The Strange Case Of Avastin Lucentis Why Does Everyone Want Independent Regulatory Agencies That Almost Nobody Ca Handle
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The Strange Case Of Avastin Lucentis
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Author : Luca Pani
language : en
Publisher: Edra
Release Date : 2017-10-31T00:00:00+01:00
The Strange Case Of Avastin Lucentis written by Luca Pani and has been published by Edra this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-10-31T00:00:00+01:00 with Medical categories.
The protagonists of the Avastin-Lucentis case are a specifically approved drug for maculopathy, i.e., Lucentis (ranibizumab) by Novartis, and a cancer drug that has been similarly employed in the ophthalmological field despite it has never been approved for the same indication, Avastin (bevacizumab) by Roche. The regulations on the marketing of drugs, caught between health protection and spending constraints, are addressed in detail by the author to explore the more general role of regulators and what the consequences of their independent assessment and judgement are.
The Strange Case Of Avastin Lucentis Why Does Everyone Want Independent Regulatory Agencies That Almost Nobody Ca Handle
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Author : Luca Pani
language : en
Publisher:
Release Date : 2017
The Strange Case Of Avastin Lucentis Why Does Everyone Want Independent Regulatory Agencies That Almost Nobody Ca Handle written by Luca Pani and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017 with Business & Economics categories.
Die Zul Ssigkeit Von Verbraucherinformationen Angesichts Des Publikumswerbeverbots F R Verschreibungspflichtige Arzneimittel
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Author : Annette Neikes-Pani
language : de
Publisher: LIT Verlag Münster
Release Date : 2021-12-09
Die Zul Ssigkeit Von Verbraucherinformationen Angesichts Des Publikumswerbeverbots F R Verschreibungspflichtige Arzneimittel written by Annette Neikes-Pani and has been published by LIT Verlag Münster this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-12-09 with categories.
Das Publikumswerbeverbot für verschreibungspflichtige Arzneimittel steht im Widerspruch zum Leitbild des "mündigen Patienten", soweit es für den Patienten nützliche Information unterdrückt. Legislatorische Bemühungen, eine Klarstellung zur Abgrenzung von Werbung und zulässiger nützlicher Information zu schaffen, blieben erfolglos. Die vorliegende Arbeit untersucht die umfassende Rechtsprechung und Literatur zur Problematik und prüft aktuelle Praxisfälle, um die Grenze des heute Zulässigen zu ermitteln. Dabei geht es nicht nur um Informationen der Hersteller, sondern auch "Dritter" wie der Ärzteschaft, der Medien oder des Staats. Ein Knackpunkt in der Beantwortung der Frage ist, inwieweit das Verbot als abstraktes Gefährdungsdelikt teleologisch und grundrechtskonform einschränkend ausgelegt werden kann.
Who Expert Committee On Biological Standardization
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Author : World Health Organization
language : en
Publisher: WHO Technical Report
Release Date : 2017
Who Expert Committee On Biological Standardization written by World Health Organization and has been published by WHO Technical Report this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017 with Medical categories.
This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances, and the establishment of international biological reference materials. Following a brief introduction, the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers and national regulatory authorities, outlines the discussions held on the development and revision of WHO Guidelines for a number of vaccines, blood products and related substances. Specific discussion areas included WHO guidance on the production and evaluation of the quality, safety and efficacy of monoclonal antibodies as similar biotherapeutic products (SBPs); blood and blood components as essential medicines; estimation of residual risk of HIV, HBV or HCV infections via cellular blood components and plasma; snake antivenom immunoglobulins; human pandemic influenza vaccines in non-vaccine-producing countries; and clinical evaluation of vaccines: regulatory expectations. In addition, the following WHO guidance documents were also adopted: WHO manual for the preparation of secondary reference materials for in vitro diagnostic assays designed for infectious disease nucleic acid or antigen detection: calibration to WHO International Standards; and Human challenge trials for vaccine development: regulatory considerations. One WHO addendum document "Labeling information of inactivated influenza vaccines for use in pregnant women" was also adopted. Subsequent sections of the report provide information on the current status, proposed development and establishment of international reference materials in the areas of: biotherapeutics other than blood products; blood products and related substances; cellular and gene therapies; in vitro diagnostics; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1). The above nine WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2-10). Finally, all additions and discontinuations made during the 2016 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 11. The updated full catalog of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.
Anti Dictator
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Author : Etienne de La Boetie
language : en
Publisher:
Release Date : 2020
Anti Dictator written by Etienne de La Boetie and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020 with Electronic books categories.
Retinal Vascular Disease
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Author : A.M. Joussen
language : en
Publisher: Springer Science & Business Media
Release Date : 2010-03-29
Retinal Vascular Disease written by A.M. Joussen 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 2010-03-29 with Medical categories.
Vascular diseases of the retina are a major cause of blindness among all age groups. Edited and written by internationally well-known experts, this state-of-the-art comprehensive overview of basic and clinical science will enhance the understanding of retinal vascular disease and help in the evaluation of current and future treatment approaches for the clinician. The well-structured and highly illustrated text is divided into three easy-to-follow sections. This unique textbook-atlas also includes topics which are not currently found in other retinal disease textbooks, such as case reports and clinical follow-ups.
Ozone
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Author : Velio Bocci
language : en
Publisher: Springer Science & Business Media
Release Date : 2010-10-05
Ozone written by Velio Bocci 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 2010-10-05 with Medical categories.
Oxygen-Ozone therapy is a complementary approach less known than homeopathy and acupuncture because it has come of age only three decades ago. This book clarifies that, in the often nebulous field of natural medicine, the biological bases of ozone therapy are totally in line with classical biochemistry, physiological and pharmacological knowledge. Ozone is an oxidizing molecule, a sort of super active oxygen, which, by reacting with blood components generates a number of chemical messengers responsible for activating crucial biological functions such as oxygen delivery, immune activation, release of hormones and induction of antioxidant enzymes, which is an exceptional property for correcting the chronic oxidative stress present in atherosclerosis, diabetes and cancer. Moreover, by inducing nitric oxide synthase, ozone therapy may mobilize endogenous stem cells, which will promote regeneration of ischemic tissues. The description of these phenomena offers the first comprehensive picture for understanding how ozone works and why. When properly used as a real drug within therapeutic range, ozone therapy does not only does not procure adverse effects but yields a feeling of wellness. Half the book describes the value of ozone treatment in several diseases, particularly cutanious infection and vascular diseases where ozone really behaves as a “wonder drug”. The book has been written for clinical researchers, physicians and ozone therapists, but also for the layman or the patient interested in this therapy.
American Dietetic Association Guide To Diabetes Medical Nutrition Therapy And Education
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Author : Tami Ross
language : en
Publisher: American Dietetic Associati
Release Date : 2005
American Dietetic Association Guide To Diabetes Medical Nutrition Therapy And Education written by Tami Ross and has been published by American Dietetic Associati this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005 with Health & Fitness categories.
Medical nutrition therapy plays an integral role in the management in diabetes. This comprehensive guide is an evidence-based review of MNT and the Nutrition Care Process and a practical reference of diabetes management tools and nutrition education. Covering practice guidelines, outcomes evaluation, nutrition assessments, goal-setting, behavior change and interventions, this guide is a must-have resource for health-care professionals serving the diabetes community.
A Star In The East
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Author : Anthony J. Culyer
language : en
Publisher:
Release Date : 2016
A Star In The East written by Anthony J. Culyer and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016 with categories.
Biotechnology And The Patent System
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Author : Claude E. Barfield
language : en
Publisher: A E I Press
Release Date : 2007
Biotechnology And The Patent System written by Claude E. Barfield and has been published by A E I Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Law categories.
American patent law has reached an unprecedented crossroads, prodded by a landmark Supreme Court decision this spring and the prospect of sweeping new federal legislation this fall. At this critical time, Biotechnology and the Patent System: Balancing Innovation and Property Rights provides a timely look at the complex issues involved in making patent law for cutting-edge high-tech industries such as the biotechnology and computer software sectors.