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and beyond to postmarketing support. This broad spectrum of responsibility places heavy demands on pharmacokinetics and metabolism expertise during the entire discovery and development process. |
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The intent of this chapter is to summarize the contributions that pharmacokinetics and metabolism make to drug discovery and development and to describe changes that are considered by this writer to be essential for these disciplines to continue to play a significant role in the total reengineering that must occur in pharmaceutical R & D in order for it to survive in an increasingly demanding and challenging environment. |
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II. Interdisciplinary Interactions |
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Pharmacokinetics and drug metabolism are among the most highly interactive disciplines in pharmaceutical R & D. This has both benefits and liabilities associated with it. Benefits include the ability of pharmacokinetics and metabolism scientists to contribute to a broad spectrum of research activities, ranging from initial discovery to final Phase 3 clinical studies, and beyond to marketing support. The major liability is that pharmacokinetics and metabolism activities are invariably dictated by events and decisions occurring in other disciplines. This is inevitable, can often be extremely frustrating, but provides a background for the many examples of procedures that need to be changed in the discovery and development process. |
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The essence of change, as applied to pharmacokinetics and metabolism interactions, must be associated with greater involvement of pharmacokinetics and metabolism scientists in preclinical and clinical strategic plans, together with judicious prospective planning and study design. This argument, while most relevant in this writer's mind to the areas of pharmacokinetics and metabolism, applies across all disciplines involved in the R & D process and necessitates discarding old concepts this is the way we do things. and replacing them with a faster, leaner, and more efficient and economically viable approach. This has to be achieved in the paradoxical environment of rapidly increasing demands and costs on the one hand and rigorous cost containment and overall reductions in health care costs on the other. |
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III. The Dynamics of Change |
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The main problem when addressing change is that in most cases, by the time the elements of change in a particular environment have been identified and characterized, the change has most likely already occurred. Thus, in most cases, time is spent catching up with change rather than anticipating it. In order to be able to truly anticipate changes, such as the type of changes that are currently |
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