Aliev A, Fedorov V, Leonov S, McHugh B (2009). PkStaMp library for optimization of sampling schemes for PK/PD models. In: Ermakov SM, Melas VB, Pepelyshev AN (Eds). Proceedings of the 6th St. Petersburg Workshop on Simulation, St. Petersburg:VVM com. Ltd, Vol.1, 368–374.
Best intention sequential designs in clinical trial studies
Val Fedorov, A.Pepelyshev, L. Pronzato, A. Zhigljavsky
Population Pharmacokinetic Measures: Estimation and Selection of Sampling Times
Sergei Leonov and Valerii Fedorov
Poster: Estimation of Population Pharmacokinetic Measures and Selection of Sampling Times
Valerii Fedorov and Sergei Leonov
Meta-analysis of clinical trials, particularly of rare adverse events
Peter Lane
Abstract: Meta-analyses are increasingly being used to summarize information across trials, often to publicize good or bad news. Public access to trial results on the Internet has made it especially easy to generate such meta-analyses, particularly of safety issues. Once the hurdles of acquiring and selecting data have been cleared, the task of analysis with some given technique is only too easy. The results can be strongly influenced, however, by the choice of technique and the approach to combining information when the operating details vary across individual trials. The analysis of rare events, particularly safety events, is prone to disagreement and misunderstanding. I will look specifically at the fixed-effect meta-analysis of a binary response, illustrated by publicly available data from the high-profile analysis in 2007 of Avandia with respect to cardiovascular safety. This raised issues including the choice of summary statistic to employ, the combination of trials with different control treatments, and the handling of trials with no events. And lurking in the background was the ever-present danger of being misled by Simpson’s Paradox.
Population models in design and analysis of dose finding experiments for binary responses
V. Fedorov
