Organic wastewater contaminants, including pharmaceuticals, caffeine, and nicotine, have received increased scrutiny because of their detection in water bodies receiving wastewater discharge. Despite recent measurement in United States streams, caffeine's effect on freshwater organisms is not well documented. The present study measured caffeine's lethal and sublethal effects on the freshwater s...

Biostatistics in pharmaceutical industry is operating in a highly regulated environment, in particular in those areas that are primarily related to the submission of new drug applications for approval by health authorities. In order to stay competitive, however, also biostatistics departments in pharmaceutical companies are challenged to contribute to speeding up the development of new drugs. R...

Participants in substance abuse research may be vulnerable for multiple reasons. International research ethics guidelines and policy statements require that researchers provide extra protections when conducting research with vulnerable subjects, but it is uncertain which measures best protect vulnerable individuals. Concerns about vulnerability have been translated into only the vaguest regulat...

OBJECTIVE To report on the results of the consensus process integrating evidence from preliminary studies to develop the first version of a Comprehensive ICF Core Set and a Brief ICF Core Set for depression. METHODS A formal decision-making and consensus process integrating evidence gathered from preliminary studies was followed. Preliminary studies included a Delphi exercise, a systematic re...

Why continuous chromagraphic processes should be explored One of the most powerful and increasingly more relied upon purification methods used in pharmaceuticals and biotechnology is chromatography. This application has also acquired added significance as regulatory bodies have required higher and higher purity and reproducibility in the new products being developed. This is especially true in ...

Joal Hill I read with interest the debate about for-profi t versus non-profi t institutional review boards (IRBs) [1], but was disappointed that no one addressed the ability (or inability) of for-profi t IRBs to review studies with the local context of research subjects in mind and then monitor what actually occurs during the consent process throughout the research trial. To my mind the “bignes...

Since the inception of the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) in 1990, six-party Expert Working Groups (EWG) have developed and revised numerous guidelines on preclinical safety evaluation (Table 1). The six parties to ICH represent the regulatory bodies and pharmaceutical manufacturing organizations in...