Current pharmaceutical biotechnology
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Curr Pharm Biotechnol · Jan 2014
Meta AnalysisThe optimal treatment of severe hypertension in pregnancy: update of the role of nicardipine.
Hypertensive disorders in pregnancy remain a major cause of maternal morbidity and mortality. Blood pressure control is essential for maternal and neonatal outcome. Therefore, we analyzed the potency and side effects of two treatment options (nicardipine compared to labetalol) in order to gain insight in improved treatment of severe hypertension during pregnancy and to evaluate the feasibility of a randomised controlled trial. ⋯ Nicardipine is a potent drug to control hypertension during pregnancy with side effects including maternal headaches, nausea and tachycardia. Labetalol had more neonatal side effects including hypotension compared with nicardipine. These results support the justification and prove that it is safe to perform a randomized controlled trial comparing nicardipine to labetalol in the treatment of severe hypertension in pregnancy.
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Curr Pharm Biotechnol · Jun 2012
Review Meta AnalysisPharmacokinetics/pharmacodynamics model-supported early drug development.
Pharmacokinetic/pharmacodynamic (PK/PD) modeling & simulation (M&S) provides quantitative assessment of dose/exposure-response relationships with extensive applications at the late stage drug development as well as during regulatory decision making. However, at preclinical and early phase clinical drug development, the importance of PK/PD M&S has not been as widely recognized. ⋯ We also reviewed several other M&S approaches that are often used in early drug development such as physiologically-based pharmacokinetic (PBPK) modeling, meta-analysis, PK-pharmacogenomics modeling, and etc. Our aims were to provide expert opinions on the practical utility of PK/PD model-based approaches that have positive impact on early decision-making with the goal of improving the success rate of early to late stage drug development.