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way. It is sufficient to plan the work for the next phase or to the next major decision point in full detail by defining each work package, its duration, prerequisites, and resource requirements, and the departments/persons responsible for its execution. For the following phases, and estimate of total time required should be made based on a listing of major, necessary studies, their sequence, and standard durations. |
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In addition to a company's standard decision points, additional decision points should be defined for recognized or probable critical issues so as not to waste resources on projects with limited chance of success. The project plan should aim to obtain the data for such decisions as early as possible even if the overall critical path analysis allows for investigations later. Examples are |
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potential for toxicity highlighted from chemical structure (e.g., phototoxicity or cancerogenicity), |
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feasibility of achieving the defined, unique, selling propositions, |
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feasibility of a commercially acceptable cost of goods, |
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feasibility of sufficient bioavailability for oral application, |
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feasibility of once daily application if required for marketing reasons, and |
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feasibility of a sufficiently stable formulation. |
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Some of these or other decision points may lead to a clear go/on go decision. Minimum performance requirements must be defined in advance. In other cases, several alternative courses of action may be possible depending on the outcome. Alternative scenario-type plans must be prepared to allow estimating the impact on total project time, commercial value, and resource requirements. |
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E.
The Management of the Planning Process |
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Pharmaceutical development involves many disciplines and functions. Planning, therefore, is best done as a team effort with representatives from all the functions led by an experienced, independent, project manager. The functional representative's task is to define the methods, protocols, and study outlines required for the necessary proofs of efficacy, safety, and technical feasibility. Responsibility for making schedule commitments for the work packages and ensuring availability of needed resources is also part of the function. The project manager's task is to focus on the project target, overall time lines, and efficient use of resources so that nothing is overlooked and that the contributions of the different disciplines follow each |
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