- Prediction of metabolizing enzymemediated clinical drug interactions using in vitro information
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Choi S, Yim DS, Bae SH
- KMID: 2538272
- Transl Clin Pharmacol.
- 2022 Mar;30(1):1-12.
- doi: 10.12793/tcp.2022.30.e6
Evaluation of drug interactions is an essential step in the new drug development process. Regulatory agencies, including U.S. Food and Drug Administrations and European Medicines Agency, have been published documents containing... -
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- Predicting human pharmacokinetics from preclinical data: volume of distribution
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Yim DS, Choi S
- KMID: 2512010
- Transl Clin Pharmacol.
- 2020 Dec;28(4):169-174.
- doi: 10.12793/tcp.2020.28.e19
This tutorial introduces background and methods to predict the human volume of distribution (Vd ) of drugs using in vitro and animal pharmacokinetic (PK) parameters. The physiologically based PK (PBPK)... -
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- Predicting human pharmacokinetics from preclinical data: absorption
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Yim DS, Choi S, Bae SH
- KMID: 2512004
- Transl Clin Pharmacol.
- 2020 Sep;28(3):126-135.
- doi: 10.12793/tcp.2020.28.e14
Predicting the rate and extent of oral absorption of drugs in humans has been a challenging task for new drug researchers. This tutorial reviews in vivo and PBPK methods reported... -
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- Potency and plasma protein binding of drugs in vitro—a potentially misleading pair for predicting in vivo efficacious concentrations in humans
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Yim DS
- KMID: 2450490
- Korean J Physiol Pharmacol.
- 2019 Jul;23(4):231-236.
- doi: 10.4196/kjpp.2019.23.4.231
In drug discovery or preclinical stages of development, potency parameters such as ICâ‚…â‚€, K(i), or K(d) in vitro have been routinely used to predict the parameters of efficacious exposure (AUC,... -
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- Five years of the CiPA project (2013–2018): what did we learn?
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Yim DS
- KMID: 2429508
- Transl Clin Pharmacol.
- 2018 Dec;26(4):145-149.
- doi: 10.12793/tcp.2018.26.4.145
Cases of drug-induced QT prolongation and sudden cardiac deaths resulted in market withdrawal of many drugs and world-wide regulatory changes through accepting the ICH guidelines E14 and S7B. However, because... -
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- Erratum: Population Pharmacokinetic Analysis of Metformin Administered as Fixed-Dose Combination in Korean Healthy Adults
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Choi S, Jeon S, Han S, Yim DS
- KMID: 2420299
- Transl Clin Pharmacol.
- 2018 Sep;26(3):143-143.
- doi: 10.12793/tcp.2018.26.3.143
In the published version of this article, the contents of Table 1 (‘Demographic characteristics of subjects’) are incorrect. -
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- Erratum: R-based reproduction of the estimation process hidden behind NONMEM Part 2: First-order conditional estimation
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Bae KS, Yim DS
- KMID: 2413834
- Transl Clin Pharmacol.
- 2018 Jun;26(2):99-99.
- doi: 10.12793/tcp.2018.26.2.99
The equations on page 162 should be corrected. -
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- Physiologically-based pharmacokinetic predictions of intestinal BCRP-mediated drug interactions of rosuvastatin in Koreans
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Bae SH, Park WS, Han S, Park GJ, Lee J, Hong T, Jeon S, Yim DS
- KMID: 2410096
- Korean J Physiol Pharmacol.
- 2018 May;22(3):321-329.
- doi: 10.4196/kjpp.2018.22.3.321
It was recently reported that the C(max) and AUC of rosuvastatin increases when it is coadministered with telmisartan and cyclosporine. Rosuvastatin is known to be a substrate of OATP1B1, OATP1B3,... -
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- Development and validation of analytical method for the determination of radotinib in human plasma using liquid chromatography-tandem mass spectrometry
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Seo HB, Cho S, Yoon YR, Yim DS
- KMID: 2407000
- Transl Clin Pharmacol.
- 2017 Dec;25(4):183-189.
- doi: 10.12793/tcp.2017.25.4.183
This study describes the development of an analytical method to determine radotinib levels in human plasma using high performance liquid chromatography (HPLC) coupled with triple quadrupole tandem mass spectrometry (MS/MS)... -
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- Principles of transparency and clinical trial registration
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Yim DS
- KMID: 2390928
- Transl Clin Pharmacol.
- 2017 Sep;25(3):113-113.
- doi: 10.12793/tcp.2017.25.3.113
No abstract available. -
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- Decreased potency of fimasartan in liver cirrhosis was quantified using mixed-effects analysis
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Kim CO, Jeon S, Han S, Hong T, Park MS, Yoon YR, Yim DS
- KMID: 2411418
- Transl Clin Pharmacol.
- 2017 Mar;25(1):43-51.
- doi: 10.12793/tcp.2017.25.1.43
Fimasartan is a nonpeptide angiotensin II receptor blocker. In a previous study that compared the pharmacokinetics (PK) of fimasartan between patients with hepatic impairment (cirrhosis) and healthy subjects, the exposure... -
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- Development of an automated appendix generation system (ARGUS) for clinical study reports
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Jang D, Han S, Yim DS
- KMID: 2411417
- Transl Clin Pharmacol.
- 2017 Mar;25(1):34-42.
- doi: 10.12793/tcp.2017.25.1.34
Data handling and tabulation are a time-consuming job when writing appendices for clinical study reports. The authors have developed an automated appendix generation system (ARGUS) conforming to the CDISC/SDTM standard... -
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- Hydrochlorothiazide does not increase furosemide's effects in end-stage renal disease
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Huh W, Oh HY, Han JS, Jang IJ, Yim DS
- KMID: 2411416
- Transl Clin Pharmacol.
- 2017 Mar;25(1):28-33.
- doi: 10.12793/tcp.2017.25.1.28
Diuretic therapy for the treatment of edema in patients with end-stage renal disease (ESRD) is unsatisfactory, and a combination of thiazide and loop diuretics may produce better clinical effects. To... -
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- Tutorial for beginners: the concept of clearance explained using the example of a vacuum cleaner
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Yim DS
- KMID: 2411411
- Transl Clin Pharmacol.
- 2017 Mar;25(1):1-4.
- doi: 10.12793/tcp.2017.25.1.1
Clearance is a key concept in pharmacokinetics, but it is not easy to understand for beginners. This tutorial aims to help beginners by using the analogy of a vacuum cleaner... -
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- R-based reproduction of the estimation process hidden behind NONMEM® Part 2: First-order conditional estimation
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Bae KS, Yim DS
- KMID: 2413837
- Transl Clin Pharmacol.
- 2016 Dec;24(4):161-168.
- doi: 10.12793/tcp.2016.24.4.161
The first-order conditional estimation (FOCE) method is more complex than the first-order (FO) approximation method because it estimates the empirical Bayes estimate (EBE) for each iteration. By contrast, it is... -
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- Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial
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Kang K, Han S, Hong T, Jeon S, Paek J, Kang JH, Yim DS
- KMID: 2427152
- Yonsei Med J.
- 2016 Nov;57(6):1354-1360.
- doi: 10.3349/ymj.2016.57.6.1354
PURPOSE: A phase I clinical trial was conducted to evaluate the immunogenicity and safety of newly developed egg-cultivated trivalent inactivated split influenza vaccine (TIV) in Korea. MATERIALS AND METHODS: The TIV... -
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- Erratum: Clearance
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Holford N, Yim DS
- KMID: 2351803
- Transl Clin Pharmacol.
- 2016 Sep;24(3):152-152.
- doi: 10.12793/tcp.2016.24.3.152
The third equation on page 44 should be corrected. -
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- Tips for the choice of initial estimates in NONMEM
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Han S, Jeon S, Yim DS
- KMID: 2351796
- Transl Clin Pharmacol.
- 2016 Sep;24(3):119-123.
- doi: 10.12793/tcp.2016.24.3.119
The importance of precise information and knowledge on the initial estimates (IEs) in modeling has not been paid its due attention so far. By focusing on the IE, this tutorial... -
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- Revisiting the well-stirred model of hepatic clearance: Q(H), CL(H) and F changing in the same direction
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Yim DS
- KMID: 2351795
- Transl Clin Pharmacol.
- 2016 Sep;24(3):115-118.
- doi: 10.12793/tcp.2016.24.3.115
This tutorial examines the relationship between CL, F, and hepatic blood flow (Q(H)) quantitatively at oral and i.v. administration as an answer to the quiz set for KSCPT members. In... -
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- Population pharmacokinetics and inter-laboratory variability of sildenafil and its metabolite after oral administration in Korean healthy male volunteers
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Youn S, Park WS, Park GJ, Jang DY, Bae SH, Han S, Yim DS
- KMID: 2290477
- Transl Clin Pharmacol.
- 2016 Jun;24(2):105-110.
- doi: 10.12793/tcp.2016.24.2.105
This study was to clarify population pharmacokinetics (PK) of sildenafil and its metabolite, N-desmethyl sildenafil (NDS) in Korean healthy male population using a pooled data from multiple clinical trials in... -
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