Measuring benefit and balancing risk: strategies for the benefit-risk assessment of new medicines in a risk-averse environment.

Measuring the benefits and risks of medicines is the underlying theme whenever the development, review, and regulation of new medicines are discussed. Workshop participants were asked to take the first steps toward defining a framework for benefit-risk (BR) assessment. The framework identifies the essential elements that both regulators and companies should consider throughout the development, review, and postmarketing experience of new medicines in order to apply a consistent approach toward the assessment of BR balance.

A new phosphate-selective sorbent for the Rem Nut process. Laboratory investigation and field experience at a medium size wastewater treatment plant.

P-control technologies for municipal wastewater are essentially based on "destructive" methods, that lead to formation of concentrated solid-phases (sludge), usually disposed-off in controlled landfills. Ion exchange, as a "non-destructive" technology, allows for selective removal and simultaneous recovery of pollutants, which can be recycled to the same and/or related productive lines. In this context, the REM NUT process removes nutrient species (HPO4 = , NH4+, K+) present in biologically oxidised municipal effluents and recovers them in the form of struvites (MgNH4PO4; MgKPO4), premium quality slow release fertilisers. The main limitation to the extensive application of this ion exchange based process is the non-availability of selective exchangers for specific removal of nutrient species. This paper illustrates laboratory investigation and pilot scale development of a so-called "P-driven" modified REM NUT scheme based on a new phosphate-selective sorbent developed at Lehigh University, PA, USA.

Rem nut ion exchange plus struvite precipitation process.

Nutrients control technologies from wastewater are based on destructive technologies which defer the problem fromthe diluted liquid-phase (effluent) to a more concentrated waste (sludge) in the case of phosphates, or to nitrogen gas and/or volatile compounds in the case of ammonia. The REM NUT process allows for simultaneous removal of phosphate and ammonium ions by selective ion exchange and recovery by chemical precipitation in the form of struvite (magnesium ammonium phosphate) from the spent exchangers regeneration eluates. In the paper revised versions of the REM NUT process, i.e., P-driven layouts, are presented and cost effectiveness is compared to chemical precipitation based on the use of ferric chloride.

Evaluation of commercial ginseng products.

The variation in panaxoside content of roots and commercial products of Panax ginseng and P. quinquefolium was evaluated by a new spectrodensitometric TLC method. The method is rapid and applicable to all commercial products, and it has a relative standard deviation of 6.4%. Panaxoside patterns of slurry-filled capsules and root extracts most closely resembled those of whole roots. Tablets did not contain detectable panaxosides while teas and granules for infusion yielded only low concentrations. The wide variation among these products indicates the need for more rigid control.