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Pharmaceutical Project Management, 2nd edition (Drugs and by Anthony Kennedy

By Anthony Kennedy

Encompassing the entire spectrum of venture administration roles and tasks encountered in undefined, this moment variation outlines the major pursuits, dangers, and demanding situations of every degree of the pharmaceutical lifecycle, from discovery and preclinical stages via production and release. gathering professional suggestions and informative articles on decision-making, source allocation, method choice, and crew management, this moment version displays most sensible practices within the box and assembles ability units, concepts, and making plans rules that each pharmaceutical undertaking supervisor needs to collect.

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Example text

This work provides a basis for assessing the differential impact of intervention with a new drug. Therefore, this type of study should be conducted early in development so that its findings are available in time to influence the protocol design of the phase 3 pivotal trials. The phase 3 pivotal studies provide an important opportunity to collect important data that can help demonstrate cost effectiveness. The limited scale of such trials, the homogenous nature of patients studied, and the protocol limitations do not make such studies typical of subsequent product use.

Alternatively, depending on the development schedule of Staminex, it is possible that this study would be conducted during or after the approval of Staminex as a phase 3b or phase 4 study to support marketing objectives. The Integrated Development Plan The IDP brings together into one document the business case for investing in a project in the short and the long term. The IDP defines through the TPP the intended product planned to be introduced to the market and when it will be available for sale.

Generally, a riskadjusted return on investment analysis will be done. Inevitably, the precision of information at the early stage of development is more limited and the product is many years from market. The review process for early-phase projects can be sensibly adapted to avoid an unrealistic expectation of precision. DEVELOPMENT STRATEGIES TO OPTIMIZE A PRODUCT The remainder of this chapter will discuss development strategies in some key project areas. The fields selected are the ones that invariably have a major impact on the success or failure of the project.

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