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without stifling creativity and scientific flair so that there is a shared understanding of the future market and current research endeavors (internal and external) and how they influence each other. Features which must be considered include scientific strengths, the stage of development and robustness of the underlying science, the current level of research competition, and the degree of advance represented by the entity under review. |
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The aim of this assessment is to understand the chances that development(s) under review passes successfully through the development process and delivers a product which meets the desired profile. This assessment is normally undertaken by the experts in each of the disciplines involved based on their knowledge of the compound. Industry and company indexes of historic probability of success provide a starting point for the review but must be utilized with care: |
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Most of these historic indices refer to the chances of achieving a registration, not the chances of registering a compound with the desired profile in the markets required at the time required. |
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They are historic; newer approaches and technologies will have an impact on their applicability to current methods of drug development. Additionally, few of them yet incorporate the impact of health economic requirements. |
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Most are influenced by the traditional customer base of the industry rather than the newer customer groups which have emerged over the last few years. |
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Many are consolidations across different therapeutic areas or classes of drug; it must be recognized that there are major differences in the probability of success between, for example, chronic and acute therapies or antibiotics and antidepressants. |
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As the cost of development inexorably rises, it is vitally important to factor this into the assessment of the attractiveness of the opportunities available, but particular consideration must be given to the way the output will be used before determining the input information required. In most cases, data on both costs and resources will be required. |
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Resources are usually estimated in terms of people needed to undertake particular tasks. Questions which might be considered with these data are |
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