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How to boost and accelerate new drug development in Korea: business ecosystem perspectives

Choi Y, Lee H

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Incorporation of real-world data to a clinical trial: use of external controls

Kim TE, Park SI, Shin KH

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

Lee MH, Bae KS

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

Bae S, Oh J, Song I, Yu KS, Lee S

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

Lee HW, Kang WY, Gwon MR, Choi EJ, Kim EH, Cho K, Lee B, Seong SJ, Yoon YR

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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