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| | Steps in the Planning Process |
| | 1. | Defining the target | | 2. | List of necessary work packages (studies) | | 3. | Determine logical sequence and estimate durations | | 4. | Determine critical path | | 5. | Optimize plan to reduce critical path length | | 6. | Plan resources and adjust for resource constraints and priorities | | 7. | Adjust plan during execution to new data as required |
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Product Profile (sometimes also called Project Target Profile or similar). In any case, it is essential that the efficacy and safety parameters are defined as quantitatively as possible so that they can serve as design parameters for clinical studies. Of course, the minimum requirements must describe a product that has a good chance to be competitive when entering the market several years in the future. If these minimum requirements are not met in the study program, then, discontinuation of the project must be considered (see example of a Target Product Profile in Fig. 1). |
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Often a development candidate offers the opportunity for development in more than one therapeutic indication or in different formulations. These form different subprojects which require their own fully detailed target profiles. Before starting the planning process, it must be decided which subproject or subprojects should be developed initially and in parallel and which are taken as options for later additions or line extensions. A parallel development of all possible options, in most cases, would require too many resources and increase considerably the development time to first marketing approval. The selection of the target for the first development may be based on the chance for clinical success, on an expected shorter time to market, or on other valid reasons. Parallel development of two indications is made easier if they use the same formulation and, therefore, can use the same nonclinical and phase I program. On the other hand, the potential of consecutive or combination therapy by i.v. and oral routes may be important enough to justify its parallel development, e.g., with certain antibiotics. |
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If broad international registration and marketing are intended, it must also be investigated if identical targets are appropriate in all countries or regions. There are significant differences in medical practice, definition of indications, and acceptance of application routes by the patient in different |
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