This study used nanofluidic protein posttranslational modification (PTM) profiling to measure the effects of six cannabidiol (CBD) oils and isolated CBD on the signaling pathways of a cultured SH-SY5Y neuronal cell line. Chemical composition analysis...
Pyrrolizidine alkaloids (PAs) present distinct toxicity potencies depending on their metabolites and in vivo toxicokinetics. To represent the potency differences of various PAs, the interim relative potency (REP) factors have been derived. However, l...
Over the last decade, incredible progress has been made in the development of non-animal tests to assess contact hypersensitivity. Four methods have been successfully validated and Organisation for Economic Co-operation and Development (OECD) guideli...
The paper provides an overview of existing Integrated Testing Strategies (ITS) for assessing hazard and potency of skin sensitization. The ITS research is active, diverse and constantly evolving as new assays are being developed and new mechanistic i...
Skin sensitisation is a critical adverse effect assessed to ensure the safety of compounds and materials exposed to the skin. Alongside the development of new approach methodologies (NAMs), defined approaches (DAs) have been established to promote sk...
Quality control testing of vaccines, including potency assessment, is critical to ensure equivalence of clinical lots. We developed a potency assay to support the clinical advancement of Nous-209, a cancer vaccine based on heterologous prime/boost ad...
Toxicological assessments of skin sensitizers have progressed towards a higher reliance on non-animal methods. Current technological trends aim to extend the utility of non-animal methods to accurately characterize skin-sensitizing potency. The GARDs...
Per- and polyfluoroalkyl substances (PFASs) are persistent and bioaccumulative contaminants frequently detected in animal-derived foods, raising concerns for consumer health. In 2020, the European Food Safety Authority (EFSA) established a group tole...
6 July 2022
Humans are routinely exposed to complex mixtures such as polycyclic aromatic hydrocarbons (PAHs) rather than to single compounds, as are often assessed for hazards. Cytochrome P450 enzymes (CYPs) metabolize PAHs, and multiple PAHs found in mixtures c...
Botulinum neurotoxins (BoNTs) are potent neurotoxins produced by bacteria, which inhibit neurotransmitter release, specifically in their physiological target known as motor neurons (MNs). For the potency assessment of BoNTs produced for treatment in...
The potency and challenges of sorghum development in tidal swamplands in Indonesia have yet to be well studied. Thus, our study is the first to evaluate the land suitability, economic performance, and strategies for developing sorghum in the tidal sw...
31 May 2021
Organophosphate pesticides (OPPs) exhibit neurodevelopmental toxicity. To evaluate the effect of prenatal exposure to OPPs in the Japan Environment and Children’s Study, a nationally representative birth cohort study, 4575 maternal urine samples were...
The potencies of topical corticosteroid products have mainly been classified using clinical data but in some instances, the US Food and Drug Administration’s (FDA’s) vasoconstrictor assay (VCA) to assess the skin blanching response has also been used...
(1) Background: When it comes to estimating the annoyance potency of odors, European countries relate to different guidelines. In a previous study we compared complaint rates for different agricultural odors, but due to different guidelines, the resu...
Botulinum neurotoxin type-A (BoNTA) is one of the seven different serotypes (A to G) produced by Clostridium botulinum. A stability-indicating size-exclusion chromatography (SEC) method was developed and validated, and the specificity was confirmed b...
For many years, oncological clinical trials have taken advantage of dendritic cells (DC) for the design of DC-based cellular therapies. This has required the design of suitable quality control assays to evaluate the potency of these products. The pur...
Transferon® is a blood product with immunomodulatory properties constituted by a complex mixture of peptides obtained from a human dialyzable leukocyte extract (DLE). Due to its complex nature, it is necessary to demonstrate batch consistency in...
Aviation is one of the sectors affecting climate change, and concerns have been raised over the increase in the number of flights all over the world. To reduce the climate impact, efforts have been dedicated to introducing biofuel blends as alternati...
Assessing the neutralization capability of nonlethal but medically relevant toxins in venom has been a challenging task. Nowadays, neutralization efficacy is evaluated based simply on the survival rates of animals injected with antivenom together wit...
Ambient PM2.5-bound ions, OC, EC, heavy metals (HMs), 18 polycyclic aromatic hydrocarbons (PAHs), 7 hopanes, and 29 n-alkanes were detected at Tuoji Island (TI), the only marine background atmospheric monitoring station in North China. The annual PM2...
The current study evaluated the effects of quality of reinforcement on the resurgence of target behavior responding. We defined higher- or lower-quality stimuli in terms of reinforcer potency, and specifically by the identified extent to which a rein...
Objectives: Developing ex vivo models that replicate immune–tumor interactions with high fidelity is essential for advancing immunotherapy research, as traditional two-dimensional in vitro systems often lack the complexity required to fully rep...
Preslaughter starvation and subacute ruminal acidosis in cattle are known to promote ruminal proliferation of atypical enteropathogenic Escherichia coli strains, thereby increasing the risk of meat and milk contamination. Using bacteriophages (hencef...
Neuraminidase is a key enzyme in the life cycle of influenza viruses and is present in some bacterial pathogens. We here assess the inhibitory potency of plant tannins versus clinically used inhibitors on both a viral and a bacterial model neuraminid...
Upper respiratory infections (URI) are the most frequent illnesses, especially in children. The majority of those infections are prescribed broad-spectrum antibiotics, which are associated with various side effects and with the increase in multi-drug...
Zika virus (ZIKV) has become endemic in multiple tropical and subtropical regions and has the potential to become widespread in countries with limited prior exposure to this infection. One of the most concerning sequelae of ZIKV infection is the tera...
Vaccinations to prevent infectious diseases are given to target the body’s innate and adaptive immune systems. In most cases, the potency of a live virus vaccine (LVV) is the most critical measurement of efficacy, though in some cases the quant...
The development of bacteriophages (phages) as active pharmaceutical ingredients for the treatment of patients is on its way and regulatory agencies are calling for reliable methods to assess phage potency. As the number of phage banks is increasing,...
The safe and effective dosing of botulinum neurotoxins (BoNTs) requires accurate and reliable methods to measure their potency. Several novel methods have been introduced over the past decade; however, only few studies have compared the potency of Bo...
Several Bevacizumab products are approved for clinical use, with many others in late-stage clinical development worldwide. To aid the harmonization of potency assessment across different Bevacizumab products, the first World Health Organization (WHO)...
Botulinum neurotoxins (BoNTs) are important therapeutic agents. The in vivo median lethal dose (LD50) assay has been commonly used to measure the potency of BoNT commercial preparations. As an alternative, we developed cell-based assays for abobotuli...
Venoms are complex mixtures of biologically active molecules that impact multiple physiological systems. Manufacture of antivenoms (AVs) therefore requires potency testing using in vivo models to ensure AV efficacy. As part of ongoing research to rep...
7 November 2018
Polycyclic aromatic hydrocarbons (PAHs) that are bound to particulate matter can have adverse effects on human health. Particle size plays an important role in assessing health risks. The aim of this study was to compare concentrations of PAHs bound...
Naja atra, also known as Taiwanese cobra, is one of the most prevalent venomous snakes in Taiwan. Clinically, freeze-dried neurotoxic antivenom (FNAV) produced from horses by Taiwan Centers for Disease Control (CDC) has been the only approved treatme...
Regulations of cosmetic ingredients and products have been the most advanced in embracing new approach methodologies (NAMs). Consequently, the cosmetic industry has assumed a forerunner role in the development and implementation of animal-free next-g...
Since 2015, outbreaks of foot-and-mouth disease (FMD) in the Middle East have been caused by a new emerging viral lineage, A/ASIA/G-VII. Invitro vaccine matching data indicated that this virus poorly matched (low r1-value) with vaccines that were bei...
The aim of this study was to evaluate an in vitro method using the EpiOralTM model, a three-dimensional cultured human buccal epithelium, for assessing the oral irritation potential of various products. We evaluated different concentrations of nine c...
The potency of vaccines must be determined to ensure that the appropriate dose is given. The manufacture and assessment of influenza vaccines are complicated by the continuously changing nature of the pathogen, which makes efficacy estimates difficul...
Geographic isolation and other factors result in evolution-driven diversity of the enzymatic composition of venom of pit vipers in the same genus. The present investigation sought to characterize venoms obtained from such genetically diverse Ovophis...
Background/Objectives: Persistent inflammation driven by cytokines/chemokines plays a crucial role in the pathogenesis of numerous chronic inflammatory and autoimmune conditions, including rheumatoid arthritis, atopic dermatitis, and ulcerative colit...
Acinetobacter baumannii is a nosocomial pathogen, and its biofilms are tolerant to desiccation, nutrient starvation, and antimicrobial treatment on biotic and abiotic surfaces, tissues, and medical devices. Biofilm formation by A. baumannii is trigge...
Pyrovalerone cathinones are potent psychoactive substances that possess a pyrrolidine moiety. Pyrovalerone-type novel psychoactive substances (NPS) are continuously detected but their pharmacology and toxicology are largely unknown. We assessed sever...
Differences in botulinum neurotoxin manufacturing, formulation, and potency evaluation can impact dose and biological activity, which ultimately affect duration of action. The potency of different labeled vials of incobotulinumtoxinA (Xeomin®; 50...
Nanoparticle engineering via plants (green synthesis) is a promising eco-friendly technique. In this work, a green protocol was applied to the preparation of silver, zinc, and selenium nanoparticle solutions supported by the extracted aerial parts of...
Background: Colorectal cancer (CRC) remains a significant global health burden, with KRAS mutations driving ~40% of cases. The efficacy of recently approved, mutant-specific KRAS inhibitors is limited by mutational status as well as intrinsic and ada...
A series of branched tetrapeptide Schiff bases 3–6 were designed and synthesized from corresponding tetrapeptide hydrazide 2 as a starting material.In vitroevaluation of the synthesized compounds 4–6 against breast MCF-7 carcinoma cells i...
21 March 2016
The present study investigated the influence of the cigarette smoke extract (CSE) on mammalian thioredoxin reductase (TrxR) activity. TrxR is a selenoenzyme with a selenocysteine (Sec) residue exposed on the enzyme’s surface. This unique Sec residue...
Kidney xenotransplantation has been attracting attention as a treatment option for end-stage renal disease. Fetal porcine kidneys are particularly promising grafts because they can reduce rejection through vascularization from host vessels. We are pr...
Pharmaceutical drugs are available to astronauts to help them overcome the deleterious effects of weightlessness, sickness and injuries. Unfortunately, recent studies have shown that some of the drugs currently used may degrade more rapidly in space,...
Background/Objectives: Antibody–drug conjugates are a rapidly evolving class of cancer therapeutics that combine the specificity of monoclonal antibodies with the potency of cytotoxic drugs. This review explores experimental and computational a...
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