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Cancer drug safety and public health policy : A changing landscape
Description and analysis of recent developments and current trends in health policy with regard to cancer drug safety. Opens with an overview of pharmacovigilance for cancer blockbuster drugs, covering both general considerations and efforts to develop a structured framework for the identification and reporting of adverse drug reactions (ADRs). A number of important examples of serious ADRs to hematology and oncology drugs are then reviewed, with evaluation of the lessons learned and the policy implications of the ensuing legal cases and their settlements. Further, the difficulty of reporting such blockbuster side effects in the medical literature is explored in an empirical study. Significant advances have been achieved in analytic methods for the identification of ADRs, and here there is a particular focus on the value of optimal discriminant analysis. Finally, the impacts on pharmacovigilance and drug safety of the huge fines paid under the U.S. False Claims Act relating to the defrauding of governmental programs also receive careful attention – these fines are playing an important role in changing the landscape for pharmaceutical safety.
Classical Methods of Statistics : With Applications in Fusion-Oriented Plasma Physics
Classical Methods of Statistics is a blend of theory and practical statistical methods written for graduate students and researchers interested in applications to plasma physics and its experimental aspects. It can also fruitfully be used by students majoring in probability theory and statistics. In the first part, the mathematical framework and some of the history of the subject are described. Many exercises help readers to understand the underlying concepts. In the second part, two case studies are presented exemplifying discriminant analysis and multivariate profile analysis. The introductions of these case studies outline contextual magnetic plasma fusion research. In the third part, an overview of statistical software is given and, in particular, SAS and S-PLUS are discussed. In the last chapter, several datasets with guided exercises, predominantly from the ASDEX Upgrade tokamak, are included and their physical background is concisely described. The book concludes with a list of essential keyword translations.
