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Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. - Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies - Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implem...

Published in 1997: Antibody Therapeutics is a comprehensive evaluation of progress toward using humanized antibodies as a new generation of therapeutics. The humanized antibodies that have led the way in product approval are discussed as case studies, offering an insight into the preclinical and clinical data acquired during the regulatory approval process. Leading experts offer their findings as examples of what works and what does not, saving you time and making your research more cost effecti...

Updated to reflect the wide spectrum of economic, regulatory, financial, ethical, and political issues impacting vaccinology in industrialized and developing nations, the Third Edition pinpoints relevant breakthroughs, trends, and advances in vaccinology and immunization science. The book highlights the most influential developments in vaccine safe

The focus of this book is on subjects related to drug delivery to the lung. The text spans topics from aerosol deposition through pharmaceutical chemistry and formulation to the final clinical evaluation of pharmaceutical products. Utilizing a multi-disciplinary approach, the chapters consider toxicology from the point of view of drugs and pharmaceutical excipients used in aerosols.

Vaccines have historically been considered to be the most cost-effective method for preventing communicable diseases. It was a vaccine that en abled global eradication of the dreaded disease smallpo. ."

This book is written to serve as a principal textbook for introductory pharmacogenomics course, emphasizing pedagogy along with applications in a way useful for students along with professionals needing an accessible resource. The text covers each of the important areas of pharmacogenomics - fundamental principles, relevant technologies, clinical applications, and societal issues. It uses diagrams, flow charts, tables and boxed material in each chapter. The author - who himself teaches and desig...

An examination of the widespread application of nano materials in biology, medicine, and pharmaceuticals and the accompanying safety concerns, Bio-interactions of Nano Materials addresses the issues related to toxicity and safety of nano materials and nano systems. It covers the interactions in biological systems and presents various tools and methods used to evaluate the nano toxicity and nano safety issues. Written by leading scientists, the book focuses on the bio-interaction of nano materia...

Researchers in the fields of organic synthesis, pharmaceutical research as well as cosmetic and agrochemicals industries need to confirm the structures of products they obtain. This was previously a time-consuming a process that took up much time. Spectroscopic methods however, made it easier, and initially R and UV helped chemists conclude structures one way or another. Initially 1D NMR, 2D NMR and sophisticated NMR measurements like COESY and NOESY were of great assistance. We demonstrate prin...

Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control laboratories, LIMS installations, or any aspect of robotic in a healthcare laboratory, this book furnishes complete validation details.International and FDA regulations and requirements are discussed and...

The Textbook of Ion Channels is a set of three volumes providing a wide-ranging reference source on ion channels for students, instructors and researchers. Ion channels are membrane proteins that control the electrical properties of neurons and cardiac cells; mediate the detection and response to sensory stimuli like light, sound, odor, and taste; and regulate the response to physical stimuli like temperature and pressure. In non-excitable tissues, ion channels are instrumental for the regulatio...

A state-of-the-art handbook of statistical analysis for use in the pharmaceutical industry. Areas covered in this reference/text include: bioavailability, repeated-measures designs, dose-response, population models, multicenter trials, handling dropouts, survival analysis, robust data analysis, cate

This book is a compilation of topics addressed by the ASA Biopharmaceutical Section work groups, including the etiology and evolution of the work groups, the work group guidelines and structure, and the statistical issues associated with clinical trials in clinical drug development programs.

By combining interdisciplinary approaches of organic and medicinal chemistry, biophysical methods, and computational chemistry, Peptide Therapeutics and Peptidomimetic Design provides a guide to rational strategies for designing peptidomimetic drugs. Author Juan Perez addresses an active field of biologics research that the pharmaceutical industry and researchers are aggressively moving into, highlighting examples of peptidomimetic drugs as enzyme inhibitors, GPCR ligands, and protein–protein i...

Light-emitting reactions occur in some living organisms, and are also now extensively exploited by industry and various branches of biomedical science. Luminescence from the natural world, particularly from marine organisms, is increasingly being harnessed by genetic and chemical manipulation to enhance the quality of human life. This volume contains cutting-edge contributions from most of the world's leading researchers in this field. It presents an up-to-date compilation of the range of biomed...

This book provides basic principles of multivalent interactions found in biological systems as well as an up-to-date and thorough coverage in design concepts, syntheses, and biological activities of multivalent molecules. * Contains practical examples of synthetic multivalent molecules in chemistry, biology, and medicine * Can be used as both a textbook for students and a reference book for libraries and professionals * Includes detailed case studies * Fills a void in current literature thro...

"Der LAffler/Petrides ist das, was sich jeder Student wA1/4nscht: Ein topaktuelles Lehrbuch, das zu jeder erdenklichen Frage eine Antwort parat hat." (Studentenzitat) Neu: Das Standardwerk der Biochemie wurde von 22 renommierten Experten in jeder Hinsicht runderneuert: - Die enge VerknA1/4pfung von theoretischen Inhalten und klinischer Praxis wird noch A1/4berzeugender herausgestellt. Die groAzA1/4gige Ausstattung mit aussagekrAftigen Abbildungen erleichtern den Zugang zu komplizierten biochemis...