Download or read book Drug Safety Data How to Analyze Summarize and Interpret to Determine Risk written by Michael J. Klepper and published by Jones & Bartlett Publishers. This book was released on 2010-09-15 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting. Key features include: * Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports * Pragmatic tips...and mistakes to avoid * Simple explanations of what safety data are collected, and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical * Examples of user-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)

Download or read book Discovering Life Manufacturing Life written by Pierre V. Vignais and published by Springer Science & Business Media. This book was released on 2010-06-21 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: Francis BACON, in his Novum Organum, Robert BOYLE, in his Skeptical Chemist and René DESCARTES, in his Discourse on Method; all of these men were witnesses to the th scientific revolution, which, in the 17 century, began to awaken the western world from a long sleep. In each of these works, the author emphasizes the role of the experimental method in exploring the laws of Nature, that is to say, the way in which an experiment is designed, implemented according to tried and tested te- niques, and used as a basis for drawing conclusions that are based only on results, with their margins of error, taking into account contemporary traditions and prejudices. Two centuries later, Claude BERNARD, in his Introduction to the Study of Experimental Medicine, made a passionate plea for the application of the experimental method when studying the functions of living beings. Twenty-first century Biology, which has been fertilized by highly sophisticated techniques inherited from Physics and Chemistry, blessed with a constantly increasing expertise in the manipulation of the genome, initiated into the mysteries of information techn- ogy, and enriched with the ever-growing fund of basic knowledge, at times appears to have forgotten its roots.

Download or read book The Basics of Cancer Immunotherapy written by Haidong Dong and published by Springer. This book was released on 2018-01-05 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides patients and their physicians (especially “non-oncologist” health care providers) with a clear and concise introduction to cancer immunotherapy, which, unlike traditional forms of cancer therapy, acts by boosting the patient’s own immune system to fight cancer. The unique features of cancer immunotherapy make its management, monitoring and side-effects different from those of traditional cancer therapy. Especially novel are the side effects of cancer immunotherapy, necessitating greater awareness for both patients and physicians in order to minimize complications of therapy. The patient-friendly, concise, easy-to-understand, and up-to-date knowledge presented in this book will inform patients about the benefits and risks of cancer immunotherapy, and help them and their care providers to understand how immunotherapy would control their unique disease. Researchers and academic professionals in the field of cancer immunotherapy will also find clear and useful information to help them communicate with patients or address unresolved problems. Some key features of the book are: Expertise. All editors and authors are scientists and oncologists specializing in cancer immunotherapy, and are involved in scientific discovery from the early stage of immune-checkpoint inhibitors to today’s daily patient care. Their insights, expertise and experience guarantee the high quality and authority in the science, medicine and practice of cancer immunotherapy. Patient-friendly. This book is written for cancer patients in order to meet their needs when considering immunotherapy. As an educational tool, this book will help the reader balance the risks and benefits based on both science and clinical facts, and therefore to make the best choice in receiving or withdrawing from immunotherapy. Disease Specificity. Cancer is a complicated disease involving multiple stages and pathology. Its response to immunotherapy is individualized and varies depending on cancer types. The authors’ expertise in treating different types of cancers, including melanoma, lung, kidney, bladder, and lymphoma, provides disease-specific insights in applying immunotherapy to each disease.

Download or read book Peptide and Protein Vaccines written by Rossen Donev and published by Academic Press. This book was released on 2015-06-08 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: Published continuously since 1944, the Advances in Protein Chemistry and Structural Biology series has been the essential resource for protein chemists. Each volume brings forth new information about protocols and analysis of proteins. Each thematically organized volume is guest edited by leading experts in a broad range of protein-related topics. - Describes advances in application of powerful techniques in a wide bioscience area - Chapters are written by authorities in their field - Targeted to a wide audience of researchers, specialists, and students - The information provided in the volume is well supported by a number of high quality illustrations, figures, and tables

Download or read book OECD Journal written by and published by . This book was released on 2009 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Immunology for Pharmacy E Book written by Dennis Flaherty and published by Elsevier Health Sciences. This book was released on 2011-09-02 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: With a new pharmacy-specific approach to immunology, Immunology for Pharmacy prepares pharmacists for practice by providing a complete understanding of the basis of immunology and the consequences of either suppressing or enhancing immune function. It covers key subjects such as prophylaxis and vaccination, antibodies as therapeutic and diagnostic agents, biological modifiers, and the rationale for use and mechanisms of therapeutic agents. Written by experienced author and educator Dennis Flaherty, this book presents topics with a logical, step-by-step approach, explaining concepts and their practical application. A companion Evolve website reinforces your understanding with flashcards and animations. - Pharmacy-specific coverage narrows the broad field of immunology to those areas most pertinent and clinically relevant to pharmacy students. - 165 full-color illustrations help to illuminate difficult concepts. - Factors That Influence the Immune Response chapter covers biological agents including bacteria, viruses, and fungi, and their related toxins and how they relate to the immune system. - Three chapters on vaccinations prepare you for this important part of the pharmacist's role by discussing cancer treatment with whole tumor vaccines, cell vaccines, and viral vector vaccines, describing other vaccines such as recombinant vaccines and plant vaccines, and examining how diseases such as diphtheria, whooping cough, and tetanus respond to vaccinations. - A summary of drugs used in treating each condition helps you understand typical treatments and their immunological mechanisms, so you can choose proper treatments. - Integrated information makes it easier to understand how various parts of the immune system work together, leading to a better understanding of immunology as a whole. - A unique focus on practical application and critical thinking shows the interrelationship of concepts and makes it easier to apply theory to practice. - Information on AIDS covers the identification and treatment of both strains of HIV as well as AIDS, preparing you for diseases you will see in practice. - Unique student-friendly features simplify your study with learning objectives and key terms at the beginning of each chapter, bulleted summaries and self-assessment questions at the end of each chapter, and a glossary at the back of the book. - Over 60 tables summarize and provide quick reference to important material. - A companion Evolve website includes animations and pharmacy terminology flashcards.

Download or read book Oral Anticoagulants written by L. Poller and published by CRC Press. This book was released on 1996-08-02 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: Warfarin and related drugs have been used for over half a century in prevention and treatment of thrombotic disorders. Only recently however has their clinical role been firmly established by randomised studies and their benefit/risk ratio improved by lower dose therapy with improvements in laboratory monitoring. 'Oral Anticoagulants' is the first comprehensive, practical survey of the subject available. An international team of recognised experts provide detailed coverage on the mode of action; clinical pharmodynamics; magnitude and sources of variability in individuals response to oral anticoagulant; methods of individualising dosing regimens; laboratory monitoring; and comparison between the different currently prescribed oral anticoagulants.

Download or read book International Ethical Guidelines for Health Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.

Download or read book The American Phonetic Dictionary of the English Language written by Daniel S. Smalley and published by . This book was released on 1855 with total page 838 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Pharmaceutical Quality by Design written by Walkiria S. Schlindwein and published by John Wiley & Sons. This book was released on 2018-01-05 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

Download or read book 7 Cents written by Richard Bissell and published by eNet Press. This book was released on 1953 with total page 197 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a rollicking romp about employees in the Sleep Tite Pajama Factory who are about to strike for a 7½ cent raise. Wisecracking dialogue and dry wit abound. 7½ Cents was adapted by Richard Bissell and George Abbott for the Broadway musical success The Pajama Game.

Download or read book You Don t Have to Be Buddhist to Know Nothing written by Joan Konner and published by Prometheus Books. This book was released on 2012-08-31 with total page 333 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this sound-bite history of the concept of nothing, distinguished journalist Konner, author of the bestselling "The Atheist's Bible," has created a unique anthology devoted to, well, nothing.

Download or read book Skin Permeability written by H. Schaefer and published by Springer Science & Business Media. This book was released on 2013-12-01 with total page 365 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Cell Line Development written by Mohamed Al-Rubeai and published by Springer Science & Business Media. This book was released on 2009-08-11 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mammalian cell lines command an effective monopoly for the production of therapeutic proteins that require post-translational modifications. This unique advantage outweighs the costs associated with mammalian cell culture, which are far grater in terms of development time and manufacturing when compared to microbial culture. The development of cell lines has undergone several advances over the years, essentially to meet the requirement to cut the time and costs associated with using such a complex hosts as production platforms. This book provides a comprehensive guide to the methodology involved in the development of cell lines and the cell engineering approach that can be employed to enhance productivity, improve cell function, glycosylation and secretion and control apoptosis. It presents an overall picture of the current topics central to expression engineering including such topics as epigenetics and the use of technologies to overcome positional dependent inactivation, the use of promoter and enhancer sequences for expression of various transgenes, site directed engineering of defined chromosomal sites, and examination of the role of eukaryotic nucleus as the controller of expression of genes that are introduced for production of a desired product. It includes a review of selection methods for high producers and an application developed by a major biopharmaceutical industry to expedite the cell line development process. The potential of cell engineering approch to enhance cell lines through the manipulation of single genes that play important roles in key metabolic and regulatory pathways is also explored throughout.

Download or read book Appity Slap written by and published by Erika Blanchard. This book was released on with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book In Silico Drug Design written by Kunal Roy and published by Academic Press. This book was released on 2019-02-12 with total page 888 pages. Available in PDF, EPUB and Kindle. Book excerpt: In Silico Drug Design: Repurposing Techniques and Methodologies explores the application of computational tools that can be utilized for this approach. The book covers theoretical background and methodologies of chem-bioinformatic techniques and network modeling and discusses the various applied strategies to systematically retrieve, integrate and analyze datasets from diverse sources. Other topics include in silico drug design methods, computational workflows for drug repurposing, and network-based in silico screening for drug efficacy. With contributions from experts in the field and the inclusion of practical case studies, this book gives scientists, researchers and R&D professionals in the pharmaceutical industry valuable insights into drug design. - Discusses the theoretical background and methodologies of useful techniques of cheminformatics and bioinformatics that can be applied for drug repurposing - Offers case studies relating to the in silico modeling of FDA-approved drugs for the discovery of antifungal, anticancer, antiplatelet agents, and for drug therapies against diseases - Covers tools and databases that can be utilized to facilitate in silico methods for drug repurposing

Download or read book Bioengineering Research of Chronic Wounds written by Amit Gefen and published by Springer Science & Business Media. This book was released on 2009-11-18 with total page 449 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pressure-related chronic wounds are an important health concern that affects millions of patients and accumulates billions in annual costs. These wounds may occur when soft tissues are mechanically compressed between bony prominences and a supporting surface. This book gives a complete and quantitative explanation of the mechanobiology which causes chronic wounds. The reviews give an overall picture on all length scales of the phenomenon, starting from musculoskeletal biomechanics to the modeling of soft tissues and their interaction with bones. At the microscopic levels, it thoroughly reviews experiments and modeling of cellular forces and molecular processes that occur during injury and healing, including the integrity of living cells subjected to sustained mechanical forces and deformations. The results allow a complete picture of the tolerance of human tissues to sustained loads, and an understanding of the risk for onset of chronic wounds. Hence, this book is also valuable for all professionals involved in the prevention and treatment of chronic wounds.