2024
Choi Y, Kim BK, Won JH, Yoo JW, Choi W, Jung S, Kim JY, Choi IY, Chung NG, Lee JW, Choi JY, Kang HJ, Lee H. A Study to Evaluate the Effectiveness and Safety of Prephase Steroid Treatment before Remission Induction Chemotherapy in Patients with Pediatric Acute Lymphoblastic Leukemia Using Common Data Model-Based Real-World Data: A Retrospective Observational Study. Clin Epidemiol. 2024 Apr 22;16:293-304. doi: 10.2147/CLEP.S454263. PMID: 38681782; PMCID: PMC11049150.
Lee KW, Han SW, Kim TW, Ahn JB, Baek JY, Cho SH,
Lee H, Kim JW, Kim JW, Kim TY, Hong YS, Beom SH, Cha Y, Choi Y, Kim S, Bang YJ. A Phase Ib/2a Study of GC1118 with 5-Fluorouracil, Leucovorin and Irinotecan (FOLFIRI) in Patients with Recurrent or Metastatic Colorectal Cancer. Cancer Res Treat. 2023 Dec 7. dot: 10.4143/crt.2023.1117
Kim A, Oh MS, Song S, Byun M, Choi D, Yu B,
Lee H. Understanding the pharmacokinetic journey of Fc-fusion protein, rhIL-7-hyFc, using complementary approach of two analytical methods, accelerator mass spectrometry and ELISA, Antibody Therapeutics, 2024, tbae004,
https://doi.org/10.1093/abt/tbae004
Kim SU,
Won J-H,
Lee DSU, Luo R, Wu L, Qin T,
Lee H. CReSE: Benchmark Data and Automatic Evaluation Framework for Recommending Eligibility Criteria from Clinical Trial Information. Findings of the Association for Computational Linguistics: EACL 2024.
2023
Choi Y, Won J-H, Kim H, Hong Y, Kim Y, Lee H. Country contribution of investigators to pivotal clinical trials and their primary publications of new oncology drugs approved by the US Food and Drug Administration. ESMO Open. Volume 8, Issue 1, Supplement 6, 2023, 102151. https://doi.org/10.1016/j.esmoop.2023.102151.
Choi Y, Kim BK, Yoo JW, Choi W,
Won J-H, Jung S, Kim JY, Choi IY, Chung N-G, Lee JW, Kang HJ,
Lee H. A Study to Evaluate the Effectiveness and Safety of Prephase Steroid Treatment before Remission Induction Chemotherapy in Patients with Pediatric Acute Lymphoblastic Leukemia Using Common Data Model-Based Real World Data. Blood (2023) 142 (Supplement 1): 3791. https://doi.org/10.1182/blood-2023-185435
Hong Y, Jeon Y, Choi, Y, Chung TK, Lee H. Effectiveness and Safety of Sodium-Glucose Cotransporter 2 Inhibitors Added to Dual or Triple Treatment in Patients with Type 2 Diabetes Mellitus. Diabetes Ther (2023). https://doi.org/10.1007/s13300-023-01518-x
Won J-H,
Chung TK, Lee J, Yoon S,
Jeon Y,
Lee H. Trends in medical care utilization in patients with cancer: An analysis of real-world data in a tertiary hospital in Korea, 2014–2019. Cancer Medicine. 2023 Oct 30. https://doi.org/10.1002/cam4.6660
이형기, 김시언, 김희주. [합성의약품 시대는 가고]바이오의약품 시대가 온다. 개정증보판. 청년의사. 2023. 9. 18. (ISBN: 9791193135044)
Kim SU, Kang T,
Chung TK, Choi Y, Hong YS, Jung K, and
Lee H. Automatic Extraction of Comprehensive Drug Safety Information from Adverse Drug Event Narratives in the Korea Adverse Event Reporting System Using Natural Language Processing Techniques. Drug Safety (2023). https://doi.org/10.1007/s40264-023-01323-2.
Lee DSU, Lee H. Clinical Characteristics Associated with Adherence and Persistence in Patients with Type 2 Diabetes Mellitus Treated with Dulaglutide. Journal of Diabetes Research, vol. 2023, 12 pages, 2023. https://doi.org/10.1155/2023/7917641
Kim SU,
Won J-H,
Lee DSU, Luo R, Wu L, Xia Y, Qin T,
Lee H. Revisiting Machine-Learning based Drug Repurposing: Drug Indications Are Not a Right Prediction Target. Proceedings of the Conference on Health, Inference, and Learning, PMLR 209:100-116, 2023.
2022
Kim S, Lee SW, Koh JY, Choi D, Heo M, Chung JY, Lee BH, Yang SH, Sung YC,
Lee H, Shin EC, Park SH. A single administration of hIL-7-hyFc induces long-lasting T-cell expansion with maintained functions and TCR diversity.
Blood Adv. 2022 Oct 7. doi: 10.1182/bloodadvances.2021006591
Choi Y, Lee H. How to boost and accelerate new drug development in Korea: business ecosystem perspectives.
Transl Clin Pharmacol. 2022 Sep;30(3):129-135. doi: 10.12793/tcp.2022.30.e17.
Chung TK, Jeon Y, HongYS, HongS, MoonJS, Lee H. Factors affecting the changes in antihypertensive medications in patients with hypertension. Frontiers in Cardiovascular Medicine. 2022: 2856.
Jang HY, Song J, Kim JH,
Lee H, Kim IW, Moon B, Oh JM. Machine learning-based quantitative prediction of drug exposure in drug-drug interactions using drug label information.
NPJ Digital Medicine. 2022; 5(1):88. doi: 10.1038/s41746-022-00639-0
Chung TK, Lee HA, Lee KR, Jang SB, Yu KS, Lee H. A population PK-PD model of YH4808, a novel P-CAB, and intragastric pH that incorporated negative feedback by increased intragastric pH onto the systemic exposure to YH4808. CPT: Pharmacometrics & Systems Pharmacology. 2022;00:1- 11. doi:10.1002/psp4.12839
최유나, 이형기, 홍예솔, 원정현.『대한민국 신약개발 성공전략』. 서울: 청년의사. 2022
전유민, 원정현, 이승우, 홍수연, 백유진, 조비룡, 이형기. 개인맞춤형 건강기능식품 추천용 설문지 개발. Korean J Health Promot. 2022; 22(1):26-39. https://dx.doi.org/10.15384/kjhp.2022.22.1.26
Kim Y, Kim S, Park J,
Lee H. Clinical Response and Hospital Costs of Therapeutic Drug Monitoring for Vancomycin in Elderly Patients.
Journal of Personalized Medicine. 2022; 12(2):163. https://doi.org/10.3390/jpm12020163
Lee DSU,
Lee H. Adherence and persistence rates of major antidibetic medications: a review.
Diabetology & Metabolic Syndrome, 14, 12 (2022). https://doi.org/10.1186/s13098-022-00785-1
Kim SU,
Choi Y,
Won J-H, Oh JM,
Lee H. An annotated corpus from biomedical articles to construct a drug-food interaction database.
Journal of Biomedical Informatics, 2022 Jan 7; 103985. https://doi.org/10.1016/j.jbi.2022.103985
Jeon Y, Lee N, Baek S, Choi JD, Jhee S, Lee H. A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic Profiles of Subcutaneous Eflapegrastim in Healthy Japanese and Caucasian Subjects. Drugs R&D (2022). https://doi.org/10.1007/s40268-021-00379-8
2021
이형기, 원정현, 홍예솔 외. 『K-방역은 없다』. 서울: 청년의사. 2021
Huh KY, Hwang JG, Shin W, Baek S, Choi J, Lee N, Cho YM,
Lee H. A double-blind, placebo-controlled, single-ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM15136, a novel long-acting glucagon analogue, in healthy subjects. Diabetes Obes Metab. 2021 Nov 2. doi: 10.1111/dom.14590.
최유나, 홍예솔, 원정현, 이형기. 신약개발을 위한 제약바이오산업 생태계 분석과 정책 제안. 2021
Jung JH, Huh KY, Jin XY, Ha A, Park KH, Park JS, Kim EJ, Lee JH, Jang IJ,
Lee H. A phase I study to evaluate the safety, tolerability, pharmacodynamic and pharmacokinetic profiles of ocular GLH8NDE in healthy male subjects. Clinical and Translational Science, 2021. https://doi.org/10.1111/cts.13150
Kim SU, Lee HA, Jang SB,
Lee H. A population pharmacokinetic-pharmacodynamic model of YH12852, a highly selective 5-hydroxytryptamine 4 receptor agonist, in healthy subjects and patients with functional constipation. CPT: Pharmacometrics & Systems Pharmacology, 2021. https://doi.org/10.1002/psp4.12664
Moon BS, Park HS, Sunwoo J, Lee IH, Kim A, Moon SJ, Lee H, Son MH, Kim SB, Park SM, Woo SK, Jang JH, Kim BS, Kim JH, Kim SE, &
Lee H. Tissue pharmacokinetics of DHP107, a novel lipid‐based oral formulation of paclitaxel, in mice and patients by positron emission tomography. Clinical and Translational Science, 2021. https://doi.org/10.1111/cts.13003
Won J-H,
Lee H. Can the COVID-19 Pandemic Disrupt the Current Drug Development Practices?
Int. J. Mol. Sci. 2021; 22(11): 5457. https://doi.org/10.3390/ijms22115457
Huh KY, Choi Y, Nissel J, Palmisano M, Wang X, Liu L, Ramirez-Valle F,
Lee H. Pharmacokinetics and tolerability of apremilast in healthy Korean adult men.
Clin Transl Sci. 2021 May 1. doi: 10.1111/cts.13013.
Choi Y, Lee H. Policy Suggestions to Improve Patient Access to New Drugs in Korea.
Korean J Clin Pharm. 2021;31:1-11. https://doi.org/10.24304/kjcp.2021.31.1.1
Chung TK, Lee HA, Park SI, Oh DY, Lee KW, Kim JW, Kim JH, Woo AM, Lee SJ, Bang YJ, Lee H. A Target-Mediated Drug Disposition Population Pharmacokinetic Model of GC1118, a Novel Anti-EGFR Antibody, in Patients with Solid Tumors. Clinical and Translational Science. 2021;00:1-12. https://doi.org/10.1111/cts.12963
2020
Won J-H,
Lee H. The Current Status of Drug Repositioning and Vaccine Developments for the COVID-19 Pandemic.
Int. J. Mol. Sci. 2020, 21(24), 9775; https://doi.org/10.3390/ijms21249775
Lee HA, Moon SJ, Yoo H, Kim MK, Jang SB, Lee S, Kim S,
Lee H. YH12852, a Potent and Selective Receptor Agonist of 5-hydroxytryptamine, Increased Gastrointestinal Motility in Healthy Volunteers and Patients with Functional Constipation. Clinical and Translational Science, 2020. https://doi.org/10.1111/cts.12924
전유민, 이형기. 임상시험의 효율적 디자인, 시뮬레이션, 사전 예측을 위한 HIRA 빅데이터 활용 가능성. 건강보험심사평가원 HIRA 빅데이터 브리프 2020;제4권2호
Lien Ngo, Jaeseong Oh, Anhye Kim, Hyun-moon Back, Won-ho Kang, Jung-woo Chae, Hwi-yeol Yun, Lee H.
Development of a Pharmacokinetic Model Describing FcRn-Mediated Recycling of HL2351, a Novel Hybrid Fc-Fused IL1Ra, to Optimize Dosage Regimen. CPT Pharmacometrics Syst Pharmacology. 2020. Oct:9(10):584-595. doi: 10.1002/psp4.12555
Anhye Kim, Stephen R Dueker, Jun Gi Hwang, Jangsoo Yoon, Sang-Won Lee, Hye Suk Lee, Byung-Yong Yu, Kyung-Sang Yu,
Lee H. An investigation of the metabolism and excretion of KD101 and its inter-individual differences: a microtracing mass balance study in humans. Clinical and Translational Science. 2020. doi: 10.1111/cts.12848
최유나, 이형기. 환자의 신약 접근성을 강화하기 위한 정책 제안. 2020
Kim SH, Kim SU, Lee H. A
critical review of the United States regulatory pathways for determining the equivalence
of efficacy between CT-P13 and original infliximab (Remicade ®). Drug Des Devel
Ther. 2020. doi: 10.2147/DDDT.S254776
Wilson JL, Cheung KWK, Lin L, Green EAE, Porrás AI, Zou L, Mukanga D, Akpa PA, Darko DM, Yuan R, Ding S, Johnson WCN,
Lee H, Cooke E, Peck CC, Kern SE, Hartman D, Hayashi Y, Marks PW, Altman RB, Lumpkin MM, Giacomini KM, Blaschke TF. Scientific considerations for global drug development.
Science Translational Medicine. 2020. doi:10.1126/scitranslmed.aax2550
Jeon Y, Choi Y, Kim EH, Oh S, Lee H. Common data model-based real-world data for practical clinical practice guidelines: clinical pharmacology perspectives. Transl Clin Pharmacol. 2020;28(2):67-72. doi:10.12793/tcp.2020.28.e11
Lee JH, Faderl S, Pagel JM, Jung CW, Yoon SS, Pardanani AD, Becker PS,
Lee H, Choi J, Lee K, Kim M, Cortes JE. Phase 1 study of CWP232291 in patients with relapsed or refractory acute myeloid leukemia and myelodysplastic syndrome.
Blood Adv. 2020;4(9):2032-2043. doi:10.1182/bloodadvances.2019000757
Jang K, Tong T, Lee J, Park T,
Lee H. Altered Gene Expression Profiles in Peripheral Blood Mononuclear Cells in Obese Subjects.
Obes Facts 2020 Jun 16;1-11. doi:10.1159/000507817
Lee SW, Choi D, Heo M, Shin EC, Park SH, Kim SJ, Oh YK, Lee BH, Yang SH, Sung YC, Lee H. hIL-7-hyFc, a long-acting IL-7, increased absolute lymphocyte count in healthy subjects. Clin. Transl. Sci. 2020 Apr 27.; doi:10.1111/cts. 12800
Gim JA, Kwon Y,
Lee HA,
Lee KR, Kim SH, Choi YJ, Kim YK,
Lee H. A Machine Learning-Based Identification of Genes Affecting the Pharmacokinetics of Tacrolimus Using the DMET
TM Plus Platform.
Int. J. Mol. Sci. 2020, 21(7) 2517. doi:10.3390/ijms21072517
Kim A, Dueker S, Dong F, Roffel AF, Lee S,
Lee H. Human ADME for YH12852 using wavelength scanning cavity ring-down spectroscopy (WS-CRDS) after a low radioactivity dose.
Bioanalysis. 2020 Jan;12(2):87-98. doi:10.4155/bio-2019-0119
Drelichman G, Castaneda-Hernandez G, Ar C, Dragosky M, Garcia R,
Lee H, Moiseev S, Naderi M, Rosenbaum H, Znidar I, Zuluaga AF, Freisens S, Mistry PK. The Road to Biosimilars in Rare Diseases - Ongoing Lessons from Gaucher Disease.
Am J Hematol. 2020 Mar;95(3):233-237; doi:10.1002/ajh.25701 [Epub 2019 Dec 3]
Oh J, Huh KY, Cho YG, Cha JE, Kim SJ, Yoon SH, Park SS, Yoon H, Lee J,
Lee H. Safety, tolerability and pharmacokinetics and pharmacodynamics of HL2351, a novel hybrid Fc-fused IL-1 receptor antagonist, in healthy subjects: a first-in-human study.
Br J Clinical Pharmacol. 2020 Feb;86(2):372-379 doi: 10.1111/bcp.14161. [Epub 2020 Jan 3]
2019
Choi J,
Gim JA, Oh C, Ha S,
Lee H, Choi H, Im HJ. Association of metabolic and genetic heterogeneity in head and neck squamous cell carcinoma with prognostic implications: integration of FDG PET and genomic analysis.
EJNMMI Res. 2019 Nov21;9(1):97. doi:10.1186/s13550-019-0563-0.
Yoon S, Yi S, Rhee SJ,
Lee HA, Kim Y, Yu KS, Chung JY. Development of physiologcally-based pharmacokinetic model for cyclosporine in Asian children with renal impairment.
Translational and Clinical Pharmacology. 2019; 27(3): 107-114. doi.org/10.12793/tcp.2019.27.3.107
김시언,
이형기. 『합성의약품 시대는 가고 바이오의약품 시대가 온다』. 서울: 청년의사. 2019
Oh DY, Lee KW, Han SW, Kim JW, Shin JW, Jo SJ, Won J, Hahn S,
Lee H, Kim WH, Bang YJ. A First-in-Human Phase I Study of GC1118, a Novel Anti-Epidermal Growth Factor Receptor Antibody, in Patients with Advanced Solid Tumors.
The Oncologist. 2019; 0294. doi:10.1634/theoncologist.
Lee HA, Yu KS, Park SI, Yoon SH, Onohara M, Ahn YJ,
Lee H. URC102, a potent and selective inhibitor of hURAT1, reduced serum uric acid in healthy volunteers.
Rheumatology. 2019. doi:10.1093/rheumatology/kez140.
Lee HA,
Lee KR, Jang SB, Chung SY, Yu KS,
Lee H. A physiologically-based pharmacokinetic model adequately predicted the human pharmacokinetic profiles of YH4808, a novel K+-competitive acid blocker.
Eur J Pharm Sci. 2019; 130:1-10. doi: 10.1016/j.ejps.2019.01.009
Son H, Jang K, Lee H, Kim SE, Kang KW,
Lee H. Use of molecular imaging in clinical drug development: a systematic review.
Nucl Med Mol Imaging. 2019; 1-8. doi: 10.1007/s13139-019-00593-y
Kim Y, Hatley O, Rhee SJ, Yi S,
Lee HA, Yoon S, Chung JY, Yu KS,
Lee H. Development of a Korean-specific virtual population for physiologically-based pharmacokinetic modeling and simulation.
Biopharm Drug Dispos. 2019;
doi: 10.1002/bdd/2178.
Polasek TM, Rostami-Hodjegan A, Yim D-S, Jamei M, Lee H, Kimko H, Kim JK, Nguyen PTT, Darwich AS, Shin J-G. What Does it Take to Make Model-Informed Precision Dosing Common Practice? Report from the 1st Asian Symposium on Precision Dosing. The AAPS Journal. 2019;21(2):17. dos: 10.1208/s12248-018-0286-6
2018
Rhee SJ,
Lee HA, Lee SY, Kim EW, Jeon IS, Song IS, Yu KS. Physiologically Based Pharmacokinetic Modeling of Fimasartan, Amlodipine, and Hydrochlorothiazide for the Investigation of Drug-Drug Interaction Potential.
Pharm Res. 2018; 35:236. doi:10.1007/s11095-018-2511-5.
Rhee SJ,
Lee H, Ahn LY, Lim KS, Yu KS. Lack of a clinically significant pharmacokinetic interaction between pregabalin and thioctic acid in healthy volunteers.
Clin Ther. 2018. doi: 10.1016/j.clinthera.2018.08.016
[Epub ahead of print]
Lee H. Data exclusivity through New Drug Reexamination in Korea: sibutramine hydrochloride (Reductil
®) vs. sibutramine mesylate (Slimmer
®) as an example.
Translational and Clinical Pharmacology 2018;26(2) 49-55. doi: 10.12793/tcp.2018.26.2.49
2017
Lee H,
Lee H, Baik J, Kim H, Kim R. Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct.
Drug Design, Development and Therapy. 2017;11:3035-3043
Kim YK, Kim A, Park SJ,
Lee H. New tablet formulation of tacrolimus with smaller interindividual variability may become a better treatment option than the conventional capsule formulation in organ transplant patients.
Drug Design Dev Ther. 2017(11):2861-2869
Kim Y, Kim A, Lee S, Choi SH, Lee DY, Song JS, Lee H, Jang IJ, Yu KS. Pharmacokinetics, Safety, and Tolerability of Tedizolid Phosphate After Single-Dose Administration in Healthy Korean Male Subjects. Clin Ther. 2017. Sep;39(9):1849-1857, ePub 2017 Aug 31.
Lee H, Chung H, Lee S, Lee H, Yang SM, Yoon SH, Cho JY, Jang IJ, Yu KS. LBEC0101, A Proposed Etanercept Biosimilar: Pharmacokinetics, Immunogenicity, and Tolerability Profiles Compared with a Reference Biologic Product in Healthy Male Subjects. BioDrugs. 2017 May 27. doi: 10.1007/s40259-017-0230-9. [Epub ahead of print]
Yi S, Lee H, Jang SB, Byun HM, Yoon SH, Cho JY, Jang IJ, Yu KS. A novel K+ competitive acid blocker, YH4808, sustains inhibition of gastric acid secretion with a faster onset than esomeprazole: randomised clinical study in healthy volunteers. Aliment Pharmacol Ther. 2017 May 21. doi: 10.1111/apt.14148. [Epub ahead of print]
Oh J, Lee S, Lee H, Cho J-Y, Yoon SH, et al. The novel carboxylesterase 1 variant c.662A>G may decrease the bioactivation of oseltamivir in humans. PLoS one. 2017;12(4):e0176320.
Rhee SJ, Lee JW, Yu KS, Hong KT, Choi JY, Hong CR, Park KD, Shin HY, Song SH, Kang HJ, Lee H. Pediatric patients undergoing hematopoietic stem cell transplantation can greatly benefit from a novel once-daily intravenous busulfan dosing nomogram. American Journal of Hematology. 2017 Mar 28. doi: 10.1002/ajh.24734. [Epub ahead of print]
Kim A, Yu BY, Dueker SR, Shin KH, Kim HS, Ahn H, Cho JY, Yu KS, Jang IJ, Lee H. An accelerator mass spectrometry-enabled microtracer study to evaluate the first-pass effect on the absorption of YH4808. Clin Pharmacol Ther. 2017.2017 Feb 18 (Epub ahead of print)
Choi Y, Jiang F, An H, Park HJ, Choi JH, Lee H. A pharmacogenomic study on the pharmacokinetics of tacrolimus in healthy subjects using the DMETTM Plus platform. The Pharmacogenomics Journal. 2017;17(2):174-179
Lee HA, Lee S, Yim SV, Kim BH. Bioequivalence of two formulations of pregabalin 150-mg capsules under fasting conditions in healthy male subjects. International Journal of Clinical Pharmacology and Therapeutics. 2017 Feb, 55(2):171-176. doi: 10.5414/CP202698
Ju SM, Kim MS, Jo YS, Jeon YM, Bae JS, Pae HO, Jeon BH. Licorice and its active compound glycyrrhizic acid ameliorates cisplatin-induced nephrotoxicity through inactivation of p53 by scavenging ROS and overexpression of p21 in human renal proximal tubular epithelial cells. Eur Rev Med Pharmacol Sci. 2017 Feb. 21(4):890-899.
Lee H, Yim SV, Kim BH, Lee S. Comparative pharmacokinetic and bioequivalence evaluation of two formulations of morniflumate 350-mg tablets in healthy male subjects. Int J Clin Pharmacol Ther. 2017 Jan;55 (2017)(1):95-101.
2016
Suh HY, Peck C, Yu K-S, Lee H. Determination of the starting dose in the first-in-human clinical trials with monoclonal antibodies: a systematic review of papers published between 1990 and 2013. Drug Des Devel Ther. 2016;Volume 10:4005-4016.
Kim A, Lim KS, Lee H, Chung H, Yoon SH, Yu KS, Cho JY, Jang IJ, Chung JY. A thorough QT study to evaluate the QTc prolongation potential of two neuropsychiatric drugs, quetiapine and escitalopram, in healthy volunteers. Int Clin Psychopharmacol. 2016;31(4):210-217.
2015
Yoon S, Shin D, Lee H, Jang IJ, Yu KS. Pharmacokinetics, pharmacodynamics, and tolerability of LC350189, a novel xanthine oxidase inhibitor, in healthy subjects. Drug design, development and therapy. 2015;9:5033-5049.
Chung H, Lee H, Han H, et al. A pharmacokinetic comparison of two voriconazole formulations and the effect of CYP2C19 polymorphism on their pharmacokinetic profiles. Drug design, development and therapy. 2015;9:2609-2616.
Oh J, Ji S, Lee H, Yu KS, Jang IJ. Response to "Induction of both P-glycoprotein and specific cytochrome P450 by Aspirin eventually does not alter the antithrombotic effect of clopidogrel". Clin. Pharmacol. Ther. 2015;97(4):325
Park SI, Lee H, Oh J, Lim KS, Jang IJ, Kim JA, Jung JH, Yu KS. A fixed-dose combination tablet of gemigliptin and metformin sustained release has comparable pharmacodynamic, pharmacokinetic, and tolerability profiles to separate tablets in healthy subjects. Drug design, development and therapy. 2015;9:729-736.
Lee H. Erratum to: Is Extrapolation of the Safety and Efficacy Data in One Indication to Another Appropriate for Biosimilars? AAPS J. 2015;17(6):1520-1521
2014
Chung I, Yoon S, Yi S, Kim B-H, Yim S-V, Jang I-J, Lee H. A bioequivalence study of two levofloxacin tablets in healthy male subjects. Translational and Clinical Pharmacology. 2014;22(2):102.
Lee J, Lee H, Jang K, Lim KS, Shin D, KS Yu. Evaluation of the pharmacokinetic and pharmacodynamic drug interactions between cilnidipine and valsartan in healthy volunteers. Drug design, development and therapy, 2014 Oct 8;8:1781-8. doi: 10.2147/DDDT.S68574.
Lee J, Yoon S, Shin D, Han H, An H, Lee J, Lim KS, Yu KS, Lee H. Predictive performance of gentamicin dosing nomograms. Drug design, development and therapy. 2014;8:1097-1106.
Yi S, An H, Lee H, Lee S, Ieiri I, Lee Y, Cho JY, Hirota T, Fukae M, Yoshida K, Nagatsuka S, Kimura M, Irie S, Sugiyama Y, Shin DW, Lim KS, Chung JY, Yu KS, Jang IJ. Korean, Japanese, and Chinese populations featured similar genes encoding drug-metabolizing enzymes and transporters: a DMET Plus microarray assessment. Pharmacogenetics and genomics. 2014;24(10):477-485.
Jang K, Yoon S, Kim SE, Cho JY, Yoon SH, Lim KS, Yu KS, Jang IJ, Lee H. Novel nanocrystal formulation of megestrol acetate has improved bioavailability compared with the conventional micronized formulation in the fasting state. Drug design, development and therapy. 2014;8:851-858.
Kim TE, Lee H, Lim KS, Lee S, Yoon SH, Park KM, Han H, Shin SG, Jang IJ, Yu KS, Cho JY. Effects of HM30181, a P-glycoprotein inhibitor, on the pharmacokinetics and pharmacodynamics of loperamide in healthy volunteers. Br J Clin Pharmacol. 2014;78(3):556-564.
Kim A, Chung I, Yoon SH, Yu KS, Lim KS, Cho JY, Lee H, Jang IJ, Chung JY. Effects of proton pump inhibitors on metformin pharmacokinetics and pharmacodynamics. Drug Metab Dispos. 2014;42(7):1174-1179.
Shin D, Cho YM, Lee S, Lim KS, Kim JA, Ahn JY, Cho JY, Lee H, Jang IJ, Yu KS. Pharmacokinetic and pharmacodynamic interaction between gemigliptin and metformin in healthy subjects. Clin Drug Investig. 2014;34(6):383-393.
Oh J, Shin D, Lim KS, Lee S, Jung KH, Chu K, Hong KS, Shin KH, Cho JY, Yoon SH, Ji SC, Yu KS, Lee H, Jang IJ. Aspirin decreases systemic exposure to clopidogrel through modulation of p-glycoprotein but does not alter its antithrombotic activity. Clin Pharmacol Ther. 2014;95(6):608-616.
Shin KH, Lim KS, Lee H, Jang IJ, Yu KS. An assessment of the pharmacokinetics, pharmacodynamics, and tolerability of GCPGC, a novel pegylated granulocyte colony-stimulating factor (G-CSF), in healthy subjects. Invest New Drugs. 2014;32(4):636-643.
Yoon S, Lee H, Kim TE, et al. Comparative steady-state pharmacokinetic study of an extended-release formulation of itopride and its immediate-release reference formulation in healthy volunteers. Drug design, development and therapy. 2014;8:123-128.
Lee H. Is Extrapolation of the Safety and Efficacy Data in One Indication to Another Appropriate for Biosimilars? AAPS J. 2014;16(1):22-26, Epub 11 Oct 2013 DOI: 10.1208/s12248-013-9534-y
Chaturvedula A, Sale ME, Lee H. Genetic algorithm guided population pharmacokinetic model development for simvastatin, concurrently or non-concurrently co-administered with amlodipine. Journal of Clinical Pharmacology. 2014;54(2):141-149, Epub 21 SEP 2013 DOI: 10.1002/jcph.176
2013
Kim DW, Gu N, Lee H, Jang IJ, Chu K, Yu KS, et al. Usefulness of oral loading of oxcarbazepine suspension in selected patients with epilepsy. Int J Clin Pharmacol Ther. 2013 Oct;51(10):780-6. doi: 10.5414/CP201896.
Cha Y-J, Lee H, Gu N, Kim T-E, Lim KS, Yoon SH, Chung J-Y, Jang I-J, Shin S-G, Yu K-S, Cho J-Y. Sustained Increase in the Oral Bioavailability of Loperamide after a Single Oral Dose of HM30181, a P-glycoprotein Inhibitor, in Healthy Male Participants. Basic Clin Pharmacol Toxicol. 2013;113(6):419-424.
Lee H, Jang I-J, Yu K-S, Choi J, Oh B-H. A Population Pharmacokinetic Analysis of Fimasartan, a Selective Angiotensin II Receptor Antagonist, in Healthy Caucasian Subjects and Korean Patients With Hypertension. Clinical Pharmacology in Drug Development. 2013;2(2):162-72. doi: 10.1002/cpdd.10.
Lee H, Kim KS, Chae SC, Jeong MH, Kim DS, Oh BH. Ambulatory Blood Pressure Response to Once-Daily Fimasartan: An 8-Week, Multicenter, Randomized, Double-Blind, Active-Comparator, Parallel-Group Study in Korean Patients With Mild To Moderate Essential Hypertension. Clin Ther. 2013;35(9):1337-49. doi: 10.1016/j.clinthera.2013.06.021.
2012
Lee H. Equivalence Margin of the Biosimilar Product. J Korean Soc Clin Pharmacol Ther. 2012;20(1):17-33
Lee H, Yang H-M, Lee H-Y, Kim J-J, Choi D-J, Seung K-B, Jeon E-S, Ha J-W, Rim S-J, Park JB, Shin J-H, Oh B-H. Efficacy and Tolerability of Once-Daily Oral Fimasartan 20 to 240 mg/d in Korean Patients with Hypertension: Findings from Two Phase II, Randomized, Double-Blind, Placebo-Controlled Studies. Clin Ther. 2012;34(6):1273-1289.
2011
Chi YH, Lee H, Paik SH et al. Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fimasartan, a Novel Angiotensin II Receptor Antagonist, Following Single and Repeated Oral Administration in the Fasted and Fed States in Healthy Subjects. Am J Cardiovasc Drugs. 2011 Oct 1. 1(5):335-46.
Xie HG, Cao YJ, Gauda EB, Agthe AG, Hendrix CW, Lee H. Clonidine Clearance Matures Rapidly during the Early Postnatal Period: A Population Pharmacokinetic Analysis in Newborns with Neonatal Abstinence Syndrome. J Clin Pharmacol. 2011:51:502-511.
2010
Park CG, Lee H, Choi JW, Lee SJ, Kim SH, Lim HE. Non-concurrent Dosing Attenuated Pharmacokinetic Drug Interaction between Amlodipine and Simvastatin. Int J Clin Pharmacol Ther. 2010; 48(8):497-503.
Xu Z, Lee H, Vu T, Hu C, Yan H, Baker D, Hsu B, Pendley C, Wagner C, Davis HM, Zhou H. Population Pharmacokinetics of Golimumab in Patients with Ankylosing Spondylitis: Impact of Body Weight and Immunogenicity. Int J Clin Pharmacol Ther. 2010;48(9):596-607.
2009
Xu Z, Vu T, Lee H, Hu C, Ling J, Yan H, Baker D, Beutler A, Pendley C, Wagner C, Davis HM, Zhou H. Population Pharmacokinetics of Golimumab, an Anti-Tumor Necrosis Factor-Alpha Human Monoclonal Antibody, in Patients with Psoriatic Arthritis. J Clin Pharmacol, 2009;49:1056-1070.
Lee H. Chapter 12. Utilizing the Preclinical Database to Support Clinical Drug Development. In: Preclinical Drug Development, edited by Mark Rogge and David R. Taft, Taylor & Francis, Boca Raton, London, New York, Singapore. 2005 & 2009 (2nd ed.) (ISBN: 978-1420084726)
Lee H. Chapter 13. Regulation for Drug Development and Competition. In: Introduction to Pharmaceutical Medicine, Novo Consulting, Seoul, 2009
Lee HA, Leavens TL, Mason SE, Monteiro-Riviere NA, Riviere JE. Comparison of quantum dot biodistribution with a blood-flow-limited physiologically based pharmacokinetic model. Nano Letters. 2009 Feb;9(2):794-9. doi: 10.1021/nl803481q.
2008
Rea RS, Capitano B, Bies R, Bigos KL, Smith R, Lee H. Suboptimal Aminoglycoside Dosing in Critically Ill Patients, Ther Drug Monit, 2008;30:674–681.
2007
O’brien S, Lee H, Ritchey, AK. Once-Daily Enoxaparin in Pediatric Thromboembolism: A Dose Finding and Pharmacodynamics Study, Journal of Thrombosis and Haemostasis, 2007 Sep;5(9):1985-7.
Lee H. Let Us Not Forget Woo-Suk Hwang. The Young Physicians Press. Seoul, Korea, 2007 (ISBN: 8991232124).
Lee HA, Imran M, Monteiro-Riviere NA, Colvin VL, Yu WW, Riviere JE. Biodistribution of quantum dot nanoparticles in perfused skin: evidence of coating dependency and periodicity in arterial extraction. Nano Letters. 2007 Sep;7(9):2865-70. doi: 10.1021/nl071563c.
2006
Tannenbaum S, Holford NHG, Lee H, Peck C, Mould DR. Simulation of Correlated Continuous and Categorical Variables using a Single Multivariate Distribution. Journal of Pharmacokinetics and Pharmacodynamics, 2006 Dec;33(6):773-94.
Lee H. Chapter 1. Disappearance of Biomedical Science, Destruction of Research Ethics. In: Hwang Woo Suk’s Scandal. Hannarae Publishing Co., Seoul, Korea (ISBN : 9788955660487)
2005
Knollmann BC, Smyth B, Garnett C, Salessiotis A, Gvodjan D, Berry NS, Lee H, Min FD. Personal Digital Assistant-Based Drug Reference Software as Tools to Improve Rational Prescribing: Benchmark Criteria and Performance.Clin Pharmacol Ther 2005 Jul;78(1):7-18.
Lee H, Yim D-S, Zhou H, Peck CC. Evidence of Effectiveness: How Much Can We Extrapolate From Existing Studies? AAPS Journal. 2005 Oct 5;7(2):E467-74.
Lack NA, Green B, Dale DC, Calandra GB, Lee H, MacFarland RT, Badel K, Liles WC, Bridger G, A Pharmacokinetic/Pharmacodynamic Model for the Mobilization of CD34+ Hematopoietic Progenitor Cells by AMD3100, Clin Pharmacol Ther 2005;77(5): 427-36.
Yim DS, Zhou H, Buckwalter M, Nestorov I, Peck CC, Lee H. Population Pharmacokinetic Analysis and Simulation of the Time Concentration Profile of Etanercept in Pediatric Patients with Juvenile Rheumatoid Arthritis, Journal of Clinical Pharmacology, 2005;45(3):246-256.
Lee H. Good Review Practices are the first step forward for the Korea Food and Drug Administration, Drug Information Journal 2005;39: 185-192.
Lee H. FDA vs. KFDA. The Young Physicians Press. Seoul, Korea, 2005 (ISBN : 8991232043)
2003
Lee H, Kimko H, Rogge M, Wang D, Nestorov I, Peck CC. Population pharmacokinetic and pharmacodynamic modeling of etanercept using logistic regression analysis. Clin Pharmacol Ther 2003;73(4): 348-365.
2002
Cross J, Lee H, Westelinck A, Nelson J, Grudzinskas C, Peck C. Postmarketing Drug Dosage Changes of 499 FDA-Approved New Molecular Entities, 1980-1999, Pharmacoepidemiology and Drug Safety, 2002;11:439-446.
Lee H, Application of foreign clinical trial data by using pharmacokinetic-pharmacodynamic modeling and simulation technique in Korea: a regulatory point of view. Kor J Clin Pharmacol Ther, 2002; 10(2): 193-9.
2001
Lee H, C Kim, S Shin. Changes in Clinical Trial Practice and the Working Environment in the Korean Pharmaceutical Industry Since the Implementation of Good Clinical Practice, Drug Info J, 2001;35:203-210.
2000
Yoon YR, Cha IJ, Shon JH, Kim KA, Kim MJ, Shin JG, Park SW, Seo SS, Choi JS, Lee H. Clinical Pharmacokinetics of Transdermal Absorption of Diclofenac Diethylammonium Plaster in Healthy Volunteers, Kor J Clin Pharmacol Ther, 2000;8(1): 101-112.
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