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fore much smaller doses are needed for effect and to essentially have the same degree of clearance from the body. While this is a general rule of thumb, it is something worth being looked at in the special population studies. There is also the aspect of pharmacodynamic action and this is so very important in the black population where some of the pathophysiology, such as in hypertension, may differ. For this reason, it seems appropriate to study ACE inhibitors, A-II blockers, and beta blockers in the black population as well as the white population. Often the exposure is there, but subset analysis has not been performed. This is, I believe, very important and it is especially incumbent upon the pharmaceutical industry to go back and review their data pool to see if the information that was so effective in the drug approval process can also aid physicians in knowing the utility of an agent in the subpopulations who might receive it. I think this is a responsibility of the pharmaceutical industry and one that should be vigorously upheld. |
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A drug development program must not be complacent while the NDA is being prepared and then reviewed. In some instances where a mortality study may be indicated, such as in heart failure, hemodynamic and exercise data may form the basis of the submission with the mortality study pending as the initial review process goes forward. As the study is completed, this type of information can be added to the NDA review or even after provisional drug approval is received. The concept of receiving approval of a drug pending the completion of a critical mortality trial has precedence in the field of heart failure and also lipid-lowering agents. Also, the planned post-marketing studies do not have to wait for approval, but can be initiated during the NDA preparation and review process. |
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The NDA preparation can be a target for streamlining and improvement. Clearly, the NDA needs to be structured in advance, the computer formats established, and as the data comes in, to be evaluated, refined, and then analyzed. The templates of summaries should already be in place, data fitted in, and obviously the information that is new and novel should be viewed and added to the data summaries. The NDA cannot take months to write after the data is collected, but needs to be put together in a short period of time to optimize the information-gathering techniques to shorten the submission process. |
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The FDA can go a long way in the facilitation of the review process. By utilizing disks provided by industry and by having systems compatible, the FDA reviewer can interact with the data and the company for a given section of the NDA. Queries can be immediately answered and facilitate the NDA application review. Clearly, as computer techniques become more sophisticated, we will be able to make use of the information-age advances by employing our computer systems to handle the vast data overload that is typical of an NDA application. It is also important that after the NDA is complete, most of its |
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