Clinical Therapeutic Tolerance First In Human Data Proceedings Of The 4th Newcastle Therapeutic Tolerance Workshop

Author : John Isaacs
Publisher : Frontiers Media SA
ISBN 13 : 2889718484
Total Pages : 110 pages
Book Rating : 4.81/5 ( download)

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Download or read book Clinical Therapeutic Tolerance: First-in-Human Data: Proceedings of the 4th Newcastle Therapeutic Tolerance Workshop written by John Isaacs and published by Frontiers Media SA. This book was released on 2021-12-20 with total page 110 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Maria Cristina Galli
Publisher : Springer Nature
ISBN 13 : 3031345673
Total Pages : 243 pages
Book Rating : 4.78/5 ( download)

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Download or read book Regulatory Aspects of Gene Therapy and Cell Therapy Products written by Maria Cristina Galli and published by Springer Nature. This book was released on 2023-08-01 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses the different regulatory pathways for Advanced Therapy Medicinal Products implemented by national agencies in North and South America, Europe and Asia and by international bodies in the effort of international harmonization. This book represents an update of the first edition, as it covers regulatory novelties and accumulated experience in the regions already addressed. In addition, this new edition offers a wider international perspective: new chapters are included covering Advanced Therapy Medicinal Products regulations in India, Malaysia, Spain and Thailand, the European Pharmacopoeia texts for gene therapy medicinal products as well as international harmonization programs. 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 and therapeutic use of these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of Advanced Therapy Medicinal Products in the areas of product quality, pharmacology and toxicology, clinical trial design and HTA pathways, 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 & 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.

Author : John Isaacs
Publisher : Frontiers Media SA
ISBN 13 : 2889631761
Total Pages : 310 pages
Book Rating : 4.66/5 ( download)

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Download or read book Tolerogenic Antigen-Presenting Cells – Modulating Unwanted Immune Response at Their Core written by John Isaacs and published by Frontiers Media SA. This book was released on 2019-12-27 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : World Health Organization
Publisher :
ISBN 13 : 9789290360742
Total Pages : 381 pages
Book Rating : 4.47/5 ( download)

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Download or read book Current Challenges in Pharmacovigilance written by World Health Organization and published by . This book was released on 2001-01-01 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author :
Publisher :
ISBN 13 :
Total Pages : 1680 pages
Book Rating : 4.52/5 ( download)

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Download or read book Medical and Health Care Books and Serials in Print written by and published by . This book was released on 1997 with total page 1680 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Tomoko Maeda-Chubachi
Publisher : Cambridge Scholars Publishing
ISBN 13 : 152755967X
Total Pages : 146 pages
Book Rating : 4.77/5 ( download)

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Download or read book Dermatological Drug Development written by Tomoko Maeda-Chubachi and published by Cambridge Scholars Publishing. This book was released on 2020-09-18 with total page 146 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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).

Author :
Publisher :
ISBN 13 :
Total Pages : 1140 pages
Book Rating : 4.51/5 ( download)

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Download or read book International Books in Print written by and published by . This book was released on 1998 with total page 1140 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Mihail C. Roco
Publisher : Springer Science & Business Media
ISBN 13 : 9401703590
Total Pages : 477 pages
Book Rating : 4.98/5 ( download)

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Download or read book Converging Technologies for Improving Human Performance written by Mihail C. Roco and published by Springer Science & Business Media. This book was released on 2013-04-17 with total page 477 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309154006
Total Pages : 246 pages
Book Rating : 4.00/5 ( download)

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Download or read book Guide for the Care and Use of Laboratory Animals written by National Research Council and published by National Academies Press. This book was released on 2011-01-27 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Bruce H. Young
Publisher :
ISBN 13 :
Total Pages : 200 pages
Book Rating : 4.62/5 ( download)

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Download or read book Disaster Mental Health Services written by Bruce H. Young and published by . This book was released on 1998 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: