- How to boost and accelerate new drug development in Korea: business ecosystem perspectives
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Choi Y, Lee H
- KMID: 2538874
- Transl Clin Pharmacol.
- 2022 Sep;30(3):129-135.
- doi: 10.12793/tcp.2022.30.e17
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- Incorporation of real-world data to a clinical trial: use of external controls
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Kim TE, Park SI, Shin KH
- KMID: 2538873
- Transl Clin Pharmacol.
- 2022 Sep;30(3):121-128.
- doi: 10.12793/tcp.2022.30.e14
As real-world data (RWD) becomes more available and the methodology for handling RWD evolves, the use of RWD in drug development and drug approval is drawing interest. One of the... -
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- Implementation of Miettinen-Nurminen score method with or without stratification in R
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Lee MH, Bae KS
- KMID: 2538877
- Transl Clin Pharmacol.
- 2022 Sep;30(3):155-162.
- doi: 10.12793/tcp.2022.30.e16
Analysis of a 2 × 2 table for clinical data involves computing the point estimate and confidence interval for risk difference, relative risk, or odds ratio. While point estimates of... -
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- Considerations for clinical evaluation of the effects of bariatric surgery on the pharmacokinetics of orally administered drugs
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Bae S, Oh J, Song I, Yu KS, Lee S
- KMID: 2538876
- Transl Clin Pharmacol.
- 2022 Sep;30(3):145-154.
- doi: 10.12793/tcp.2022.30.e15
Obesity has been a growing worldwide concern, and surgical intervention including bariatric surgery is considered as one of the options for treatment. However, there still is controversy over the change... -
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- A randomized, open-label, single-dose, two-way crossover study to assess the pharmacokinetics between two tablets of fixed-dose combination formulation with raloxifene and cholecalciferol and concomitant administration of each agents in healthy male volunteers
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Lee HW, Kang WY, Gwon MR, Choi EJ, Kim EH, Cho K, Lee B, Seong SJ, Yoon YR
- KMID: 2538875
- Transl Clin Pharmacol.
- 2022 Sep;30(3):136-144.
- doi: 10.12793/tcp.2022.30.e13
A new fixed-dose combination (FDC) formulation of raloxifene 60 mg and cholecalciferol 800 IU was developed to improve the medication compliance and overall efficacy of raloxifene treatment in postmenopausal osteoporosis... -
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