Search Results (1,784)

Background/Objectives: Estimating the post-mortem interval (PMI) of human skeletal remains remains challenging because bone undergoes structural, molecular and optical changes that evolve differently over time and are strongly influenced by taphonomic conditions. Rather than assuming that a single multimodal classifier performs equally well across all PMI intervals, this study aimed to determine which imaging or spectroscopic modality is most informative for specific forensic decision tasks and to derive an exploratory task-specific diagnostic decision-support framework based on internally evaluated sample-level analyses. Methods: Human femoral bone samples were assigned to five PMI classes ranging from 0–2 weeks to >100 years and examined using micro-computed tomography, hyperspectral imaging, handheld and microscopic Raman spectroscopy, and NIR-ONE spectroscopy. Repeated acquisitions were aggregated at the physical-sample level. Four targeted diagnostic contrasts were defined for the present reanalysis: archaeological class 5 versus classes 1–4, early classes 1 + 2 versus later classes 4 + 5, classes 1 + 2 versus class 4 within the Raman-compatible forensic range, and class 1 versus class 2. In addition, an exploratory direct pairwise comparison of class 4 versus class 5 was performed to specifically assess the boundary between the latest forensic interval and archaeological material. Parameter-wise ROC analysis, bootstrap confidence intervals, exploratory operating points at approximately 95% specificity, and repeated stratified cross-validation were used. All preprocessing for multivariate modelling was performed within the respective cross-validation folds. Results: Diagnostic performance was strongly task-dependent. Archaeological class 5 was distinguished from classes 1–4 by micro-CT Mean2 (AUC 0.984), NIR-ONE reflectance at 1944 nm (AUC 0.980), and HSI-derived tissue water index (TWI; AUC 0.961). In the additional exploratory direct C4-versus-C5 analysis, micro-CT Mean2 showed complete separation of the available samples (AUC 1.000), while NIR-ONE reflectance at 1944 nm retained excellent discriminatory performance (AUC 0.963). In contrast, HSI-derived TWI showed only moderate direct C4-versus-C5 discrimination (AUC 0.742). For early classes 1 + 2 versus later classes 4 + 5, the device-derived HSI StO₂ index showed the highest univariate performance (AUC 0.940), followed by TWI (AUC 0.894) and the NIR spectral slope between 1550 and 1950 nm (AUC 0.860). Within the Raman-compatible forensic range, HSI remained highly informative, while Raman carbonate/phosphate and crystallinity parameters provided complementary molecular information. Class 1 versus class 2 discrimination remained moderate. Corrected five-class modelling achieved only moderate balanced accuracy and did not consistently improve upon NIR-ONE alone. Conclusions: Diagnostic performance was strongly task-dependent. In this internally evaluated cohort, micro-CT Mean2 and high-wavelength NIR-ONE features showed the strongest discrimination of archaeological-compatible C5 material, whereas HSI-derived optical indices were most informative for the separated early-versus-later contrast and Raman spectroscopy provided complementary molecular information within C1–C4. Because C5 comprised only six unique physical samples and archaeological context was confounded with chronological age, the very high C5-related AUC estimates should be regarded as exploratory, hypothesis-generating estimates rather than validated measures of chronological PMI. The proposed decision-support framework is likewise exploratory and requires independent external validation before forensic implementation. Full article

Background/Objectives: Medico-legal preparedness is relevant throughout dental education because awareness develops before independent clinical responsibility is assumed. This study examined malpractice awareness, self-perceived preparedness, legal awareness and defensive-practice tendencies among Romanian dental students, residents and dentists. Methods: A cross-sectional survey was conducted between May and June 2026 among 176 participants from the Faculty of Dentistry and its associated professional community in Craiova, Romania. The author-developed questionnaire was completed online (n = 134) or on paper at a professional conference (n = 42). Associations were assessed using non-parametric tests, ordinal logistic regression and robust linear regression. A sensitivity analysis excluded early-year students. Results: Respondents demonstrated moderate legal awareness (mean 3.29 of 5), whilst only 8.0% felt well or very well prepared to manage a malpractice-related situation. In the main model, previous legal training was associated with greater preparedness (adjusted odds ratio 2.52, 95% CI 1.03–6.15), as were resident status and professional clinical experience. In the clinically exposed subgroup (n = 68), practising dentists reported greater preparedness than clinical-year students, whereas familiarity with malpractice and paper-based participation were associated with stronger defensive-practice tendencies. Conclusions: Awareness of medico-legal issues is present across dental education, but perceived preparedness remains limited. The findings support longitudinal, applied medico-legal education and require cautious interpretation because early-year and clinically experienced respondents evaluated partly different aspects of the same phenomenon. Full article

Pedestrian-detection research and pre-crash safety assessment predominantly represent upright pedestrians, although prone, supine, lateral, seated, crouched, kneeling, partially collapsed, and fall-transition states alter target geometry, visibility, sensor signatures, and intervention time. Cross-study comparison is further limited by inconsistent posture labels, data provenance, latency boundaries, uncertainty reporting, and vehicle-response assumptions. We developed NUP-REPORT 1.0 as a provisional reporting and benchmarking framework through a structured narrative synthesis of a 45-source derivation corpus covering epidemiology, sensing benchmarks, uncertainty and assurance methods, reporting-guideline methodology, and public safety protocols. A reconstructed decision ledger documented 46 candidate concepts: 30 were retained as checklist items, 10 were assigned to an extended descriptor set, and six were merged. Each retained item was mapped to supporting evidence and classified as universal core (n = 19), component-contingent core (n = 4), or conditional (n = 7). The framework comprises six domains, a scenario-coverage matrix, five non-overlapping event timestamps, detection-referenced stopping equations, and a 30-item checklist. A purposive feasibility audit of 20 publications, including the adjacent pedestrian-detection literature not designed specifically for non-upright evaluation, illustrated checklist use. Within this sample, target orientation and static-versus-transition state were each reported explicitly in five of 20 publications (25%); none of the 17 applicable papers reported both time-to-first-detection and detection distance, none evaluated confidence calibration, and none of the 20 reported independent-unit uncertainty intervals. Vehicle-response items were non-applicable to papers making no intervention claim. These observations are sample-specific and do not estimate field-wide reporting prevalence. NUP-REPORT is not a consensus standard, certification procedure, or safety score; it is a traceable Version 1.0 proposal for study design, retrospective audit, and stakeholder refinement. Full article

Background/Objectives: Sex estimation is a fundamental component of the forensic biological profile, and the pelvis is widely regarded as the most sexually dimorphic skeletal element. This study aimed to quantify pelvic sexual dimorphism in a contemporary Turkish sample using computed tomography (CT)-derived morphometric measurements, and to evaluate the performance of several machine learning (ML) algorithms for sex classification. Methods: Fourteen pelvic measurements were obtained from CT reconstructions of 201 individuals (101 males, 100 females) by a single observer; a stratified subset of 30 cases (15 males, 15 females) was remeasured by the same observer and by a second observer to assess intra- and inter-observer reliability. Four supervised ML classifiers—logistic regression, linear discriminant analysis (LDA), random forest, and support vector machine (SVM)—were trained and evaluated using stratified 10-fold cross-validation and an independent 30% hold-out test set. Results: Thirteen of the fourteen measurements differed significantly between sexes (p < 0.05). Intra-observer reliability was excellent for all 14 measurements (ICC = 0.943–0.998), and inter-observer reliability was good to excellent (ICC = 0.834–0.996), with the lowest value observed for pubic length. Cross-validated classification accuracy ranged from 98.0% (random forest) to 99.0% (logistic regression, LDA, and SVM), with corresponding cross-validated AUC values of 0.991–0.994, with logistic regression, LDA, and SVM each achieving 100% accuracy (AUC = 1.000) on the independent hold-out set (random forest: 96.7%, AUC = 0.999). Acetabular width was identified as the single most informative predictor (univariate area under the curve = 0.972), followed by acetabular height, the subpubic angle, ischial length, the transverse pelvic outlet, and the angle of the greater sciatic notch. Conclusions: These findings demonstrate that CT-derived pelvic morphometrics, combined with machine learning classification, provide a highly accurate and reproducible method for sex estimation in a Turkish forensic context, and support the development of population-specific standards for forensic anthropological casework, pending independent external validation; the classification and effect-size estimates reported here were, however, stable under repeated cross-validation and hyperparameter optimisation. Full article

As driving becomes more automated, the driver–car interaction is changing. The steering wheel, traditionally the main interface between the driver and the vehicle, is reduced to being a part of the environment in autonomous driving. Its influence on kinematic reactions to decelerations without a prompt to take over control of the vehicle is still unknown. Therefore, low-speed sled tests with seven female volunteers matching 5th or 50th percentile anthropometrics were performed, including three upright trials and two reclined trials at backrest angles of 23° and 45° during a standardized braking pulse. A steering wheel was placed in front of the volunteers to limit available space when moving forward. Kinematic analysis focused on the forward head movement. The study showed that no targeted hand grasping towards the steering wheel occurred in either backrest configuration. Head forward excursion was slightly higher in the first upright trial for some volunteers. Less variation and lower absolute forward excursion of the head were found in the reclined trials. Without the need for a required vehicle takeover, no grasping of the steering wheel was observed among the participants studied. Full article

Forensic age determination in presumed minors is affected by a structural tension between biological uncertainty, juridical thresholds, and the ethical duty to protect childhood. Conventional dental age estimation methods provide point estimates of chronological age but do not directly address the question central to legal proceedings: whether adult status can be affirmed with certainty. This short communication introduces MIDAS (Maturity Index for Determination of Adult Status), a certainty-based, hybrid human–AI framework for adult age determination. Two forensic odontologists independently assessed mandibular third-molar development (Radicular Completion Ratio, R₈; Apical Closure Index, A₈) in 180 anonymized orthopantomographs of individuals aged 14–25 years, complemented by an AI-assisted radiomorphometric module extracting root density relative to enamel (D₇) and trabecular texture homogeneity (T_m). These parameters were integrated into a continuous Integrated Dental Maturity Index (IMD). By raising the biological reference age to 20 years and excluding the 17–20-year interval from affirmative adult classification, the framework operationalizes the precautionary principle, interpreting residual uncertainty in favor of childhood protection. As a proof of concept, this study establishes the conceptual and operational architecture of MIDAS rather than its diagnostic accuracy. Formal validation on larger and more diverse populations is required before routine forensic and medico-legal application. Should such validation confirm its performance, MIDAS could offer an ethically grounded, legally coherent, and scientifically transparent complement to conventional methods of dental age estimation and adulthood determination. Full article

Background: The forensic diagnosis of drowning lacks pathognomonic signs, and visceral weight-based indices normalised to spleen or heart weight have shown variable discriminant performance. We assessed a height-normalised revised Drowning Index (rDI) as a measure of thoracic fluid burden in confirmed drowning cases, not as a case–control test of drowning versus non-drowning deaths. Methods: Fifty-five institutional drowning cases (Ancona and Turin Province, Italy, 2008–2020) were analysed. The rDI and the original spleen-normalised Drowning Index (DI) were calculated. A multivariable linear regression assessed sex, water type, and toxicological status as simultaneous covariates; a receiver operating characteristic (ROC) analysis evaluated the within-cohort classification of water type; and the associations with the postmortem interval (PMI) were explored separately. Results: The rDI was independently associated with the male sex (standardised β = 0.391, p = 0.002) and saltwater drowning (β = 0.331, p = 0.011; adjusted R² = 0.269). The three benzodiazepine-positive institutional cases had a lower rDI in the univariate analysis (p = 0.019), but the association was not retained in the multivariable model or in a freshwater-restricted sensitivity analysis. Alcohol exposure showed no association. The water-type ROC analysis yielded an area under the curve of 0.727 (95% CI 0.553–0.871); the distributions overlapped substantially. The original DI was not associated with the variables studied. The rDI showed no significant association with the PMI within the range represented by all but one case (1–12 days). Conclusions: The rDI quantified the variation in the thoracic fluid burden within this cohort of confirmed drownings and showed moderate, exploratory water-type classification. It is not a stand-alone diagnostic test, and its discrimination ability between drowning and non-drowning deaths was not assessed. Dedicated case–control and external validation studies are required before forensic cut-offs can be recommended. Full article

The growing accumulation of microplastics in marine ecosystems, coupled with the presence of emerging contaminants such as pharmaceuticals, represents an environmental problem that has received little attention to date. The present study evaluates the potential of microplastics to act as transport vectors for pharmaceuticals through their adsorption onto two plastic polymers widely used today: polyethylene terephthalate (PET) and medium-density polyethylene (MDPE) in seawater. As a control, the same experiments were conducted in ultrapure water (Milli-Q). Both plastics were exposed to a mixture of 29 pharmaceuticals belonging to different therapeutic classes over a 28-day period, with sampling conducted at various time intervals. The identification, quantification, and characterization of the compounds were performed using ultra-high-performance liquid chromatography coupled with mass spectrometry detection. Statistical analysis was performed using R-Studio software. Outcomes reveal that the type of polymer significantly influences adsorption, with MDPE being more efficient than PET. In contrast, the type of water and the therapeutic class of the drugs were not identified as determining factors. Furthermore, a positive, albeit moderate, correlation was observed between the hydrophobicity of the pharmaceutical and its adsorption efficiency on MDPE. These findings suggest that hydrophobic interactions play a key role in the adsorption of drugs onto microplastics, providing a solid foundation for future research, such as predictive models or mitigation strategies in aquatic ecosystems. Full article

Battery state-of-health (SOH) benchmarks often mix cycles from the same cell across training and test sets. We examined whether predictor structure changes the gap between within-cell interpolation and cross-cell transfer. Seven regressors and five predictor sets were evaluated in four NASA cells (636 cycles) using ten random 80:20 splits and leave-one-cell-out (LOCO) testing repeated over ten model seeds. Across-model median random split RMSE fell from 5.00 SOH points with age alone to 1.52 with diagnostics plus age, whereas median LOCO RMSE fell only from 5.83 to 4.61; the absolute protocol gap therefore increased from 0.83 to 3.09 points, and the median cell-paired LOCO/random ratio increased from 1.24 to 4.53. With all diagnostics, model-level ratios ranged from 1.65 to 5.16, and random-versus-LOCO ranks were uncorrelated (descriptive Spearman ρ = 0.00). Holding the number of training cycles constant, increasing the number of source cells from one to three reduced median LOCO RMSE from 5.25 to 4.73 points, but 32.1% of cell–model pairs did not improve. Standardised sliced Wasserstein shift was associated with the validation ratio (descriptive ρ = 0.73) but not with absolute LOCO RMSE (ρ = −0.01). Rated capacity normalisation preserved the predictor-dependent gradient. An eight-cell Oxford analysis was limited to an age-only boundary check and was not a feature-matched replication. These four-cell laboratory results show that richer discharge diagnostics can improve represented cell interpolation much more than unseen cell transfer; claims should therefore report absolute and relative errors with complete cell-held-out validation. Full article

Background: Pharmacists, as healthcare professionals of public trust, operate within a complex legal environment involving multiple forms of professional liability, particularly civil and criminal liability. Although these forms of responsibility are formally regulated by statutory law, the practical distinction between them remains largely dependent on judicial interpretation and case-specific circumstances. Objective: The aim of this study was to assess the scale and nature of judicial proceedings involving pharmacists and to identify the most common factors leading to civil and criminal liability. Additionally, the study sought to highlight the largely under-recognized phenomenon of legal actions involving pharmacists and to determine which areas of pharmacy practice generate the greatest legal risk. Methods: The study employed a mixed-methods design combining qualitative case law analysis with descriptive quantitative assessment. A total of 146 judicial decisions involving pharmacists were reviewed, including 43 civil and 19 criminal cases constituting the principal subject of the analysis. The examined judgments were assessed with regard to factual background, legal qualification, judicial reasoning, applied legal provisions, and type of liability imposed. Cases were additionally categorized according to the nature of the violation and the protected legal interest affected. Results: A total of 146 judicial decisions involving pharmacists were identified and analyzed, including 43 civil cases and 19 criminal cases. The findings demonstrate that legal proceedings involving pharmacists are not isolated events but represent a recurring phenomenon within professional practice. Civil cases were dominated by disputes related to reimbursement claims, prescription processing, and regulatory compliance, accounting for over half of all analyzed civil proceedings. In contrast, criminal cases were less frequent but displayed substantial heterogeneity, including unlawful medicine distribution, reimbursement fraud, breaches of professional duties, and other criminal offences. Importantly, only a minority of cases involved direct patient harm, while the majority arose from administrative, organizational, and regulatory obligations associated with pharmacy practice. The analysis identified prescription reimbursement procedures, medicine dispensing regulations, and pharmacy management responsibilities as the principal sources of legal risk for pharmacists. Conclusions: Published case law demonstrates the recurrent presence and considerable diversity of legal proceedings involving pharmacists. Most cases do not arise from direct patient harm but rather from regulatory, administrative, and organizational obligations associated with pharmacy practice. Civil proceedings are predominantly linked to reimbursement and prescription-related disputes, whereas criminal cases are less common but more diverse in nature. The results highlight the need for greater legal awareness among pharmacists, enhanced risk-management education, and stronger integration of legal competencies into undergraduate and postgraduate pharmacy training. Increased recognition of legal risks may contribute to both professional protection and improved patient safety. Full article

Background: Rare diseases collectively affect millions of children worldwide and are a major cause of pediatric morbidity, mortality, and lifelong disability. Although most have a genetic basis, obtaining a timely molecular diagnosis remains challenging because of substantial clinical and genetic heterogeneity. Advances in genomic medicine are transforming rare disease diagnosis and establishing genomics as the center of precision medicine. Methods: This review summarizes current evidence on genomic approaches for pediatric rare diseases, including established and emerging sequencing technologies, their clinical applications, implementation challenges, and future directions. Results: Whole-genome sequencing is increasingly being adopted as a first-line genomic test for suspected rare genetic disorders, particularly when the phenotype is heterogeneous or does not point to a specific diagnosis. Conventional cytogenetic and targeted molecular techniques remain important complementary approaches for selected phenotypes, variant classes, and orthogonal confirmation. Gene panels are effective for well-defined phenotypes, whereas whole-exome sequencing remains a high-yield approach for genetically heterogeneous disorders, particularly when whole-genome sequencing is not available or is not clinically indicated. Long-read whole-genome sequencing expands diagnostic capacity by detecting structural variants, repeat expansions, complex rearrangements, and non-coding pathogenic variants that frequently escape short-read technologies. Emerging multi-omics approaches further improve variant interpretation and help resolve previously unsolved cases. Beyond diagnosis, molecular findings guide personalized clinical management, genetic counselling, reproductive planning, and access to targeted therapies and genotype-driven clinical trials. However, broad implementation is constrained by challenges in variant interpretation, ethical and legal considerations, data governance, workforce capacity, cost, and inequitable access to genomic services. Artificial intelligence, international data-sharing initiatives, and coordinated healthcare networks are helping overcome these barriers and improve diagnostic equity. Conclusions: Whole-genome sequencing is increasingly emerging as a first-line genomic strategy for pediatric rare diseases, while complementary technologies, expert phenotyping, and iterative data interpretation remain essential for comprehensive and accurate diagnosis and equitable access to genomic medicine. Full article

(1) Background: Communication barriers may complicate forensic psychiatric assessment of deaf or hard-of-hearing individuals. (2) Methods: This retrospective descriptive case series reviewed 450 unique adults with institutional and forensic psychiatric records at a high-security hospital in Iasi County, Romania (2015–2025). Six individuals (N = 6; 6/450, 1.33%) met the record-based criteria for profound bilateral hearing loss with severe speech or spoken-language impairment. No examination was performed specifically for the study. (3) Results: Four of six individuals had documented congenital or prelingual profound bilateral hearing loss, and two had profound bilateral coexisting conductive and sensorineural hearing-loss components. Four had no formal schooling, and two had partial compulsory schooling; all six lacked documented standardized sign-language competence. Initial records did not document effective communication access or audiological confirmation, and psychiatric formulations were inconclusive or changed over time. Forensic discernment was recorded as absent in 5/6 individuals (83.3%). (4) Conclusions: Communication limitations may have contributed to assessment uncertainty alongside educational, cognitive, psychiatric, and social factors. The series does not confirm misdiagnosis, causation, or population prevalence. Full article

Programmed death-ligand 1 (PD-L1) expression in Grade Group 1 (GG1) prostate carcinoma biopsies has not been established as a marker of pathological upgrading at radical prostatectomy (RP). This two-center retrospective case–control study included 172 men with GG1 carcinoma in the biopsy closest to RP: all 86 patients upgraded to GG2 and 86 randomly selected non-upgraded controls from 126 eligible GG1 patients. PD-L1 was assessed with the SP263 clone using the combined positive score (CPS), with CPS ≥ 1 predefined before outcome comparison. CPS ≥ 1 occurred in 36/86 upgraded cases (41.9%) and 18/86 controls (20.9%; unadjusted odds ratio [OR], 2.72; 95% confidence interval [CI], 1.39–5.33; p = 0.005). After adjustment for serum prostate-specific antigen, positive-core count, Prostate Imaging Reporting and Data System category, and center, CPS ≥ 1 remained associated with upgrading (adjusted OR, 2.91; 95% CI, 1.47–5.97; p = 0.003). A Firth bias-reduced sensitivity model including digital rectal examination yielded a similar CPS estimate. Biopsy CPS ≥ 1 was associated with biopsy–RP grade discordance, but the study does not establish an optimal cutoff, predictive performance, or clinical utility. Prospective multicenter validation, including active-surveillance outcomes, is required. Full article

Background: Cannabis contains Δ⁹-tetrahydrocannabinol (THC) together with numerous other constituents, whereas HU210 (HU) is a synthetic full agonist at cannabinoid receptors. We applied integrated metabolomics and proteomics to compare Cannabis extract (CS) and HU in GT1-7 neuronal cells. Methods: Cytotoxicity was evaluated using a lactate dehydrogenase assay. Metabolites and proteins were extracted sequentially from single-cell pellets and analyzed using gas chromatography–tandem mass spectrometry and nano-liquid chromatography–quadrupole–Orbitrap mass spectrometry, respectively. Cannabinoids in the exposure medium were quantified using liquid chromatography–tandem mass spectrometry. Results: The lowest CS and HU concentrations that were cytotoxic at 24 h and non-cytotoxic at 3 h were 2000 µg/mL and 20 µM, respectively; CS delivered 166 nM THC, 800 nM tetrahydrocannabinolic acid, and 11.3 nM cannabidiol. After 3 h, HU altered both the metabolome and the proteome, whereas CS altered the metabolome with minimal proteome change (8 of 2720 proteins). Six pathways differed, including the citrate cycle and pentose phosphate pathway. Relative to both the control and CS, HU decreased citrate; increased 2-ketoglutarate, fumarate, malate, gluconate, ribose-5-phosphate and ribose; and increased phosphoenolpyruvate carboxykinase 2, isocitrate dehydrogenase 3 subunit α, 2-oxoglutarate dehydrogenase complex component E1, succinate dehydrogenase flavoprotein subunit, malate dehydrogenase 1, 6-phosphogluconolactonase, 6-phosphogluconate dehydrogenase and phosphoglucomutase-1. CS showed the opposite metabolite changes without corresponding enzyme changes. Conclusions: At a pre-lethal time point, CS and HU produced metabolic changes in opposite directions—broad suppression versus coordinated mobilisation—despite comparable cytotoxicity at 24 h. Full article

Background: Iatrogenic fungal infections associated with contaminated parenteral products are uncommon but potentially severe, particularly when the affected patients are critically ill and the microorganism is not included in routine diagnostic panels. Here, we describe C. viswanathii candidemia associated with contaminated milrinone in an extremely preterm infant and place the case within the context of the published clinical evidence. Methods: The infant’s clinical course, microbiological findings, milrinone exposure and pharmaceutical-source investigation were retrospectively reconstructed. Published human C. viswanathii infections were reviewed systematically, together with Italian pharmacovigilance communications concerning milrinone. Results: A 600 g preterm infant developed candidemia on Day 7 of life. A central-venous-catheter (CVC) blood culture became positive for yeasts after 7 h, while the BIOFIRE^® Blood Culture Identification 2 (BCID2) Panel remained negative. C. viswanathii was recovered from blood, urine and bronchoalveolar lavage fluid (BAL). Voriconazole was started, and anidulafungin was subsequently added. The infant died on Day 13 following accidental extubation and unsuccessful resuscitation. Exposure reconstruction identified a contaminated milrinone lot, and the source investigation linked the case to the wider Italian multicenter cluster. The literature review showed that C. viswanathii can cause bloodstream, central nervous system, deep-seated and osteoarticular infection, with variable susceptibility, particularly for azoles, but no previous iatrogenic sources were found, and its ecological niche remains undefined. Conclusion: This case provides additional evidence that the Italian C. viswanathii outbreak was an iatrogenic event associated with contaminated milrinone. Recognition depended on combining extended yeast identification with medication-lot traceability and interinstitutional pharmacovigilance. Full article