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Trends of clinical trials from 2014 to 2016 in South Korea

Huh KY, Hwang JG, Lee S

Mandatory registration of clinical trials in public registry can ensure the transparency of clinical trials. Public clinical trial registry of can provide current chronological and geographical distribution of clinical trial...
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Development of a user-friendly training software for pharmacokinetic concepts and models

Han S, Lim B, Lee H, Bae SH

Although there are many commercially available training software programs for pharmacokinetics, they lack flexibility and convenience. In this study, we develop simulation software to facilitate pharmacokinetics education. General formulas for...
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Prediction of the human in vivo antiplatelet effect of S- and R-indobufen using population pharmacodynamic modeling and simulation based on in vitro platelet aggregation test

Noh YH, Han S, Choe S, Jung JA, Jung JA, Hwang AK, Lim HS

Indobufen (Ibustrin®), a reversible inhibitor of platelet aggregation, exists in two enantiomeric forms in 1:1 ratio. Here, we characterized the anti-platelet effect of S- and R-indobufen using response surface modeling...
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Regulatory innovation for expansion of indications and pediatric drug development

Park MS

For regulatory approval of a new drug, the most preferred and reliable source of evidence would be randomized controlled trials (RCT). However, a great number of drugs, being developed as...
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Pharmacodynamic principles and target concentration intervention

Holford N

This tutorial reviews the principles of dose individualisation with an emphasis on target concentration intervention (TCI). Once a target effect is chosen then pharmacodynamics can predict the target concentration and...
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Five years of the CiPA project (2013–2018): what did we learn?

Yim DS

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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