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standardized path and therefore, may be planned and started before a complete project plan has been finalized. The main tasks of the preclinical program are shown in Table 4. The early development will be designed after careful review of the preclinical research data. Furthermore, the intended therapeutic use is taken into account for finalizing the toxicological study plan with regard to choice of species and treatment duration. |
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The first outline of the project plan will usually be a list of nonclinical and clinical studies with their estimated durations and logical dependencies (see example in Table 5). A simple graphical representation of these data will show which sequence of activities determines the critical path of the project and its minimum total duration (Fig. 3). Then, milestones and decision points are added on the time axis. A standard plan is a very useful tool for the project manager to check for the completeness of this first plan and to obtain initial time estimates. However, these must be confirmed later or adjusted depending on resource availability and agreement with the group carrying out the task. |
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It is advantageous to complement the list and time schedule with a narrative describing the assumptions and rationale underlying the plan. In particular, this should refer to the guidelines and regulations considered. The narrative should also point out which plan details are considered preliminary and need further information for finalizing. It may also be useful to document the reasons for major deviations from the standard plan. |
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The first plan may result in an unacceptably long total development time. Probably, possibilities of parallel work and overlap have not yet been carefully investigated. In other parts, it may also be too optimistic because some prerequisites were overlooked or do not agree with current regulations. |
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Consequently, plan optimization above all, should address the completeness of the plan and shortening of the critical path. Effective plan optimization is greatly facilitated by an experienced project manager. He must ask the right questions and insist on a thorough evaluation of the optimization potential. Although safety and ethical reasons prescribe a consecutive and stepwise performance of preclinical and clinical studies, considerable flexibility for optimization exists. Much of the potential for time reduction is in the evaluation phase of studies. However, it is often not necessary to evaluate all data before the decision to start the next study. The following are examples of typical questions to be addressed in plan optimization: |
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