Evaluation and investigation

Systematic use of data mining tools in a large spontaneous ADR database will identify large numbers of statistical signals. Evaluating all of them in detail would have major resource implications but many will turn out not to be real or to require no action. Possible signals have often been evaluated or dismissed on the basis of subjective judgements but two methods of prioritisation have been proposed  

Triage is analogous to a process used in emergency medicine to decide on priorities - essentially it is a quick look at the most important features of a case to decide on the urgency of further assessment and treatment relative to other cases. Impact analysis is more quantitative and involves calculating two scores which are then used to decide an overall priority. These are  

The overall categories derived from these scores are as follows  

It is important to recognise that these scores are only a means of deciding whether further evaluation is currently warranted and that impact analysis can and should be repeated if more evidence emerges. 

In terms of frequency, the following descriptors are generally used, based on orders of magnitude and expressed as a simple proportion of patients affected  

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As indicated in Chapter 1, pharmacovigilance is essentially a risk management process for medicines. The process starts with identification of a possible hazard, this is then evaluated and investigated and, if necessary, some action is then taken with a view to minimising risk. Implementation requires tools for communicating with users and the final step should be that an assessment of effectiveness is made. The process is iterative because new evidence may emerge or the measures taken may mm out to be insufficient. Rarely can a dmg safety issue be considered completely and permanently resolved. 

Evaluates and investigates past incidents or accidents Uses risk management to control losses Satisfied with reducing accident recurrence Disciplines unsafe actions and behaviors Accepts some losses if not too severe Documents errors and primary causes Responsive to formal culture expectations Leaders delegate responsibilities to others... 

The internal-oversight mechanism shall be a functional unit within the Technical Secretariat designed to carry out the functions of internal audit, inspection, evaluation and investigation. 

Sunk costs, such as costs for project evaluation and investigation of already purchased land... 

Ramesh, S., Liew, C.-W., and Ramesh, K. (2011) Evaluation and investigation on the effect of ionic liquid onto PMMA-PVC gel polymer blend electrolytes. J. Non-Cryst. Solids, 357, 2132-2138. 

Anticipates, recognizes, and identifies hazards Evaluates and investigates past incidents or accidents... 

Imagine for a moment that the exploration activities carried out in the previous section have resulted in a successful discovery well. Some time will have passed before the results of the exploration campaign have been evaluated and documented. The next step will be the appraisal of the accumulation, and therefore at some stage a number of additional appraisal wells will be required. The following section will focus on these drilling activities, and will also investigate the interactions between the drilling team and the other E P functions. 

The choice of drilling fluid has a major impact on the evaluation and" production of a well. Later in this section, we will investigate the interaction between drilling fluids, logging operations and the potential damage to well productivity caused by mud invasion into the formation. 

The preclinical trials are performed in in vitro and animal studies to assess the biological activity of the new compound. In phase 1 of the clinical trials the safety of a new drug is examined and the dosage is determined by administering the compound to about 20 to 100 healthy volunteers. The focus in phase II is directed onto the issues of safety, evaluation of efficacy, and investigation of side effects in 100 to 300 patient volimteers. More than 1000 patient volunteers are treated with the new drug in phase 111 to prove its efficacy and safety over long-term use. 

Both items are repeated until the intermediates are reasonably priced commercial starting materials. The resulting antithetic schemes are then evaluated and the most promising ones can be converted into synthetic plans and be investigated in the laboratory. 

The hterature is hiU of detailed evaluations of recycled petroleum products (2,6,17,18,23,28) and investigations into the environmental ramifications of the recycling processes themselves (30). 

Several other antigens with good immunocontraceptive potential have been identified and investigated in laboratory animals. In most studies, the rate and duration of the immunocontraceptive effect are less than acceptable. A potential problem in immunological approaches to antifertUity research is the need for a safe, effective adjuvant and suitable animal models for evaluating the efficacy and safety of methods (111). Newer and more effective adjuvants are required for contraceptive vaccines and vaccines in general. 

Table A.4, taken from the CCPS Guidelines for Chemical Reactivity Evaluation and Application to Process Design, shows the questions which need to be asked regarding the safety of the proposed reaction, the data required to answer those questions and some selected methods of investigation. The experimental analysis is extremely specialized, and companies should consider outsourcing the tests if they do not have specialists in this area.

For a major incident investigation using a comprehensive root cause analysis system, teams will be formed to acquire information relevant to determine the structure and analyze the causes in depth. In addition to evaluations of the immediate causes, imderlying causes are likely to be evaluated by investigations in areas such as safety and quality management. Both paper- and computer-based systems will be used to acquire and record information for subsequent detailed analyses. 

The sponsor and investigator, as appropriate, must retain all essential documents relating to the trial for at least 5 years after its completion. Documents should be securely archived, with restricted access to maintain subject confidentiality. Collectively, these constitute the Trial Master File, and facilitate any audit and evaluation of... 

Second, the sensitivity of the flame structure and extinction limit to the description of the outer-flow field was examined. Comparison of the flame structure obtained from different boundary conditions at the extinction state suggested that the reported discrepancies in the computed extinction stretch rates were simply the consequences of how the velocity gradient was evaluated. Further investigation is required to identify an unambiguous parameter characterizing the counterflow-flame extinction limit. 

In the case of pharmaceutical quality control, and in many other spheres, methods which give an answer in a shorter hme are being investigated, evaluated and in some cases used. Some of these quicker or rapid methods will be referred to in this sechon. 

Synergy may be evaluated and displayed by preparing mixtures of the two compounds being investigated and determining their growth inhibitory power by means of an MIC determination (section 3.6.1). 

In this study we intend to investigate if a correlation between sensory evaluation and instrumental measurements of the low-methoxyl pectin jellies could be established. 

Evaluation and selection of field investigators and testing personnel... 

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