It has been estimated that there are 1 000 000 or more proteins encoded by 20 000 – 25 000 genes in the human genome. Most drugs act by inhibiting a protein in the system and thus the number of potential compounds for therapy is virtually infinite. According to a report by the Tufts Center for the Study of Drug Development, the cost of developing a new drug and bringing it to the market is $802 million over 10 - 15 years. The steps involved in bringing a drug to market include discovery, development, testing and launch. Because it takes more than a decade to bring a drug to the market it is pivotal that the success rate of clinical trials be the priority. Over the past few years there has been an increase in the number of productive discovery programs and better pre-clinical screening methods, which can boost the success rate from 1 in 5 to 1 in 3. The improvement in success rate not only increases the success rates of clinical testing but also significantly reduces total capital cost by $221 – 242 million (~30%) per drug. It is because of these costly factors that the pharmaceutical industry is continually searching for ways to more efficiently eliminate or identify candidate molecules earlier in the development process.
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Toxicity Testing and the CFC Assay
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