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Author: David Pryde Publisher: Royal Society of Chemistry ISBN: 1782624201 Category : Science Languages : en Pages : 487
Book Description
Orphan drugs are designated drug substances that are intended to treat rare or ‘orphan’ diseases. More than 7000 rare diseases are known that collectively affect some 6-7% of the developed world’s population; however, individually, any single, rare disease may only affect a handful of people making them commercially unattractive for the biopharmaceutical industry to target. Ground breaking legislation, starting with the Orphan Drug Act that was passed in the US in 1983 to provide financial incentives for companies to develop orphan drugs, has sparked ever increasing interest from biopharmaceutical companies to tackle rare diseases. These developments have made rare diseases, and the orphan drugs that treat them, sufficiently attractive to pharmaceutical development and many pharmaceutical companies now have research units dedicated to this area of research. It is therefore timely to review the area of orphan drugs and some of the basic science, drug discovery and regulatory factors that underpin this important, and growing, area of biomedical research. Written by a combination of academic and industry experts working in the field, this text brings together expert authors in the regulatory, drug development, genetics, biochemistry, patient advocacy group, medicinal chemistry and commercial domains to create a unique and timely reference for all biomedical researchers interested in finding out more about orphan drugs and the rare diseases they treat. Providing an up-to-date monograph, this book covers the basic science, drug discovery and regulatory elements behind orphan drugs and will appeal to medicinal and pharmaceutical chemists, biochemists and anyone working within the fields of rare disease research and drug development or pharmaceuticals in industry or academia.
Author: Allen R. Nissenson Publisher: Lippincott Williams & Wilkins ISBN: Category : Medical Languages : en Pages : 434
Book Description
A comprehensive reference covering all aspects of the clinical management of adult and child dialysis patients. This edition includes seven new chapters including one on EPO use in dialysis patients and one on the HIV positive patient.
Author: Tom Brody Publisher: Academic Press ISBN: 0128146486 Category : Medical Languages : en Pages : 671
Book Description
FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label. - Reveals strategies for winning FDA approval and for drafting the package label - Examples are from one hundred FDA-submissions (NDAs, BLAs) for one hundred different drugs, e.g., for oncology, metabolic diseases, autoimmune diseases, and neurological diseases - This book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely, the data from NDAs and BLAs as published on FDA's website at the time FDA grants approval to the drug
Author: Ruth Winter Publisher: Crown Archetype ISBN: 030745259X Category : Health & Fitness Languages : en Pages : 607
Book Description
An Essential Household Reference…Revised and Updated With our culture’s growing interest in organic foods and healthy eating, it is important to understand what food labels mean and to learn how to read between the lines. This completely revised and updated edition of A Consumer’s Dictionary of Food Additives gives you the facts about the safety and side effects of more than 12,000 ingredients–such as preservatives, food-tainting pesticides, and animal drugs–that end up in food as a result of processing and curing. It tells you what’s safe and what you should leave on the grocery-store shelves. In addition to updated entries that cover the latest medical and scientific research on substances such as food enhancers and preservatives, this must-have guide includes more than 650 new chemicals now commonly used in food. You’ll also find information on modern food-production technologies such as bovine growth hormone and genetically engineered vegetables. Alphabetically organized, cross-referenced, and written in everyday language, this is a precise tool for understanding food labels and knowing which products are best to bring home to your family.
Author: Robert Kizior Publisher: Elsevier Health Sciences ISBN: 0323694012 Category : Medical Languages : en Pages : 1512
Book Description
The go-to guide for students and nurses alike to promote better patient care! Saunders Nursing Drug Handbook 2020 provides you with essential information on more than 1,000 generic and 4,000 trade name drugs. This handy user-friendly guide features updated Black Box Alerts and comprehensive coverage of IV drug administration, nursing considerations, and fixed combinations. It uniquely guides you through clinical priorities in the practice setting and is organized alphabetically by generic drug name for quick reference. Detailed information for each drug distinguishes side effects and adverse reactions and lists the effect or reaction by frequency of occurrence to allow the nurse to easily identify which are most likely to occur. Plus, new drug monographs cover approximately 32 newly approved drugs by the FDA; and thoroughly updated monographs include new interactions, precautions, and alerts. - Over 1,000 generic name drugs (encompassing over 4,000 trade name drugs) are organized alphabetically with A to Z tabs to make accessing important information quick and easy. - Detailed information for each drug distinguishes side effects and adverse reactions to help you identify which are most likely to occur. - Special text treatment for high-alert drugs that pose the greatest risk for patient harm, as well as an appendix for drug names that sound alike and look alike, help promote safe drug administration. - UNIQUE! Frequently-used herb monographs and herb interactions keep you informed of the effects of commonly encountered herbs.Classifications s - ection features an overview of actions and uses for drug families.T - op 100 Drugs list helps you easily identify the most frequently administered drugs.N - ursing implications are organized in a functional nursing process framework and include headings for Baseline Assessment, Intervention/Evaluation, and Patient/Family Teaching. - Information on lifespan and disorder-related dosage variations equips you with special considerations for pediatric, geriatric, hepatic, and immune-or renal-compromised patients. - Extensively expanded IV content features a heading for IV compatibilities and expanded rates of infusion, reconstitutions, drip rates, test doses, flushing, and incompatibilities. - Fixed combinations are included in dosages of each combined drug directly within the individual monographs to help you understand different drug dose options for specific diseases. - Cross-references to the 400 top U.S. brand-name drugs are located directly in the main section of the book for easier accessibility. - Customizable and printable monographs for 100 of the most commonly used drugs and quarterly drug updates are located on the free Evolve companion site. - Therapeutic and toxic blood level information shows students the patient implications for drug administration. - Comprehensive IV Compatibility Chart foldout arms you with compatibility information for 65 intravenous drugs. - Newly approved drugs are listed in the front of the book for quick and easy access to this timely information. - Highlights the features of a sample drug monograph with callouts to help you understand how to use the book more efficiently.
Author: Andrew A. Adams Publisher: John Wiley & Sons ISBN: 0470065532 Category : Computers Languages : en Pages : 674
Book Description
Computing technology is constantly evolving and changing, developing and consolidating its position as a vital component of our lives. It no longer plays a minor part in society – it is embedded in, and affects, all aspects of life, from education to healthcare to war. Dealing with the implications of this is a major challenge, and one that can impact upon us, both personally and professionally. As a consequence, it is vital that all in the computing industry make wise decisions regarding their conduct. Using case studies and discussion topics drawn from entertaining real world examples, Pandora’s Box examines the background of a wide range of vital contemporary issues, encouraging readers to examine the social, legal and ethical challenges they will face in their own careers. Written in an engaging style and packed with international examples, this book addresses topics which have come to the forefront of public consciousness in recent years, such as online crime, piracy and peer to peer file sharing. Comprehensive coverage is provided of digital entertainment, censorship and privacy issues, presenting a rich source of context in which to consider ethical matters. Suitable for students on computer science degree programmes, as well as those taking IT related modules on other courses which consider the impact of technology on 21st century living, Pandora’s Box is an essential read and a unique and timely textbook.
Author: John A. Kellum Publisher: Oxford University Press, USA ISBN: 0199751609 Category : Medical Languages : en Pages : 240
Book Description
This book presents a road map of the interactions among metabolic, electrolyte, acid-base and endocrine problems and suggesting clear lines of action for the ICU clinician. Each chapter provides guidelines for understanding "how did we get here" and "what should we do now", as quickly and safely as possible.
Author: Hans-Beat Bürgi Publisher: John Wiley & Sons ISBN: 352761608X Category : Science Languages : de Pages : 936
Book Description
This book leaves the conventional view of chemical structures far behind: it demonstrates how a wealth of valuable, but hitherto unused information can be extracted from available structural data. For example, a single structure determination does not reveal much about a reaction pathway, but a sufficiently large number of comparable structures does. Finding the 'right' question is as important as is the intelligent use of crystallographic databases. Contributions by F.H. Allen, T.L. Blundell, I.D. Brown, H.B. Bürgi, J.D. Dunitz, L. Leiserowitz and others, authoritatively discuss the structure correlation method as well as illustrative results in detail, covering such apparently unrelated subjects as * Bond strength relations in soldis * Crystal structure prediction * Reaction pathways of organic molecules * Ligand/receptor interactions and enzyme mechanisms This book will be useful to the academic and industrial reader alike. It offers both fundamental aspects and diverse applications of what will surely become a powerful branch of structural chemistry.
Author: DrugPatentWatch
Author: DrugPatentWatch
Author: DrugPatentWatch
Author: David Pryde
Author: Allen R. Nissenson
Author: Tom Brody
Author: Ruth Winter
Author: Robert Kizior
Author: Andrew A. Adams
Author: John A. Kellum
Author: Hans-Beat Bürgi