Kyun-Seop Bae, MD, PhD

Full Name & Degree

Kyun-Seop Bae M.D.Ph.D.

Office Address

Department of Clinical Pharmacology and Therapeutics

Asan Medical Center (AMC), University of Ulsan

88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea

E-mail

ksbae@amc.seoul.kr

Current Positions

Professor, Department of Clinical Pharmacology and Therapeutics, Asan Medical Center
Director of Policy, Korean Society for Clinical Pharmacology and Therapeutics (KSCPT)
Auditor, Korean Association of Institutional Review Board (KAIRB)
Member, Central Pharmaceutical Affairs Council (CPAC), Ministry of Food and Drug Safety(MFDS), Korea

Education

University	Major	Degree	Year
Seoul National University, Korea	Medicine	M.D.	1994
Seoul National University, Korea	Clinical Pharmacology	M.S.	2000
Seoul National University, Korea	Clinical Pharmacology	Ph.D.	2002

Career

2016.10 - present	Professor, Asan Medical Center/University of Ulsan, Korea
2012.3 – 2018.2	Chair, Department of Clinical Pharmacology andTherapeutics, AMC
2010.10 – 2016.9	Associate Professor, Asan Medical Center/University of Ulsan, Korea
2009.1 – 2009.7 2018.9 - 2019.8	Visiting Scholar, University of Southern California, USA
2008.1 – 2009.1	International Fellow, Pfizer Global Research and Development – La Jolla, USA
2004.9 – 2010.9	Assistant Professor, Asan Medical Center/University of Ulsan, Korea
2002.6 – 2004.9	Clinical Lecturer, Asan Medical Center/University of Ulsan, Korea

Description

Prof. Bae is a professor at the Department of Clinical Pharmacology and Therapeutics of Asan Medical Center(AMC)

and University of Ulsan. He graduated from Seoul National University College of Medicine in 1994. After clinical pharmacology training at Seoul National University Hospital, he joined AMC in 2002. He conducted more than 90 phase 1 clinical trials as principal investigator at AMC. His academic interests are methodic aspects of drug development.

Research

♦ Clinical Pharmacology Trials

• First in Human Trial (SAD, MAD)

• Drug-Drug Interaction (DDI) Study

• Food Effect Study (FES), Food-Drug Interaction (FDI) Study

• Bioequivalence(BE) Trial, Formulation BE trial, Comparative Pharmacokinetics (PK) Study

• Special Population Study (Renally and Hepatically Impaired, Elderly)

♦ Pharmacometrics

• Population Pharmacokinetics-Pharmacodynamics Modeling and Simulation (Pop PK-PD M&S)

• Clinical Trial Simulation (CTS) with Compliance and Drop-out Model

♦ New Drug Development Strategy (NDDS)

• Decision under Uncertainty (Frequentist and Likelihoodist Approach)

• Phase 2/3 Design and End of Phase 2 Meeting

♦ Clinical Trial Design and Data Analysis

• Linear and Nonlinear Mixed Effects Modeling for Repeated Measures and Longitudinal Data

• Design and Analysis of Complex Designs: Split-Plot Design, Nested Design, Group Sequential Design (GSD)

♦ Individualized Optimal Pharmacotherapy

• Therapeutic Drug Monitoring(TDM) or Target Concentration Intervention(TCI)

• Medication Reconciliation (esp. for Elderly)

Publications

Original Articles

[SCI/SCIE Journals]

Kim CG, Bae KS. A Comparison of the Charlson and Elixhauser Methods for Predicting Nursing Indicators in Gastrectomy with Gastric Cancer Patients. Healthcare 2023 Jun 22; 11(13), 1830; PMID: 37444664
Lee MH, Yoon SK, Kim H, Cho YS, Han S, Lee SH, Bae KS, Jung J, Hong SH, Lim HS. Pharmacokinetic Interactions Between Bazedoxifene and Cholecalciferol: An Open-Label, Randomized, Crossover Study in Healthy Male Volunteers. Drug Des Devel Ther. 2023 Apr 12;17:1107-1114. PMID: 37077410
Kim CG, Kim JS, Bae KS. Association between nurse staffing levels and rotavirus infection in neonatal intensive care units: A retrospective observational study. Intensive Crit Care Nurs. 2023 Feb;74:103314. PMID: 36153186
Han S, Choi HY, Kim YH, Choi S, Kim S, Nam JY, Kim B, Song GS, Lim HS, Bae KS. Comparison of Pharmacodynamics between Tegoprazan and Dexlansoprazole Regarding Nocturnal Acid Breakthrough: A Randomized Crossover Study. Gut Liver. 2023 Jan 15;17(1):92-99. PMID: 36317518
Cho YS, Bae KS, Choi SC, Cho JM, Lim HS. Population Pharmacokinetic and Pharmacodynamic Analysis of Polmacoxib in Healthy Volunteers and Patients With Osteoarthritis. Clin Ther. 2022 Jan;44(1):67-80. PMID: 34974943
Han S, Choi HY, Kim YH, Nam JY, Kim B, Song GS, Lim HS, Bae KS. Effect of Food on the Pharmacokinetics and Pharmacodynamics of a Single Oral Dose of Tegoprazan. Clin Ther. 2021 Aug;43(8):1371-1380. PMID: 34246485
Han S, Cho YS, Yoon SK, Lim KS, Cho SH, Kim J, Choe S, Jung J, Ghim JL, Choi S, Lee M, Kim SM, Kim HT, Lim HS, Shim JY, Bae KS. First-in-human, double-blind, randomized controlled trial of an oral dose of GnRH antagonist, TU2670 in healthy women. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1111-e1120. PMID: 33347565
Han S, Kim YH, Choi HY, Soh DJ, Kim J, Nam J, Kim JW, Bae KS, Lim HS. First-in-Human Evaluation of the Safety, Tolerability, and Pharmacokinetics of a Neuroprotective Poly (ADP-ribose) Polymerase-1 Inhibitor, JPI-289, in Healthy Volunteers. Drug Des Devel Ther. 2020 Aug 5;14:3189-3199. PMID: 32801651.
Yoon SK, Bae KS, Hong DH, Kim SS, Choi YK, Lim HS. Pharmacokinetic Evaluation by Modeling and Simulation Analysis of a Donepezil Patch Formulation in Healthy Male Volunteers. Drug Des Devel Ther. 2020 May 5;14:1729-1737. PMID: 32440098.
Cui A, Kim YH, Ghim JL, Ah Jung J, Cho SH, Choe S, Choi HY, Bae KS, Lim HS. Pharmacokinetic modeling analysis of cilostazol and its active metabolites (OPC-13015 and OPC-13213) after multiple oral doses of cilostazol in healthy Korean volunteers. Xenobiotica. 2020 Mar;50(3):288-296. PMID: 31181990.
Yoon S, Bae KS, Cho YS, Han S, Kim H, Lim HS. Disease Progression Modeling Analysis of the Change of Bone Mineral Density by Postoperative Hormone Therapies in Postmenopausal Patients With Early Breast Cancer. J Clin Pharmacol. 2019 Nov; 59(11):1543-1550. PMID: 31172521.
Han S, Choi HY, Kim YH, Nam JY, Kim B, Song GS, Lim HS, Bae KS. Randomised clinical trial: safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of tegoprazan (CJ-12420), a novel potassium-competitive acid blocker, in healthy male subjects. Aliment Pharmacol Ther. 2019 Oct;50(7):751-759. PMID: 31437865.
Han S, Kim YH, Choi HY, Kim MJ, Kim WJ, Park H, Bae KS, Lim HS. Pharmacokinetic and Pharmacodynamic Modeling and Simulation Analysis of CTB-001, a Recently Developed Generic of Bivalirudin. Pharm Res. 2019 Aug 8;36(10):146. PMID: 31396727.
Cui A, Kim YH, Ghim JL, Ah Jung J, Cho SH, Choe S, Choi HY, Bae KS, Lim HS. Pharmacokinetic modeling analysis of cilostazol and its active metabolites (OPC-13015 and OPC-13213) after multiple oral doses of cilostazol in healthy Korean volunteers. Xenobiotica. 2019 Jul 3:1-9. PMID: 31181990.
Yoon S, Bae KS, Cho YS, Han S, Kim H, Lim HS. Disease Progression Modeling Analysis of the Change of Bone Mineral Density by Postoperative Hormone Therapies in Postmenopausal Patients With Early Breast Cancer. J Clin Pharmacol. 2019 Jun 6. PMID: 31172521.
Koh A, Pak KC, Choi HY, Ryu S, Choi SE, Kim KS, Bae KS, Lim HS. Quantitative Modeling Analysis Demonstrates the Impact of CYP2C19 and CYP2D6 Genetic Polymorphisms on the Pharmacokinetics of Amitriptyline and Its Metabolite, Nortriptyline. J Clin Pharmacol. 2019 Apr;59(4):532-540. PMID: 30452773.
Cho YS, Lim HS, Han S, Yoon SK, Kim H, Cho YL, Nam HS, Bae KS. Single-dose Intravenous Safety, Tolerability, and Pharmacokinetics and Absolute Bioavailability of LCB01-0371. Clin Ther. 2019 Jan;41(1):92-106. PMID: 30559004.
Cho YS, Lim HS, Cho YL, Nam HS, Bae KS. Multiple-dose Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral LCB01-0371 in Healthy Male Volunteers. Clin Ther. 2018 Dec;40(12):2050-2064. PMID: 30420289.
Cho YS, Lee SH, Lim HS, Bae KS. Pharmacokinetic Equivalence of the High Dose Strength Fixed-Dose Combination Tablet of Gemigliptin/Metformin Sustained Release (SR) and Individual Component Gemigliptin and Metformin XR Tablets in Healthy Subjects. J Korean Med Sci. 2018 Sep 5;33(41):e258. PMID: 30288156.
Cho YS, Lim HS, Lee SH, Cho YL, Nam HS, Bae KS. Pharmacokinetics, Pharmacodynamics, and Tolerability of Single-Dose Oral LCB01-0371, a Novel Oxazolidinone with Broad-Spectrum Activity, in Healthy Volunteers. Antimicrob Agents Chemother. 2018 Jun 26;62(7). pii: e00451-18. PMID: 29712654.
Kim H, Choi HY, Kim YH, Bae KS, Jung J, Son H, Lim HS. Pharmacokinetic interactions and tolerability of rosuvastatin and ezetimibe: an open-label, randomized, multiple-dose, crossover study in healthy male volunteers. Drug Des Devel Ther. 2018 Apr 11;12:815-821. PMID: 29692602.
Cho YS, Noh YH, Lim HS, Cho SH, Ghim JL, Choe S, Kim SB, Park JS, Lee SK, Yang WS, Chang JW, Bahng MY, Bae KS. Effects of Renal Impairment on the Pharmacokinetics and Safety of Udenafil. J Clin Pharmacol. 2018 Jul;58(7):905-912. PMID: 29537612.
Cho H, Yoon DH, Kim KP, Bae KS, Kim WS, Eom HS, Kim JS, Hong JY, Kim SJ, Lee H, Kim SJ, Suh C. Phase I study of CKD-581, a pan-histone deacetylase inhibitor, in patients with lymphoma or multiple myeloma refractory to standard therapy. Invest New Drugs. 2018 Oct;36(5):877-885. PMID:29520651.
Kim CG, Bae KS. Relationship between nurse staffing level and adult nursing-sensitive outcomes in tertiary hospitals of Korea: Retrospective observational study. Int J Nurs Stud. 2018 Apr;80:155-164. PMID:29455061.
Park GC, Jung JA, Bae KS, Lim HS. A Simulation Study to Compare the Treatment Effect of Tamoxifen by CYP2D6 Genotypes and Third-Generation Aromatase Inhibitors. J Clin Pharmacol. 2017 Sep;57(9):1088-1096. Epub 2017 Apr 3. PMID: 28369967
Hur EH, Goo BK, Moon J, Choi Y, Hwang JJ, Kim CS, Bae KS, Choi J, Cho SY, Yang SH, Seo J, Lee G, Lee JH. Induction of immunoglobulin transcription factor 2 and resistance to MEK inhibitor in melanoma cells. Oncotarget. 2017 Jun 20;8(25):41387-41400. PMID: 28574827
Ryu MH, Ryoo BY, Kim TW, Kim SB, Lim HS, Bae KS, Park SR, Jo YW, Cho HJ, Kang YK. A Phase I/IIa Study of DHP107, a Novel Oral Paclitaxel Formulation, in Patients with Advanced Solid Tumors or Gastric Cancer. Oncologist. 2017 Feb;22(2):129-e8. PMID: 28196905
Choi YJ, Kim KP, Park S, Park MY, Kim S, Kim YK, Bae KS, Beck SH, Choi KE, Chung JW, Lim YS, Kim TW. Process Innovation Improves Trial Operational Efficiency. Therapeutic Innovation & Regulatory Science. 2016 July;50(4): 510-514. PMID: 30227017
Cho SH, Lee JH, Lim HS, Lee KH, Kim DY, Choe S, Bae KS, Lee JH. Prospective validation of a novel dosing scheme for intravenous busulfan in adult patients undergoing hematopoietic stem cell transplantation. Korean J Physiol Pharmacol. 2016 May;20(3):245-51. Epub 2016 Apr 26. PMID: 27162478
Choi HY, Bae KS, Cho SH, Ghim JL, Choe S, Jung JA, Lim HS. Population plasma and urine pharmacokinetics of ivabradine and its active metabolite S18982 in Korean healthy volunteers. J Clin Pharmacol. 2016 Apr;56(4):439-49. Epub 2015 Nov 17. PMID: 26265098
Choi HY, Bae KS, Cho SH, Ghim JL, Choe S, Jung JA, Jin SJ, Kim HS, Lim HS. Impact of CYP2D6, CYP3A5, CYP2C19, CYP2A6, SLCO1B1, ABCB1, and ABCG2 gene polymorphisms on the pharmacokinetics of simvastatin and simvastatin acid. Pharmacogenet Genomics. 2015 Dec;25(12):595-608. PMID: 26367500
Lee JW, Kim Y, Perera V, McLachlan AJ, Bae KS. Prediction of plasma caffeine concentrations in young adolescents following ingestion of caffeinated energy drinks: a Monte Carlo simulation. Eur J Pediatr. 2015 Dec;174(12):1671-8. PMID: 26113286
Kim KP, Park SJ, Kim JE, Hong YS, Lee JL, Bae KS, Cha H, Kwon SK, Ro S, Cho J, Kim TW. First-in-human study of the toxicity, pharmacokinetics, and pharmacodynamics of CG200745, a pan-HDAC inhibitor, in patients with refractory solid malignancies. Invest New Drugs. 2015 Oct;33(5):1048-57. PMID: 26076682
Choi HY, Kim YH, Hong D, Kim SS, Bae KS, Lim HS. Therapeutic dosage assessment based on population pharmacokinetics of a novel single-dose transdermal donepezil patch in healthy volunteers. Eur J Clin Pharmacol. 2015 Aug;71(8):967-77. PMID: 26014587
Kim YH, Ghim JL, Jung JA, Cho SH, Choe S, Choi HY, Bae KS, Lim HS. Pharmacokinetic comparison of sustained- and immediate-release formulations of cilostazol after multiple oral doses in fed healthy male Korean volunteers. Drug Des Devel Ther. 2015 Jul 9;9:3571-7. PMID: 26185423
Kim YH, Choi HY, Noh YH, Lee SH, Lim HS, Kim C, Bae KS. Dose proportionality and pharmacokinetics of carvedilol sustained-release formulation: a single dose-ascending 10-sequence incomplete block study. Drug Des Devel Ther. 2015 Jun 8;9:2911-8. PMID: 26089641
Kim KP, Hong YS, Lee JL, Bae KS, Kim HS, Shin JG, Lee JS, Kim TW. A Phase I Study of UGT1A1 * 28/ * 6 Genotype-Directed Dosing of Irinotecan (CPT-11) in Korean Patients with Metastatic Colorectal Cancer Receiving FOLFIRI. Oncology. 2015;88(3):164-72. PMID: 25427841
Lim HS, Bae KS. Modeling and simulation analysis of the relationship between lesion recurrence on brain images and clinical recurrence in patients with ischemic stroke. J Clin Pharmacol. 2015 Apr;55(4):458-66. PMID: 25387691
Kim YH, Choi HY, Lee SH, Lim HS, Miki T, Kang JK, Han KG, Bae KS. Single and multiple dose pharmacokinetics and tolerability of HX-1171, a novel antioxidant, in healthy volunteers. Drug Des Devel Ther. 2015 Mar 23;9:1735-42. PMID: 25848210
Kim YH, Choi HY, Lim HS, Lee SH, Jeon HS, Hong D, Kim SS, Choi YK, Bae KS. Single dose pharmacokinetics of the novel transdermal donepezil patch in healthy volunteers. Drug Des Devel Ther. 2015 Mar 10;9:1419-26. PMID: 25792802
Jeon HS, Kim MJ, Choi HY, Kim YH, Kim EH, Kim AR, Park HJ, Bae KS, Lim HS. Pharmacokinetics and Pharmacodynamics of Ticagrelor and Prasugrel in Healthy Male Korean Volunteers. Clin Ther. 2015 Mar 1;37(3):563-73. PMID: 25697420
Kim YH, Choi HY, Lee SH, Jeon HS, Lim HS, Bahng MY, Bae KS. Pharmacokinetic interaction between udenafil and dapoxetine: a randomized, open-labeled crossover study in healthy male volunteers. Drug Des Devel Ther. 2015 Feb 23;9:1209-16. PMID: 25759565
Lim HS, Bae KS, Jung JA, Noh YH, Hwang AK, Jo YW, Hong YS, Kim K, Lee JL, Joon Park S, Kim JE, Kang YK, Kim TW. Predicting the Efficacy of an Oral Paclitaxel Formulation (DHP107) Through Modeling and Simulation. Clin Ther. 2015 Feb 1;37(2):402-17. PMID: 25579984
Choi HY, Lim HS, Kim YH, Jeon HS, Kim MJ, Lee SH, Jung JH, Lee YK, Kim HJ, Bae KS. Evaluation of the pharmacokinetics of the DPP-4 inhibitor gemigliptin when coadministered with rosuvastatin or irbesartan to healthy subjects. Curr Med Res Opin. 2015 Feb;31(2):229-41. PMID: 25350224
Kim YH, Choi HY, Jin S, Noh YH, Kim MJ, Park HJ, Lim HS, Bang K, Lee SH, Bae KS. Tolerability and Pharmacokinetics of Two Formulations of Megestrol Acetate under Fed Conditions in Healthy Volunteers. Clin Ther. 2015 Feb 1;37(2):439-47. PMID: 25450470
Noh YH, Lim HS, Jung JA, Song TH, Bae KS. Population pharmacokinetics of HM781-36 (poziotinib), pan-human EGF receptor (HER) inhibitor, and its two metabolites in patients with advanced solid malignancies. Cancer Chemother Pharmacol. 2015 Jan;75(1):97-109. PMID: 25377158
Kim MJ, Lim HS, Jin S, Jung JA, Noh YH, Kim YH, Bae KS. Pharmacokinetic, Pharmacodynamic, and Safety/Tolerability Profiles of CG100649, a Novel COX-2 Inhibitor: Results of a Phase I, Randomized, Multiple-Dose Study in Healthy Korean Men and Women. Clin Ther. 2015 Jan 1;37(1):197-210. PMID: 25097102
Wang E, Kang D, Bae KS, Marshall MA, Pavlov D, Parivar K. Population pharmacokinetic and pharmacodynamic analysis of tremelimumab in patients with metastatic melanoma. J Clin Pharmacol. 2014 Oct;54(10):1108-16. PMID: 24737343
Choi HY, Kim YH, Kim MJ, Lee SH, Bang K, Han S, Lim HS, Bae KS. Evaluation of Pharmacokinetic Drug Interactions between Gemigliptin (Dipeptidylpeptidase-4 Inhibitor) and Glimepiride (Sulfonylurea) in Healthy Volunteers. Drugs R D. 2014 Sep;14(3):165-76. PMID: 24962635
Jin SJ, Bae KS, Cho SH, Jung JA, Kim U, Choe S, Ghim JL, Noh YH, Park HJ, Kim HS, Lim HS. Population Pharmacokinetic Analysis of Simvastatin and its Active Metabolite with the Characterization of Atypical Complex Absorption Kinetics. Pharm Res. 2014 Jul;31(7):1801-12. PMID: 24549818
Choi HY, Noh YH, Kim YH, Kim MJ, Lee SH, Kim JA, Kim B, Lim HS, Bae KS. Effects of food on the pharmacokinetics of gemigliptin/metformin sustained-release 50/1,000 mg (25/500 mg × 2 tablets) fixed dose combination tablet in healthy male volunteers. Int J Clin Pharmacol Ther. 2014 May;52(5):381-91. PMID: 24495314
Kim MJ, Lim HS, Cho SH, Bae KS. Comparative Pharmacokinetics and Bioavailability of Gemifloxacin Administered as an Intravenous 200 mg Formulation or an Oral 320 mg Tablet. Clin Drug Investig. 2014 Mar;34(3):195-201. PMID: 24385283
Choi HY, Kim YH, Kim MJ, Noh YH, Lee SH, Bae KS, Lim HS. Pharmacokinetics, Tolerability, and Safety of the Single Oral Administration of AGSAV301 vs Exforge: A Randomized Crossover Study of Healthy Male Volunteers. Am J Cardiovasc Drugs. 2014 Feb;14(1):63-72. PMID: 24174172
Choi HY, Jin SJ, Jung JA, Kim UJ, Ko YJ, Noh YH, Bae KS, Lim HS. Effects of Ketoconazole on the Pharmacokinetic Properties of CG100649, A Novel NSAID: A Randomized, Open-Label Crossover Study in Healthy Korean Male Volunteers. Clin Ther. 2014 Jan 1;36(1):115-25. PMID: 24417786
Kim MJ, Lim HS, Noh YH, Kim YH, Choi HY, Park KM, Kim SE, Bae KS. Pharmacokinetic interactions between eperisone hydrochloride and aceclofenac: a randomized, open-label, crossover study of healthy Korean men. Clin Ther. 2013 Oct;35(10):1528-35. PMID: 24050970
Choi HY, Noh YH, Cho SH, Ghim JL, Choe S, Kim UJ, Ah Jung J, Bae KS, Lim HS. Evaluation of Pharmacokinetic and Pharmacodynamic Profiles and Tolerability After Single (2.5, 5, or 10 mg) and Repeated (2.5, 5, or 10 mg BID for 4.5 days) Oral Administration of Ivabradine in Healthy Male Korean Volunteers. Clin Ther. 2013 Jun;35(6): 819-35. PMID: 23755867
Kim KP, Kim HS, Sym SJ, Bae KS, Hong YS, Chang HM, Lee JL, Kang YK, Lee JS, Shin JG, Kim TW. A UGT1A1*28 and *6 genotype-directed phase I dose-escalation trial of irinotecan with fixed-dose capecitabine in Korean patients with metastatic colorectal cancer. Cancer Chemother Pharmacol. 2013 Jun;71(6):1609-17. PMID: 23595344
Hong YS, Kim KP, Lim HS, Bae KS, Ryu MH, Lee JL, Chang HM, Kang YK, Kim H, Kim TW. A phase I study of DHP107, a mucoadhesive lipid form of oral paclitaxel, in patients with advanced solid tumors: Crossover comparisons with intravenous paclitaxel. Invest New Drugs. 2013 Jun;31(3):616-22. PMID: 22695940
Noh YH, Lim HS, Cho SH, Ghim JL, Choe S, Jung JA, Kim MJ, Kim YH, Jin SJ, Kim SB, Park JS, Lee SK, Yang WS, Chang JW, Lee B, Bae KS. Assessment of the influence of severe renal impairment on the pharmacokinetics of mirodenafil in Korean male volunteers. Int J Clin Pharmacol Ther. 2012 Dec;50(12):880-8. PMID: 23006442
Choe S, Kim G, Lim HS, Cho SH, Ghim JL, Jung JA, Kim UJ, Noh G, Bae KS, Lee D. A simple dosing scheme for intravenous busulfan based on retrospective population pharmacokinetic analysis in Korean patients. Korean J Physiol Pharmacol. 2012 Aug;16(4):273-80. PMID: 22915993
Choi HY, Noh YH, Jin SJ, Kim YH, Kim MJ, Sung H, Jang SB, Lee SJ, Bae KS, Lim HS. Bioavailability and Tolerability of Combination Treatment with Revaprazan 200 mg + Itopride 150 mg: A Randomized Crossover Study in Healthy Male Korean Volunteers. Clin Ther. 2012 Sep;34(9):1999–2010. PMID: 22858177
Noh YH, Lim HS, Jung JA, Jin SJ, Kim MJ, Kim YH, Park HJ, Bae KS. A single-dose, crossover study comparing the pharmacokinetics and pharmacodynamics of 2 formulations of metformin in healthy volunteers. Int J Clin Pharmacol Ther. 2012 Aug;50(8):605-13. PMID: 22762856
Jin SJ, Jung JA, Cho SH, Kim UJ, Choe S, Ghim JL, Noh OH, Park HJ, Kim JC, Jung JA, Lim HS, Bae KS. The pharmacokinetics of letrozole - its association with key body mass metrics. Int J Clin Pharmacol Ther. 2012 Aug;50(8):557-65. PMID: 22735458
Noh YH, Lim HS, Kim MJ, Kim YH, Choi HY, Sung HR, Jin SJ, Lim J, Bae KS. Pharmacokinetic Interaction of Telmisartan with S-Amlodipine: An Open-Label, Two-Period Crossover Study in Healthy Korean Male Volunteers. Clin Ther. 2012 Jul;34(7):1625-35. PMID: 22721873
Noh YH, Lim HS, Jin SJ, Kim MJ, Kim YH, Sung HR, Choi HY, Bae KS. Effects of Ketoconazole and Rifampicin on the Pharmacokinetics of Gemigliptin, a Dipeptidyl Peptidase-IV Inhibitor: A Crossover Drug-Drug Interaction Study in Healthy Male Korean Volunteers. Clin Ther. 2012 May;34(5):1182-94. PMID: 22534255
Choi Y, Lee JH, Hur EH, Kang MJ, Kim SD, Lee JH, Kim DY, Lim SN, Bae KS, Lim HS, Seol M, Kang YA, Lee KH. Single nucleotide polymorphism of Wilms' tumor 1 gene rs16754 in Korean patients with cytogenetically normal acute myeloid leukemia. Ann Hematol. 2012 May;91(5):671-7. PMID: 22015946
Kang D, Bae KS, Houk BE, Savic RM, Karlsson MO. Standard Error of Empirical Bayes Estimate in NONMEM^® VI. Korean J Physiol Pharmacol. 2012 Apr;16(2):97-106. PMID: 22563254
Jung JA, Noh YH, Jin S, Kim MJ, Kim YH, Jung JA, Lim HS, Bae KS. Pharmacokinetic Interaction between Pitavastatin and Valsartan: A Randomized, Open-Labeled Crossover Study in Healthy Male Korean Volunteers. Clin Ther. 2012 Apr;34(4):958-65. PMID: 22410289
Noh YH, Ko YJ, Cho SH, Ghim JL, Choe S, Jung JA, Kim UJ, Jin SJ, Park HJ, Song GS, Lim HS, Bae KS. Pharmacokinetic Comparison of 2 Formulations of Anastrozole (1 mg) in Healthy Korean Male Volunteers: A Randomized, Single-Dose, 2-Period, 2-Sequence, Crossover Study. Clin Ther. 2012 Feb;34(2):305-13. PMID: 22281018
Noh YH, Lim HS, Cho SH, Ghim JL, Choe S, Jung JA, Kim UJ, Park KM, Jang MJ, Bae KS. Pharmacokinetic Comparison of Controlled- and Immediate-Release Formulations of Dexibuprofen after Single and Multiple Oral Doses in Fasting Healthy Male Korean Volunteers. Clin Ther. 2011 Sep;33(9):1132-41. PMID: 21864907
Kim SD, Lee JH, Hur EH, Lee JH, Kim DY, Lim SN, Choi Y, Lim HS, Bae KS, Noh GJ, Yun SC, Han SB, Lee KH. Influence of GST gene polymorphisms on the clearance of intravenous busulfan in adult patients undergoing hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2011 Aug;17(8):1222-30. PMID: 21215809
Kim KP, Jang G, Hong YS, Lim HS, Bae KS, Kim HS, Lee SS, Shin JG, Lee JL, Ryu MH, Chang HM, Kang YK, Kim TW. Phase II study of S-1 combined with oxaliplatin as therapy for patients with metastatic biliary tract cancer: influence of the CYP2A6 polymorphism on pharmacokinetics and clinical activity. Br J Cancer. 2011 Feb 15;104(4):605-12. PMID: 21326246
Jung J, Choi S, Cho SH, Ghim JL, Hwang A, Kim U, Kim BS, Koguchi A, Miyoshi S, Okabe H, Bae KS, Lim HS. Tolerability and Pharmacokinetics of Avanafil, a Phosphodiesterase Type 5 Inhibitor: A Single- and Multiple-Dose, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study in Healthy Korean Male Volunteers. Clin Ther. 2010 Jun ;32(6):1178-87. PMID: 20637970
Park I, Lee JL, Ryu MH, Chang HM, Kim TW, Sym SJ, Lee SS, Jang G, Yoo C, Bae KS, Kang YK. Phase I/II and pharmacokinetic study of S-1 and oxaliplatin in previously untreated advanced gastric cancer. Cancer Chemother Pharmacol. 2010 Feb;65(3):473-80. PMID: 19551382
Kim GY, Bae KS, Noh GJ, Min WK. Estimation of indocyanine green elimination rate constant k and retention rate at 15 min using patient age, weight bilirubin, and albumin. J Hepatobiliary Pancreat Surg. 2009 Jul;16(4):521-8. PMID: 19365598
Cho SH, Lim HS, Ghim JL, Choe S, Kim UJ, Jung JA, Bae KS. Pharmacokinetic tolerability, and bioequivalence comparison of three different intravenous formulations of recombinant human erythropoietin in healthy Korean adult male volunteers: an open-label, randomized-sequence, three-treatment, three-way crossover study. Clin Ther. 2009 May;31(5):1046-53. PMID: 19539105
Lim HS, Im JS, Cho JY, Bae KS, Klein TA, Yeom JS, Kim TS, Choi JS, Jang IJ, Park JW. Pharmacokinetics of hydroxychloroquine and its clinical implications in chemoprophylaxis against malaria caused by Plasmodium vivax. Antimicrob Agents Chemother. 2009 Apr;53(4):1468-75. PMID: 19188392
Lee DH, Kim SW, Bae KS, Hong JS, Suh C, Kang YK, Lee JS. A Phase I and Pharmacologic Study of Belotecan in Combination with Cisplatin in Patients with Previously Untreated Extensive-Stage Disease Small Cell Lung Cancer. Clin Cancer Res. 2007 Oct 15;13(20):6182-6. PMID: 17947485
Ryu SG, Lee JH, Choi SJ, Lee JH, Lee YS, Seol M, Hur EH, Lee SH, Bae KS, Noh GJ, Lee MS, Yun SC, Han SB, Lee KH. Randomized comparison of four-times-daily versus once-daily intravenous busulfan in conditioning therapy for hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2007 Sep;13(9):1095-105. PMID: 17697972
Kang SH, Poynton MR, Kim KM, Lee H, Kim DH, Lee SH, Bae KS, Linares O, Kern SE, Noh GJ. Population pharmacokinetic and pharmacodynamic models of remifentanil in healthy volunteers using artificial neural network analysis. Br J Clin Pharmacol. 2007 Jul;64(1):3-13. PMID: 17324247
Kim KM, Choi BM, Park SW, Lee SH, Christensen LV, Zhou J, Yoo BH, Shin HW, Bae KS, Kern SE, Kang SH, Noh GJ. Pharmacokinetics and pharmacodynamics of propofol microemulsion and lipid emulsion after an intravenous bolus and variable rate infusion. Anesthesiology. 2007 May;106(5):924-34. PMID: 17457123
Lim HS, Cho JY, Oh DS, Chung JY, Hong KS, Bae KS, Yu KS, Lee KH, Jang IJ, Shin SG. Angiotensin II type 1 receptor 1166A/C polymorphism in association with blood pressure response to exogenous angiotensin II. Eur J Clin Pharmacol. 2007 Jan;63(1):17-26. PMID: 17146658
Kwon JH, Kim JS, Kang DW, Bae KS, Kwon SU. The thickness and texture of temporal bone in brain CT predict acoustic window failure of transcranial Doppler. J Neuroimaging. 2006 Oct;16(4):347-52. PMID: 17032385
Yu KS, Bae KS, Shon JH, Cho JY, Yi SY, Chung JY, Lim HS, Jang IJ, Shin SG, Song KS, Moon BS. Pharmacokinetic and pharmacodynamic evaluation of a novel proton pump inhibitor, YH1885, in healthy volunteers. J Clin Pharmacol. 2004 Jan;44(1):73-82. PMID: 14681344
Kim MK, Cho JY, Lim HS, Hong KS, Chung JY, Bae KS, Oh DS, Shin SG, Lee SH, Lee DH, Min B, Jang IJ. Effect of the CYP2D6 genotype on the pharmacokinetics of tropisetron in healthy Korean subjects. Eur J Clin Pharmacol. 2003 Jun;59(2):111-6. PMID: 12728290
Cho JY, Seo HB, Yu KS, Bae KS, Yi SY, Jang IJ, Shin SG. Simple and sensitive determination of the new antitumor drug CKD-602 in human plasma by liquid chromatography. J Chromatogr B Analyt Technol Biomed Life Sci. 2003 Jan 25;784(1):25-31. PMID: 12504179
Yu KS, Cho JY, Shon JH, Bae KS, Yi SY, Lim HS, Jang IJ, Shin SG. Ethnic differences and relationships in the oral pharmacokinetics of nifedipine and erythromycin. Clin Pharmacol Ther. 2001 Sep;70(3):228-36. PMID: 11557910
Na KY, Han JS, Kim YS, Ahn C, Kim S, Lee JS, Bae KS, Jang IJ, Shin SG, Huh W, Jeon US. Does albumin preinfusion potentiate diuretic action of furosemide in patients with nephrotic syndrome? J Korean Med Sci. 2001 Aug;16(4):448-54. PMID: 11511790
Yu KS, Yim DS, Cho JY, Park SS, Park JY, Lee KH, Jang IJ, Yi SY, Bae KS, Shin SG. Effect of omeprazole on the pharmacokinetics of moclobemide according to the genetic polymorphism of CYP2C19. Clin Pharmacol Ther. 2001 Apr;69(4):266-73. PMID: 11309556
Jang IJ, Yu KS, Shon JH, Bae KS, Cho JY, Yi SY, Shin SG, Ryu KH, Cho YB, Kim DK, Yoo SE. Pharmacokinetic/pharmacodynamic evaluation of a novel potassium channel opener, SKP-450, in healthy volunteers. J Clin Pharmacol. 2000 Jul;40(7):752-61. PMID: 10883417

[Non SCI Journals]

Park G, Kim H, Bae KS. Bioequivalence data analysis. Transl Clin Pharmacol. 2020 Dec;28(4):175-180.
Sunwoo J, Kim H, Choi D, Bae KS. Validation of "sasLM," an R package for linear models with type III sum of squares. Transl Clin Pharmacol. 2020 Jun;28(2):83-91.
Kim H, Han S, Cho YS, Yoon SK, Bae KS. Development of R packages: ‘NonCompart’ and ‘ncar’ for noncompartmental analysis (NCA). Transl Clin Pharmacol. 2018;26(1):10-15.
Bae KS, Kang SH. Bioequivalence data analysis for the case of separate hospitalization. Transl Clin Pharmacol. 2017;25(2):93-100.
Lim HS, Soung JH, Bae KS. Forensic science meets clinical pharmacology: pharmacokinetic model based estimation of alcohol concentration of a defendant as requested by a local prosecutor’s office. Transl Clin Pharmacol. 2017;25(1):5-9.
Choi HY, Kim MJ, Kim YH, Noh YH, Lee JW, Lee TW, Kim MG, Bae KS. Pharmacokinetic Characteristics of Ibandronate and Tolerability of DP-R206 (150 mg Ibandronate/24,000 IU Vitamin D3) Compared to the Ibandronate (150 mg) Monotherapy in Healthy Adults. Transl Clin Pharmacol. 2014 Jun 22(1):22-29.
Kim MJ, Lim HS, Cho SH, Bae KS. Pharmacodynamic Comparison of Two Formulations of Voglibose 0.3 mg Tablet. J Korean Soc Clin Pharmacol Ther. 2013;21(1):34-40.
Lihm HS, Cha J, Seo JJ, Park J, Lee J, Lee HW, Bae KS, Kim W, Yoon YR. Targeted Plasma Metabolite Profiling of Metformin in Healthy Korean Volunteers. J Korean Soc Clin Pharmacol Ther. 2012;20(2):175-81.
Noh YH, Bae KS, Cho SH, Choe S, Ghim JL, Jung JA, Kim UJ, Jin SJ, Park HJ, Kim JC, Lim HS. Comparison of Pharmacokinetics and Safety of Two Formulations of Letrozole (2.5 mg) in Healthy Male Volunteers. J Korean Soc Clin Pharmacol Ther. 2012;20(2):135-44.
Choi HY, Kim JW, Lim HS, Cho SH, Ghim JL, Choe S, Jung JA, Lim J, Bae KS. Comparison of Pharmacokinetic Characteristics and the Safety between Amlodipine Maleate Tablet 5 mg and Amlodipine Besylate Tablet 5 mg. J Korean Soc Clin Pharmacol Ther. 2012;20(1):42-50.
Noh YH, Ko YJ, Jung JA, Kim UJ, Jin SJ, Hwang AK, Park HJ, Bae KS, Lim HS. Population Pharmacokinetic Analysis of Anastrozole in Healthy Korean Male Volunteers. J Korean Soc Clin Pharmacol Ther. 2010;18(1):23-33.
Chang HC, Lee MS, Ryu CH, Lyu SH, Cho SH, Choi YJ, Hwang AK, Kim YA, Park SH, Yoon JW, Bae KS. The Bioequivalence of Plunazol^® Tablet (Fluconazole 150 mg) to Three capsules of Diflucan^® 50 mg. Journal of the Korean Pharmaceutical Science. 2009 Mar;39(3):207-16.
Choi BM, Jung SM, Bae KS, Noh GJ. Population Pharmacokinetic and Pharmacodynamic Modeling in Beagle Dogs Sedated by Propofol Microemulsion. Korean Journal of Anesthesiology. 2006;50(06): 689-97.
Lee SM, Kim SH, Kim HJ, Kim OJ, Bae KS, Park BJ. Current Status of the Joint Institutional Review Boards in Foreign Countries and Suggestions for Operating in Korea. J Korean Soc Clin Pharmacol Ther. 2006;14(2):142-51.
Lee SH, Bae CS, Noh GJ, Bae KS, Kim JY, Chung BH. The assessment of anesthetic depth by quantitative electroencephalography in intravenous anesthesia by intermittent bolus injection. Korean Journal of Veterinary Research. 2005;45(1):131-7.
Yi SY, Jang IJ, Bae KS, Cho JY, Yu KS, Lim HS, Chung JY, Hong KS, Bang YJ, Shin SG. Pharmacokinetic / Pharmacodynamic Model for the Time Course of Myelosuppression of New Anticancer Drug (CKD-602). J Korean Soc Clin Pharmacol Ther. 2004;12(1):16-26.
Chung JY, Lim HS, Hong KS, Bae KS, Yu KS, Cho JY, Yi SY, Ko JW, Jang IJ, Shin SG. Evaluation of Safety and Pharmacokinetics of Tegaserod After Multiple Oral Administrations in Healthy Korean Subjects. J Korean Soc Clin Pharmacol Ther. 2003;11(2):128-36.
Kim OG, Kim SH, Kim JH, Bae KS, Kim HJ, Park BJ. Information Technologies for Solving the Problems of Paper Based Clinical Trial. J Korean Soc Clin Pharmacol Ther. 2003;11(2):71-9.
Lee DG, Choi SM, Yoo JH, Yim DS, Bae KS, Shin WG, Kim CC. Population Pharmacokinetics of Cefepime in Febrile Neutropenic Patients. J Korean Soc Clin Pharmacol Ther. 2003;11(1):23-9.
Bae KS, Jang IJ, Lim HS, Lee KH, Yim DS, Shin SG. Study On The Age-Related Changes In The Activities Of Drug Metabolizing Enzymes: CYP2D6 And N-Acetyltransferase J Korean Soc Clin Pharmacol Ther. 2002;10(2):153-64.
Hong KS, Bae KS, Lim HS, Chung JY, Kim MK, Baik JM, Kang KJ, Park GJ, Jang IJ, Shin SG. Validation of the Assay for the Glucose of Human Venous Blood Using a Handy Blood Sugar Measuring Instrument. J Korean Soc Clin Pharmacol Ther. 2002;10(1):34-49.
Chung JY, Lim HS, Bae KS, Yu KS, Hong KS, Cho JY, Yi SY, Shin SG. Evaluation of Safety, Tolerability and Pharmacokinetics of Lebecel®(DDB-S); a Phase I Clinical Trial. J Korean Soc Clin Pharmacol Ther. 2001;9(2):188-96.
Lim HS, Hong KS, Chung JY, Yi SY, Bae KS, Kim MK, Cho JY, Jang IJ. Analysis of Dose-Titration Trial for Barnidipine with Nonlinear Mixed Effect Modeling and naive Pooled Data Method. J Korean Soc Clin Pharmacol Ther. 2001;9(2):174-87.
Yi SY, Bae KS, Lim HS, Cho JY, Yu KS, Park SS, Jang IJ, Shin SG. Population PK-PD modeling of Captopril in healthy volunteers. J Korean Soc Clin Pharmacol Ther. 2001;9(1):37-47.
Lim HS, Yi SY, Cho JY, Bae KS, Yu KS, Yim DS, Jang IJ, Shin SG. Pharmacokinetic Comparison of Two Formulations Containing Silymarin: Legalon cap. 140^® vs. a Generic Formulation. J Korean Soc Clin Pharmacol Ther. 2001;9(1):19-25.
Lim HS, Yi SY, Cho JY, Bae KS, Yu KS, Jang IJ, Shin SG. Bioequivalence Study of Two Terazosin Formulations: TZC^® Tablet and Hytrin^® Tablet. J Korean Soc Clin Pharmacol Ther. 2001;9(1)57-65.
Cho JY, Bae KS, Yu KS, Yi SY, Kim SJ, Ha JW, Ahn C, Jang IJ, Shin SG. Effect of Erythrocyte Thiopurine Methyltransferase(TPMT) Activity on Azathioprine Immunosuppression Therapy in Renal Transplant Recipients. J Korean Soc Clin Pharmacol Ther. 2000;8(1): 60-71.
Kim KS, Yim DS, Lee KH, Jang IJ, Yu KS, Bae KS, Shin SG, Han JS, Kim SK, Lee JS. Simultaneous PK-PD Modeling of a Loop Diuretics (Bumetanide) for the Exploration of Resistance Mechanism in Nephritic Syndrome Patients. J Korean Soc Clin Pharmacol Ther. 1999;7(1-2):17-28.
Cho JY, Bae KS, Jung IS, Yu KS, Jang IJ, Shin SG. Pharmacokinetic Evaluation of Two Formulations Containing Silymarin: Legalon 140®cap. and Silymarin^®. J Korean Soc Clin Pharmacol Ther. 1998;6(2):119-27.
Yu KS, Bae KS, Cho JY, Jang IJ, Shin SG. Pharmacokinetic/pharmacodynamic Analysis for Development of a Controlled-Release Diltiazem Formulation. J Korean Soc Clin Pharmacol Ther. 1998;6(2):128-41.
Yu KS, Bae KS, Lee JY, Cho JY, Jang IJ, Shin SG, Shin WG. Population Pharmacokinetics of Vancomycin in Korean Patients. J Korean Soc Clin Pharmacol Ther. 1998;6(2):142-51.
Yu KS, Bae KS, Jang IJ, Shin SG, Cho SH, Shin WG. Nonparametric PK/PD Analysis of Controlled-Release Formulations Showing Double Peak Concentrations: Application of the Spline Function. Korean J Korean Soc Clin Pharmacol Ther. 1998;6(1):16-24.
Yu KS, Bae KS, Cho JY, Jang IJ, Lim YC, Shin SG. Pharmacokinetic Evaluation of Two Controlled Release Formulations of Nifedipine : GITS (Adalat Oros^®) and Rhotard (Hadipine^®). J Korean Soc Clin Pharmacol Ther. 1998;6(1):25-35.

Reviews or editorials

D’Argenio DZ, Bae KS. Analytical solution of linear multi-compartment models with non-zero initial condition and its implementation with R. Transl Clin Pharmacol. 2019;27(2):43-51.
Bae KS, Yim DS. R-based reproduction of the estimation process hidden behind NONMEM® Part 2: First-order conditional estimation. Transl Clin Pharmacol. 2016;24(4):161-168. doi.org/10.12793/tcp.2016.24.4.161
Kim MG, Yim DS, Bae KS. R-based reproduction of the estimation process hidden behind NONMEM® Part 1: first-order approximation method. Transl Clin Pharmacol. 2015:23(1):01-07. doi.org/10.12793/tcp.2015.23.1.1
Bae KS. Nonlinear Mixed Effects Modeling and NONMEM^®. Journal of Korean Society for Intravenous Anesthesia. 2003;7(2):31-42.
Jang IJ, Lee MS, Bae KS. Study Design and Analysis for Creating Bridging Data. Korean Journal of Clinical Pharmacology and Therapeutics. 2002;10(2);204-7.
Bae KS, Shin SG. Regulation and Management of Generic Drugs to Assure Therapeutic Equivalence in the United States. Korean Journal of Clinical Pharmacology and Therapeutics.2001;9(1):3-18.
Bae KS. Generic Substitution. Korean Journal of Clinical Pharmacology and Therapeutics. 2000; 8(2): 262-4.

Books or chapters in books

Bae KS. Data Analysis with R, Hakjisa Medical. Seoul, 2023
Park HS, Bae KS. Design of Experiment and Analysis of Variance Using R. Free Academy Inc. Seoul. 2023
Bae KS, Shin SG. Clinical Pharmacokinetics and Pharmacodynamics in Prescription Guidance for the Primary Physicians 3e by Korean Society of Internal Medicine. Korean Institute of Medicine. Seoul, 2010.
[Translation into Korean] Shin SG, Bae KS et. al. Applied Pharmacokinetics and Pharmacodynamics. Shinil Books. Seoul, 2007.
Bae KS. Statistical Treatment of Bioequivalence in Understanding Bioequivalence. Korea Food and Drug Administration. 2006.
Bae KS, Shin SG. Clinical Pharmacokinetics and Pharmacodynamics in Prescription Guidance for the Primary Physicians 2e by Korean Society of Internal Medicine. Korean Institute of Medicine. Seoul, 2004.
[Translation into Korean] Bae KS, Shin JG, Shin SG et. al. Principles of Drug Therapy in Harrison’s Principles of Internal Medicine 15th ed. MIT Press Korea. Seoul, 2003.
Bae KS, Shin SG. Clinical Pharmacokinetics and Pharmacodynamics in Prescription Guidance for the Primary Physicians by Korean Society of Internal Medicine. Korean Institute of Medicine. Seoul, 2000.

아산 주요뉴스 모아보기

임상약리학과

과 소개