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Titlebook: Biosimilars; A New Generation of Jean-Louis Prugnaud,Jean-Hugues Trouvin Book 2013 Springer-Verlag France 2013 Biomedicine.Biosimilars.Cos

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Learning Business English in ChinaConditions under which G-CSF biosimilars have been authorised for patients’ treatment: conducted studies, recommendations of the European Medicines Agency, indications authorised comparatively to the reference product. In the same way are detailed the conditions of prescription and interchangeability for that type of medicines.
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,G-CSFs: Onco-Hematologist’s Point of View,Conditions under which G-CSF biosimilars have been authorised for patients’ treatment: conducted studies, recommendations of the European Medicines Agency, indications authorised comparatively to the reference product. In the same way are detailed the conditions of prescription and interchangeability for that type of medicines.
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,The Oncologist’s Point of View,EPO’s biosimilars in oncology. After a reminder on general conditions for prescribing EPOs and international recommendations, the more specific prescription of biosimilars, their interchangeability, guidelines, traceability, are considered.
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Book 2013prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the “generic rule” valid for small chemical entities.. .In re
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istration conditions.Analysis of these drugs’ marketing (dru.Biologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world.
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Learning Business English in Chinahe conditions of biosimilars’ interchangeability compared to reference products’. Interchangeability is the result of a medical prescription processed by the various players of medical treatment and according to predefined recommendations.
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,Biologicals’ Characteristics,cess, an element of their characterisation. This process should be perfectly mastered in spite of variables inherent to the particular mode of expression of genetically engineered substances. In this chapter this complexity’s various elements are studied, with recombinant proteins taken as typical molecules.
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