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- Vas Dev, Sobhan Phookan, Vinod P Sharma, Suraj P Anand
- The American journal of tropical medicine and…
- 2004

Fever surveys were conducted in several districts of the Indian state of Assam to ascertain the prevalence of malaria in relation to vector abundance, entomologic inoculation rates (EIRs), and geographic location of human settlements. Anopheles minimus were incriminated, but their relative abundance and biting rates varied among districts, and no… (More)

- Suraj P Anand, Sujit K Ghosh
- Journal of statistical theory and practice
- 2009

The standard approach to investigating a drug for its potential for QT prolongation is to construct a 90% two-sided (or a 95% one-sided) confidence interval (CI), for the difference in baseline corrected mean QTc (heart-rate corrected version of QT) between drug and placebo at each time-point, and to conclude non-inferiority if the upper limit for each CI… (More)

The standard approach to investigating a drug for its potential for QT prolongation is to construct a 90% two-sided (or a 95% one-sided) confidence interval (CI), for the difference in baseline corrected mean QTc (heart-rate corrected version of QT) between drug and placebo at each time-point, and to conclude non-inferiority if the upper limit for each CI… (More)

The ICH E14 guidelines recommend performing a ‘thorough QT/QTc study’ to support the safety profile of a drug. The standard way of analyzing a ‘thorough QT/QTc study’ to assess a drug for its potential for QT prolongation is to construct a 90% two-sided (or a 95% one-sided) confidence interval (CI), for the difference in baseline corrected mean QTc… (More)

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)

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)

- Suraj P Anand, Sujit K Ghosh
- Pharmaceutical statistics
- 2011

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)

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