Damaraju Raghavarao

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To reduce the cost of stability testing in drug research and development, both bracketing and matrixing designs are recommended in the U.S. Food and Drug Administration's (FDA) guidelines for drug products with a single active ingredient (component). When the drug product contains multiple active components, the naïve approach is to take the minimum of(More)
In this note we discuss the relationship between the underlying kinetic model and the statistical (or analytic) model used to study degradation. For small degradation rates, the zeroth, first, and second order statistical models give approximately the same fits and predictions on either the original assay scale or the percent of label claim scale. However,(More)
The constrained four parameter logistic model has found wide application in describing dose response relationships across many assay systems. This discussion examines the basic model and its practical application to potency testing in the context of the 96 well plate. A two step procedure is recommended for the analysis: (i) the constrained logistic model(More)
In this article we focus on the optimal factorial and fractional-factorial designs when observations within blocks are correlated. The topic was motivated by a problem when the pharmaceutical experimenter needed to develop a controlled release, once-daily tablet formulation. Typically, in order to compare different formulations, trials are conducted in(More)
As part of an application for licensure of a new drug, it is necessary to provide data on the stability of the product over time under various conditions. If every combination of conditions is studied at every sampling time, the cost of the study can be substantial. To minimize expense, matrix designs are discussed, whereby only a fraction of the various(More)
D-optimal designs for nonlinear models are often minimally supported. They have been frequently criticized for their inability to test for lack of fit. We construct alternative designs to address this issue for some commonly used sigmoid curves, including logistic, probit, and Gompertz models with two, three, or four parameters. For each model, we compare(More)
The use of subjective measures in the evaluation of treatment efficacy in clinical trials may introduce bias into the response variables of interest when investigators attempt to guess the treatment that patients are receiving. The bias may be introduced even in the setting of double-blind clinical trials due to the presence of characteristic side effects.(More)