The fact that prescription drugs will ultimately alter the physical chemistry of people requires that a comprehensive system of product development be put in place. To meet this requirement, the actual production process doesn't begin until extensive research, and development and testing trials are completed. The hard work is done at the very onset where researchers must "discover" a new drug treatment for a current illness, or disease. After a series of laboratory trials, animal testing is done to verify the drug's effectiveness and safety. Clinical trials done on humans are then carried out to pinpoint specific drug effects. The next step requires a whole new series of testing which is carried out by the Food & Drug Administration. The entire process is lengthy and costly, where only 1 out of every 5,000 to 10,000 drugs actually make it out into the marketplace.
Research and Development
The process of developing a new prescription drug begins by creating a compound that is targeted for a specific use. As scientists work towards a better understanding of how the body works, new avenues for drug development arise. New discoveries provide a starting point for research and development specialists to better match a chemical's effects with the body's responses. New compounds are put through a screening process in which samples are observed within a culture preparation to see if the anticipated effects occur. Compounds are then administered on laboratory animals who display characteristics of the illness that the compound is meant to cure. If no therapeutic benefits are seen at this point, the screenings end. Otherwise, further testing will occur with human subjects using placebo, or healthy, group samples to determine baseline dosage levels and side effect risks. The final group of test subjects will be carefully selected according to health conditions which most resemble the target treatment range for the compound.
Once a drug passes the clinical testing trials, manufacturers then submit it for approval to the U.S. Food & Drug Administration -- Center for Drug Evaluation and Research. The drug is retested on human patients to evaluate its safety and effectiveness. Drugs which make it past this point, finally come to the production phase, where the actual manufacturing of the drug can begin. Careful consideration is made as to what production methods will be used, as well as the cost-effectiveness of the process. The overall goal is to be able to manufacture the drug on a mass production scale, in the most cost effective way possible. Tools used in the manufacturing process are typically automated, and designed to mill, pulverize and mix chemical compounds into specified dosage amounts, according to formula. Packaging tasks are also automated where the finished compound is put into capsule, tablet or liquid form.
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