Estudos de medicamentos biosimilares

In Brazil, the registration of new drugs is carried out only when the regulatory agency (Anvisa, acronym in Portuguese) is fully satisfied with the evidence of their quality, efficacy and safety, presented by a pharmaceutical industry that strive for this registration. With the patent expiration, pharmaceutical companies are attracted to produce biological medicines called biosimilar or biogenerics or simply generics, whose approval may result in reduced treatment costs. But it is necessary that the biosimilar be, at least, equally efective and safe and without contaminants in relation to the original. Recent consensus guidelines aim to establish criteria for efcacy and safety of these medicines. Preclinical studies in vitro and in vivo, the origin of raw materials and clinical studies phase I, II and III are recommended for biosimilar medicine registration in the international market. Low molecular weight heparins are found in this situation. In this review we specifcally addressed this type of medicine, which could serve as a benchmark for other biosimilar medicines.

Geographic distribution and parturition of mabuya arajara Rebouças-Spieker, 1981 (Squamata, sauria, scincidae) from Ceará, northeastern Brazil

Mabuya arajara Rebouças-Spieker, 1981 has been considered an endemic species from the southern of state of Ceará, restricted to the Deciduous Dry Forests in the slopes of Plateau of Araripe (Chapada do Araripe). Here, we present an updated distributional map for the species and demonstrate that its range is not restricted as formerly believed. In addition, we had an opportunity to observe a gravid female and we describe aspects regarding parturition and number of offspring for the species.

Path formulation for multiparameter D3-equivariant bifurcation problems

We implement a singularity theory approach, the path formulation, to classify D3-equivariant bifurcation problems of corank 2, with one or two distinguished parameters, and their perturbations. The bifurcation diagrams are identified with sections over paths in the parameter space of a Ba-miniversal unfolding f0 of their cores. Equivalence between paths is given by diffeomorphisms liftable over the projection from the zero-set of F0 onto its unfolding parameter space. We apply our results to degenerate bifurcation of period-3 subharmonics in reversible systems, in particular in the 1:1-resonance.

Poverty and income distribution in Latin America: on the complementarities between trade policy and social public spending

Includes bibliography

Integración regional y políticas públicas: evaluación de la experiencia europea y posibles implicaciones para la integración latinoamericana

Incluye Bibliografía

Changes in the distribution of income and the New Economic Model in Jamaica

Includes bibliography

Notes on the measurement of poverty by the income method

Includes bibliography

Policy response to poverty and inequality in the developing world

Includes bibliography

Pharmacokinetic Profile of A New Diclofenac Prodrug without Gastroulcerogenic Effect

Gastrotoxicity is a major problem for long-term therapy with non-steroidal anti-inflammatory drugs (NSAIDs). DICCIC (1-(2,6-dichlorophenyl)indolin-2-one) is a new diclofenac prodrug, which has proven anti-inflammatory activity without gastroulcerogenic effect. The aim of this work was to compare the pharmacokinetic profiles of diclofenac from DICCIC (7.6 mg/kg equivalent to 8.1 mg/kg diclofenac) and diclofenac (8.1 mg/kg) administration in Wistar rats weighing 250-300 g (n=20). The doses were calculated by interspecific allometric scaling based on the 2 mg/kg from diary human dose of diclofenac. Blood samples were collected in heparinized tubes via the femoral artery through the implanted catheter. The plasma was separated and quantitation was made in a HPLC system with a UV-Vis detector. The confidence limits of the bioanalytical method were appropriate for its application in a preclinical pharmacokinetic study. The AUC of diclofenac from DICCIC (53.7± 5.8 ug/mL.min) was significantly less (Mann Whitney test, p<0.05) than that of diclofenac from diclofenac administration (885.9 ± 124,8 ug/mL.min). Terminal half-life of diclofenac from DICCIC (50.1 ± 17.2 min) was significantly less (Mann Whitney test, p<0.05) than that of diclofenac from diclofenac administration (247.4 ± 100.9 min). Still the parameters clearance and distribution volume were calculated for diclofenac from diclofenac, whose results were 9.2 ±1.2 mL/min.kg and 3.3 ±1.2 L/kg, respectively. The results of DICCIC from DICCIC administration were 108.9 ± 19.6 mL/min.kg and 7.8 ± 2.4 L/kg for clearance and distribution volume, respectively. The pharmacokinetic profile demonstrated that there was an increase in diclofenac elimination and a lower exposure to diclofenac with administration of DICCIC compared to diclofenac. © 2013 Bentham Science Publishers.

From widespread to microendemic: Molecular and acoustic analyses show that Ischnocnema guentheri (Amphibia: Brachycephalidae) is endemic to Rio de Janeiro, Brazil

Many species of tropical amphibians are restricted to very small ranges, and this microendemism coupled with ongoing habitat loss and susceptibility to emerging pathogens imperils the long-term persistence of these species. Incomplete taxonomic and distributional knowledge may obscure conservation assessment, particularly in putatively widespread species that are typically considered to be of Least Concern in Red List assessments, but that in fact may constitute complexes of partly microendemic species. Such is the case in the Steindachner's Robber Frog, Ischnocnema guentheri which, together with the recently recognized Ischnocnema henselii, is thought to occupy most of the Brazilian Atlantic Forest. To test whether these taxa may constitute a species complex of range-restricted and thus potentially threatened species, we analyzed 160 samples of I. guentheri and/or I. henselii for two molecular markers, 16S rRNA (16S) and recombination activation gene 1 (RAG1). To verify the monophyly of the complex, closely related species were also included in the 16S analysis. Congruent evidence from the molecular data and from analyses of advertisement calls support the existence of six distinct species within the complex: I. guentheri and I. henselii as well as four candidate new species. The lineages are distributed as a mosaic in the Atlantic Forest and are sympatric at some localities without indication of admixture. Their phylogeographical pattern partially agrees with paleo-models for the Atlantic Forest, but also suggests the existence of micro-refugia in less stable areas. I. guentheri, previously considered to be widespread, was found only in its type locality, a reserve within the urban area of Rio de Janeiro city. Although none of the species studied appears highly threatened with extinction, we recommend their IUCN threat status to be re-evaluated carefully for the next comprehensive update of the Red List of Brazil's amphibians. © 2013 Springer Science+Business Media Dordrecht.

The dimensional regularization in light front

We use dimensional regularization (DR) to evaluate a one-loop four-point function to order g2 in a scalar φ4 model using the light-front coordinates and performing the light-front energy variable integration in the first place. The DR in the light-front is applied to the D - 2 transverse variables. We show the equivalence of the result thus obtained with the standard DR applied to D dimensions. © 2013 American Institute of Physics.

Pareiorhina hyptiorhachis, a new catfish species from Rio Paraíba do Sul basin, Southeastern Brazil (Siluriformes, Loricariidae)

Pareiorhina hyptiorhachis is described from Ribeirão Fernandes and Rio Pomba, Rio Paraíba do Sul basin, Brazil. The new species is distinguished from its congeners (P. brachyrhyncha, P. carrancas, P. cepta, and P. rudolphi) by the presence of a conspicuous ridge on the trunk posterior to the dorsal fin (postdorsal ridge), simple teeth, a completely naked abdomen, a round dorsal profile of the head, greater suborbital depth and greater head width. We discuss the distributional pattern of the new species and its congeners and hypothesize that headwater capture is responsible for the distribution of Pareiorhina species across different watersheds in southeastern of Brazil.

A new species of Metrodorea (Rutaceae) from Brazil: Morphology, molecular phylogenetics, and distribution

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Painéis de partículas de madeira leucena e resina poliuretana derivada de óleo de mamona

This research aimed to test particleboard with leucena (Leucaena leucocephala) wood particles and polyurethane resin castor oil based. The response variables are: modulus of rupture (MOR), internal adhesion (AI), apparent density (dap) and wood moisture content (um). The experiments were developed based on the methodological procedures of the ABNT NBR 14810:2002 standard. The particleboards were manufactured by hot-pressing at 4MPa and 90°C, using timber particles with 5% of moisture content and 10% of monocomponent and bicomponent polyurethane resin. The higher moisture content was achieved when the monocomponent polyurethane resin was used. The bicomponent polyurethane resin provided a percent increase of 43.7% and 22.7% on the modulus of rupture and apparent density, respectively, when compared to the standard limit. The internal adhesion of the panels manufactured with monocomponent resin was 2.45 times higher than the standard limit. The confidence interval between means revealed that the internal adhesion and apparent density exhibited statistical equivalence. A good correlation between the internal adhesion and apparent density was found, for this reason it was possible to estimate the internal adhesion of the panels based on the apparent density data.

The algebraic structure behind the derivative nonlinear Schrödinger equation

The Kaup-Newell (KN) hierarchy contains the derivative nonlinear Schrödinger equation (DNLSE) amongst others interesting and important nonlinear integrable equations. In this paper, a general higher grading affine algebraic construction of integrable hierarchies is proposed and the KN hierarchy is established in terms of an Ŝℓ2Kac-Moody algebra and principal gradation. In this form, our spectral problem is linear in the spectral parameter. The positive and negative flows are derived, showing that some interesting physical models arise from the same algebraic structure. For instance, the DNLSE is obtained as the second positive, while the Mikhailov model as the first negative flows. The equivalence between the latter and the massive Thirring model is also explicitly demonstrated. The algebraic dressing method is employed to construct soliton solutions in a systematic manner for all members of the hierarchy. Finally, the equivalence of the spectral problem introduced in this paper with the usual one, which is quadratic in the spectral parameter, is achieved by setting a particular automorphism of the affine algebra, which maps the homogeneous into principal gradation. © 2013 IOP Publishing Ltd.