This paper examines how current legislative and regulatory models do not adequately govern the pharmaceutical industry towards ethical scientific conduct. In the context of a highly profit-driven industry, governments need to ensure ethical and legal standards are not only in place for companies but that they are enforceable. We demonstrate with examples from both industrialized and developing ...

Non-interventional studies (NIS) have for decades been an established part of post-authorisation medicinal research. As early as the mid-nineties, there were at least rudimentary demands for controllable data quality. Beginning with the recommendations of the Federal Institute for Drugs and Medical Devices (BfArM) on the execution of non interventional (observational) studies of 1998 and finall...

BACKGROUND A training physician has his first interaction with a pharmaceutical representative during medical school. Medical students are often provided with small gifts such as pens, calendars and books, as well as free lunches as part of drug promotion offers. Ethical impact of these transactions as perceived by young medical students has not been investigated in Pakistan before. This study ...

In today’s intensely competitive business environment, pharmaceutical companies are augmenting their product pipelines by both developing drugs on their own and inlicensing proprietary compounds or drug discovery–related technologies from smaller biotechnology companies. In this work, the OptFolio model of pharmaceutical R&D portfolio management is extended to evaluate partnership opportunities...

OBJECTIVES To analyse patterns and characteristics of pharmaceutical industry sponsorship of events for Australian health professionals and to understand the implications of recent changes in transparency provisions that no longer require reporting of payments for food and beverages. DESIGN Cross-sectional analysis. PARTICIPANTS AND SETTING 301 publicly available company transparency report...

BACKGROUND Access to medicines and the development of a strong national pharmaceutical industry are two longstanding pillars of health policy in Brazil. This is reflected in a clear emphasis by Brazil's Federal Government on improving access to medicine in national health plans and industrial policies aimed at promoting domestic pharmaceutical development. This research proposes that such polic...

On November 11, 1965, research on DMSO in the United States came to an abrupt halt. A conference between the Food and Drug Administration and the pharmaceutical companies who were involved in the research was called because lens changes had been observed in a number of mammalian species. No changes ha been observed in man or any primates. The FDA and the pharmaceutical companies agreed, because...

PURPOSE/OBJECTIVES To discuss the process, considerations, benefits, and challenges of the nurse as principal investigator in a cancer care drug trial. DATA SOURCES Published articles, anecdotal experience, and completed research studies. DATA SYNTHESIS The specific processes that must be considered are funding sources, protocol development, trial implementation, dissemination of results, a...

Most of the world's health problems afflict poor countries and their poorest inhabitants. There are many reasons why so many people die of poverty-related causes. One reason is that the poor cannot access many of the existing drugs and technologies they need. Another, is that little of the research and development (R&D) done on new drugs and technologies benefits the poor. There are several pro...

Economic barriers, along with regulatory complexity and uncertainty, are shaping the biosimilars industry into something entirely different from the generic small molecule pharmaceutical industry. The sharp demarcation between branded and generic small molecule pharmaceutical companies may not exist in the biologics context. The emerging biosimilars industry may present opportunities for both p...