Preclinical trials cost studies

A well planned simulation project increases the likelihood of providing meaningful and timely simulation results that will enhance the design and improve the efficiency, robustness, power, and informativeness of preclinical and clinical studies. An increase in the efficiency and power of clinical trials should reduce the number of studies and time needed to complete the drug development process with the resultant reduction in cost of pharmacotherapy to the consumer. 

Only after all these exhaustive tests are a few candidates selected for preclinical in vivo studies using animal disease models. The current approach is to perform as much as possible of the tests based on tissue cultures or cell-based assays, as they are less costly and provide results more readily. At the end of this long process is the availability of selected drug candidates with sufficient efficacy and safety required for human clinical trial. 

This section mainly addresses the purpose and technical aspects of preclinical studies which are described and recommended in the registration guidelines of the EEC, Japan and the USA. The following brief descriptions of commonly used test procedures cannot replace the detailed study of guidelines by those who conduct these trials. They are intended to give the less experienced an idea about the safety standards, which have to be fulfilled by a medicinal product and about the purpose and conduct of these tests. This enables scientists in research and development to judge essential parts of a project for themselves and to make better and informed decisions. It also assists in planning time and cost of a project. 

At this moment the attrition rate in clinical trials is far too high. If, better-quality candidates are developed in preclinical research, the likelihood that they will pass the clinical trials will be increased. The cost savings in such a, case will be enormous. A recent study has revealed that more than 40% of the candidates in clinical trials fail due to poor (bio)pharmaceutical properties and more than 20% due to toxicity. These reasons depend heavily on the chemistry of the candidate and probably could be identified in preclinical research. The rate-limiting aspect of drug discovery is not in finding the lead it is turning the... 

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