Unlike the conventional, more common small molecular weight human medicines and chemical generics, protein-based medicines exhibit higher molecular weight, complexity in structure and function that can be affected by changes in the manufacturing process. Therefore, biosimilars represent a relatively heterogeneous class of medicinal products that make their regulation quite challenging. According
to the current understanding in the EU, a biosimilar is a copy version of an already authorized this website biopharmaceutical (or reference product) with similar biologic activity, physicochemical characteristics, efficacy, and safety, based on a full comparability exercise at quality, preclinical and Fer-1 in vitro clinical level to ensure similar efficacy and safety. Guidance has been provided through several Committee for Medicinal Products for Human Use (CHMP) guidelines as well as individual scientific advice requested from the European Medicines Agency (EMA) by various companies for the development and regulation of biosimilars. This review is
mainly focused on the current status of regulation of biosimilars in the EU as well as on future challenges lying ahead for the improvement of the requirements needed for the marketing authorization of biosimilars. Emphasis is given on the quality requirements concerning these medicinal products (biologics).”
“Ultrafine Y2O3:Eu3+ phosphors were prepared by a modified solution combustion method. The as-prepared samples with sizes of 17.6-80 nm (nanophosphors) and 300 nm (submicron phosphors) were characterized by x-ray diffraction, learn more transmission electron microscope, scanning electron microscopy, selected area electron diffraction, and energy dispersive x-ray spectroscopy. The emission spectra of the samples are unchanged in comparison with that of standard material. The excitation spectra show a redshift in the charge-transfer-state band
and a blueshift in the host gap band. In relation to commercial sample, the relative luminescence intensities of nano- and submicron phosphors are increased sufficiently to 64.4% and 93.6%, respectively. Higher quenching concentration of the activator Eu3+ ion was observed in the nanophosphor than that in the phosphor synthesized by solid state reaction.”
“Histopathological examination was carried out on post mortem samples of liver from 12 donkeys (Equus asinus), aged 21-57 years (4 females, 1 stallion, 7 geldings). Variable amounts of haemosiderin were present in Kupffer cells, portal macrophages and hepatocytes in all cases. In all cases there was infiltration of connective tissue around portal tracts by variable numbers of inflammatory cells (lymphocytes, plasma cells and macrophages) but obvious portal fibrosis was present in only four animals.