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1.
Mechanism of action, potency and efficacy : considerations for cell therapies
Carl G. Simon Jr., Erich H. Bozenhardt, Christina M. Celluzzi, David Dobnik, Melanie L. Grant, Uma Lakshmipathy, Thiana Nebel, 2024, izvirni znanstveni članek

Povzetek: One of the most challenging aspects of developing advanced cell therapy products (CTPs) is defining the mechanism of action (MOA), potency and efficacy of the product. This perspective examines these concepts and presents helpful ways to think about them through the lens of metrology. A logical framework for thinking about MOA, potency and efficacy is presented that is consistent with the existing regulatory guidelines, but also accommodates what has been learned from the 27 US FDA-approved CTPs. Available information regarding MOA, potency and efficacy for the 27 FDA-approved CTPs is reviewed to provide background and perspective. Potency process and efficacy process charts are introduced to clarify and illustrate the relationships between six key concepts: MOA, potency, potency test, efficacy, efficacy endpoint and efficacy endpoint test. Careful consideration of the meaning of these terms makes it easier to discuss the challenges of correlating potency test results with clinical outcomes and to understand how the relationships between the concepts can be misunderstood during development and clinical trials. Examples of how a product can be “potent but not efficacious” or “not potent but efficacious” are presented. Two example applications of the framework compare how MOA is assessed in cell cultures, animal models and human clinical trials and reveals the challenge of establishing MOA in humans. Lastly, important considerations for the development of potency tests for a CTP are discussed. These perspectives can help product developers set appropriate expectations for understanding a product’s MOA and potency, avoid unrealistic assumptions and improve communication among team members during the development of CTPs.
Ključne besede: cell therapy product, efficacy endpoint test, mechanism of action, potency test, metrology
Objavljeno v DiRROS: 27.05.2024; Ogledov: 36; Prenosov: 22
.pdf Celotno besedilo (4,26 MB)
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2.
Susceptibility of X17CrNi16-2 martensitic stainless steel to hydrogen embrittlement after conventional and deep cryogenic heat treatment
Mirjam Bajt Leban, Bojan Zajec, Bojan Podgornik, Črtomir Donik, Patricia Jovičević Klug, Miha Hren, Andraž Legat, 2024, izvirni znanstveni članek

Povzetek: A low carbon/ high chromium martensitic stainless steel, X17CrNi16-2, was heat treated using two different hardening and tempering regimes (1050 ◦ C/480 ◦ C or 980 ◦C/600 ◦C) — promoting either a high strength or high toughness state, respectively and further combined with deep cryogenic treatment (DCT) at 196 ◦C for 24 h. Over recent years DCT has been recognized as a promising technique to improve the properties of steel, predominantly with respect to its tensile strength, toughness and wear resistance. The influence of DCT on the hydrogen embrittlement resistance of martensitic stainless steel has not yet, however, been reported. A slow strain rate tensile test (SSRT) with simultaneous cathodic hydrogen charging was selected as the method to assess potential susceptibility to hydrogen embrittlement (HE). Relatively low-intensity hydrogen charging, utilizing a constant current density of 0.1 mA/cm2, in a non-corrosive, slightly alkaline buffer solution, led to a clear reduction in the ultimate tensile stress. This reduction, and therefore the HE susceptibility, was more pronounced in the steel with a higher strength (i.e. that subject to the 1050 ◦C/ 480 ◦C heat treatment condition). Furthermore, DCT did not appear to have any impact on the steel’s mechanical properties in the presence of hydrogen. Fractographic analysis showed clear evidence of HE in the hydrogen-charged specimens. This paper presents results of the SSRT tests and further fractography results, and discusses the impact of conventional and deep cryogenic treatment on HE susceptibility.
Ključne besede: martensitic stainless steel, deep cryogenic treatment, hydrogen embrittlement, slow strain rate tensile test
Objavljeno v DiRROS: 23.05.2024; Ogledov: 75; Prenosov: 75
.pdf Celotno besedilo (17,73 MB)
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3.
Influence of test methodology on the characterization of the parallel-to-grain timber embedment strength and foundation modulus of dowels
Caroline D. Aquino, Rodrigues Leonardo G., Michael Schweigler, Meta Kržan, Zheng Li, Jorge M. Branco, 2024, izvirni znanstveni članek

Povzetek: A reliable determination of the embedment strength and foundation modulus of timber elements is critical for the design and safety assessment of joints in timber structures. However, the existence of various test configurations for characterising the embedding properties of large diameter steel fasteners in timber elements poses challenges in directly comparing and utilising available test data. This paper aims to provide an insight into the influence of embedment property test methods, comparing experimental results from different test setups within the guidelines of the EN 383 and ASTM D 5764-97a standards for European softwood species, Scots pine wood (Pinus sylvestris) and Norway spruce (Picea abies). In addition to the test guidelines, the thickness of the specimen and the application of the load was evaluated within the protocols. A comprehensive statistical analysis was performed to identify statistically significant differences between the groups evaluated. The results of the analysis revealed disagreement between the standards in the evaluation of the strength of the embedding, highlighting the potential bias inserted by the experimental setup and protocol. Furthermore, it was proven that the thickness of the specimens influences both the embedding strength and the foundation modulus of the wood species tested. Finally, no distinctions were observed between tensile and compressive loading within the guidelines of the EN 383 standard.
Ključne besede: embedment strength, foundation modulus, dowel-type connections, test methods
Objavljeno v DiRROS: 15.04.2024; Ogledov: 148; Prenosov: 80
.pdf Celotno besedilo (3,96 MB)
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4.
Quality checking of polymer modified bitumens in Slovenia
Marjan Tušar, Lidija Ržek, Mojca Ravnikar Turk, 2021, objavljeni znanstveni prispevek na konferenci

Povzetek: For many years the properties of bitumen have been determined based on mechanical tests as needle penetration, Ring&Ball and Fraass fracture temperature. For elastomer (styrene-butadiene-styrene) polymer modified bitumens these tests are not sufficient to show the important differences in bitumens. Elastic recovery and cohesion provide better insight, but rheological properties cannot be adequately described with conventional test. The requirements of the polymer modified bitumens (PmB) in Europe were defined in EN14023 in 2010 [1]. Since then several new tests were introduced in the research field and their procedures improved. In the European Standards Committee (CEN) TC 336, there is on-going work to develop performance related specifications. New laboratory test methods from American standards were adapted and transformed into EN standards (bitumen laboratory aging methods and rheological tests). These test methods are not yet employed in the cur-rent PmB European standard, however, the draft prEN 14023, April 2020 [2] suggests these new tests. In the recent years at ZAG Laboratory for asphalts and bitumen-based products long-term aging of bitumen by pressure aging vessel (PAV) and rheological tests were introduced. Traditional bitumen test methods are performed together with new rheological testse.g. Dynamic Shear Rheometer (DSR) testing, to characterize complex modulus and phase angle, and Multiple Stress Creep Recovery Test (MSCRT) in order to develop a preliminary data base on PmB’s, which are frequently used in Slovenia. The paper presents the current requirements for PmB’s in Slovenia and test results on PmB 45/80-65, original, laboratory aged and extracted from produced asphalt mixtures.
Ključne besede: polymer modified bitumen, recovered bitumen, laboratory ageing, dynamic shear rheometer, multiple stress creep recovery test
Objavljeno v DiRROS: 28.02.2024; Ogledov: 173; Prenosov: 125
.pdf Celotno besedilo (703,78 KB)
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5.
Grain size distribution of DP 600 steel using single-pass asymmetrical wedge test
Urška Klančnik, Peter Fajfar, Jan Foder, Heinz Palkowski, Jaka Burja, Grega Klančnik, 2023, izvirni znanstveni članek

Ključne besede: wedge test, hot-rolling, grain size distribution, dual-phase steel
Objavljeno v DiRROS: 07.02.2024; Ogledov: 223; Prenosov: 92
.pdf Celotno besedilo (4,64 MB)
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6.
An outbreak of Verticillium dahliae on sycamore maple in a forest stand in Slovenia
Ana Brglez, Zina Devetak, Nikica Ogris, Sebastjan Radišek, Barbara Piškur, 2024, izvirni znanstveni članek

Povzetek: Verticillium dahliae Kleb., the causal agent of Verticillium wilts, is a devastating plant disease affecting many plant species. Fungus V. dahliae was detected in a partially artificially established Acer pseudoplatanus L. forest stand in central Slovenia. This finding incited further study about the risk of different sources of V. dahliae isolates for maples in forests and the pathogenicity of three V. dahliae isolates of different origins was tested on saplings of A. pseudoplatanus, A. platanoides L., and A. campestre L. The inoculated saplings exhibited disease symptoms, i.e., leaf necrosis and wilting. At the end of the pathogenicity test, typical xylem browning was visible on the cross-sections, and the pathogen was successfully re-isolated. The isolates showed significant differences in their pathogenicity to specific maple hosts, with the agricultural isolate (originated from bell pepper) being the most aggressive on all three maple species. The disease severity index (DSI) and relative area under the disease progress curve (rAUDPC), as well as the success of re-isolation, indicate that A. platanoides is the most susceptible to inoculation with V. dahliae. In addition, significant differences in sapling biomass were observed between treated and control plants. These results suggest that maples in forest stands are threatened by V. dahliae, and biosecurity measures should be considered and implemented in forest management to reduce the transmission and potential spread of the pathogen.
Ključne besede: Verticillium wilt, Acer spp., pathogenicity test, Disease severity index, DSI, Area under the disease progress curve, AUDPC, biosecurity
Objavljeno v DiRROS: 07.02.2024; Ogledov: 317; Prenosov: 288
.pdf Celotno besedilo (1,72 MB)
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7.
8.
Mechanical properties of high carbon low-density steels
Jiri Hajek, Zbyšek Nový, Ludmila Kucerova, Hana Jirková, Črtomir Donik, Zdeňek Jansa, 2023, izvirni znanstveni članek

Ključne besede: low density steels, heat treatment, tensile test
Objavljeno v DiRROS: 02.02.2024; Ogledov: 197; Prenosov: 89
.pdf Celotno besedilo (10,85 MB)
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9.
Patogenost izolatov izbranih vrst gliv na Pinus sylvestris L. IN P. nigra Arnold
Ana Brglez, Barbara Piškur, Nikica Ogris, 2023, izvirni znanstveni članek

Povzetek: Na sadikah rdečega in črnega bora smo testirali patogenost osmih izbranih izolatov gliv (Corinectria fuckeliana, Diaporthe eres, Diplodia pinea, Fusarium sp. 1 in 2, Fusicolla sp., Nectria dematiosa in Tympanis sp.), ki smo jih izolirali iz obolelih borovih dreves v Sloveniji v letih 2020 in 2021. Inokulirali smo skupno 115 sadik borov (vključno s kontrolo), periodično smo preverjali njihovo zdravstveno stanje in ob prvih znakih sušenja opravili reizolacije iz robov nastalih nekroz. Reizolacije so bile uspešne le v primeru inokulacije z vrstami gliv Diplodia pinea, Diaporthe eres in Fusarium sp. 2. Povprečna dolžina nekroz sadik rdečega bora, inokuliranih z D. pinea, Di. eres in Tympanis sp., se je statistično značilno razlikovala od kontrolnih sadik (p < 0,05). Pri sadikah črnega bora pa so se za statistično značilne izkazale povprečne dolžine nekroz pri kontroli in inokulacijah z glivama D. pinea in Tympanis sp. (p < 0,05).
Ključne besede: test patogenosti, reizolacije, Pinus sylvestris, rdeči bor, Pinus nigra, črni bor
Objavljeno v DiRROS: 25.01.2024; Ogledov: 550; Prenosov: 219
.pdf Celotno besedilo (2,17 MB)
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10.
Evaluation of ash pozzolanic activity by means of the strength activity index test, frattini test and DTA/TG analysis
Sabina Dolenec, Vilma Ducman, 2018, izvirni znanstveni članek

Povzetek: The pozzolanic activity of five different types of ash was studied using various direct and indirect methods. In addition to strength activity index (SAI) determination and the Frattini test, ash pozzolanicity was assessed via differential thermal and thermogravimetric analyses (DTA/TG) after curing for 7, 28 and 90 days. The results showed that, due to their respective mineralogical, chemical and physical characteristics, the ashes exhibited different levels of pozzolanic activity in terms of the amount of lime with which they could chemically bind, as well as reaction kinetics. Although SAI and Frattini test results were not in agreement in the case of some of the ashes, DTA/TG analysis revealed that a certain amount of portlandite was consumed, thus confirming the occurrence of a pozzolanic reaction. The results also showed that ashes with higher amounts of reactive SiO2 were more reactive, while those with higher BET surface areas displayed a faster pozzolanic reaction rate.
Ključne besede: biomass ash, DTA/TG, fly ash, Frattini test, pozzolanic activity, SAI
Objavljeno v DiRROS: 11.12.2023; Ogledov: 244; Prenosov: 115
.pdf Celotno besedilo (1,05 MB)
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