- Comparison of international guidelines for early-phase clinical trials of cellular and gene therapy products
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Shin W, Kim MG, Kim A
- KMID: 2538268
- Transl Clin Pharmacol.
- 2022 Mar;30(1):13-23.
- doi: 10.12793/tcp.2022.30.e2
Cellular and gene therapies (CGT) are promising fields that are bringing significant clinical benefits to patients by directly targeting the underlying cause of disease. In line with this trend, regulatory... -
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- 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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- Physiologically-based pharmacokinetic modeling of nafamostat to support dose selection for treatment of pediatric patients with COVID-19
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Cho YS, Shin JG
- KMID: 2538269
- Transl Clin Pharmacol.
- 2022 Mar;30(1):24-36.
- doi: 10.12793/tcp.2022.30.e4
Pediatric patients with coronavirus disease 2019 (COVID-19) are increasing, and severe cases such as multisystem inflammatory syndrome are being reported. Nafamostat, a repurposing drug, is currently being explored for the... -
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- Stability of acetylsalicylic acid in human blood collected using volumetric absorptive microsampling (VAMS) under various drying conditions
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Moon SJ, Han SH, Kwak YG, Kim MG
- KMID: 2538270
- Transl Clin Pharmacol.
- 2022 Mar;30(1):57-69.
- doi: 10.12793/tcp.2022.30.e5
Acetylsalicylic acid (ASA) is one of the most commonly used medications in global market, with a risk of intoxication in certain patients. However, monitoring blood drug concentration often requires frequent... -
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- Evaluation of food effects on the pharmacokinetics of Pelargonium sidoides and Coptis with each bioactive compound berberine and epicatechin after a single oral dose of an expectorant and antitussive agent UI026 in healthy subjects
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Park Y, Jung W, Yang E, Nam KY, Bong WR, Kim J, Kim KY, Lee S, Cho JY, Hong JH, Kim J
- KMID: 2538273
- Transl Clin Pharmacol.
- 2022 Mar;30(1):49-56.
- doi: 10.12793/tcp.2022.30.e3
UI026 is an expectorant and antitussive agent which is a new combination of Pelargonium sidoides extract andCoptis extract. The bioactive compounds of Pelargonium sidoides and Coptis extracts were identified as... -
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- Ultrafast liquid chromatographytandem mass spectrometry determination of donepezil in human plasma: application to a bioequivalence study
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Huang YW, Ding L, Chen YM, Lin Wc, Lin F, Hsieh Y
- KMID: 2538271
- Transl Clin Pharmacol.
- 2022 Mar;30(1):37-48.
- doi: 10.12793/tcp.2022.30.e1
A liquid chromatography equipped with tandem mass spectrometric method using multistage flow rates was developed for the determination of donepezil in human plasma to support a randomized, crossover bioequivalence (BE)... -
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