The Portuguese Society of Rheumatology position paper on the use of biosimilars

Biotechnological drugs have become a fundamental resource for the treatment of rheumatic patients. Patent expiry of some of these drugs created the opportunity for biopharmaceutical manufacturers to develop biosimilar drugs intended to be as efficacious as the originator product but with a lower cost to healthcare systems. Due to the complex manufacturing process and highly intricate structure of biologicals, a biosimilar can never be an exact copy of its reference product. Consequently, regulatory authorities issued strict preclinical and clinical guidelines to ensure safety and efficacy equivalence and, in September 2013, the biosimilar of infliximab was the first biosimilar monoclonal antibody to be authorized for use in the European Union. The current document is a position statement of the "Sociedade Portuguesa de Reumatologia" (Portuguese Society of Rheumatology) on the use of biosimilar drugs in rheumatic diseases. Two systematic literature reviews were performed, one concerning clinical trials and the other one concerning international position papers on biosimilars. The results were presented and discussed in a national meeting and a final position document was discussed, written and approved by Portuguese rheumatologists. Briefly, this position statement is contrary to automatic substitution of the originator by the biosimilar, defends either a different INN or the prescription by brand name, supports that switching between biosimilars and the originator molecule should be done after at least 6 months of treatment and based on the attending physician decision and after adequate patient information, recommends the registration of all biosimilar treated patients in Reuma.pt for efficacy, safety and immunogenicity surveillance, following the strategy already ongoing for originators, and opposes to extrapolation of indications approved to the originator to completely different diseases and/or age groups without adequate pre-clinical, safety or efficacy data.info:eu-repo/semantics/publishedVersio

Control of the infestations by Polydora spp. in Crassostea angulata

Trabalho apresentado em XVII Congreso Nacional de Acuicultura, 7-10 maio de 2019, Murcia, Espanha Peer review:N/

Síntese e caracterização estrutural de pigmentos cerâmicos a base de cromita por método químico

The ceramic pigments are colored inorganic substances that during the process of dispersion in the ceramic glazes and subsequent calcination, are stable against physical and chemical attack. Therefore, they are crystalline compounds applied in the ceramic industry for coloring vitreous base. In this study, the Pechini method was used for obtaining the pigment CuCr2O4 with heat treatment at the temperatures of 800, 900 and 1000 ° C. The powder pigments were characterized on their structural, morphological and colorimetric aspects. The thermal analysis conducted on an amorphous precursor in a TG / DTA indicates the weight loss in the entire temperature range investigated, with characteristic exothermic peak of the elimination of the organic composition of the precursor around 300°C. The development of the crystalline phases were investigated by XRD, using a diffractometer with Cu Ka radiation and graphite monochromator, where it was observed the presence of crystalline phases corresponding to Cr2O3 and CuCr2O4.The measurements of the specific surface area of the powders pigments were carried out in an equipment Micromeritcs, model ASAP 2000, using N2 as gas of adsorption/desorption. The colorimetric measurements of the pigments were made in a colorimeter Gretac Macbeth Color-eye spectrophotometer 2180 / 2180UV in CIELAB standards. Based on the obtained results, it can be verified the thermal stability of the powder pigments of green coloration, which enables it as an alternative to the materials currently used in the manufacture of ceramic tiles.Os pigmentos cerâmicos são substâncias inorgânicas coloridas que durante o processo de dispersas nos esmaltes cerâmicos e posterior calcinação, se mantêm estáveis frente ao ataque físico e químico. Por conseguinte, são compostos cristalinos aplicados na indústria cerâmica para colorir bases vítreas. Neste trabalho foi utilizado o método Pechini na obtenção do pigmento CuCr2O4 com tratamento térmico nas temperaturas de 800, 900 e 1000 °C. Os pós pigmentantes foram caracterizados nos aspectos estruturais, morfológicos e colorimétricos. A análise térmica realizada no precursor amorfo em um TG/DTA revela a perda de massa em todo o intervalo de temperatura investigado, com pico exotérmico característico da eliminação da composição orgânica do precursor em torno de 300°C. A evolu- ção das fases cristalinas foi investigada por DRX, utilizando um difra de grafite onde se observou a presença de fases cristalinas correspondentes ao Cr2O3 e CuCr2O4. As medidas de área superficial específica dos pós pigmentantes foram realizadas em um equipamento Micromeritcs modelo ASAP 2000, utilizando N2 como gás de adsorção/desorção. As medidas colorimétricas dos pigmentos foram realizadas em um colorímetro Gretac Macbeth Color-eye spectrophotometer 2180/ 2180UV, nos padrões CIELAB. Com base nos resultados obtidos verifica-se a estabilidade térmica dos pós pigmentantes de coloração verde, o que o habilita como alternativa aos materiais atualmente empregados na indústria de pisos cerâmicos