Safety Assessment Research Articles

Efficacy and safety of insulin glargine 300 U/mL in people with type 2 diabetes in China: The INITIATION study.

To evaluate the efficacy and safety of insulin glargine 300 U/mL (Gla-300) in people with suboptimally controlled type 2 diabetes (T2D) in China. INITIATION (NCT05002933) was a prospective, interventional, multicentre, single-arm, phase IV study conducted in China. Individuals with suboptimally controlled T2D who were insulin naïve or switching from another basal insulin (insulin experienced) were included. The primary endpoint was the change in HbA1c from baseline to week 24. Safety assessments included hypoglycaemia and adverse events (AEs). In total, 568 participants were enrolled and 562 initiated Gla-300 treatment (189 in the insulin-naïve subgroup; 373 in the insulin-experienced subgroup). At week 24, the mean ± standard error (SE) change in HbA1c from baseline was -0.91% ± 0.05% (-9.9 ± 0.5 mmol/mol; P < .0001). Significant HbA1c reductions were also observed in the insulin-naïve (mean ± SE change: -1.38% ± 0.09% [-15.1 ± 1.0 mmol/mol]) and insulin-experienced (-0.68% ± 0.05% [-7.4 ± 0.5 mmol/mol]) subgroups (both P < .0001). During the 24-week treatment period, the incidence of confirmed hypoglycaemia (plasma glucose ≤ 3.9 mmol/L) was 39.7% for all hypoglycaemia and 13.3% for nocturnal hypoglycaemia; the incidence of severe hypoglycaemia was low (0.5%). Overall, treatment-emergent AEs (TEAEs) were reported in 126 participants (22.4%), with no serious treatment-related TEAEs. Gla-300 was effective in improving glycaemic control and had a relatively low risk of hypoglycaemia in people with suboptimally controlled T2D who were insulin naïve or switching from another basal insulin in China.

A case study to address the limitation of accident scenario identifications with respect to diverse manual responses

Probabilistic safety assessment (PSA) is a tool for securing the operational safety of nuclear power plants. One unique benefit of PSA is to identify accident scenarios leading to undesirable consequences. Since these accident scenarios result from highly complicated combinations of automatic and manual responses, a huge number of simulations are generally required with a precise thermal-hydraulic (TH) code. Therefore, current PSA typically reduces the number of TH code runs by focusing on limited numbers of safety-critical components with reasonable engineering assumptions. Nevertheless, it has been pointed out that the current catalog of accident scenarios in PSA may be insufficient to some extent. In order to corroborate this claim, in this work, 14,348,907 simulation conditions were randomly generated after combining 79 manual responses identified from the emergency operating procedure of a steam generator tube rupture (SGTR) event in a reference nuclear power plant. Results show that about 14.7 % of the simulations correspond to an undesirable consequence pertaining to the SGTR. Accordingly, in terms of enhancing the quality of PSA results, the results of this study support that it is inevitable to develop a promising way to reduce the amount of computational resources required by large numbers of TH code runs.

Critical Review of Hydrogen Safety Assessment Tools: Indian Perspective

Critical Review of Hydrogen Safety Assessment Tools: Indian Perspective

A Comparative Clinical Pharmacology Analysis of FDA-Approved Targeted Covalent Inhibitors vs. Reversible Inhibitors in Oncology.

Targeted covalent inhibitors (TCIs) are an emerging class of anticancer therapeutics. TCIs are designed to selectively engage their targeted proteins via covalent warheads. From the drug development standpoint, the covalent inhibition mechanism is anticipated to elicit the following theoretical benefits: (i) an extended duration of therapeutic action that is determined by the target protein turnover rate and not necessarily by drug half-life, (ii) a lower therapeutic dose owing to greater pharmacological potency, (iii) lower risk of off-target binding and associated adverse events, and (iv) reduced drug-drug interaction (DDI) liability due to high selectivity and low dose. Elucidating the clinical relevance of these expected benefits requires an integrated assessment of pharmacokinetics (PK), efficacy, safety, and DDI data. In this review, we compared the clinical pharmacology attributes of FDA-approved oncology TCIs within the last 10 years against their reversible inhibitor (RI) counterparts. Our findings indicated that (i) PK half-lives of TCIs were typically shorter and (ii) at their respective recommended clinical doses per drug label, the molar unbound steady state areas under the concentration-time curve (AUCss) of TCIs were lower than those of RIs, but with longer clinically observed durations of response. However, (iii) there was no conclusive evidence supporting improved clinical safety profiles for TCIs, and (iv) DDI perpetrator profiles appeared to be similar between TCIs and RIs. The overall clinical pharmacology comparison of TCI vs. RI surveyed in this paper suggested that at least two of the four forecasted clinical benefits were achieved by TCIs.

Use of catastrophe theory to establish safety assessment model for timber-framed heritage buildings

Use of catastrophe theory to establish safety assessment model for timber-framed heritage buildings

Update to RIFM fragrance ingredient safety assessment, β-methylphenethyl alcohol, CAS Registry Number 1123-85-9

Update to RIFM fragrance ingredient safety assessment, β-methylphenethyl alcohol, CAS Registry Number 1123-85-9

RF-DYNA — Software for optimized random finite element simulation using LS-DYNA

This paper presents a user-friendly software to assign spatially distributed material properties to nonlinear finite element models in LS-DYNA using discretized three dimensional random fields and random variables. The purpose of the software is to enable probabilistic analysis frameworks that incorporate results from LS-DYNA simulations with random material properties. The software leverages the existing well-established deterministic formulation of LS-DYNA by utilizing inbuilt material constitutive laws. K-nearest neighbors spatial interpolation and k-means clustering are implemented to streamline the generation and assignment of random fields to parts in LS-DYNA models. The functionality of the software is demonstrated through real-life safety assessments of two marine structural elements composed of steel-reinforced concrete. Analysis results demonstrated the robustness and efficiency of the software where it can be successfully integrated into analysis frameworks to evaluate the safety of structural members.

The investigation on an ethnic medicinal plant of Elsholtiza bodinieri Vaniot: Chemical constituents, acute, 28-day subacute and 90-day subchronic toxicity evaluation

Ethnopharmacological significanceElsholtiza bodinieri Vaniot, belonging to the family Lamiaceae, has important medicinal value in Yunnan province of China. Traditionally, its aerial parts have been used as an ethnomedicine to treat diaphoresis, headache, fever, cough, pharyngitis, dyspepsia, and hepatitis. However, the safety assessment of E. bodinieri is still unexplored.Aim of the study: This study aimed to investigate the phytochemical constituents of the hot water extract from E. bodinieri (HEEB) and evaluate the 14-day acute, 28-day subacute and 90-day subchronic toxicity by oral administration in Sprague-Dawley (SD) rats. Materials and methodsThe chemical constituents of HEEB were analyzed by UHPLC-ESI-HRMS/MS. Firstly, SD rats were chosen for a single oral administration of the maximum dose of 5000 mg/kg to evaluate toxicity. Subsequently, consecutive 28-day subacute and 90-day subchronic toxicity assessments of HEEB were conducted on Sprague-Dawley (SD) rats through repeated doses of 2500, 1250, 625, and 312.5 mg/kg for the former, and 1500, 1000, and 500 mg/kg for the latter. For toxicity evaluation, hematology and serum biochemical indicators were determined, and major organs of the rats were collected to calculate organ coefficients. Additionally, hematoxylin-eosin (H&E) staining was performed on the collected tissues to assess histopathological changes induced by repeated oral administration of HEEB. ResultsA total of 23 compounds were identified by UHPLC-ESI-HRMS/MS analysis. Acute toxicity assessment revealed that oral administration of HEEB did not induce mortality and unnormal behavior changes in female rats over a 14-day period, suggesting that the approximate lethal dose (ALD) was higher than 5000 mg/kg. In consecutive 28-day and 90-day toxicity evaluations, HEEB doses of 2500 mg/kg and 1500 mg/kg resulted in hepatic and kidney tissue damage in both female and male rats, which was verified by the increased levels of AST, ALT, BUN, Na+, and Cl−. ConclusionsAfter the acute, 28-day subacute and 90-day subchronic toxicity evaluation, the No Observed Adverse Effect Level (NOAEL) was determined as 1000 mg/kg/day. These findings not only provided a safety information for its medicinal and edible application, but also promoted the further comprehensive development of this plant.

Multicenter, open-label, prospective study shows safety and therapeutic benefits of a defined ginkgo biloba extract for adults with Major Neurocognitive Disorder.

Safety and therapeutic effects of gingko biloba extract EGb 761® to treat cognitive decline have been demonstrated in numerous clinical trials. However, trials in Indian populations have been lacking. This open-label, multicenter, single-arm, phase IV trial enrolled 150 patients aged ≥50 years with Major Neurocognitive Disorder due to Alzheimer's disease, major vascular neurocognitive disorder, or mixed forms of both according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria and a Mini-Mental State Examination (MMSE) score of 12-24. Patients took 120 mg EGb 761® twice daily for 18 weeks. Therapeutic effects were assessed by CERAD Constructional Praxis and Recall of Constructional Praxis (CERAD CP, CERAD Recall of CP), Trail-Making Test (TMT), Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD), Clinical Global Impressions (CGI) scale and 11-point box scales for tinnitus and vertigo. Safety assessment was based on the occurrence of adverse events as well as changes in clinical, laboratory and functional parameters. After 18 weeks, significant improvements compared to baseline were found in constructional praxis (CERAD CP, p&lt;0.0001), memory (CERAD Recall of CP, p&lt;0.0001), speed and executive functioning (TMT A, p&lt;0.0001; TMT B, p&lt;0.0001), and behavioral symptoms (BEHAVE-AD, p&lt;0.0001). Forty-five adverse events were reported in 33 (22.0%) patients in total, including ten presumed adverse drug reactions in 9 (6.0%) patients. Headache and diarrhea of mild-to-moderate severity were the most frequent events. Two serious adverse events, both considered unrelated to the study drug, occurred in 2 (1.3%) patients. This study confirmed the favorable safety profile and suggested therapeutic benefits of EGb 761® in Indian patients with Major Neurocognitive Disorder.

Characterization of omalizumab updosing patterns and predictive factors in chronic spontaneous urticaria: A prospective multicentric observational study.

Limited information is available on the use of omalizumab (OMA) updosing since its introduction as a second-line therapy in chronic spontaneous urticaria (CSU) in 2014. Practical guidelines from health authorities are lacking, and the specific characteristics of patients requiring higher doses remain unknown. Our objectives were to characterize the patterns of OMA updosing (defined as changes in dose and/or injection intervals), to identify the predictive factors associated with updosing, and to improve CSU management. We conducted a prospective, multicentric, real-life observational study, including patients diagnosed with CSU and starting OMA. The data were collected at 0, 3, 6, and 9 months. The primary endpoint was the frequency of OMA updosing at 3 months. The secondary endpoints included an analysis of updosed patients' profile, and an assessment of OMA efficacy and safety. We included 153 patients. Twenty percent of patients were updosed at 3 months, and 27% in total during the 9-month follow-up. Practitioners mainly chose to increase the frequency of injections (66%). At baseline, the updosed patients were more likely to have more severe CSU (UCT < 4, p < 0.030), a lower lymphocyte count (<2000/mm3, p = 0.037), and low IgE levels (<70 UI/mL, p = 0.024). The side effects of OMA were not more frequent after updosing. One in five patient underwent updosing within just 3 months. OMA updosing is frequent in particular in cases of severe disease and low IgE blood levels.

Integration of miniaturized sample preparation and molecularly imprinted polymers in food analysis

The use of innumerable chemical compounds in food production to enhance agricultural quality and yield has raised significant global concerns regarding food safety. To address these concerns, miniaturized solid sample preparation techniques have emerged as an appealing strategy for analyzing chemical residues in complex samples, notably those found in food matrices. The efficacy of these miniaturized solid extraction procedures hinges largely on the choice of the sorbent phase. Molecularly imprinted polymers (MIPs) have been introduced as highly selective and versatile sorbent phases for a wide range of miniaturized solid techniques. Their remarkable selectivity is attributed to the creation of distinct cavities during the synthesis process, which subsequently accommodate the target analyte when the sample is applied. This unique characteristic empowers MIP polymers to exhibit exceptional specificity toward the desired analyte. The use of MIPs as sorbent phases in miniaturized sample preparation methods has shown great potential to increase the analytical performance of residue evaluation in food matrices. Therefore, here we present a comprehensive overview of the current landscape of miniaturized solid sample techniques employing MIPs as sorbent phases for the assessment of residues in food samples. Moreover, this review is primarily on recent reports concerning the application of MIPs in solid-phase microextraction (SPME), in-tube SPME, microextraction by packed sorbent (MEPS), disposable pipette extraction (DPX), solid-phase extraction in pipette tip (SPE-PT) and stir bar sorptive extraction (SBSE). Lastly, we will bring some future topics concerning the use of MIPs in miniaturized sample preparation methods for food analysis in order to bring some new avenues for enhancing food products' safety and quality assessment.

Clinical reasoning and clinical judgment in nursing research: A bibliometric analysis.

To characterize the thematic foci, structure, and evolution of nursing research on clinical reasoning and judgment. Bibliometric analysis. We used a bibliometric method to analyze 1528 articles. We searched the Scopus bibliographic database on January 7, 2024. Through a keyword co-occurrence analysis, we found the most frequent keywords to be clinical judgment, clinical reasoning, nursing education, simulation, nursing, clinical decision-making, nursing students, nursing assessment, critical thinking, nursing diagnosis, patient safety, nurses, nursing process, clinical competence, and risk assessment. The focal themes, structure, and evolution of nursing research on clinical reasoning and judgment were revealed by keyword mapping, clustering, and time-tracking. By assessing key nursing research areas, we extend the current discourse on clinical reasoning and clinical judgment for researchers, educators, and practitioners. Critical challenges must still be met by nursing professionals with regard to their use of clinical reasoning and judgment within their clinical practice. Further knowledge and comprehension of the clinical reasoning process and the development of clinical judgment must be successfully translated from research to nursing education and practice. This study highlights the nursing knowledge gaps with regard to nurses' use of clinical reasoning and judgment and encourages nursing educators and professionals to focus on developing nurses' clinical reasoning and judgment with regard to their patients' safety. In addressing nurses' use of clinical reasoning and judgment, and with regard to patient safety in particular, this study found that, in certain clinical settings, the use of clinical reasoning and judgment remains a challenge for nursing professionals. This study should thus have an effect on nursing academics' research choices, on nursing educators' teaching practices, and on nurses' clinical practices. Relevant EQUATOR guidelines have been adhered to by employing recognized bibliometric reporting methods.

Safety assessment of electrosurgical electrodes by using mini pig tissue

Electrosurgical electrodes are the main dissecting devices widely used for surgeries throughout the world. The present study aimed to evaluate the thermal injury and safety within animals' organs following a minimally invasive electrosurgery technique with electrosurgical electrode AE40-300 (LIPO) and AE20-80 (LIFT). To ensure the effective application of electrosurgery in a clinical environment, it is crucial to minimize heat-induced injury to nearby tissues. In this study, the skin, liver, kidney, and femoral muscle dissected from 9 minipigs were used in tissue thermal spread experiments. Thermal imaging area analysis, maximum temperature, and time to reach basal temperature were evaluated. Thermography results revealed that the surgical temperature was significantly lower in the minimally invasive electrosurgery with AE40-300 (LIPO) and AE20-80 (LIFT) compared to the predicate device. In addition, AE40-300 (LIPO) and AE20-80 (LIFT) created a relatively small thermal injury area and thermal diffusion. Our results indicated that the tested devices named AE40-300 (LIPO) and AE20-80 (LIFT) reduced excessive thermal injury and could be applied to clinical use safely.

Study on percutaneous penetration of representative cosmetic ingredients in a baby wipe product in an in vitro diaper rash skin model

Studying percutaneous penetration of various cosmetic ingredients through intact and compromised skin can provide insight on quantitative exposure assessment for baby products intended for diapered skin. We developed an in vitro model (tape-stripped human skin) designed to achieve the Trans-Epidermal Water Loss values measured in babies with various degrees of diaper dermatitis. Six reference compounds showed the impact of physicochemical properties on absorption through this “diaper rash” skin model. Under simulated diaper conditions, dermal absorption of cosmetic ingredients (phenoxyethanol, sodium benzoate, benzyl alcohol, disodium EDTA, and propylene glycol) was different, but <100%. Additionally, the effect of diaper rash on dermal absorption of phenoxyethanol, sodium benzoate, and benzyl alcohol (well-absorbed ingredients) was limited (enhancement of 1.1–1.3), while the enhancement for disodium EDTA and propylene glycol (moderately absorbed compounds) was 1.8–3.3. Absorption via skin with “diaper rash” is specific to individual ingredients and exposure conditions, so a fixed uncertainty factor is not appropriate for safety assessment. The data support that the default 100% dermal absorption commonly used in first-tier risk assessments for diapered skin is conservative. This diaper rash skin model provides a practical tool of estimating absorption of various ingredients in baby products intended for diapered skin.

Bearing capacity and failure behavior of segments with a mid-span opening of a shield subway tunnel

This paper investigates the load-bearing properties and failure mechanisms of shield segments with a circular mid-span opening in shield subway tunnels. Two full-scale specimens with opening diameters of 100 and 200 mm were manufactured and tested, revealing that with an increasing opening diameter, the failure mode transferred from uniform tensile fracture of inner arc concrete to the peeling and crushing of the outer arc concrete. Moreover, the loading process can be divided into four stages, i.e. elastic, plastic expansion, failure, and ultimate stages, and each stage shares a critical load. Subsequently, numerical models were established using the elastoplastic damage constitutive of concrete, and its reliability is verified by the experimental results. Afterward, parametric analysis was performed considering the plain concrete loss and reinforced concrete loss. The analysis results show that the plain concrete loss significantly weakens the cracking load of the segment, while reinforced concrete loss has the greatest impact on the failure load. Finally, a comparative analysis is conducted between the bearing characteristics of the local failure segment, standard shield segment, and the segment joint. Overall, the research results can provide a theoretical basis for the field reinforcement and the safety assessment of local failed shield tunnels.

An Analytical Safety Tree for Heritage Buildings: Application to the Archaeological Museum “Domenico Ridola”, Matera (Italy)

ABSTRACT Historical masonry construction is a significant architectural typology that represents the cultural identity of Western Europe. Exposure to seismic events seriously compromises the conservation of architectural heritage, as evidenced by recent earthquakes. In this context, the process of knowledge acquisition, vulnerability evaluation, and planning interventions becomes fundamentally important to identify and implement maintenance and conservation strategies. Safety trees, never used for seismic engineering purposes, are particularly effective in making safety-related decisions in potentially hazardous or complex situations. This paper proposes an analytical framework to evaluate the structural safety of cultural heritage buildings, using an analytical safety tree. This instrument is here applied to assist safety assessments, risk management, and process optimization. Specifically, the proposed tree encompasses a multi-step procedure characterized by three possible vulnerability assessments, with the advantage of providing an overview of the knowledge state, detected pathologies, and analysis of a heritage building, outlining a path to follow to ensure the safety of built heritage. The work first formalizes this new tool, starting from the classical theory of safety decision trees. Secondly, to demonstrate the potential of the approach, the decision tree is developed and applied to the safety assessment of the Archaeological Museum “Domenico Ridola” in Matera, Italy.

Comprehensive assessment of clean-up strategies for optimizing an analytical multi-method to determine pesticides and mycotoxins in Brazilian medicinal herbs using QuEChERS-LC-TQ-MS/MS.

The use of medicinal herbs has increased significantly. However, the presence of pesticide residues and mycotoxins in medicinal herbs has generated constant discussion and concern among regulatory agencies. Developing and validating an analytical method for determining pesticides and mycotoxins in medicinal plants is challenging due to the naturally occurring substances in these plants. The purpose of this work was to develop and to optimize a sensitive, accurate, precise, effective QuEChERS method for simultaneous determination of over 160 pesticide and mycotoxin residues in complex medicinal plant matrices using LC-TQ-MS/MS. A comprehensive comparison of clean-up procedures and other parameters was conducted to achieve this goal. The validation procedure was performed according to SANTE 11312/2021. More polar analytes, such as acephate, methamidophos and omethoate, presented a higher negative matrix effect in both Melissa officinalis L. and Malva sylvestris L. However, other molecules, such as spirodiclofen, showed a 24% signal enhancement in M. officinalis and a 46% signal suppression in M. sylvestris, indicating that a representative matrix-matched calibration would lead to inaccurate quantification of the analyte. Accuracy and precision were satisfactory according to SANTE 11312/2021 for 157 pesticide residues and mycotoxins in M. officinalis and for 152 molecules in M. sylvestris. LOQs at 10 µg kg-1 were achieved for 117 pesticides in M. officinalis and 99 pesticides in M. sylvestris. Among the mycotoxins, all four aflatoxins (B1, B2, G1 and G2) presented LOQs of 5 µg kg-1, and ochratoxin A had an LOQ of 10 µg kg-1 in M. officinalis. The same LOQ values were shown for these mycotoxins in M. sylvestris, except for aflatoxin B2 and ochratoxin A, which had LOQs of 20 µg kg-1. Moreover, in Southern Brazil, there has been no previous study on mycotoxin and pesticide contamination in medicinal herbs. Therefore, the application of this method was assessed through the analysis of forty-two real samples. Imidacloprid was found in M. officinalis, and methyl pirimiphos was found in M. sylvestris. The proposed method not only serves as a helpful tool for routine monitoring but also offers a basis for further research on risk assessment and control in food safety.

A Phase 1 Assessment of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of (2R,6R)-Hydroxynorketamine in Healthy Volunteers.

(R,S)-Ketamine (ketamine) is a dissociative anesthetic that also possesses analgesic and antidepressant activity. Undesirable dissociative side effects and misuse potential limit expanded use of ketamine in several mental health disorders despite promising clinical activity and intensifying medical need. (2R,6R)-Hydroxynorketamine (RR-HNK) is a metabolite of ketamine that lacks anesthetic and dissociative activity but maintains antidepressant and analgesic activity in multiple preclinical models. To enable future assessments in selected human indications, we report the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of RR-HNK in a Phase 1 study in healthy volunteers (NCT04711005). A six-level single-ascending dose (SAD) (0.1-4 mg/kg) and a two-level multiple ascending dose (MAD) (1 and 2 mg/kg) study was performed using a 40-minute IV administration emulating the common practice for ketamine administration for depression. Safety assessments showed RR-HNK possessed a minimal adverse event profile and no serious adverse events at all doses examined. Evaluations of dissociation and sedation demonstrated that RR-HNK did not possess anesthetic or dissociative characteristics in the doses examined. RR-HNK PK parameters were measured in both the SAD and MAD studies and exhibited dose-proportional increases in exposure. Quantitative electroencephalography (EEG) measurements collected as a PD parameter based on preclinical findings and ketamine's established effect on gamma-power oscillations demonstrated increases of gamma power in some participants at the lower/mid-range doses examined. Cerebrospinal fluid examination confirmed RR-HNK exposure within the central nervous system (CNS). Collectively, these data demonstrate RR-HNK is well tolerated with an acceptable PK profile and promising PD outcomes to support the progression into Phase 2.

Safety Assessment of Methylxanthines as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of three methylxanthines, Caffeine, Theobromine, and Theophylline, as used in cosmetics. All of these ingredients are reported to function as skin-conditioning agents in cosmetic products. The Panel reviewed the data relevant to the safety of these ingredients and concluded that Caffeine, Theobromine, and Theophylline are safe in cosmetics in the present practices of use and concentration described in this safety assessment.

Probiotic Potential of Lactobacillus and Enterococcus Strains Isolated From the Faecal Microbiota of Critically Endangered Hangul Deer (Cervus hanglu hanglu): Implications for Conservation Management.

The mammalian gut microbiota plays a crucial role in promoting host health, and lactic acid bacteria (LAB) are commonly employed as probiotics for their beneficial effects. The Hangul deer (Cervus hanglu hanglu), a critically endangered red deer subspecies found in the Indian subcontinent, requires meticulous health management for its conservation. This pioneering study aimed to isolate, identify, and evaluate the in-vitro probiotic functional properties of LAB strains from the faeces of Hangul deer. A total of 27 LAB strains were isolated and identified using 16S rDNA gene sequencing, followed by comprehensive probiotic characterization and safety assessment. Remarkably, four species exhibited robust resistance and survivability against varying pH levels and bile salts, along with high aggregation and co-aggregation capacities. Notably, Lactobacillus acidophilus and Enterococcus mundtii strains displayed antibacterial activities. Safety assessment revealed the absence of hemolytic activity and virulence genes in all four strains. Antibiotic susceptibility testing showed that Lactobacillus acidophilus and Enterococcus casseliflavus were susceptible to all tested antibiotics, while Enterococcus mundtii exhibited resistance to clindamycin, and Enterococcus gallinarum exhibited resistance to erythromycin. These findings suggest that the isolated LAB strains possess advantageous probiotic characteristics and hold potential as dietary supplements for promoting the health and disease management of Hangul deer.