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S D Dubey

Publications and source records attributed to S D Dubey.

6 recordsLinked to original sources

Some comments on frequently used multiple endpoint adjustment methods in clinical trials.

Confirmatory clinical trials often classify clinical response variables into primary and secondary endpoints. The presence of two or more primary endpoints in a clinical trial usually means that some adjustments of the observed p-values for multiplicity of tests may be required for the control of the type I error rate. In this paper, we discuss statistical concerns associated with some commonly used multiple endpoint adjustment procedures. We also present limited Monte Carlo simulation results to demonstrate the performance of selected p-value-based methods in protecting the type I error rate.

Algorithms↗

Some thoughts on the one-sided and two-sided tests.

This paper addresses some scientific and regulatory perspectives, insightful regulatory experiences, academic views, and current practices pertinent to one-sided and two-sided tests within the framework of clinical trials designed for specific diseases and drugs. It makes compelling points in favor of applying a two-sided test under a wide variety of situations. Additionally, it discusses situations where one may reasonably argue for use of a one-sided test and concludes by suggesting the use of two-sided tests in controversial situations.

Biopharmaceutics↗

Competing risk analysis of life table data: application to lifetime risk computation.

In this pedagogic note we propose to assess the safety of treatment in a clinical trial, or the effect of risk exposure in a chronic animal study, in terms of two lifetime risks. These risks are computable from life table type data and take into account the effects of competing risks. We first describe their computational procedures in detail to demonstrate the need for their implementation in a computer program. We then illustrate their practical application through use of the data obtained from an actual clinical study.

Health Status Indicators↗

Brief information about Siddhasāra Nighantu of Ravigupta.

Siddhasāra nighanti, is authored by 'Bauddhācārya Ravigupta'. On the basis of various evidences, its period is considered as 7th century A.D. Actually Ravigupta has written 'Siddhasāra Samhita', the last part of which is known as "Siddhasāra Nighantu'. The second chapter of Siddhasāra Samhita is 'Dravyasamgrahaniya', where 33 Ganas out of 37 Ganas of Suśruta Samhita of 'Dravyasamgrahaniya", chapter have been mentioned. The Dravyas have been described in Paryāya śaily and with 96 Slokas.

Books↗