Author: John IsaacsPublisher: Frontiers Media SA
ISBN: 2889718484
Category : Medical
Languages : en
Pages : 110
Book Description
Clinical Therapeutic Tolerance: First-in-Human Data: Proceedings of the 4th Newcastle Therapeutic Tolerance Workshop
Author: John IsaacsPublisher: Frontiers Media SA
ISBN: 2889718484
Category : Medical
Languages : en
Pages : 110
Book Description
Regulatory Aspects of Gene Therapy and Cell Therapy Products
Author: Maria Cristina GalliPublisher: Springer
ISBN: 3319186183
Category : Medical
Languages : en
Pages : 235
Book Description
This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
Medical and Health Care Books and Serials in Print
Author: Guide for the Care and Use of Laboratory Animals
Author: National Research CouncilPublisher: National Academies Press
ISBN: 0309154006
Category : Science
Languages : en
Pages : 246
Book Description
A respected resource for decades, the Guide for the Care and Use of Laboratory Animals has been updated by a committee of experts, taking into consideration input from the scientific and laboratory animal communities and the public at large. The Guide incorporates new scientific information on common laboratory animals, including aquatic species, and includes extensive references. It is organized around major components of animal use: Key concepts of animal care and use. The Guide sets the framework for the humane care and use of laboratory animals. Animal care and use program. The Guide discusses the concept of a broad Program of Animal Care and Use, including roles and responsibilities of the Institutional Official, Attending Veterinarian and the Institutional Animal Care and Use Committee. Animal environment, husbandry, and management. A chapter on this topic is now divided into sections on terrestrial and aquatic animals and provides recommendations for housing and environment, husbandry, behavioral and population management, and more. Veterinary care. The Guide discusses veterinary care and the responsibilities of the Attending Veterinarian. It includes recommendations on animal procurement and transportation, preventive medicine (including animal biosecurity), and clinical care and management. The Guide addresses distress and pain recognition and relief, and issues surrounding euthanasia. Physical plant. The Guide identifies design issues, providing construction guidelines for functional areas; considerations such as drainage, vibration and noise control, and environmental monitoring; and specialized facilities for animal housing and research needs. The Guide for the Care and Use of Laboratory Animals provides a framework for the judgments required in the management of animal facilities. This updated and expanded resource of proven value will be important to scientists and researchers, veterinarians, animal care personnel, facilities managers, institutional administrators, policy makers involved in research issues, and animal welfare advocates.
Converging Technologies for Improving Human Performance
Author: Mihail C. RocoPublisher: Springer Science & Business Media
ISBN: 9401703590
Category : Technology & Engineering
Languages : en
Pages : 477
Book Description
M. C. Roco and W.S. Bainbridge In the early decades of the 21st century, concentrated efforts can unify science based on the unity of nature, thereby advancing the combination of nanotechnology, biotechnology, information technology, and new technologies based in cognitive science. With proper attention to ethical issues and societal needs, converging in human abilities, societal technologies could achieve a tremendous improvement outcomes, the nation's productivity, and the quality of life. This is a broad, cross cutting, emerging and timely opportunity of interest to individuals, society and humanity in the long term. The phrase "convergent technologies" refers to the synergistic combination of four major "NBIC" (nano-bio-info-cogno) provinces of science and technology, each of which is currently progressing at a rapid rate: (a) nanoscience and nanotechnology; (b) biotechnology and biomedicine, including genetic engineering; (c) information technology, including advanced computing and communications; (d) cognitive science, including cognitive neuroscience. Timely and Broad Opportunity. Convergence of diverse technologies is based on material unity at the nanoscale and on technology integration from that scale.
International Books in Print
Author: Structured Interview for DSM-IV Personality
Author: Bruce PfohlPublisher: American Psychiatric Pub
ISBN: 9780880489379
Category : Medical
Languages : en
Pages : 50
Book Description
Updated for DSM-IV, the Structured Interview for DSM-IV Personality (SIDP-IV) is a semi-structured interview that uses nonpejorative questions to examine behavior and personality traits from the patient's perspective. The SIDP-IV is organized by topic sections rather than disorder to allow for a more natural conversational flow, a method that gleans useful information from related interview questions and produces a more accurate diagnosis. Designed as a follow-up to a general psychiatric interview and chart review that assesses episodic psychiatric disorders, the SIDP-IV helps the interviewer to more easily distinguish lifelong behavior from temporary states that result from an episodic psychiatric disorder. During the session, the interviewer can also refer to the specific DSM-IV criterion associated with that question set. In the event that the clinician decides to interview a third-party informant such as family members or close friends, a consent form is provided at the end of the interview. With this useful, concise interview in hand, clinicians can move quickly from diagnosis to treatment and begin to improve their patient's quality of life.
Current Challenges in Pharmacovigilance
Author: World Health OrganizationPublisher:
ISBN: 9789290360742
Category : Medical
Languages : en
Pages : 381
Book Description
In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.
Mucosal T Cells
Author: Thomas T. MacDonaldPublisher: S Karger Ag
ISBN: 9783805567220
Category : Medical
Languages : en
Pages : 241
Book Description
There are more T cells in the gastrointestinal tract and lung than in the rest of the body combined. The aim of this book is to cover all the important aspects of the biology of these cells in animals and in man. Basic observations are described as well as disease states where aberrant activation of mucosal T cells causes tissue damage. The continuing discovery of features of mucosal T cells which make them different from T cells in the periphery is a consistent theme throughout the text. Topics discussed include new developments in understanding why the characteristic response of mucosal T cells to soluble antigens is tolerance, the role of the gut epithelium in intestinal immunity, the molecular basis by which T cells home to the gut mucosa, the functions of gammadelta T cells, the discovery of a new lymphoid organ - the cryptopatch - in the mouse gut, and the remarkable oligoclonality of the alphabeta and gammadelta T cells in the gut epithelium. In more disease-related sections, the way in which T cells play a role in asthma and protection from parasite infection, and how they cause inflammatory bowel disease in man and animals are described. Providing an excellent survey of the field, this book is a valuable resource for both basic scientists and clinicians interested in intestinal immunology and gastrointestinal disease.
Dermatological Drug Development
Author: Tomoko Maeda-ChubachiPublisher: Cambridge Scholars Publishing
ISBN: 152755967X
Category : Medical
Languages : en
Pages : 146
Book Description
This book uniquely summarizes approaches to developing dermatological drugs in a regulated environment from the perspective of the pharmaceutical industry. It brings together the insights of skilled and experienced industry experts to reveal the complexities of dermatological drug development, covering topical, oral, and biologic drugs. This book fills an important gap, as there is currently no other textbook addressing dermatological drug development, explaining and illustrating why unique nonclinical and clinical studies are necessary and how they are typically designed and conducted. The drug development process is also an evolving strategy that is characterized by communicating, negotiating, and agreeing with regulatory agencies, such as FDA (US), EMA (EU), and PMDA (Japan).