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

vitamin-D

書目名稱Biosimilars影響因子(影響力)




書目名稱Biosimilars影響因子(影響力)學(xué)科排名




書目名稱Biosimilars網(wǎng)絡(luò)公開度




書目名稱Biosimilars網(wǎng)絡(luò)公開度學(xué)科排名




書目名稱Biosimilars被引頻次




書目名稱Biosimilars被引頻次學(xué)科排名




書目名稱Biosimilars年度引用




書目名稱Biosimilars年度引用學(xué)科排名




書目名稱Biosimilars讀者反饋




書目名稱Biosimilars讀者反饋學(xué)科排名

phase-2-enzyme

Book 2013 other issues, such as cost management and international nomenclature..?.This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products wi

WATER

,Biologicals’ Characteristics,his complexity’s consequence resides in the analytical techniques for the study of various structural aspects of the molecule population of interest. Powerful physico-chemical and biological methods have to be used in order to globally apprehend the molecules tridimensional integrity and ensure a th

BLA

From the Biosimilar Concept to the Marketing Authorisation,adequate to evidence a biosimilar’s quality, safety and efficacy, due to the complexity of the products themselves but also of their production processes. The registration of biological products’ copies has been made possible by the creation of a specific regulatory framework by European regulatory

鞭子

Immunogenicity,ors influencing immunogenicity—structural, linked to impurities and other production contaminants, factors linked to the medicine’s formulation, or linked to patients and treatment dependant—are studied in that chapter, as well as their consequences in regulatory terms.

micturition

Substitution and Interchangeability,n of biosimilars is centralised as for reference products, the issue of substitution remains the specific field of the European Community Member States. In this chapter is described the French regulatory position—that does not allow the substitution of a reference biological product by a biosimilar,

Fatten

Mutter

alleviate

Wouter van Toll,Arjan Egges,Jeroen D. Fokkerarket in value), payers’ (significant savings expected for all parties), at last doctors and pharmacists’. How costs are established, what savings may be expected, is there a liability specific to biosimilars? In this chapter, a quick comparative view of European and American approaches and the concept of interchangeability.

記憶法

Jean-Louis Prugnaud,Jean-Hugues TrouvinAnalysis of the complete legal and regulatory framework.Approach of the context of copies of biology and biotechnology drugs.Details the registration conditions.Analysis of these drugs’ marketing (dru