Drug Safety Evaluation


Book Description

This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition







Pediatric Drug Development


Book Description

Pediatric Drug Development: Concepts and Applications is designed as a reference and textbook and is meant to address the science of differences between the pediatric and adult subject in the development of pharmaceutical products. Considered are the ethics and medical needs of proper understanding the pediatric and adult differences, the business case for proper development of drugs for children, as well as the technical feasibility studies and processes that are necessary for a proper pediatric drug development program. The applications of these approaches will benefit all stakeholders and ultimately not only educate but also provide better and safer drugs for pediatric patients.







Current Catalog


Book Description

First multi-year cumulation covers six years: 1965-70.




Clinical Infectious Disease


Book Description

This clinically-oriented text focuses on the diagnostic protocols and treatment strategies with which physicians must be familiar when managing infectious disease patients. Informative algorithms, tables, and high-quality color photographs supplement many of the chapters in this conveniently-sized volume. The orientation of the volume is multi-faceted: in addition to the traditional organization of organ system and pathogen-related information, this text includes specific sections on the susceptible host (with individual chapters on the diabetic, the elderly, the injection drug user, and the neonate), travel-related infections, nosocomial infections, infections related to surgery and trauma, and bioterrorism. Informative algorithms, tables, and high-quality color photographs supplement many of the chapters. The convenient size of this book places it between the available encyclopedic tomes and the small pocket guides, making it a comprehensive but user-friendly and practical reference for the practising clinician.




Addressing the Barriers to Pediatric Drug Development


Book Description

Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.




Pediatric Rheumatology for the Practitioner


Book Description

One of the founders of the field of pediatric rheumatology, Dr. Jerry C. Jacobs, comprehensively discusses the care of children with rheumatic diseases and musculoskeletal disorders in this clinical reference. The author has completely revised and updated the text and references. A significant portion of the book is devoted to differential diagnosis; in fact, one of the book's strongest points is the detailed, illustrated description of the physical examination of joints in children. From the reviews of the first edition: "The section on the differential diagnosis of arthritis is the most comprehensive treatise of the subject that I have seen." #New England Journal of Medicine#1 "This is a book that one can pick up and read sections of and go back to again and again, and as such should be readily available wherever people are caring for children with joint complaints." #British Medical Journal#2 "Photographs, both clinical and pathological, radiographs, tables and graphs appear on almost every page and the layout is good so that the text is attractive as well as readable." #British Journal of Rheumatology#3 "...deals with all the facets of rheumatism or arthritis likely to be met with in the clinic. ...Above all the book is user friendly: very comprehensive index sections facilitate access to material, and the provision of many lists and summary tables helps in the location and clarification of information. ...The whole results in a book that is pleasant and surprisingly easy to read ...it would form an ideal library copy, both for selective reading and reference, and should be read by all paediatric rheumatologists." #The Lancet#4




Frontiers in Pediatric Neurology


Book Description

This book is a complete guide to paediatric neurology for clinicians. Beginning with an overview of potential pitfalls in neurological examination of children, the following chapters discuss the diagnosis and management of numerous neurological disorders that may be encountered in daily paediatric practice. Topics covered include cerebral palsy, Guillan-Barré Syndrome, febrile seizures, muscle disorders, cerebral edema, epilepsy, neurogenic bladder dysfunction and much more. Each section is presented with an emphasis on the importance of accurate clinical examination, and covers all the latest developments and management strategies. The comprehensive text is highly illustrated with clinical images and diagrams to enhance learning. Key Points Comprehensive guide to paediatric neurology Covers diagnosis and management of numerous disorders with emphasis on importance of accurate clinical examination Includes discussion on potential pitfalls in neurological examination of children Highly illustrated with clinical photographs and diagrams