Summary of the 2006 Work Programme of the European Medicines Agency PDF Download
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Languages : en
Pages : 33
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Author:
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ISBN:
Category :
Languages : en
Pages : 33
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Book Description
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ISBN: 9789291550449
Category :
Languages : en
Pages : 33
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ISBN: 9789291550463
Category :
Languages : en
Pages : 26
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ISBN: 9789291550487
Category :
Languages : en
Pages : 28
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Book Description
Author: Ala F. Nassar
Publisher: John Wiley & Sons
ISBN: 0470439254
Category : Medical
Languages : en
Pages : 1059
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Book Description
A valuable reference tool for professionals involved in the industry, Drug Metabolism in Pharmaceuticals covers new tools such as LC-MS and LC-MS-NMR along with experimental aspects of drug metabolism. This work fills a gap in the literature by covering the concepts and applications of pharmaceutical research, development, and assessment from the point of view of drug metabolism. By providing both a solid conceptual understanding of the drug metabolism system, and a well illustrated, detailed demonstration and explanation of cutting edge tools and techniques, this book serves as a valuable reference tool for bench scientists, medical students, and students of general health sciences.
Author: Anthony C. Cartwright
Publisher: CRC Press
ISBN: 1420081837
Category : Medical
Languages : en
Pages : 804
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Book Description
Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.This cutting-edge resou
Author: Mianna Meskus
Publisher: Springer
ISBN: 1137469102
Category : Social Science
Languages : en
Pages : 243
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Book Description
This book explores the new ways in which biology is becoming technology. The revolutionary iPS cell technology has made it possible to turn human skin and blood cells into pluripotent stem cells, thus providing an unprecedented opportunity to study the pathophysiology of diseases, understand human developmental biology, and generate new therapies. Drawing from a rich ethnographic study, Meskus traces the making of the iPS cell technology through the perspectives of clinical translation, laboratory experimentation, and tissue donation by voluntary patients. Discussing non-human agency, the embodied and affective basis of knowledge production, and the material politics of science, the book develops the idea of an instrumentality-care continuum as a fundamental dynamic of biomedical craft. This continuum, Meskus argues, opens up a novel perspective to the commercialization and industrial-scale appropriation of human biology, and thereby to the future of ethical biomedical research.
Author: Amy Rosenberg
Publisher: Springer
ISBN: 1493925431
Category : Medical
Languages : en
Pages : 384
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Book Description
“Biobetters: Protein Engineering to Approach the Curative” discusses the optimization of protein therapeutic products for treatment of human diseases. It is based on the fact that though numerous important therapeutic protein products have been developed for life threatening and chronic diseases that possess acceptable safety and efficacy profiles, these products have generally not been reexamined and modified for an improved clinical performance, with enhancements both to safety and efficacy profiles. Advances in protein engineering, coupled with greatly enhanced understanding of critical product quality attributes for efficacy and safety, make it possible to optimize predecessor products for clinical performance, thereby enhancing patient quality of life and with the potential for great savings in health care costs. Yet despite such knowledge, there is little movement towards such modifications. This book examines engineering protein therapeutic products such that they exhibit an optimal, not just an adequate, clinical performance profile. Two product classes, therapeutic enzymes for lysosomal storage diseases (enzyme replacement therapies, ERT) and monoclonal antibodies (mAbs), are used as examples of what modifications to such proteins could be made to enhance clinical performance, “closer to a cure” as it were. For ERT, the key to optimizing clinical performance is to ensure the ERT is endowed with moieties that target the protein to the relevant target tissue. Thus, for Gaucher Disease, our best example of how to optimize an ERT to address a disease that manifests in specific target tissues (macrophages and monocytes), the enzyme has been extensively modified to target macrophages. For diseases such as Pompe Disease, largely a disorder of muscle, optimal performance of ERT will depend on endowing the enzyme with the ability to be taken up via the Mannose 6 Phosphate Receptor, and so one of the chapters in the book will discuss such approaches. Moreover, a major failure of biotechnology based products is to gain access to the CNS, a key target tissue in numerous diseases. Thus, a chapter has been devoted to strategies to access the CNS. Additionally, immune responses to therapeutic proteins can be highly problematic, eliminating the efficacy of life saving or highly effective protein therapeutics. This is especially poignant in the case of Pompe Disease wherein great improvement in muscle strength and functionality is lost following development of an immune response to the ERT with consequent patient deterioration and death. Thus, a chapter regarding protein engineering, as well as other non-clinical approaches to diminishing immunogenicity is a valuable part of the book. Monoclonal antibodies (mAbs) can be engineered to bind targets relevant to a wide variety of diseases; binding affinity, however, is only part of the equation and one of the chapters will present a molecular assessment approach that balances affinity with pharmacokinetics and manufacturability. As with other proteins immunogenicity can be problematic, being responsible for loss of efficacy of anti-TNF mAbs, often after prolonged successful treatment. The authors will also share their perspective on the consequences of physico-chemical modifications occurring to mAbs once they reach the circulation or their target, a research area open to further development from a protein engineering as well as analytical perspective. This book will also discuss novel platforms for protein therapeutics, technologies that exceed mAbs with respect to potency, and hence, potentially efficacy. These platforms consist largely of repeat domain proteins with very high affinity for their target ligands, but while potentially more efficacious, immunogenicity may be a major problem limiting use. The economics surrounding the issue of biobetters is another high-profile issue - this final chapter will explore the incentives and disincentives for developing biobetters and consider incentives that might make their pursuit more rewarding.
Author: Jarle Trondal
Publisher: Oxford University Press
ISBN: 0199579423
Category : Language Arts & Disciplines
Languages : en
Pages : 312
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Book Description
The book examines how the European Union profoundly penetrates the domestic branch of executive government. The author explores the accumulated organisational capacities and the every-day decision-making dynamics inside three key institutions: the European Commission, EU-level agencies, and EU committees.
Author: Council of Europe
Publisher: Council of Europe
ISBN: 9287161739
Category : Political Science
Languages : en
Pages : 121
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Book Description
The implementation of the recommendations of the 3rd Summit of Heads of State and Government of the Council of Europe (Warsaw, May 2005) resulted in the launch in 2006 of a number of European campaigns, in particular "Building a Europe for and with children"; the "Campaign to combat trafficking in human beings"; "All different, All equal"; "Stop domestic violence against women"; and the 'Dosta!" awareness-raising campaign to end prejudice against the Roma. Kosovo was a major political concern for the Council of Europe. Through its Venice Commission, it provided expert input for the preparation of the future status of the region and continued to provide expert advice on the implementation of European standards in such fields as the protection of human rights, minority rights, decentralisation, cultural heritage protection and constitutional law. The Republic of Montenegro applied for membership of the Council of Europe following the 21 May referendum, which paved the way for its independence. Serbia, on the other hand, succeeded the former State Union of Serbia and Montenegro as a member state of the Organisation. The Council of Europe was the first organisation to look into the allegations of secret detentions and unlawful transfers of suspected terrorists in the member states. The Parliamentary Assembly and the Secretary General each carried out investigations which revealed that Council of Europe member states have not set up effective legal safeguards against such practices, which violate the European Convention on Human Rights.
