Diagnostics At A Crossroads Navigating Ivd Regulation In A Changing Environment
DOWNLOAD
Download Diagnostics At A Crossroads Navigating Ivd Regulation In A Changing Environment PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Diagnostics At A Crossroads Navigating Ivd Regulation In A Changing Environment book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page
Diagnostics At A Crossroads Navigating Ivd Regulation In A Changing Environment
DOWNLOAD
Author : Jeffrey Gibbs
language : en
Publisher:
Release Date : 2020-12-20
Diagnostics At A Crossroads Navigating Ivd Regulation In A Changing Environment written by Jeffrey Gibbs and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-12-20 with categories.
Drug Safety Data How To Analyze Summarize And Interpret To Determine Risk
DOWNLOAD
Author : Michael J. Klepper
language : en
Publisher: Jones & Bartlett Publishers
Release Date : 2010-09-15
Drug Safety Data How To Analyze Summarize And Interpret To Determine Risk written by Michael J. Klepper and has been published by Jones & Bartlett Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-09-15 with Medical categories.
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)
Traumatic Brain And Spinal Cord Injury
DOWNLOAD
Author : Cristina Morganti-Kossmann
language : en
Publisher: Cambridge University Press
Release Date : 2012-07-19
Traumatic Brain And Spinal Cord Injury written by Cristina Morganti-Kossmann and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-07-19 with Medical categories.
Traumatic Brain and Spinal Cord Injury comprehensively covers the medical and pathological issues related to neurotrauma and its often devastating consequences. Written by globally renowned experts in the field, both clinicians and researchers will find this book invaluable to update their knowledge. This volume is divided into two sections, one covering the brain, the other the spinal cord. Each section discusses the following topics: • The demographic in the developed and developing world where neurotrauma is witnessing a massive expansion • Major clinical issues including advanced semi-experimental monitoring techniques utilized by neurosurgeons and intensivists and the potential use of identifying markers of tissue injury • Overview of major pathophysiological changes • The development of animal models; successes and limitations • Past, current and future therapeutic strategies including rehabilitative opportunities. Presenting the most up-to-date clinical and experimental research in neurotrauma, this volume is essential reading for neurologists, neurosurgeons, intensive care physicians and rehabilitative physicians.
Rare Disease Drug Development
DOWNLOAD
Author : Raymond A. Huml
language : en
Publisher: Springer Nature
Release Date : 2021-11-08
Rare Disease Drug Development written by Raymond A. Huml and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-11-08 with Medical categories.
This book provides a broad overview of rare disease drug development. It offers unique insights from various perspectives, including third-party capital providers, caregivers, patient advocacy groups, drug development professionals, marketing and commercial experts, and patients. A unique reference, the book begins with narratives on the many challenges faced by rare disease patient and their caregivers. Subsequent chapters underscore the critical, multidimensional role of patient advocacy groups and the novel approaches to related clinical trials, investment decisions, and the optimization of rare disease registries. The book addresses various rare disease drug development processes by disciplines such as oncology, hematology, pediatrics, and gene therapy. Chapters then address the operational aspects of drug development, including approval processes, development accelerations, and market access strategies. The book concludes with reflections on the authors' case for real-world data and evidence generation in orphan medicinal drug development. Rare Disease Drug Development is an expertly written text optimized for biopharmaceutical R&D experts, commercial experts, third-party capital providers, patient advocacy groups, patients, and caregivers.
Coagulase Negative Staphylococci
DOWNLOAD
Author : Per-Anders Mårdh
language : en
Publisher: Coronet Books
Release Date : 1986
Coagulase Negative Staphylococci written by Per-Anders Mårdh and has been published by Coronet Books this book supported file pdf, txt, epub, kindle and other format this book has been release on 1986 with Coagulase categories.
Strategic Operations Management
DOWNLOAD
Author : Steve Brown
language : en
Publisher: Routledge
Release Date : 2007-06-01
Strategic Operations Management written by Steve Brown and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-06-01 with Business & Economics categories.
This is a substantial new edition of a successful textbook which continues to have a sensible and 'easy to read' style. Each Chapter has a past/present/future theme with a real strategic approach. Strategic Operations Managment shows operations as combining products and services into a complete offer for the customer. Services are therefore seen as key and are integrated throughout the material in each chapter. Manufacturing, service supply and other key factors are all shown to be in place. In an era where companies are fond of talking about core competences but still struggle to understand their operations, this is an important for academics and practitioners alike. Only when managers understand their operations will they be able to leverage them into any sort of capabilities that will lead to competitive advantage. Online tutor resource materials accompany the book.
The Arc Of Crisis In The Mena Region
DOWNLOAD
Author : Karim Mezran
language : en
Publisher: Ledizioni
Release Date : 2018-10-08
The Arc Of Crisis In The Mena Region written by Karim Mezran and has been published by Ledizioni this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-10-08 with Political Science categories.
The volume deals with the countries of the Middle East and North Africa that are facing a particularly troubled period in their historical development. Syria, Iraq, Libya, Egypt and to a lesser extent Jordan and Tunisia have plunged into a legitimacy crisis that in some cases has turned into civil war or violent upheaval. As traditional authorities lose their legitimacy, two alternatives are emerging. The first is a more decentralized system of government, evinced by the empowerment of subnational government bodies and the growing legitimacy of local authorities; in this trend, the local authorities are able to keep the state united and more functional. The second is a growing number of political groups that act as opposition to authoritarianism, which is experiencing a revival. The analysis herein also focuses on Islamist movements; namely, their organizational and ideological development as well as how the shrinking of the political space affects them and the entire polity. This Report explores the distinctive dynamics and characteristics of these challenges in the post-Arab Spring era.
Biotech Innovations And Fundamental Rights
DOWNLOAD
Author : Roberto Bin
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-05-13
Biotech Innovations And Fundamental Rights written by Roberto Bin and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-05-13 with Law categories.
Biotechnology is a recognized research area that has increasingly advanced into new technologies and modern practices raising several legal, ethical and regulatory issues. The revolutionary speed of biotech innovations has had a significant impact on the protection of the rights of the individual. Fundamental rights provide a framework within which the justification of limitations and restrictions to biotechnology innovations and research results have to be assessed. The legal regulation of scientific research and scientific investigations impact more and more directly on the freedom of research and therapies as well as on the broad diffusion of knowledge. Closely related is also the debated question of the technological manipulation of life and the boundary of scientific knowledge with regard to the topical question of genetic invention patents and their side effects on access to scientific information and health care opportunities. Drawing on expertise from different disciplines, the volume comprises invited papers and plenary presentations given at the conference entitled “Biotech Innovations & Fundamental Rights” that took place on Januray 20-21 2011 at the Department of Juridical Sciences of the University of Ferrara. Each contribution covers a different aspect of the legal and scientific issues involved in regulation of biotechnology. In particular the focus of attention has been given to genetic research, genetic data, freedom of scientific research in genetics and biotech patents.
Cancer Nanotechnology
DOWNLOAD
Author :
language : en
Publisher: Academic Press
Release Date : 2018-06-23
Cancer Nanotechnology written by and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-06-23 with Medical categories.
Advances in Cancer Research, Volume 139, provides invaluable information on the exciting and fast-moving field of cancer research. Original reviews are presented on a variety of topics relating to the rapidly developing intersection between nanotechnology and cancer research, with unique sections in the new release focusing on Exosomes as a theranostic for lung cancer, Nanotechnology and cancer immunotherapy, Ultrasound imaging agents and delivery systems, Dendronized systems for the delivery of chemotherapeutics, Thermosensitive liposomes for image-guided drug delivery, Supramolecular Chemistry in Tumor Analysis and Drug Delivery, Gold nanoparticles for delivery of cancer therapeutics, and Single cell barcode microchip for cancer research and therapy. - Provides the latest information on cancer research - Offers outstanding and original reviews on a range of cancer research topics - Serves as an indispensable reference for researchers and students alike