The first biosimilar approved for the treatment of osteoporosis

To demonstrate the clinical comparability between RGB-10 (a biosimilar teriparatide) and the originator, a comparative pharmacokinetic trial was conducted. The study was successful in establishing bioequivalence. Marketing authorisation for RGB-10 (Terrosa®) was granted by the European Medicines Agency in 2017.Teriparatide, the first bone anabolic agent, is the biologically active fragment of human parathyroid hormone. The imminent patent expiry of the originator will open the door for biosimilars to enter the osteology market, thereby improving access to a highly effective, yet prohibitively expensive therapy.Subsequent to establishing comparability on the quality and non-clinical levels between RGB-10, a biosimilar teriparatide, and its reference product (Forsteo®), a randomised, double-blind, 2-way cross-over comparative study (duration: four days) was conducted in 54 healthy women (ages: 18 to 55 years) to demonstrate the pharmacokinetic/pharmacodynamic (PK/PD) equivalence and comparable safety of these products. Extents of exposure (AUC0-tlast) and peak exposure (Cmax), as measured by means of ELISA, were evaluated as co-primary PK endpoints, and serum calcium levels, as measured using standard automated techniques, were assessed for PD effects. Safety was monitored throughout the study.The 94.12% CIs for the ratio of the test to the reference treatments, used due to the two-stage design (85.20-98.60% and 85.51-99.52% for AUC0-tlast and Cmax, respectively), fell within the 80.00-125.00% acceptance range. The calcium PD parameters were essentially identical with geometric mean ratios (GMRs) of 99.93% and 99.87% for AUC and Cmax, respectively. Analysis of the safety data did not reveal any differences between RGB-10 and its reference.Based on the high level of similarity in the preclinical data and the results of this clinical study, marketing authorisation for RGB-10 (Terrosa®) was granted by the European Medicines Agency (EMA) in 2017

ACE and ACTN3 genes polymorphisms among female Hungarian athletes in the aspect of sport disciplines

The aim of the study was to determine the importance of two sport-associated gene polymorphisms, alpha-actinin-3 R577X (ACTN3) and angiotensin-converting enzyme I/D (ACE), among Hungarian athletes in different sports. The examination was carried out only on women (n = 100). Sport-specific groups were formed in order to guarantee the most homogeneous clusters. Human genomic DNA was isolated from blood, and genotyping was performed by polymerase chain reaction. To measure the differences between the participating groups, Chi-squared test was performed using Statistica 9.0 for Windows® (significance level: p 0.05) were compared. A similarity was detectable in the I allele frequencies of the water polo (61.11%) and kayaking/rowing (56.67%) groups. The ACTN3 R/X polymorphism showed no differences in comparison with the sport groups. R allele frequencies were higher in every group compared to the X allele. The potential significance of the ACE I allele in sports of an aerobic nature was not clearly confirmed among Hungarian athletes

ROLE OF ENVIRONMENTAL FACTORS ON THE REPRODUCIBILITY OF LEMNA TEST

Lemna minor is a species easy to collect and culture in laboratory, and can give rapid test results. However, in order to standardise toxicity tests using Lemna minor as test organism, it is important to find out what natural variability different populations might have. Five Lemna populations were used for comparison. It contained two standard cultures and three populations collected in natural habitats. Potassium dichromate was applied as test material. Lemna populations cultured under the same condi- tions showed different TD and LC50 values. There is an inverse relation between the sensitivity and TD of the strains. It is supposed that growth rate and sensitivity of Lemna populations depend on environmen- tal factors characterising the habitat in which the given popluation originally lives

Sensitivity of ecotoxicological tests in analysis of superfund sites

During the analysis of environmental risk posed by hazardous waste disposal sites, ecological impact on whole ecosystems should be assessed. It requires a complex testing scheme where surrogate species represent key elements of the ecosystem. However, different organisms are exposed to a differing degree, also, their sensitivity to the same contaminant may vary. A possible way to determine which test reflects most the actual toxic conditions, correlation can be calculated between the measured ecological parameter (such as growth inhibition, mortality, etc.) and  a contaminant gradient. The basic aim of this study was to determine which ecotoxicological test shows the best correlation with the measured analytical parameters. The selected tests were Lemna minor (representing primary producers), Thamnocephalusplatyurus (a primary consumer organism) and Vibrio fischeri (decomposer). When testing soil samples, the Thamnocephalus test showed excellent consistency with most contaminants but was oversensitive in the case of groundwater samples. The Vibriofischeri bioluminescence inhibition test (ToxAlert) behaved in a different way, reflecting well the distribution of most contaminants in groundwater samples. Finally, Lemna test proved to be completely inadequate

Assessment of degradability in whole effluent toxicity testing using bioluminescent bacteria

In whole effluent toxicity (WET) testing the aggregate toxicity of an effluent is measured, using different test organisms. Although these predicted deleterious effects will occur in natural (real-world) ecosystems, the tests are performed in the laboratory, under strictly controlled conditions. However, there are many reasons why these test results cannot be directly applied for real-world ecosystems. One basic problem is that exposure changes with space and time. Several physical, chemical and biological processes can result in significant decreases in exposure concentrations of a test substance over time. For many industrial effluents biodegradation is perhaps the most important process which affects the environmental concentration of the test substance. Biodegradation is a specific process as not only appropriate abiotic conditions are necessary but also a competent bacterial population, both anaerob and aerob should be established. Our main goal was to assess how toxicity of a selected industrial effluent changes over time, caused by degradation. In order to measure the aggregate toxicity of the effluent the ToxAlert ®100 luminometer was used, developed by Merck. This test is in compliance with ISO/EN/DIN 11348. The use of the bioluminescent bacterium Vibrio fischeri (or other bacteria) has several advantages comparing to conventional toxicity testing. The test is rapid and causes no ethical problems. Our results has shown that toxicity changes caused by degradation can be appropriately followed by bioluminescent bacteria