Pharmaceuticals Policy and Law - Volume 14, issue 1
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The new international review,
Pharmaceuticals Policy and Law, appears with the aim of studying and evaluating the
legal status of medicinal products in the European Union, and its implications in other markets such as the USA and Japan, without neglecting the specific problems of developing countries.
Pharmaceuticals Policy and Law intends to participate in the process of world convergence of pharmaceutical legislation helped by a network of academic centers specializing in pharmaceutical law, without omitting a scientific, economic and social approach to medicinal products.
The specificity of medicinal products conditions their legal status. Legislation regulating other goods cannot be applied to them. To begin with, they are the result of scientific and technical innovation. Research policies determine their progress. The pharmaceutical industry is, by nature, multinational. But, next to these global trends, different traditions still remain at a national level. Within the EU, barriers to free trade in medicinal products still remain despite more than thirty years of harmonisation. The social dimension of medicinal products is complex and very significant in the preoccupations of our societies. Patenting is essential but not sufficient. The life-cycle of medicinal products is protected by professional responsibility, required in the general concept of health safety. It is important to remember their ethical dimension, including research and innovation in new fields such as genetic manipulation and biotechnology, which requires social consent to preserve human dignity and fundamental rights.
Abstract: Cost and outcomes data within pharmacoeconomic analyses often possess distributional properties that require advanced statistical approaches to yield robust findings. An analyst's failure to recognize and control for these characteristics may result in inappropriate evaluations of statistical associations or causal effects which may ultimately support incorrect policy decisionmaking. Given the importance of appropriate analysis and interpretation in pharmacoeconomics, the purpose of this paper is to address the more common statistical issues encountered…in assessing healthcare costs or outcomes, emphasizing approaches that may be employed to analyze these data. More specifically, statistical methods used commonly with retrospective cohort analyses are presented including least squares (e.g., ordinary least squares, OLS), logarithmic transformations, log-plus-constant models, two-part models, maximum likelihood estimation (MLE), and generalized linear models (GLM) and extensions, among others.
Keywords: Regression, retrospective databases, costs and outcomes