Clinical trials in South Korea are heavily concentrated in Seoul, limiting patient access in other regions. We conducted a cross-sectional ecological study of 17 Korean administrative divisions to assess regional infrastructure readiness for decentralized clinical trial (DCT) implementation, using data from the Health Insurance Review and Assessment Service (2024), the National Health Insurance Service (2024), and the Ministry of Food and Drug Safety (2024 to 2025). Provincial densities for four resource domains (specialists, nurses, beds, and medical equipment) were calculated per 100,000 patients and normalized to Seoul (= 1.00). Area-specific composite indices for four therapeutic areas were computed as the capped geometric mean of specialist and equipment densities, and an overall infrastructure index as the capped geometric mean of all four domain densities. Trial density was derived from 1,924 approved trials yielding 7,760 trial-center pairs (99% mapping rate). Among the 16 non-Seoul provinces, bed density was the most dispersed (coefficient of variation [CV] = 0.39, range 0.58 to 2.91), whereas specialist density was the most Seoul-concentrated of the four domains: no non-Seoul province reached 80% of Seoul's level (CV = 0.23, range 0.42 to 0.79). The four therapeutic-area composite indices showed comparable dispersion (CV 0.15 to 0.23; composite infrastructure CV 0.16; Pearson r = 0.72). Gwangju exhibited the largest gap between infrastructure capacity (index 0.94) and trial activity (density ratio 0.18). Clinical trial activity in Korea is disproportionately low relative to infrastructure, and regionspecific DCT strategies matched to local resource profiles can provide a practical framework for balanced trial participation.
Pharmacometrics has become a pivotal component of drug development and regulatory science in Korea, evolving from traditional pharmacokinetic (PK)/pharmacodynamic (PD) modeling to advanced approaches such as physiologically based pharmacokinetic (PBPK) modeling and quantitative systems pharmacology (QSP). This study reviews 192 pharmacometrics projects conducted between 2016 and 2024 by Korea's first pharmacometrics service company, covering diverse modalities, indications, and development stages. Key applications included first-in-human dose prediction, clinical trial design, and patient population-specific PK/PD modeling, with systematic tracking of regulatory outcomes and publications. While oncology remained the dominant therapeutic area, recent projects expanded into gene therapy, GLP-1 agonists, pediatric orphan indications, and advanced biologics including antibody-drug conjugates, bispecific antibodies, and engineered fusion proteins-using PBPK and semi-mechanistic models. These case-driven analyses highlight the growing regulatory impact and strategic value of pharmacometrics. As the field moves into a new era shaped by artificial intelligence/machine learning integration and Food and Drug Administration-driven new approach methodologies initiatives, this review not only reflects on past practices and achievements but also provides strategic perspectives to guide the future direction of pharmacometrics in Korea.
Low-dose combination therapies are recommended when monotherapy fails to control hypertension. This exploratory study aimed to compare the pharmacokinetics (PK) of 2 fixed-dose combinations (FDCs) of telmisartan, amlodipine, and chlorthalidone: half-dose test FDC (20/2.5/6.25 mg) and a conventional-dose reference FDC (40/5/12.5 mg). A randomized, open-label, single-dose, parallel-group study was conducted in healthy participants. Each participant received a single oral dose of either the test or reference FDC. Serial blood samples for telmisartan, amlodipine, and chlorthalidone were collected up to 72 hours post-dose, and PK parameters were calculated using noncompartmental analysis. The mean maximum plasma concentrations (Cmax) of telmisartan, amlodipine, and chlorthalidone were 41.34 and 155.75 μg/L, 1.74 and 4.42 μg/L, and 39.36 and 104.86 μg/L for the test and reference FDCs, respectively. The mean area under the concentration-time curves to the last measurable time point (AUClast) were 659.93 and 1,673.51 h·μg/L for telmisartan, 57.98 and 128.75 h·μg/L for amlodipine, and 831.73 and 1,826.86 h·μg/L for chlorthalidone. The test FDC demonstrated systemic exposure levels ranging from 0.27- to 0.39-fold for telmisartan, 0.39- to 0.44-fold for amlodipine, and 0.38- to 0.46-fold for chlorthalidone, compared to the reference FDC. In conclusion, the PK profiles of the half-dose test FDC were consistent with the known characteristics of the individual components. These provide the first PK data for this half-dose test FDC and may support its potential as an alternative treatment option for hypertension. However, as this was an exploratory study, the results should be interpreted with caution. Trial Registration:Clinical Research Information Service Identifier: KCT0010166.
Drug-drug interactions (DDIs) are a significant concern in clinical practice, DDIs might be relevant when drugs with pH-dependent solubility are co-administered with gastric acid-reducing agents (ARAs) such as histamine, H2-receptor antagonists and proton pump inhibitors. One class prone to such DDI at the absorption phase are the weakly basic protein kinase inhibitors (PKIs). The aim of this work is to review recent Food & Drug Administration (FDA) and European Medicines Agency (EMA) submissions for PKIs and evaluate the various approaches by drug developers to characterize pH-dependent DDI liability potentially affecting efficacy in this class of drugs and assess how this impacts the labelling. For this purpose, 32 FDA New Drug Applications (NDAs) and 25 EMA Market Authorization Applications of PKIs in the last 5 years (2019 through 2024) were reviewed More than two-thirds of the submissions included a dedicated clinical DDI studies with an ARA, which remains the most frequent approach to evaluating gastric pH-dependent DDIs among the PKIs investigated, albeit model-informed drug development approaches are also attempted by applicants in about 20% of the submissions. In cases where no clinical DDI study was submitted and alternative approaches taken, this was accepted by the approving agencies. Only the complete absence of data on the DDI potential triggered the request to provide the information post-marketing. A risk-based approach, considering the drug's properties and patient population, is crucial for determining the need for a clinical DDI study and should be discussed with the agencies during drug development.
Linezolid is an oxazolidinone antibiotic widely used to treat gram-positive infections and is associated with frequent adverse drug reactions (ADRs). Nevertheless, comprehensive evaluations of the incidence and risk factors of linezolid-related ADRs remain limited, with substantial variability across studies. This study aimed to evaluate the incidence of linezolid-associated ADRs and identify potential risk factors. A retrospective analysis was conducted using the Clinical Data Warehouse of Seoul National University Bundang Hospital (2003-2025). Among patients receiving at least one dose of linezolid, thrombocytopenia, neutropenia, anemia, leukopenia, and lactic acidosis were identified as ADRs. Kaplan-Meier analysis assessed cumulative incidence, and univariable and multivariable logistic regression were performed to identify risk factors. Among 1,198 patients, the cumulative incidences of thrombocytopenia, anemia, leukopenia, neutropenia, and lactic acidosis within three months after linezolid treatment initiation were 44.7%, 57.3%, 45.8%, 29.9%, and 27.5%, respectively. Concomitant use of trimethoprim-sulfamethoxazole was associated with anemia, while female sex and receipt of fresh frozen plasma transfusion were associated with lactic acidosis. Red blood cell transfusion was associated with an increased incidence of thrombocytopenia. This study demonstrated a higher incidence of linezolid-associated ADRs than previously reported in registration clinical trials. While several concomitant medications and clinical factors were identified as potential risk factors, associations involving transfusion-related variables should be interpreted cautiously, as they likely reflect underlying clinical vulnerability rather than a direct causal effect. These findings emphasize the importance of ADR monitoring during linezolid therapy and further research on the underlying mechanisms of linezolid-associated toxicity.
Management of hypertension and hyperlipidemia is important to reduce the risk of cardiovascular disease, and a fixed-dose combination (FDC) of antihypertensive and lipid-lowering drugs is expected to reduce the pill burden and increase patient compliance. The aim of this study was to compare the pharmacokinetics (PKs) of candesartan, amlodipine, and atorvastatin FDC versus separate tablets. A randomized, open-label, single-dose, 2-treatment, 3-sequence, 3-period, partial replicated crossover study was conducted in healthy subjects. A total of 51 subjects were randomized into 1 of 3 sequences and received a single dose of either an FDC or separate tablets of candesartan 8 mg, amlodipine 5 mg, and atorvastatin 10 mg, with a 14-day washout period in between. Plasma samples were collected up to 72 hours after dosing. Plasma concentrations of candesartan, amlodipine and atorvastatin were assayed using a validated LC-MS/MS method, and PK parameters were determined by noncompartmental analysis. As a result, 43 subjects were included in PK analysis for candesartan, atorvastatin, and 42 subjects were included in PK analysis for amlodipine. The geometric mean ratios (90% confidence intervals) of the area under the plasma concentration-time curve from time zero to the last sampling time and maximum plasma concentration were 0.9637 (0.9192-1.0104) and 0.9360 (0.8885-0.9861) for candesartan, 0.9694 (0.9417-0.9978) and 0.9930 (0.9575-1.0299) for amlodipine, and 1.0350 (0.9891-1.0831) and 1.0658 (0.9370-1.2123) for atorvastatin, respectively. This study suggested that the FDC formulation of candesartan, amlodipine, and atorvastatin showed PK equivalence compared to separate tablets. Trial Registration:ClinicalTrials.gov Identifier: NCT04611932.
Alzheimer's disease (AD) is the most common cause of dementia. AD exhibits notable sex-related disparities in prevalence, progression, and treatment response. With the recent approval of anti-amyloid-beta monoclonal antibodies-aducanumab, lecanemab, and donanemab-understanding sex differences in their clinical effects has become increasingly relevant. This review article investigates sex differences in the pharmacokinetics, efficacy, and safety of aducanumab, lecanemab, and donanemab and discusses the possible mechanism underlying the observed differences. Although sex-specific analyses were largely underreported in clinical trials, population pharmacokinetic models identified sex as a covariate affecting clearance and volume of distribution for aducanumab and lecanemab and higher exposure to lecanemab was predicted for females. Subgroup analyses of phase 3 trials revealed that males tended to experience greater benefit from aducanumab and lecanemab, whereas females showed better response to donanemab. The overall incidence of adverse events, including amyloid-related imaging abnormalities, did not show significant differences between sexes. Potential mechanisms underlying these differences include sex-related variations in blood-brain barrier permeability, apolipoprotein E4-associated neuroinflammatory responses, and baseline disease characteristics. These findings underscore the need for future AD clinical trials to incorporate sex-based analyses and to consider sex as a key factor in optimizing treatment strategies.
Tegoprazan is a potassium-competitive acid blocker that directly inhibits the gastric proton pump, whereas famotidine is a histamine-2 receptor antagonist that indirectly suppresses acid secretion with known tolerance to repeated dosing. This phase 1 study evaluated the pharmacokinetics, pharmacodynamics, and safety of tegoprazan 12.5 mg twice daily (BID) compared with tegoprazan 25 mg once daily (QD) and famotidine 20 mg BID in healthy subjects. Thirty-six participants were randomized to one of the 3 regimens for 14 days. In pharmacokinetic analysis, tegoprazan 12.5 mg BID showed lower steady-state Cmax but higher trough concentrations than 25 mg QD, while overall systemic exposure was comparable, with a Day 14 geometric mean ratio for area under the concentration-time curve over 24 hours of 1.08 (90% confidence interval, 0.85-1.36). Pharmacodynamic assessment using 24-hour intragastric pH monitoring demonstrated superior and sustained acid suppression with tegoprazan 12.5 mg BID. On Day 14, the percentage of time with intragastric pH > 3 over 24 hours was 75.1% with tegoprazan 12.5 mg BID, compared with 55.4% with 25 mg QD and 40.3% with famotidine. Both tegoprazan regimens maintained relatively consistent acid suppression from Day 1 to Day 14 (71.8% to 75.1% and 56.4% to 55.4%), whereas famotidine showed a decline (65.3% to 40.3%). Similar time-dependent patterns were observed during the nighttime period and in the supine position. Tegoprazan 12.5 mg BID was well tolerated, with no adverse events reported in this group. These findings suggest that low-dose tegoprazan 12.5 mg BID provides safe and sustained acid suppression.
Orlistat, phentermine/topiramate, and liraglutide are widely used obesity pharmacotherapies, but comparative data from Asian real-world settings remain limited. We compared their effects on body weight, glycemic control, and persistence. We performed a retrospective cohort study using electronic health records from a tertiary hospital in Korea. Adults prescribed orlistat, phentermine/topiramate, or liraglutide between 2018 and 2025 were included. The primary endpoint was percentage weight change at 6 months. Secondary endpoints were the proportions achieving ≥5% and ≥10% weight loss, weight change at 3, 6, and 12 months, change in HbA1c, and 12-month treatment persistence. We applied multivariable linear and logistic regression, linear mixed-effects models, propensity score-weighted models, and Kaplan-Meier and restricted mean survival time (RMST) methods. Among 1,910 treatment episodes, 505 involved orlistat, 777 phentermine/topiramate, and 628 liraglutide. Phentermine/topiramate showed greater mean percentage weight loss at 6 months than orlistat (adjusted difference, -1.59 percentage points; p < 0.001), whereas liraglutide produced similar weight loss to orlistat. The odds of achieving ≥5% weight loss were higher with phentermine/topiramate than with orlistat (adjusted odds ratio, 2.21), while liraglutide showed a smaller effect. Liraglutide tended to reduce HbA1c more than orlistat, but this difference was attenuated after propensity score weighting. Twelve-month treatment persistence and RMST were lower with liraglutide than with the oral agents. In this real-world cohort, phentermine/topiramate achieved the most pronounced and sustained weight loss. Liraglutide and orlistat produced similar overall weight reduction, but liraglutide showed lower long-term persistence.
Everolimus, an inhibitor of the mammalian target of the rapamycin signaling pathway, is used to treat tuberous sclerosis complex (TSC), certain cancers, and organ transplantation. Although a dispersible formulation has been approved for pediatric patients with TSC-associated seizures, no dispersible everolimus formulation has been approved for adults with swallowing difficulties. This study aimed to evaluate the pharmacokinetics (PK) of a newly developed dispersible everolimus tablet (SVG101) in healthy adult males and determine an optimal dosing regimen to achieve therapeutic trough concentrations. This randomized, open-label, single-dose, 2 × 2 crossover study included 26 healthy Korean males. The participants received either the reference tablet or SVG101, with a minimum 10-day washout period between treatments. Blood samples were collected up to 144 hours post-dosing. Population PK modeling was performed using a two-compartment model with dual absorption kinetics (zero-order kinetics, followed by first-order kinetics with lag time). The model evaluation demonstrated good agreement between the observed and predicted concentrations, with no significant covariates identified. Simulation of steady-state trough concentrations indicated that daily doses of 3-4 mg of dispersible everolimus resulted in trough levels within the therapeutic range (5-15 ng/mL), whereas the 5 mg dose exceeded this range. These findings suggest that a daily dose of 3-4 mg is appropriate to maintain target trough concentrations in adults. This study supports the development of a dispersible everolimus formulation for adults with swallowing difficulties that can improve adherence and clinical outcomes. Further studies involving diverse patient populations are required to confirm these findings.
European Public Assessment Reports (EPARs) are among the most scientifically rigorous sources available for evaluating newly approved oncology therapeutics, yet their complexity often limits clinical use. This tutorial aims to equip practicing oncologists and clinical pharmacologists with practical strategies for extracting actionable insights from EPARs. Using the regulatory assessment of tislelizumab in non-small cell lung cancer as an exemplar, this tutorial provides a structured framework for navigating EPAR content and translating technical findings into clinical practice. The analysis highlights how the EMA evaluates molecular design, pharmacokinetic modeling, exposure-response relationships, and safety data to guide therapeutic decisions. The tutorial illustrates how population pharmacokinetics informed the adoption of flat dosing, how exposure-efficacy analyses were interpreted in light of confounding by disease severity, and how differential indication approvals were justified by benefit-risk analyses. Mastering EPAR review enables clinicians to refine patient selection, anticipate pharmacologic variability, and better understand the scientific rationale behind a therapeutic label. This framework supports more informed, evidence-based prescribing decisions across oncology practice.
Vaccines are vital to global public health, especially as population growth and climate change increase the risk of infectious disease outbreaks. While randomized controlled trials (RCTs) remain the gold standard for evaluating vaccine safety and efficacy, traditional RCTs often face limitations including time constraints, resource demands, and ethical concerns. Adaptive endpoint-driven trial designs offer a promising alternative by allowing protocol modifications based on interim analyses while preserving scientific validity. Despite their potential, the adoption of such designs in prophylactic vaccine trials remains limited, with few real-world examples. This scoping review investigates the implementation of adaptive endpoint-driven methodologies in prophylactic vaccine RCTs. Using PRISMA-P and Joanna Briggs Institute guidelines, a systematic search was conducted across MEDLINE, Embase, and ClinicalTrials.gov. Eligible studies were Phase I-III vaccine RCTs employing adaptive endpoint-driven strategies. Multiple reviewers independently extracted data and assessed risk of bias, with findings synthesized descriptively. Seven studies met inclusion criteria, demonstrating adaptive methods such as interim analyses, sample size re-estimation, and modification of trial arms. Endpoints were identified through clinical evaluations, laboratory confirmation, and epidemiological surveillance, often supported by digital tools like mobile-based reporting and real-time diagnostics. These approaches enhanced flexibility and operational efficiency but faced challenges including statistical complexity, regulatory constraints, and maintaining control of bias. The findings highlight the emerging utility of adaptive endpoint-driven designs in vaccine research. Future efforts should focus on improving endpoint tools, addressing regulatory concerns, and evaluating how adaptive designs impact approval timelines and public health outcomes.
Serum insulin-like growth factor 1 (IGF-1) and insulin-like growth factor binding protein 3 (IGFBP-3) levels are regulated by growth hormone, nutritional status, and other endocrine factors, and are implicated in aging, metabolic disorders, and malignancies. Establishing appropriate reference ranges for these biomarkers is essential for safety monitoring and pharmacodynamic assessments in clinical trials. Although various detection methods-including enzyme-linked immunosorbent assay, chemiluminescence immunoassay, radioimmunoassay, and immunoradiometric assay (IRMA)-are available, defining reliable reference intervals remains challenging due to variability linked to age, sex, season, and assay methodology. IRMA manufacturers typically provide generalized reference values and recommend that laboratories establish context-specific ranges; however, data from healthy adult populations are limited. We analyzed data from 255 self-reported healthy Korean men aged 19-40 years using the IRMA method and R software. Age-specific reference ranges and standardized centile curves for serum IGF-1 and IGFBP-3 were established. Both biomarkers demonstrated significant seasonal variation, with notable differences observed among spring, autumn, and winter groups. This study presents a method for establishing institution-specific reference ranges and highlights the importance of considering seasonal variations to help reduce unnecessary dropouts during clinical trials.
This paper aims to elucidate the characteristics of healthy volunteers in Korea and Japan. Clinical trials can be divided into Phases 1 through 4 based on the stage of research. Unlike other phase, Phase 1 trials administer new drugs to healthy volunteers. Although Phase 1 trials are the first stage of drug administration to humans, without therapeutic purposes. Healthy volunteers must have no history of diseases that could affect the study and must have normal physical measurements. They are also defined as individuals who understand the study and can voluntarily consent to participate. Also, it is crucial to conduct them ethically. To date, there has been insufficient research on the Phase 1 clinical trials in Korea and Japan, and in-depth analysis of the perceptions and the motivations. This study enrolled healthy volunteers in Korea and Japan to conduct surveys related to demographic information and their perception.
Vancomycin is widely used as a prophylactic antibiotic for ventricular assist device (VAD) implantation to prevent infections, the most common complication. As vancomycin is renally eliminated, an accurate renal function estimation is essential. However, it has been reported that creatinine-based models inaccurately estimate renal function in VAD recipients, and cystatin C could alleviate the limitation. This study analyzed the association between renal function estimation methods and vancomycin trough concentrations in VAD recipients. Clinical data of VAD recipients who received prophylactic vancomycin at Seoul National University Hospital between 2014 and 2023 were retrospectively analyzed. Recipients were categorized into high trough (> 15 mg/dL) or non-high trough (≤ 15 mg/dL) groups based on the 1st vancomycin trough concentration after surgery. The estimated glomerular filtration rates (eGFRs) based on creatinine alone (eGFRCr), combined with cystatin C (eGFRCr-Cys-C), and their differences (eGFRdiff) were compared between the 2 groups. The association between the eGFRs and vancomycin trough concentrations was evaluated using Pearson's method. Among the 20 recipients, 13 were the high trough group and 7 were the non-high trough group. The high trough group had a significantly higher eGFRdiff than non-high trough group (8.9 vs. -5.1 mL/min/1.73 m2, p = 0.0265), while other eGFRs were comparable. Among the three eGFR estimates, eGFRdiff showed the strongest correlation (r = 0.41) with the first measured vancomycin trough levels. In conclusion, creatinine-based eGFR might not fully capture vancomycin pharmacokinetics in VAD recipients. The difference between eGFRCr and eGFRCr-Cys-C is associated with vancomycin trough concentration in VAD recipients.
Methotrexate (MTX), a folate antagonist, is commonly administered at low doses for the treatment of Crohn's disease (CD). Anti-inflammatory effects of MTX are facilitated by its intracellular conversion to MTX polyglutamates (MTX-PGs). Because plasma-based monitoring of therapeutic response does not accurately reflect the therapeutic efficacy of MTX, quantifying intracellular MTX-PGs, potential biomarkers of the MTX response, is crucial. However, it is challenging to routinely monitor intracellular MTX metabolites in patients with CD due to the low concentrations of MTX-PGs. Therefore, quantitating MTX-PGs in clinical samples with a high-sensitivity method is necessary. We established a high-sensitivity method to quantify three MTX-PGs using perchloric acid deproteinization followed by high-performance liquid chromatography-tandem mass spectrometry. Calibration curves were generated using human red blood cells as biological matrix. This method was applied to analyze MTX-PGs in red blood cells (RBCs) from patients with CD undergoing MTX therapy. The method achieved a lower limit of quantification of 1 ng/mL for individual MTX-PGs. A nine-point calibration curve covering 1-400 ng/mL showed excellent linearity. Precision (relative standard deviation < 15%) and accuracy (93.41-109.37%) were satisfactory in both intra- and inter-day assays. Plasma MTX levels were not significantly correlated with any individual RBC MTX-PG level (p = 0.998, 0.640, and 0.587, respectively). The lack of correlation supports our conclusion that plasma MTX levels may not reliably represent intracellular accumulation. The developed quantitative method provides a useful tool to improve our understanding of MTX metabolism and may facilitate therapeutic drug monitoring in MTX therapy.
Zastaprazan (JP-1366) is a new potassium-competitive acid blocker being developed for treating gastrointestinal reflux disease. It is an orally administered small molecule that inhibits gastric H+ and K+-ATPases differently from proton pump inhibitors, which act quickly and have dose-dependent effects on acid secretion. Celecoxib, a selective cyclooxygenase 2 inhibitor, will likely be used with zastaprazan in clinical settings and trials. The objective of current physiologically based pharmacokinetic (PBPK) modeling study is to predict drug-drug interaction (DDI) risk between zastaprazan (perpetrator) and celecoxib (victim). A human PBPK model for zastaprazan was built using experimental physicochemical properties and in silico predictions. The model was optimized with clinical pharmacokinetic (PK) data from a phase 1 study (Protocol No. JP-1366-105). The PBPK model for celecoxib was constructed using the data from previous studies and in silico predictions. The final PBPK model encompassing zastaprazan and celecoxib was used to quantitatively predicted DDI risks in humans. The final PBPK models accurately predicted zastaprazan's PK profiles after single dose in human, and it also well predicted plasma celecoxib concentrations over time. At doses of 20 mg of zastaprazan citrate (JAQBO® tablet) and 200 mg of celecoxib, multiple oral doses of zastaprazan every 24 hours for 7 days did not increase celecoxib's area under the curve (AUC) and maximum plasma concentration (Cmax), with ratios of 1 in both AUC and Cmax, indicating no effect of zastaprazan on celecoxib's PK. The PBPK modeling approach provides scientific predictions of DDIs between zastaprazan and celecoxib, guiding future clinical development.
Tuberculosis (TB) remains one of the leading causes of infectious disease-related deaths worldwide. Model-informed precision dosing-based therapeutic drug monitoring (TDM) is a promising strategy to optimize anti-TB drugs doses based on pharmacokinetic (PK) profiles of patients. However, this approach requires significant time and trained personnel to interpret the results. To address this limitation, we developed and utilized an automated, web-based TDM platform that simplifies implementation and enhances accessibility, ultimately aiming to improve treatment outcomes. The system incorporates population PK models for both first- and second-line anti-TB drugs, integrating clinical data including demographics, NAT2 genotype and drug concentrations from limited sampling strategies. Bayesian forecasting is used to estimate individual PK parameters and simulate optimized dosing regimens. Clinicians can use the platform to automatically generate the individual concentration-time curve plot that compares a patient's exposure with population level references, along with a table displaying the estimated individual PK parameters. If the dose adjustment is needed, users may input alternative regimens and run the simulation to predict the corresponding PK metrics. These features enable users to visualize predicted outcomes, compare exposures against therapeutic targets, and support optimal dose selection. The system produces downloadable reports containing patient specific data, PK parameter values, graphical PK profiles, and pharmacogenomic interpretations with minimal user input. This automated web-based platform enhances the time-efficiency and accessibility of TDM, making it a practical tool for personalized TB therapy. It is especially valuable in resource-limited settings where expert support is limited, by supporting clinical decision making and improving patient outcomes.
