S. Prabhu Anand

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Thorough QT studies are becoming a necessary part of the clinical profile of existing and investigational new drugs. The E14 guidelines mandate performing a thorough QT study on any non antiarrythmic drug to ensure that the drug does not produce a QT prolongation effect before it can be approved and marketed. The cost involved in running a thorough QT study(More)
Antihyperglycemic activity of methanol and aqueous extracts of Pergularia daemia Linn. The objective of this study was to evaluate the antidiabetic activities of methanol and aqueous extracts of Pergularia daemia in alloxan induced diabetic rats. Methods used was methanol and aqueous extracts (250 mg/kg b.w.) of P. daemia was administered to alloxan induced(More)
Thorough QT/QTc (TQT) trials are conducted to assess a drug's risk potential for prolonging the QT interval. In a randomized crossover, multiple postdose electrocardiograph (ECG) readings are collected over time, within each period leading to a repeated-measures scenario. Additionally, baseline readings at single or multiple time points are collected prior(More)
The standard methods for analyzing data arising from a 'thorough QT/QTc study' are based on multivariate normal models with common variance structure for both drug and placebo. Such modeling assumptions may be violated and when the sample sizes are small, the statistical inference can be sensitive to such stringent assumptions. This article proposes a(More)
The cost involved in running a 'thorough QT/QTc study' is substantial and an adverse outcome of the study can be detrimental to the safety profile of the drug, hence sample size calculations play a very important role in ensuring an adequately powered thorough QT study. Current literature offers some help in designing such studies but these methods are(More)
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