The European Medicines Agency, the U.S. Food and Drug Administration, other regulatory agencies expect that all pharmaceutical products be assessed for potential presence of N-nitrosoamine (nitrosamine) impurities. This white paper addresses general considerations nitrosamine risk assessments oligonucleotide products. authors propose a assessment platform which should facilitate safe, consisten...

Security risk assessment is an important task in systems engineering. It used to derive security requirements for a secure system design and evaluate alternatives as well vulnerabilities. also complex interdisciplinary task, where experts from the application domain have collaborate understand each other. Automated tool-supported approaches are desired help manage complexity. However, models en...

ion as supported by Rigi merged with the SHriMP capabilities of nested graphs would be a nice start. We have pointed out the importance of keeping focus and context while carrying operations that affect the graph structure. When having to understand small portions of large graphs, these operation features help raise model comprehension by reducing confusion by sudden changes of the layout.

The spectrum of respiratory disease associated with exposure to metal working fluids. Robertson AS, Burge PS. Fifteen-year trends in occupational asthma: data from the Shield surveillance scheme. cross-reactivity between nickel and chromium salts in electroplating-induced asthma. Many years ago, I had the responsibility once a month of doing a tuberculosis clinic in deepest West Virginia. The s...

Risk assessment is a reasoned, structured approach to address uncertainty based on scientific and technical evidence. It forms the foundation for regulatory decision-making, which is bound by legislative and policy requirements, as well as the need for making timely decisions using available resources. In order to be most useful, environmental risk assessments (ERAs) for genetically modified (G...