Method Development An Industry Perspective

These changes in BE requirements that move away from the in vivo study requirement in certain cases and rely more on dissolution test results, emphasize the significance of dissolution test applications. In all cases where the dissolution 

For the dissolution test to be used as an effective drug product characterization and quality control tool, the method must be developed with the various end uses in mind. In some cases, the method used in the early phase of product and formulation development could be different from the final test procedure utilized for control of the product quality. Methods used for formulation screening or BA and/or bioequivalency evaluations may simply be impractical for a quality control environment. It is essential that with the accumulation of experience, the early method be critically re-evaluated and potentially simplified, giving preference to compendial apparatus and media. Hence, the final dissolution method submitted for product registration may not necessarily closely imitate the in vivo environment but should still test the key performance indicators of the formulation. 

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Since latex dispersion application properties are related to the surface properties of the latex particles, there is a need for surface characterization of the particles at large. Historically, these types of systems have been applied as model colloids (Hearn et al, 1981) and therefore required well-characterized surfaces but as the sophistication of new coatings increase, the latex particle surfaces become more important from an industrial perspective. In addition to these applications the utilization of latex particles in pharmaceutical and biomedical applications has also contributed to the development of new surface characterization methods. The surface engineering, that is, variations in size, surface charge and surface hydrophobicity, of latex particles as colloidal carriers has been demonstrated to provide opportunities for the site-specific delivery of drugs (Ilium Davis, 1982). Surface... 

The chapters in Characterization and Catalyst Development An Interactive Approach, assembled from both academic and industrial contributors, give a unique perspective on catalyst development Some chapters thoroughly characterize the catalyst prior to plant evaluation, whereas others utilize characterization to explain performance variances. Some new types of catalysts incorporated into this volume include the preparation of novel catalyst supports based on alumina and hydrous titanates. Attrition-resistant catalysts and ultrafine ceramics were prepared by modified spray-drying methods. New catalyst compositions based on vanadium-containing anionic clays were proposed for oxidation. A recently commercialized catalyst based on magnesium spinel was proposed for use in the abatement of sulfur oxide pollutants in fluid... 

This book is written from the perspective of an NMR facility manager in an academic research laboratory and as such the topics included are naturally influenced by the areas of chemistry I encounter. The methods are chosen, however, for their wide applicability and robustness, and because, in many cases, they have already become established techniques in NMR laboratories in both academic and industrial establishments. This is not intended as a review of aU recent developments in NMR techniques. Not only would this be too immense to fit within a single volume, but the majority of the methods would have little significance for most research chemists. Instead, this is a distillation of the very many methods developed over the years, with only the most appropriate fractions retained. It should find use in academic and industrial research laboratories alike, and could provide the foundation for graduate level courses on NMR techniques in chemical research. 

Abstract Local and short haul (L/SH) drivers work in various other work environments in addition to that of the truck cab, and the safety of these environments vary widely. In this study, we combined methods from three time perspectives accident statistics analyses (past) video observations (present) and scenario workshops (future) in order to provide new knowledge that can be applied to design and management process development in the transportation industry. Even though new technologies have and will emerge to ease drivers work, the work that is performed in environments other than truck cabs still involves tasks that require physical activities and pose risks of occupational diseases and accidents. Thus, drivers safety at work and work ability issues remain an area that needs continuous, systemic development. The results inevitably show that in order to successfully improve L/SH drivers work, the relevant stakeholders participation and a systemic approach is crucial. 

The need for weU-trained technical service professionals is expected to continue as an essential aspect of the chemical industry, despite the phenomenal growth ia electronic methods of information storage, retrieval, and transmission. Advanced troubleshooting of complex customer processes and accelerated accurate product development and market introductions should continue to be principal elements of technical service personnel duties. Increased levels of integration, perhaps blurring the lines between suppHer and customer, may come to pass. There are already instances of personnel swapping between customers and suppHers for extended periods to allow cross-fertilization of ideas and provide more accurate perspectives for the companies involved in these efforts. Technical service and research personnel have been those persons most directly involved in such efforts. 

This chapter describes external influences upon an organization s performance objectives as well as some methods to develop and understand the external perspective. This chapter also discusses how external comparisons drive performance inside the company and across the industry. 

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