Re-formulating drugs and vaccines for intranasal delivery: maximum benefits for minimum risks?

The challenges being faced by the pharmaceutical industry in terms of patent expiries and a sparse pipeline of new products are well documented, as are the risks and costs associated with developing new molecular entities. Major pharmaceutical companies are increasingly looking to augment their traditional core expertise in the discovery of small molecules with the development of biologicals (e.g. peptide-based, protein-based, antibody-based and nucleic-acid-based therapies), which are seen as a key element in achieving long-term growth. There is also considerable current interest in vaccines, both in the traditional area of mass immunization against infections and as a novel approach to disease treatment.

The development of industry-specific odor impact criteria for feedlots using models.

Emissions from feedlot operations are known to vary by environmental conditions and few if any techniques or models exist to predict the variability of odor emission rates from feedlots. The purpose of this paper is to outline and summarize unpublished reports that are the result of a collective effort to develop industry-specific odor impact criteria for Australian feedlots. This effort used over 250 olfactometry samples collected with a wind tunnel and past research to develop emission models for pads, sediment basins, holding ponds, and manure storage areas over a range of environmental conditions and tested using dynamic olfactometry. A process was developed to integrate these emission models into odor dispersion modeling for the development of impact criteria. The approach used a feedlot hydrology model to derive daily feedlot pad moisture, temperature, and thickness. A submodel converted these daily data to hourly data. A feedlot pad emissions model was developed that predicts feedlot pad emissions as a function of temperature, moisture content, and pad depth. Emissions from sediment basins and holding ponds were predicted using a basin emissions model as a function of days since rain, inflow volume, inflow ratio (pond volume), and temperature. This is the first attempt to model all odor source emissions from a feedlot as variable hourly emissions on the basis of climate, management, and site-specific conditions. Results from the holding pond, sediment basin, and manure storage emission models performed well, but additional work on the pad emissions model may be warranted. This methodology mimics the variable odor emissions and odor impact expected from feedlots due to climate and management effects. The main outcome of the work is the recognition that an industry-specific odor impact criterion must be expressed in terms of all of the components of the assessment methodology.