Proposed best practice for statisticians in the reporting and publication of pharmaceutical industry-sponsored clinical trials

In this paper we set out what we consider to be a set of best practices for statisticians in the reporting of pharmaceutical industry-sponsored clinical trials. We make eight recommendations covering: author responsibilities and recognition; publication timing; conflicts of interest; freedom to act; full author access to data; trial registration and independent review. These recommendations are made in the context of the prominent role played by statisticians in the design, conduct, analysis and reporting of pharmaceutical sponsored trials and the perception of the reporting of these trials in the wider community.

Open Innovation in the pharmaceutical industry

O objetivo desse estudo é discutir a estratégia de inovação aberta adotada pelas quarto maior companhias farmacêuticas norte-americanas nos último quarto anos. A inovação tem sido reconhecida como uma fonte essencial de vantagem competitiva de uma firma. A partir do momento em que empresas começam a expandir e interagir em escala global, sua estratégia de inovação começa a mudar, e adquire um aspecto mais integrado, intensificando seu relacionamento com atores externos e recursos. Essa mudança tem como objetivo reduzir o custo da inovação e aumentar sua eficiência, e tem impacto nos resultados da empresa. Essa pesquisa realiza uma pesquisa exploratória usando dois modelos de inovação aberta como referência, Lichtenthaler (2008) e Lazzarotti-Manzini-Pellegrini (2010). Entender como firmas aplicam estratégias de inovação aberta é o primeiro passo para avaliar seu impacto na estratégia geral da mesma na nova conjuntura internacional.

Non-conventional applications of computerized tomography: Analysis of solid dosage forms produced by pharmaceutical industry

X-ray computed tomography (CT) refers to the cross-sectional imaging of an object measuring the transmitted radiation at different directions. In this work, we describe a non-conventional application of computerized tomography: visualization and improvements in the understanding of some internal structural features of solid dosage forms. A micro-CT X-ray scanner, with a minimum resolution of 30 μm was used to characterize some pharmaceutical tablets, granules, controlled-release osmotic tablet and liquid-filled soft-gelatin capsules. The analysis presented in this work are essentially qualitative, but quantitative parameters, such as porosity, density distribution, tablets dimensions, etc. could also be obtained using the related CT techniques. © 2010 American Institute of Physics.

Validation of analytical methodology for quantification of cefazolin sodium pharmaceutical dosage form by high performance liquid chromatography to be applied for quality control in pharmaceutical industry

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Inferring the Effects of Vertical Integration from Entry Games : An Analysis of the Generic Pharmaceutical Industry

This paper introduces a novel method for examining the effects of vertical integration. The basic idea is to estimate the parameters of a vertical entry game. By carefully specifying firms' payoff equations and constructing appropriate tests, it is possible to use estimates on rival profit effects to make inferences about the existence of vertical foreclosure. I estimate the vertical entry model using data from the US generic pharmaceutical industry. The estimates indicate that vertical integration is unlikely to generate anticompetitive foreclosure effects. On the other hand, significant efficiency effects are found to arise from vertical integration. I use the parameter estimates to simulate a policy that bans vertically integrated entry. The simulation results suggest that such a ban is counterproductive; it is likely to reduce entry into smaller markets.