Critical paths identifying

A technique widely used by the industry is Critical Path Analysis (CPA or Network Analysis ) which is a method for systematically analysing the schedule of large projects, so that activities within a project can be phased logically, and dependencies identified. All activities are given a duration and the longest route through the network is known as the critical path. 

The process of updating the schedule is basically the same as that used in planning the shutdown. It is simply based on new information and deals only with the remaining portion of the shutdown. In some very large shutdowns, it may be desirable to perform time-cost trade-off analysis, resource leveling, etc., each time the shutdown CPM is updated. In many cases, however, the update will involve only the basic forward, backward and slack computations. These calculations will allow for development of a revised schedule. They will also identify the critical path that is likely to change over the course of the shutdown. 

The importance of identifying pivotal studies and studies on the critical path was discussed in a previous section, it is important that these studies are given the highest priority both in execution and reporting and that provision is made to identify early if there are problems recruiting patients so that appropriate remedial action can be taken. The studies of longest duration should be started first. 

The declining economic efficiency of drug development led the FDA to try to identify root causes and potential solutions to this problem in its Critical Path Initiative, in which pharmacogenomics was recognized as one of the technologies that will lead to iimova-tion in the pharmaceutical industry (6). This has been followed by several advisories to industry, such as an opportunity for safe-harbor voluntary submission of genomic data by sponsors (50) and a series of collaborative workshops (7). 

The submission project plan should identify the critical path of the application and the major milestones influencing the timeline. An index should be prepared identifying the critical sections and associated documents and the targeted availability of the documents for inclusion in the application. Systems should be in place for the controlled physical assembly of the application, including appropriate procedures for assembling the application and performing adequate quality control. Checklists are very helpful in ensuring that all necessary elements are included. 

If one wants to plan and control a larger project in a serious manner, project management software packages are essential and save a lot of time. These programs use entry data such as task descriptions, their duration, start or finish times, tasks dependencies and milestones to automatically sequence and schedule the project tasks. Conflicts and logic errors are identified and the project is re-scheduled after these have been corrected. A critical path analysis function reveals and... 

Once an attractive product has been identified, the time factor becomes extremely important, risk and cost are no longer the only relevant criteria. From now on speed and efficiency are of paramount importance. A minor planning error which results in a delay of a task on the critical path for only one month can delay the entire project by one month. Almost inevitably it also adds 1/12 of the annual budget to the development cost. Thus, in a project with an average annual budget of 2.5 million, a delay like this can cost more than 200,000. Apart from these direct cost, later access to the market can cause much higher losses. 

How many critical paths have been identified ... 

The critical path and floats must be clearly identified. 

PERT (Performance Evaluation Review, and Tracking) and CPM (Critical Path Method) charts (flowcharts) show the flow, connectivity, and interdependency of project tasks, activities, and goals. A PERT chart (Figure 27.9) depicts the activities in the order that they will need to be carried out, either in series or in parallel. These charts also identify which activities need to be completed (or initiated) before the next activity, which is dependent on it, can be initiated. 

CPM is the methodology used to identify the longest, or critical -path from project initiation to project completion. In Figure 27.9, the critical path is Path 3(A + B-bE-bG-b H), since this path is the... 

In 2004, FDA proposed the critical path initiative to develop a new product development toolkit (e.g., animal- or computer-based predictive models, biomarkers for safety and effectiveness, new clinical evaluation techniques, better manufacturing technologies) to improve the predictability and efficiency of the development process spanning laboratory concept to commercial product (http //www.fda.gov/oc/initiatives/ criticalpath). Three areas, where FDA s unique experience can facilitate improvement and streamlining, were identified ... 

The critical path is identified for two reasons. First, if unexpected issues or changes occur to a given task after the project begins, the impact, if any, on the overall project schedule can be determined quickly. Second, knowing the critical path enables the project manager and team to consider quickly where the schedule can be compressed to accommodate project imperatives and unexpected changes. 

Resource loading follows the critical path analysis. Resource loading specifies the resources that will be needed for each planning period (typically one week) on the project timeline. The benefit of resource loading is that it identifies conflicts in the schedule (i.e., resources assigned to different... 

The most useful markers for changes in renal function and renal toxicity without special manipulation are clinical chemistry markers, including the newly identified set of seven identified by the Critical Path Initiative [5]. These can identify specific impaired function or toxicity (Table 7.7). 

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