Biosimilars (97 Ergebnisse)

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Soft cover. Zustand: New. 1st Edition. A drug is typically manufactured through chemical synthesis, which means that it is made by combining specific chemical ingredients in an ordered process. Biologics are medicines made from living cells through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics are used to prevent, treat, diagnose, or cure a variety of diseases including cancer, chronic kidney disease, autoimmune disorders, and infectious diseases. A biosimilar is a biologic that is similar to another biologic drug already that has already been approved. This book is a complete guide to the use of biologics and biosimilars in the treatment of dermatologic disorders. Beginning with an overview of the history and classification of biologics and the concept of biosimilars, the following chapters explain their therapeutic use for different skin conditions. The final sections cover related topics such as cost effectiveness and quality of life with biologic therapy, and the book concludes with discussion on future developments and the use of small molecule treatment. Key points Complete guide to use of biologics and biosimilars in treatment of dermatologic disorders Covers many different skin diseases and conditions Discusses related topics such as cost effectiveness and quality of life Covers future development of small molecule therapy.…

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Paperback. Zustand: Brand New. 3rd (2016) edition. 430 pages. 11.00x8.50x0.97 inches. In Stock.

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Zustand: New. KlappentextThe BiblioGov Project is an effort to expand awareness of the public documents and records of the U.S. Government via print publications. In broadening the public understanding of government and its work, an enlightened democ.

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PAP. Zustand: New. New Book. Shipped from UK. Established seller since 2000.

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PAP. Zustand: New. New Book. Shipped from UK. Established seller since 2000.

Taschenbuch. Zustand: Neu. Druck auf Anfrage Neuware - Printed after ordering - Master's Thesis from the year 2013 in the subject Medicine - Pharmacology, grade: 1 st CLASS HONS, Dublin Institute of Technology (Chemistry), course: Pharmaceutical Quality Assurance / Regulatory Affairs, language: English, abstract: During the course of this thesis evidence was presented and discussed related to the research questions. The fundamental question related to the heterogeneity and variation through the life cycle of the biosimilar and the reference biologic remains neglected, based on the results collected during this thesis, by the stakeholders, mainly because those issues where not addressed in any official regulatory guidance document.As clear guidance from the EMA is lacking, with the only available guidance being that once a marketing authorization is issued it is accepted that the quality profiles of the reference biologic and the biosimilar will have different quality profiles.Abstract:Within the biosimilar development context, there are unaddressed questions by the European Medicines Agency (EMA) with regard to the impacts of shifts of the quality profile (purity- and impurity levels) of the reference biologic for the biosimilar development program. This dynamic is an open issues has potentially implications on the comparability exercise of the before mentioned.Opinions from experts involved in the guidance drafting process of EMA and other were evaluated with regard to the issue.[.]. …

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Zustand: New. This complete guide to the use of biologics and biosimilars in the treatment of dermatologic disorders covers many different skin diseases and conditions. It discusses related topics such as cost effectiveness and quality of life as well as future developme.

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Zustand: New. 2024. 1st Edition. paperback. . . . . . Books ship from the US and Ireland.

Taschenbuch. Zustand: Neu. Neuware - This complete guide to the use of biologics and biosimilars in the treatment of dermatologic disorders covers many different skin diseases and conditions. It discusses related topics such as cost effectiveness and quality of life as well as future development of small molecule therapy.…

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Taschenbuch. Zustand: Neu. Druck auf Anfrage Neuware - Printed after ordering - Essay aus dem Jahr 2021 im Fachbereich Medizin - Pharmakologie, Arzneimittelwesen, Note: 1,3, FOM Essen, Hochschule für Oekonomie & Management gemeinnützige GmbH, Hochschulleitung Essen früher Fachhochschule, Sprache: Deutsch, Abstract: Diese Arbeit analysiert, welche Argumente für und gegen die Anwendung von Biosimilars sprechen und welche Kritikpunkte sich an dem Zulassungsprozess von Biosimilars finden lassen.Biosimilars sind biologisch hergestellte Pharmazeutika, die einem bereits existierenden und zugelassenen Medikament, dem Referenzmedikament, ähneln. Sie sind die 'Generika' der Biopharmabranche. Im Gegensatz zu den Generika kann jedoch keine exakte Kopie zum Referenzprodukt erreicht werden. Biopharmazeutika können aufgrund ihrer komplexen Struktur nicht genau nachgebildet werden, sondern es wird nur eine signifikante Vergleichbarkeit erreicht. …