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pro vyhledávání: '"Kallappa M. Koti"'
Autor:
Kallappa M. Koti
Publikováno v:
Statistics in Biopharmaceutical Research. 13:113-118
Randomized clinical trials designed to establish noninferiority of an experimental therapy as compared to a standard (active-control) therapy as measured by binomial proportions are being widely us...
Autor:
Kallappa M. Koti
Publikováno v:
Statistics in Biopharmaceutical Research. 8:35-39
The underlying statistical exercise in some noninferiority studies is to test a composite null hypothesis of a nonzero difference in the means of two normally distributed populations. These noninferiority studies are often analyzed under equal varian
Autor:
Kallappa M. Koti
Publikováno v:
Open Journal of Statistics. :55-64
We propose a new nonparametric method for assessing non-inferiority of an experimental therapy compared to a standard of care. The ratio μE/μR of true median survival times is the parameter of interest. This is of considerable interest in clinical
Autor:
Kallappa M. Koti
Publikováno v:
Statistics in Biopharmaceutical Research. 3:425-433
Progression-free survival (PFS) results from the Amgen Study 20020408 were presented and discussed in the December 2008 Oncologic Drugs Advisory Committee. Using the retrospective “sorted” subgroup analyses it was claimed that Kirsten rat Sarcoma
Autor:
Kallappa M. Koti
Publikováno v:
Drug Information Journal. 43:585-593
A predictive marker is a marker that predicts the differential efficacy of a particular therapy based on marker status. Standard statistical methods compare treatments, not validate prediction. We propose a failure-time mixture model that achieves bo
Autor:
Kallappa M. Koti
Publikováno v:
Journal of Biopharmaceutical Statistics. 17:229-245
Testing for noninferiority and equivalence between an experimental therapy and a standard therapy in terms of the ratio of binomial proportions is considered. New tests based on the Fieller-Hinkley distribution of the ratio of random variables are pr
Autor:
Kallappa M. Koti
Publikováno v:
Pharmaceutical Statistics. 2:133-144
We propose to use mixture survival models to establish the efficacy of the trial treatment. In particular, we consider the lognormal distribution to model the right-censored event time and a logistic regression for the incidence part of the model. Th
Autor:
KALLAPPA M. KOTI
Publikováno v:
Proceedings of Indian National Science Academy, Vol 22, Iss 5 (2015)
SOME INEQUALITIES IN HYPERGEOMETRIC FUNCTIONS USING STATISTICAL TECHNIQUES
Autor:
Kallappa M. Koti
Publikováno v:
Drug Information Journal. 35:1253-1260
We propose to use mixture survival models to establish the efficacy of the trial treatment. In particular, we consider the lognormal distribution to model the right-censored event time and a logistic regression for the incidence part of the model. Th
Autor:
Kallappa M. Koti
Publikováno v:
Drug Information Journal. 35:157-162
In some confirmatory clinical trials, data on the number of episodes of a particular type during baseline and treatment phase periods are collected. The primary efficacy variable proposed by the sponsor to compare the test drug with placebo is Y=(B -