Preparation summary

The summary s importance cannot be overstated. In this section, the sponsor can state and argue its case for the product s approval. A well-prepared summary includes a straightforward description of the product and its manufacturing technology, testing data, nonclinical data, clinical data, and adverse and beneficial effects. Such a summary can build CBER s confidence in the applicant, the validity of the BLA s information, and the product itself. In addition, because the summary is one of the few sections reviewed by all members of the BLA licensing committee, it can be pivotal in establishing a foundation for product approval. 

Prepare summary and listing of recommendations in order of priority (ranking). 

Certain international organizations and United States agencies with international programs prepare summaries and compilations, essentially of the data taken from the national official publications. The principal source of such information, specifically on chemicals in foreign nations, was for a number of years and until the end of 1950 the Office of International Trade of the Bureau of Foreign and Domestic Commerce since the beginning of 1951 the major part of the program of commodities information has been in the National Production Authority. 

For the maximum benefit to the participants and the technical discussion, the organizer should prepare summaries of method descriptions including information on the most critical steps in the analytical procedures, e.g. calibration, pre-treatment, extraction and clean-up, separation and final detection. If possible, the methods described in brief should be presented in the form of simple table showing the most important parameter grouped by item or analytical step. 

It is often helpful to have people who are not directly connected to a program provide an independent evaluation. External evaluators may be provided with questions such as those listed in Table 9.1. In preparation for visiting committees, program personnel often prepare summary materials that include... 

Prepare summaries of all meetings Prepare summaries of monthly project status meetings with clients... 

OSHA mandated Material Safety Data Sheets (MSDSs) contain important safety information that should be incorporated into undergraduate chemistry instruction. Ho>vever, these documents are not well designed for the academic teaching laboratory. Additionally, there is little or no coverage of MSDSs in chemistry laboratory manuals or textbooks. One approach to the incorporation of this topic this is the introduction of a student exercise that involves the preparation of an experiment-specific laboratory chemical safety summary (LCSS) based on the LCSSs presented in the latest edition of Prudent Practices in the Laboratory (1). These one-page student-prepared summaries use information obtained from MSDSs, but are modified to the actual quantities, concentrations, and procedures used in the experiment. This approach provides beginning chemistry students with appropriate education about MSDSs. 

Nonetheless, computers are convenient as word processors to prepare summary reports of original research and to store original experimental data in compact form. Computer records also can be easily and rapidly searched for key words and phrases. Compared to traditional notebooks, however, these labor- and time-saving features are accompanied by risks of reduced permanence, lack of contemporaneity, inaccuracies, loss, or compromise. There also is a concern that the electronically stored data is not easily identified as being written by the author, while handwriting identifies a notebook as being authored by the person. This issue has not been tested in priority claims. 

A comprehensive summary of the preparation of high-silica zeolites. 

A detailed and weU-defined estimate of world phosphate resources and reserves was prepared in 1979 (105). A summary is presented in Table 14. 

Other Asymmetric Membrane Preparation Techniques. A number of other methods of preparing membranes have been reported i the literature and are used on a small scale. Table 1 provides a brief summary of these techniques. 

A wide variety of methods are available for the preparation of quaternary ammonium compounds (218—220). Significantly fewer can be used on a commercial scale. A summary of the most commonly used commercial methods is given herein. 

A general summary on the preparation, physical and chemical properties, and information relative to uses for ethylene urea is available (68). The widespread interest in ethyleneurea is reflected by the number of organi2ations holding patents in this area. 

Preparation and chemistry of chromium compounds can be found ia several standard reference books and advanced texts (7,11,12,14). Standard reduction potentials for select chromium species are given ia Table 2 whereas Table 3 is a summary of hydrolysis, complex formation, or other equilibrium constants for oxidation states II, III, and VI. 

Phase 1 - Preparation. This is often referred to as the pre-experimental stage. Experiments can take considerable time and resources, and good preparation is all important. The results from other techniques are important inputs to this phase of the methodology, providing focus and priority selection filtering. A summary of the steps that should be considered is given below ... 

After a brief historical review in Chapter 1 the following five chapters provide a short summary of the general methods of preparation of plastics materials and follow on by showing how properties are related to chemical structure. These particular chapters are largely qualitative in nature and are aimed not so much at the theoretical physical chemist but rather at the polymer technologist and the organic chemist who will require this knowledge in the practice of polymer and compound formulation. 

By the end of 1952 it was eertain that a PIPPA design had been produeed whieh eould and should be built. A summary report was prepared in January 1953, and soon after approval was granted for eonstmetion of the first two Magnox reaetors at Calder HaU. Before the first reaetor went eritieal in 1956 work had started on a further two reaetors at Calder Hall, and all four were at power in 1959. Constraetion at Chapeleross, in the southwest of Seotland, began in 1955. The fist... 

The notification dossier may also contain a risk assessment prepared by the notifier. The precise contents of a notification will depend on, e.g., the quantity of the substance to be placed on the market and, to an extent, on the properties and uses of the substance. The thresholds for notification and a summary of the information requirements are given in Table 14.12. 

When the review progresses to the point that the staff concludes that the documentation is acceptable, a Safety Evaluation Report is prepared that represents a summary of the review and evaluation of the application by the staff. 

Even, limited PSAs use and contain much information. This information may come as memos and process reports and flow sheets, equipment layout, system descriptions, toxic inventory, hazardous chemical reactions, test, maintenance and operating descriptions. From this, data and analyses are prepared regarding release quantities, doses, equipment reliability, probability of exposure, and the risk to workers, public, and environment. An executive summary analysis is detailed, and recommendations made for risk reduction. Thus the information will be text, calculations of envelope fracture stresses, temperatures, fire propagation, air dispersion, doses, and failure probabilities - primarily in tabular form. 

Prelog and Bozieevie applied to this problem a method for the preparation of dieyclic bases of this type, which may be represented by the following summary of generalised formulae. 

Since the foregoing summary was prepared a preliminary account of an ingenious explanation of these results, involving a molecular rearrangement of a new type, has been published by Robinson which cannot be adequately dealt with here and for which the reader must be referred to the original. 

---