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Saliva-based lacosamide monitoring paves the way toward personalized epilepsy pharmacotherapy - PubMedSaliva, known for better patient compliance and simpler collection, is ideal for monitoring antiseizure medication (ASM) levels. This study aimed to validate saliva for measuring lacosamide, develop a pharmacokinetic (PK) model, and determine the optimal saliva concentration for seizure control in e …

Population pharmacokinetic and pharmacodynamic model guided weight-tiered dose of AST-001 in pediatric patients with autism spectrum disorder - PubMedAST-001, a novel syrup formulation of L-serine, was developed for the treatment of autism spectrum disorders (ASD) in pediatric patients. This study aimed to establish a pharmacokinetic (PK)-pharmacodynamic (PD) model to elucidate the effect of AST-001 on adaptive behavior in children with ASD. Due …

Topiramate dosage optimization for effective antiseizure management via population pharmacokinetic modeling Objective Despite the suggested topiramate serum level of 5–20 mg/L, numerous institutions have observed substantial drug response at lower levels. We aim to investigate the correlation between topi...

Population pharmacokinetic and pharmacodynamic model of evogliptin: Severe uremia increases the bioavailability of evogliptinUremia, a condition characterized by the retention of uremic toxins due to impaired renal function, may affect drug metabolism mediated by CYP3A4 enzymes. Evogliptin is a dipeptidyl peptidase-4 (DPP-...

Pharmacokinetic and Pharmacodynamic Characteristics of Tripegfilgrastim, a Pegylated G-CSF, in Pediatric Patients with Solid Tumors - PubMedA long-acting granulocyte colony-stimulating factor, tripegfilgrastim, was approved in Korea for the prevention of chemotherapy-induced neutropenia in adult patients. In this study, we evaluated the pharmacokinetics, pharmacodynamics, and safety of tripegfilgrastim in pediatric patients. A phase I, …

Semimechanistic pharmacokinetic-pharmacodynamic model of tripegfilgrastim for pediatric patients after chemotherapy - PubMedTripegfilgrastim is a long-acting granulocyte colony-stimulating factor (G-CSF) that has been used to prevent chemotherapy-induced neutropenia in adults. This study aimed to establish a pharmacokinetic (PK)-pharmacodynamic (PD) model to explore the impact of chemotherapy and tripegfilgrastim on abso …

Frontiers | Population Pharmacokinetic Model of AST-001, L-Isomer of Serine, Combining Endogenous Production and Exogenous Administration in Healthy SubjectsAST-001 is an isomer of non-essential amino acids that has protective effects in neurological disorders. This study aimed to establish a population pharmacok...

Pharmacokinetic comparison of a fixed-dose combination of telmisartan/rosuvastatin/ezetimibe/amlodipine 80/20/10/5 mg and a loose-dose combination of ezetimibe/rosuvastatin 10/20 mg and telmisartan/amlodipine 80/5 mg in healthy male subjects - PubMedThis study aimed to compare the pharmacokinetic (PK) profiles of a fixed-dose combination (FDC) tablet of telmisartan/rosuvastatin/ezetimibe/amlodipine 80/20/10/5 mg and a loose-dose combination (LDC) of two FDC tablets, ezetimibe/rosuvastatin 10/20 mg and telmisartan/amlodipine 80/5 mg, in healthy …

Publication (ALL)

Jeon J, Jeon J, Yun HY, Lee S, Chae JW, Kim J. Prediction of systemic exposure by food effect on a fixed-dose combination of linagliptin and metformin extended-release. Diabetes Obes Metab. 2025 Jul 4. doi: 10.1111/dom.16564. Epub ahead of print. PMID: 40613232.
Jang Y, Ahn SJ, Lee S*, Kim Y, Lee HS, Lee YK, Shin YW, Lee ST, Jung KH, Park KI, Jung KY, Cho JY, Lee S, Yu KS, Chu K, Jang IJ, Lee SK. Saliva-based lacosamide monitoring paves the way toward personalized epilepsy pharmacotherapy. Sci Rep. 2025 May 31;15(1):19181. doi: 10.1038/s41598-025-04044-x. PMID: 40450138; PMCID: PMC12126552.
Park S, Song SS, Jung W, Yun HY, Lee S, Kang SW, Chae JW. Mechanistic in vitro-in vivo extrapolation (IVIVE) approach using a biomimetic in vitro system for the prediction of hepatic clearance. Comput Struct Biotechnol J. 2025 May 26;27:2424-2433. doi: 10.1016/j.csbj.2025.05.036. PMID: 40535108; PMCID: PMC12173689.
Yang SY, Ngo LT, Lee S, Yun HY, Bui TT, Kim DH, Chae JW, Park S. Model-Based Evaluation of HangAmDan-B1 and Afatinib Combination Therapy in HCC827 Xenograft Mice with Resistance to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor. Pharmaceuticals (Basel). 2025 May 19;18(5):748. doi: 10.3390/ph18050748. PMID: 40430565; PMCID: PMC12114871.
Jeon HS, Lee SW, Jung W, Jung H, Choi D, Byun MS, Yun HY, Lee S, Kim A, Chae JW, Lee H. Dose Optimization of rhIL-7-hyFc for Patients With Lymphopenia Using a Neonatal Fc Receptor-Mediated Recycling-Based and Target-Mediated Drug Disposition Pharmacokinetic Model. Clin Transl Sci. 2025 May;18(5):e70252. doi: 10.1111/cts.70252. PMID: 40396986; PMCID: PMC12094080.
Tran QT, Bui TT, Ngo LT, Yang BR, Baek IH, Nguyen VH, Lee KA, Yun HY, Chae JW, Lee S, Kim JH, Jung W. Model-Based Meta-Analysis of the Relationship Between Pioglitazone and Histological Outcomes in Metabolic Dysfunction-Associated Steatohepatitis Patients. CPT Pharmacometrics Syst Pharmacol. 2025 Apr 18. doi: 10.1002/psp4.70034. Epub ahead of print. PMID: 40248984.
Kim, B., Kim, J. E., Lee, S., Oh, J., Cho, J. Y., Jang, I. J., ... & Yoon, S. (2025). Population pharmacokinetic and pharmacodynamic model of evogliptin: Severe uremia increases the bioavailability of evogliptin. CPT: Pharmacometrics & Systems Pharmacology.
Lee, S., Kim, H. C., Kim, K. T., Kang, S. H., Lee, S., Yu, K. S., & Lee, S.* (2025). Pharmacokinetic comparison of a fixed-dose combination of telmisartan/rosuvastatin/ezetimibe/amlodipine 80/20/10/5 mg and a loose-dose combination of ezetimibe/rosuvastatin 10/20 mg and telmisartan/amlodipine 80/5 mg in healthy male subjects. Naunyn-Schmiedeberg's Archives of Pharmacology, 1-12.
Lee, S.*, Hwang, S. K., Cho, J. S., Ryu, H. C., & Chung, J. Y. (2024). Population pharmacokinetic and pharmacodynamic model guided weight-tiered dose of AST-001 in pediatric patients with autism spectrum disorder. Frontiers in Pharmacology, 15, 1452526.
Dang, H. T., La Do, T., Duong, K. L., Vu, N. A. T., Cao, D. T., Van Hung, N., ... & Lee, S.* (2024). Lessons From the International Exchange Program for Clinical Pharmacy at a University. Researh in Clinical Pharmacy, 2(2), 73-81.
Khwarg, J., Lee, S., Jang, I. J., Kang, W. H., Lee, H. J., Kim, K. Y., ... & Oh, J. (2024). Pharmacokinetic Comparison Between a Fixed-Dose Combination of Atorvastatin/Omega-3-Acid Ethyl Esters and the Corresponding Loose Combination in Healthy Korean Male Subjects. Drug Design, Development and Therapy, 395-406.
Khwarg, J., Chung, W. K., Lee, S., Yang, E., Ryu, C., Lee, D. Y., Lee, M., Jang, I. J., Yu, K. S., Lee, S. (2023). Evaluation of Food Effect on the Pharmacokinetics of Velufenacin, a New Muscarinic Receptor Antagonist, in Healthy Subjects. Clinical Pharmacology in Drug Development.
Kim, H. C., Yang, E., Lee, S., Oh, J., Lee, M., Lee, C., Ha, K., Lee, W., Jang, I. J., Yu, K. S. (2023). Effects of food and ethnicity on the pharmacokinetics of venadaparib, a next-generation PARP inhibitor, in healthy Korean, Caucasian, and Chinese male subjects. Investigational New Drugs.
Lee, S., Kim, H. C., Jang, Y., Lee, H. S., Ahn, S. J., Lee, S. T., Jung, K. H., Park, K. I., Jung, K. Y., Oh, J., Lee, S., Yu, K. S., Jang, I. J., Lee, S.*, Chu, K., Lee, S. K. (2023). Topiramate dosage optimization for effective antiseizure management via population pharmacokinetic modeling. Annals of Clinical and Translational Neurology.
Hwang, S., Lee, S., Yoon, J., Chung, J. Y. (2023). Population Pharmacokinetic− Pharmacodynamic Modeling of Carvedilol to Evaluate the Effect of Cytochrome P450 2D6 Genotype on the Heart Rate Reduction. Journal of Korean Medical Science, 38(22).
Lee, S.*, Hong, K. T., Jang, I. J., Yu, K. S., Kang, H. J., Oh, J. (2023). Semimechanistic pharmacokinetic–pharmacodynamic model of tripegfilgrastim for pediatric patients after chemotherapy. CPT: Pharmacometrics & Systems Pharmacology, 12(9), 1319-1334.
Lee, H., Chung, J. Y., Yu, K. S., Park, S. J., Lee, S.* (2023). Pharmacokinetic Comparison Between a Fixed‐Dose Combination of Empagliflozin L‐Proline/Metformin and Empagliflozin/Metformin in Healthy Korean Subjects. Clinical Pharmacology in Drug Development.
Lee, S.*, Hwang, S. K., Nam, H. S., Cho, J. S., Chung, J. Y. (2022). Population Pharmacokinetic Model of AST-001, L-Isomer of Serine, Combining Endogenous Production and Exogenous Administration in Healthy Subjects. Frontiers in Pharmacology.
Hwang, S., Lee, S., Kim, E., Hwang, I., Cho, J. Y., Chung, J. Y., Jang, I. J., Oh, J. (2022). The pharmacokinetic, safety, and tolerability profiles of eslicarbazepine acetate are comparable between Korean and White subjects. Clinical and Translational Science.
Lee, S.*, Hong, K. T., Moon, S. J., Choi, J. Y., Hong, C. R., Shin, H. Y., Oh, J. & Kang, H. J. (2021). Pharmacokinetic and pharmacodynamic characteristics of tripegfilgrastim, a pegylated G‐CSF, in pediatric patients with solid tumors. Clinical Pharmacology & Therapeutics.
Huh, K. Y., Kim, E., Lee, S., Yoo, H., Yoon, S., Yu, K. S., & Chung, J. Y. (2021). Current bioequivalence study designs in Republic of Korea: a comprehensive analysis of bioequivalence study reports between 2013 and 2019. Frontiers in pharmacology, 12.
Lee, S.*, Lee, Y., Kim, A. H., Yoon, S., Lee, J., Ji, S. C., Yoon, S. H., Lee, S., Yu, K. S., Jang, I. J., & Cho, J. Y. (2020). Urinary metabolic markers reflect on hepatic, not intestinal, CYP3A activity in healthy subjects. Drug Metabolism and Pharmacokinetics.
Lee, S.*, Kim, A. H., Yoon, S., Lee, J., Lee, Y., Ji, S. C., Yoon, S. H., Lee, S., Yu, K. S., Jang, I. J., & Cho, J. Y. (2020). The utility of CYP3A activity endogenous markers for evaluating drug-drug interaction between sildenafil and CYP3A inhibitors in healthy subjects. Drug Metabolism and Pharmacokinetics.
Jung, J., Lee, S., Oh, J., Lee, S., Jang, I. J., Lee, D., & Yu, K. S. (2021). Pharmacokinetic comparison between a fixed-dose combination of fimasartan/amlodipine/hydrochlorothiazide 60/10/25 mg and a corresponding loose combination of fimasartan/amlodipine 60/25 mg and hydrochlorothiazide 25 mg in healthy subjects. Translational and Clinical Pharmacology, 29(1), 53.
Yoon, D. Y., Lee, S., Ban, M. S., Jang, I. J., Lee S. (2020). Pharmacogenomic information from CPIC and DPWG guidelines and its application on drug labels. Translational and Clinical Pharmacology, 28(4), 189-198.
Yang, E., Lee, S., Lee, H., Hwang, I., Jang, I. J., Yu, K. S., & Lee, S. (2019). Pharmacokinetic comparison between fixed-dose combination of fimasartan/amlodipine 60/10 mg and the corresponding loose combination through partial replicated crossover study in healthy subjects. Translational and Clinical Pharmacology, 27(4), 134-140.
Lee, S.*, Yoon, S., Chung, H., Ji, S. C., Yoon, S. H., Yu, K. S., & Chung, J. Y. (2019). Pharmacokinetics of Ursodeoxycholic Acid in Elderly Volunteers Compared With Younger Adults in a Korean Population. The Journal of Clinical Pharmacology, 59(8), 1085-1092.
Rhee, S., Lee, H. A., Lee, S., Kim, E., Jeon, I., Song, I. S., & Kyung-Sang, Y. (2018). Physiologically Based Pharmacokinetic Modeling of Fimasartan, Amlodipine, and Hydrochlorothiazide for the Investigation of Drug–Drug Interaction Potentials. Pharmaceutical Research, 35(12), 1-10.
Lee, S*., Kim, Y., Lee, J. J. S., Im, G., Cho, J. Y., Chung, J. Y., & Yoon, S. (2018). A pharmacokinetic drug-drug interaction study between pregabalin and tramadol in healthy volunteers. European journal of clinical pharmacology, 74(12), 1605-1613.
Lee, S.*, Nam, K. Y., Oh, J., Lee, S., Cho, S. M., Choi, Y. W., & Hong, J. H. (2018). Evaluation of the effects of food on levodropropizine controlled-release tablet and its pharmacokinetic profile in comparison to that of immediate-release tablet. Drug design, development and therapy, 12, 1413.

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