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The success, efficiency, and wisdom exhibited in bringing new drug therapy to treat unmet therapeutic needs of patients is the direct result of the vision, leadership, and skill of many types of people Among them is the clinical pharmacologist. Clinical pharmacologists contribute to the development of life-saving or pain-alleviating therapies in multiple ways: |
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assisting discovery scientists in focusing on therapeutic targets and selecting screens or surrogates that are likely to predict the desired activity in humans. |
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designing the early clinical development program to determine both pharmacodynamic (safety and efficacy surrogates) and pharmacokinetic milestones. |
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collaborating with preclinical development scientists to both screen and test new chemical entities (NCEs) in preparation for human testing. |
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designing, conducting, and analyzing studies leading to dosage regimen recommendations throughout development. |
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The actual work and leadership in each of these areas is collaborative with a wide variety of other disciplines. Indeed, no activity is the universal domain of the clinical pharmacologist. The core skills needed are usually not embodied in one person. |
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The quality of this work has a direct impact on achieving the desired effect for the patient, the clinician's confidence in the reliability of the drug and its supporting information, and the investor's confidence in the future value of the company. |
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Clinical pharmacology is currently practiced across the industry in a heterogeneous manner that makes it difficult to find the clinical pharmacologist who has expertise in all the above areas. Large companies tend to have larger clinical pharmacology departments that focus on both science and process. Smaller, one-drug companies may have no clinical pharmacologist and may never consider the value of interspecies scaling for estimating the first human dose, physiologic models to predict human absorption, preclinical-to-clinical links in surrogate dynamic markers, or high-intensity clinical pharmacokinetic/ dynamic (PK/PD) studies to estimate dosage regimens. Indeed, little time may be spent in Phases I and II before moving to the pivotal clinical trials. |
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The perspective taken in this discourse is that of the large company challenged with simultaneously investigating a hundred discovery targets and developing a similar number of drugs, new indications, and dosage forms while maintaining a large marketed product portfolio. In this environment both science and process become critical to finding, developing, and supporting drug therapies. An assumption made is that while drugs can be developed without |
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