Recommendations development issues

Vaccines are used in either the general population of children or adults or for special groups. Recommendations for vaccine usage are made by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control. The Committee on Infectious Diseases of the American Academy of Pediatrics (Redbook Committee) also makes recommendations for infants through adolescents, and the American Academy of Family Physicians makes recommendations for adults. An excellent review of vaccine history, development, usage, and related regulatory issues is available (2). 

Methods for vapor cloud explosion blast prediction based on TNT equivalency are widely used. Over the years, many authors, companies, and authorities have developed their own procedures and recommendations with respect to issues surrounding such predictions. Some of the differences in these procedures include the following ... 

Although the issue of PIF interactions has long been recognized by human factors researchers, little has been done to develop practical recommendations. This is partially a result of the large number of possible PIF combinations and the complexity of their interactions. One of the most effective ways of studying this interaction is through an in-company human factors study which will use operational feedback to evaluate the results of design and human factors innovations. 

This chapter addresses all these issues. As with several of the earlier chapters, the overall approach to developing a plan should be modeled on that described in Chapter 5 of the CCPS publication Guidelines for Implementing Process Safety Management Systems. The approach recommended there is summarized in the following paragraphs. 

Enzymatic reactions are influenced by a variety of solution conditions that must be well controlled in HTS assays. Buffer components, pH, ionic strength, solvent polarity, viscosity, and temperature can all influence the initial velocity and the interactions of enzymes with substrate and inhibitor molecules. Space does not permit a comprehensive discussion of these factors, but a more detailed presentation can be found in the text by Copeland (2000). Here we simply make the recommendation that all of these solution conditions be optimized in the course of assay development. It is worth noting that there can be differences in optimal conditions for enzyme stability and enzyme activity. For example, the initial velocity may be greatest at 37°C and pH 5.0, but one may find that the enzyme denatures during the course of the assay time under these conditions. In situations like this one must experimentally determine the best compromise between reaction rate and protein stability. Again, a more detailed discussion of this issue, and methods for diagnosing enzyme denaturation during reaction can be found in Copeland (2000). 

From Sect. 2.8.6, it is clear that FEP calculations for many systems of practical interest are expected to be computationally very demanding. It is, thus, important to develop numerical techniques that allow us to apply the theory outlined so far in an efficient manner. If properly used, these techniques make calculations better in every sense - i.e., they improve both their accuracy and efficiency. It is, therefore, highly recommended that they be employed in practical applications of FEP. Chapter 6 is devoted entirely to this topic. Here, we only give the reader a preview of a few issues that will be covered in that chapter. In addition, we will discuss two other promising techniques that fall outside the conceptual framework developed in Chap. 6. 

Work To Date. From 1977-80, the most intensive and productive OECD activities focused upon Mutual Acceptance of Data (MAD) and the development of test guidelines and GLP s. Efforts also were devoted to the Step Sequence Group and, in particular, that body s efforts to develop a Minimum Pre-Marketing Set of Data (MPD). Technical and scientific work also progressed on the various hazard assessment issues and expert groups worked on recommendations concerning confidential data, definitions of key terms, and principles of information exchange. 

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