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XIV. Dose and Serum Concentration Measurements |
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XV. Methodologies and Drug Development |
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XVI. Integrating Technologies |
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XVII. Decisions in Development |
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XVIII. The Scientific Advancement of Knowledge |
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XIX. From Trial Results to Approval |
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XX. Conclusion |
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References |
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Change is part of the human condition, but often we fail to notice the pace of change. When change is rapid, even being part of the system does not obscure the results of the rapid change taking place. The drug development process is undergoing considerable change; one can even discern a major revolutionary process that is ongoing. Over the last 100 years, we have evolved through several stages of drug development, but perhaps all that has passed will pale in comparison to the dramatic information age before us that will markedly alter the environment in which we work and the drug development process. |
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To deny the forces of change is to make a fundamental error that will swamp even the most powerful and wealthiest of companies engaged in drug discovery and development. The evolution of the computer age gave IBM the opportunity to expand and alter its business from analog systems and adding machines to punch cards and then to complex computer systems. As the computer age developed, IBM led with the innovative personal computer although actually this innovation was copied from others. Recently, the lead has been lost by IBM because the language of the machine and the software has become the core of the information age, along with the chips that permit the exponential growth in machine computing performance. Thus, Microsoft, just a concept 20 years ago, is more dominant in today's information age than IBM. Remaining a leader in technology advances, IBM leads in new fundamental patents and has a strong marketing and sales force to market a robust product line. It kept up in technology, but its management failed to perceive the salient change in the information age from large computers to small, and then the importance |
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