new discipline, epistructural biology, centered on the interactions of water and bio molecular structures across the interface. The author introduces powerf...

This book provides an up-to-date review of the general principles of and techniques for confirmatory adaptive designs. Confirmatory adaptive designs are a generalization of group sequential designs. With these designs, interim analyses are performed in order to stop the trial prematurely under control of the Type I error rate. In adaptive designs, it is also permissible to perform a data-driven change of relevant aspects of the study design at interim stages. This includes, for example, a ...

Introduction to Fragment-Based Drug Discovery, by Daniel A. ErlansonFragment Screening Using X-Ray Crystallography, by Thomas G. Davies and Ian J. TickleHsp90 Inhibitors and Drugs from Fragment and Virtual Screening, by Stephen Roughley, Lisa Wright, Paul Brough, Andrew Massey and Roderick E. HubbardCombining NMR and X-ray Crystallography in Fragment-Based Drug Discovery: Discovery of Highly Potent and Selective BACE-1 Inhibitors, by Daniel F. Wyss, Yu-Sen Wang, Hug...

This volume will consider one of ICH’s major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that a...