Translational and Clinical Pharmacology最新文献

{"title":"Pioneering pharmacometrics practice in Korea: an eight-year retrospective analysis of 192 projects from the first dedicated service organization (2016-2024).","authors":"So Jin Lee, Soo Hyeon Bae, Jinha Park, Yunjung Hong, Yearin Jun, Seunghoon Han, Dong-Seok Yim","doi":"10.12793/tcp.2026.34.e4","DOIUrl":"10.12793/tcp.2026.34.e4","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"34 1","pages":"15-34"},"PeriodicalIF":2.4,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13062166/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147676375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Erratum: A review of clinical pharmacology considerations in antibody-drug conjugates approved by the US Food and Drug Administration between 2000 and 2025.","authors":"Seoyoung Koo, Chae Yeon Kim, Jeong Hyeon Lim, Eunyoung Lee, In Young Kim, Young G Shin, Hanlim Moon","doi":"10.12793/tcp.2026.34.e3","DOIUrl":"10.12793/tcp.2026.34.e3","url":null,"abstract":"<p><p>[This corrects the article on p. 197 in vol. 33, PMID: 41551730.].</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"34 1","pages":"69"},"PeriodicalIF":2.4,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13062481/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147676991","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Incidence and sex-related risk factors of linezolid-associated adverse drug reactions identified through electronic health records.","authors":"Seunghwan Baek, JungJin Oh, SiYeon Yoon, Seonghae Yoon, Jae-Yong Chung","doi":"10.12793/tcp.2026.34.e1","DOIUrl":"10.12793/tcp.2026.34.e1","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"34 1","pages":"35-44"},"PeriodicalIF":2.4,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13062168/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147677036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative pharmacokinetics of a candesartan/amlodipine/atorvastatin fixed-dose combination 8 mg/5 mg/10 mg versus separate tablets in healthy subjects: a partial replicated crossover study.","authors":"So-Yeon Kim, Yong-Geun Kwak, Min-Gul Kim, Seol Ju Moon","doi":"10.12793/tcp.2026.34.e2","DOIUrl":"10.12793/tcp.2026.34.e2","url":null,"abstract":"<p><p>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT04611932.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"34 1","pages":"58-68"},"PeriodicalIF":2.4,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13062482/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147677045","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acid-suppressive effect of tegoprazan 12.5 mg BID: a phase 1 comparative study with tegoprazan 25 mg QD and famotidine 20 mg BID.","authors":"Ho-Sook Kim, Young-Kyung Choi, Minkyung Oh, Yong-Soon Cho, Jong-Lyul Ghim","doi":"10.12793/tcp.2025.33.e18","DOIUrl":"10.12793/tcp.2025.33.e18","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"33 4","pages":"238-251"},"PeriodicalIF":1.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12806658/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145999052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative effectiveness of long-term anti-obesity medications in routine clinical practice: a retrospective cohort study using real-world data.","authors":"Chul-Gyu Kim, Jung-Min Koh, Kyun-Seop Bae","doi":"10.12793/tcp.2025.33.e20","DOIUrl":"10.12793/tcp.2025.33.e20","url":null,"abstract":"<p><p>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; <i>p</i> < 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.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"33 4","pages":"224-237"},"PeriodicalIF":1.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12806651/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145998565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A review of clinical pharmacology considerations in antibody-drug conjugates approved by the US Food and Drug Administration between 2000 and 2025.","authors":"Seoyoung Koo, Chae Yeon Kim, Jeong-Hyeon Lim, Eunyoung Lee, In Young Kim, Young G Shin, Hanlim Moon","doi":"10.12793/tcp.2025.33.e21","DOIUrl":"10.12793/tcp.2025.33.e21","url":null,"abstract":"<p><p>Antibody-drug conjugates (ADCs) represent a promising class of anticancer therapies with rapidly expanding development. However, regulatory approval remains complex due to their unique pharmacological properties. We systematically analyzed U.S. Food and Drug Administration (FDA)'s clinical pharmacology considerations across all approved ADCs to identify consistent regulatory patterns and inform future development strategies. We comprehensively reviewed 13 FDA-approved ADCs as of March 2025, examining clinical pharmacology and/or multidisciplinary reviews from Drugs@FDA. Six key parameters from the <i>FDA's Clinical Pharmacology Considerations for Antibody</i>-<i>Drug Conjugates: Guidance for Industry (2024)</i> were evaluated: bioanalytical methods, exposure-response relationships, intrinsic factors, extrinsic factors, QTc prolongation, and immunogenicity. For each parameter, we assessed: 1) submission completeness, 2) FDA's assessment, and 3) whether they led to regulatory actions such as post-marketing requirements/commitments (PMRs/PMCs). All 6 clinical pharmacology considerations were consistently applied throughout ADC approval history, well before the issuance of formal guidance. The FDA maintained particularly rigorous standards across a few critical domains. Exposure-response interpretation considering critical safety issues, intrinsic factor analyses-particularly hepatic impairment and racial variations-and validated immunogenicity assays including the neutralizing antibody emerged as primary scrutiny points. These factors repeatedly triggered similar PMRs/PMCs across multiple ADCs, underscoring their regulatory significance. Core clinical pharmacology parameters consistently shape FDA assessments of ADCs. Proactive alignment with regulatory expectations can streamline development, mitigate potential delays, and reduce post-marketing obligations. Our historical analysis provides strategic insights that may support clinical investigators for optimizing future ADC development.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"33 4","pages":"197-211"},"PeriodicalIF":1.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12806659/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145999071","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sex differences in efficacy/safety of anti-amyloid-beta monoclonal antibodies for the treatment of Alzheimer's disease.","authors":"SoHyeon Lim, Hyun-Woo Lee, Siyeon Yoon, Ji Won Han, Jae-Yong Chung, Seonghae Yoon","doi":"10.12793/tcp.2025.33.e19","DOIUrl":"10.12793/tcp.2025.33.e19","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"33 4","pages":"212-223"},"PeriodicalIF":1.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12806652/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145998550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Serum IGF-1 and IGFBP-3 levels in healthy Korean men aged 19-40 years: a cross-sectional analysis of reference ranges and seasonal variation.","authors":"Soo-Min Jung, Shi-Hyang Lee, Hyoeun Lee, Eun Na Kim, Kyun-Seop Bae","doi":"10.12793/tcp.2025.33.e13","DOIUrl":"10.12793/tcp.2025.33.e13","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"33 3","pages":"145-155"},"PeriodicalIF":1.5,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12518213/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145303743","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Application of population pharmacokinetic modeling of SVG-101 to evaluate proper dose selection.","authors":"Kyoung Hoon Mo, Dongwoo Chae, Yun Seob Jung, Byung Hak Jin, Do Hoon Keum, Min Kyu Choi, Jun Seok Cha, Min Soo Park, Choon Ok Kim","doi":"10.12793/tcp.2025.33.e14","DOIUrl":"10.12793/tcp.2025.33.e14","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":"33 3","pages":"156-167"},"PeriodicalIF":1.5,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12518218/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145303748","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}